KEPERAWATAN MEDIKAL

ANALISIS JURNAL MAHILA: A PROTOCOL FOR EVALUATING A

NURSE-DELIVERED MHEALTH INTERVENTION FOR
WOMEN WITH HIV AND PSYCHOSOCIAL
RISK FACTORS IN INDIA

Oleh
Kelompok 3

Yunizar firda alfianti NIM 142310101013

Faizah Wahyuningprianti NIM 142310101025
Rize kumala Putri pratiwi NIM 142310101043
Berrylianti Ariesta Eldoris NIM 142310101076
Della Annisa W.P. NIM 142310101098

PROGRAM STUDI ILMU KEPERAWATAN

UNIVERSITAS JEMBER
2016

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 DAFTAR ISI

HALAMAN JUDUL ...................................................................................... i

DAFTAR ISI................................................................................................... ii
KATA PENGANTAR.................................................................................... iii
BAB 1. PENDAHULUAN ............................................................................. 1
1.1 Latar Belakang ......................................................................................... 1
BAB 2.ANALISIS PICO................................................................................ 3
2.1 PICO Frame Work .................................................................................. 3
2.2 Tinjauan Pustaka ..................................................................................... 7
2.3 Prosedur Penatalaksanaan Intervensi ................................................... 13
BAB 3. PEMBAHASAN ................................................................................ 14
BAB 4. PENUTUP.......................................................................................... 19
4.1 Kesimpulan ............................................................................................... 19
4.2 Saran ......................................................................................................... 19
DAFTAR PUSTAKA ..................................................................................... 20

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 KATA PENGANTAR

Puji syukur ke hadirat Allah Swt. atas segala rahmat dan hidayah-Nya
sehingga penulis dapat menyelesaikan analisa jurnal yang berjudul MAHILA : A
Protocol For Evaluating A Nurse-Delivered m-Health Intervention For Women
With HIV And Psychososcial Risk Factors In India dengan baik dan tepat pada
waktunya. Makalah analisa jurnal ini disusun untuk memenuhi tugas mata kuliah
Keperawatan Medikal.
Penyusunan makalah analisa jurnal ini tidak lepas dari bantuan berbagai pihak.
Oleh karena itu, penulis menyampaikan terima kasih kepada:
1. Ns. Jon Hafan Sutawardana.,M.Kep.,Sp.Kep.MB selaku PJMK mata
kuliah Keperawatan Medikal,
2. Ns. Mulia Hakan.,M.Kep.,Sp.Kep.MB selaku dosen pembimbing
kelompok kami (Kelompok 3 kelas C angkatan 2014),
3. teman-teman yang telah membantu;
Penulis juga menerima segala kritik dan saran dari semua pihak demi
kesempurnaan makalah ini. Penulis berharap semoga makalah ini dapat
bermanfaat dan menambah pengetahuan pembaca.

Jember, November 2016

Penulis

iii
 BAB 1. PENDAHULUAN

1.1 Latar Belakang

HIV menjadi salah satu masalah nasional maupun internasional. Hal ini
dikarenakan HIV meluas dengan cepat dan menjadi epidemi di seluruh dunia.
Penyakit infeksi HIV sejak kemunculannya hingga kini terus menyebabkan
berbagai permasalahan kesehatan. Permasalahan kesehatan yang dimaksud adalah
masih tingginya transmisi infeksi, angka kesakitan, serta angka kematian akibat
HIV.
Seperti yang kita ketahui bersama, HIV/AIDS adalah suatu penyakit
autoimun yang menyerang sistem pertahanan tubuh penderita yang belum ada
obatnya dan belum ada vaksin yang bisa mencegah serangan virus HIV, sehingga
penyakit ini merupakan salah satu penyakit yang sangat berbahaya bagi kehidupan
manusia baik sekarang maupun waktu yang datang. Selain itu HIV juga dapat
menimbulkan penderitaan, baik dari segi fisik maupun dari segi psikologis.
Di India Sekitar 2,9 juta penduduk adalah Orang Dengan HIV AIDS
(ODHA). Jumlah tertinggi pasien terkena HIV karena darah terkontaminasi di
rumah sakit, berasal dari negara bagian Uttar Pradesh (di bagian utara India)
dengan 361 kasus, demikian hasil penyelidikan yang dilakukan Kothari. Negara
bagian di barat, Gujarat, 292 kasus dan Maharashtra dengan 276 kejadian di
urutan kedua dan ketiga. Begitu juga di ibu kota India, Delhi, di urutan keempat
dengan 264 kasus. Penderita HIV rentan terhadap berbagai masalah psikososial
yang membatasi akses dan kepatuhan terhadap pengobatan. Stres psikososial-
spiritual pasien yang terinfeksi HIV akan mempercepat kejadian AIDS dan
bahkan meningkatkan angka kematian.
Perawat merupakan faktor yang mempunyai peran penting khususnya
dalam memfasilitasi dan mengarahkan koping pasien yang konstruktif agar pasien
dapat beradaptasi dengan sakitnya dan pemberian dukungan sosial, berupa
dukungan emosional, informasi, dan material. Salah satu metoda yang digunakan
dalam penerapan teknologi ini adalah menerapkan model asuhan keperawatan
dengan intervensi mobile health digunakan sebagai pendekatan konseling dalam
peningkatan kesehatan berbasis media komunikasi handphone, baca tulis (literasi)

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pesan singkat, serta upaya peningkatan perilaku kepatuhan dalam pengobatan
ODHA menggunakan antiretrovial (ARV) yang selanjutnya dalam jurnal disebut
sebagai MAHILA .

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 BAB 2. ANALISIS PICO
2.1 PICO Frame Work
Analisis jurnal dari jurnal utama berjudul MAHILA : A Protocol
For Evaluating A Nurse-Delivered m-Health Intervention For Women With HIV
And Psychososcial Risk Factors In India berdasarkan analisa jurnal
menggunakan PICO sebagai berikut :
a. Patient and Clinical Problem (P)
Saat ini mulai ada perbaikan pada sistem terapi antiretroviral (ART) bagi
pasien HIV. Pada tahun 2014, 14,9 juta orang yang hidup dengan Human
ImmunodeficiencyVirus (HIV) telah menerima terapi ART secara global, 13,5
juta diantaranya adalah penduduk yang tinggal di negara berpenghasilan rendah
dan menengah (LMICs). Namun, ketika terapi ART telah berkembang secara
signifikan dan menyebabkan progniosis orang yang hidup dengan HIV, terjadi
defisit dalam kepatuhan menjalankan perawatan HIV yang menimbulkan
hambatan signifikan untuk keberhasilan jangka panjang. ART yang efektif
membutuhkan kepatuhan optimal untuk mempertahankan pemusnahan reprilakasi
virus. Akan tetapi, dengan adanya ketidakpatuhan terhadap terapi dapat
mengakibatkan kegagalan dalam pengobatan, penyakit semakin berkembang, dan
munculnya resistensi terhadap obat.
Meskipun di India telah terjadi penurnan sebanyak 19 % pada kasus
infeksi HIV baru, namun negara ini menduduki temapat tertinggi ketiga taksiran
orang yang hidup dengan HIV di dunia dan 39% diantaranya adalah perempuan.
Jumlah ini sekitar 0,82 juta penduduk dari total keseluruhan penduduk di India.
Banyak bukti menunjukkan bahwa perempuan di India rentan untuk pencegahan
dan pengobaan HIV. Perempuan di India menghadapi hambatan situasional dan
psikososial yang membatasi akses mereka untuk melakukan perawatan dan patuh
melakukan terapi ART dari waktu ke waktu. Hambatan tersebut diantaranya, buta
huruf, stigma, diskriminasi dan dukungan sosial yang rendah. Depresi adalah
suatu faktor yang paling menonjol dari ketidakpatuhan perempuan di India dalam
melakukan terapi ART.
Kepatuhan yang baik sangat penting dalam pencegahan HIV dan
keberhasilan pengobatan, untuk itu diperlukan sedikit perhatian kepada

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pengembangan intervensi yang difokuskan pada perempuan yang hidup dengan
HIV dan depresi atau resiko psikososial lainnya. Untuk itu dibutuhkan intervensi
yang dapat meningkatkan kepatuhan dan mengurangi hambatan terapi ART yang
sangat dibutuhkan terutama bagi perempuan.
b. Intervention (I)
Tujuan dari penelitian ini adalah untuk mengevaluasi kelayakan,
penerimaan ,dan keberhasilan awal dari intervensi mobile health atau layanan
telepon untuk mengurangi hambatan dan mendukung pengobatan serta kepatuhan
terapi ART. M-health atau mobile health merupakan suatu program yang
memakai teknologi informasi dan komunikasi (information and communication
technology/ ICT) misalnya saja komputer, telepon seluler, dan komunikasi satelit
yang digunakan untuk layanan dan informasi kesehatan.Terapi ART ditambah
dengan ntervensi m-health terbukti dapat lebih efektif dibandingakan jika hanya
melakukan terapi ART saja. Intervensi dengan menggunakan ponsel sangat efektif
digunakan di India mengingat meluasnya teknologi posel saat ini. Ponsel berbasis
pendekatan peningkatan kesehatan,literasi dan kepatuhan trial (Mahila) digunakan
untuk menilai kelayakan dan penerimaan. Mobile health disampaikan pada
perawat untuk meningkatkan perawatan diri dan kepatuhan pengobatan di antara
perempuan yang terinfeksi HIV di India. Intervensi ini berpusat pada pasien dan
digunakan untuk penyedia hubungan pasien dan perawat, menetapkan sumber
dukungan, dan memungkinkan dan memberdayakan pemecahan masalah terhadap
hambatan situasional dan psikososial untuk merawat. Intervensi kepatuhan
menggunakan mobile health (M-Health) juga mengandalkan pesan berbasis teks
pengingat. Selanjutnya pesan-pesan ini berfungsi terutama sebagai pengingat
obat-obatan apa saja yang digunakan dan mengatasi faktor psikososial yang
menghambat.
Intervensi inidilakukan pada 120 perempuan terinfeksi HIV secara acak,
dan dibagi menjadi dua kelompok.Kelompok kontrol kelompok yang hanya
menggunakan terapi ART dan kelompok eksperimen yang menggunakan terapi
ART dan MAHILA m-health).Intervensi mobile health dapat menangangani
hambatan yang menonjol (misalnya, gejala depresi), meningkatkan pengetahuan,
dukungan, dan pemecahan masalah yang lebih baik dalam perawatan dan

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kepatuhan. Dalam pengaplikasiannya, intervensi ini dilakukan oleh perawat non
spesialis yang sudah dilatih sebagai bagian dari penelitian ini pada aspek klinis
dan psikososial dari HIV/AIDS, dasar-dasar skrining kesehatan mental, konseling
berbasis telepon dan intervensi perawatan diri di empat lokakarya berbeda.
Peserta yang menjadi sampel harus memenuhi syarat diantaranya :
1. Mampu memberikan informasi persetujuan
2. Mampu dan mau diubungi melalui ponsel
3. Berusia 18 tahun atau lebih tua
4. Berbicara Kanada, Inggris, atau Hindi
5. HIV + dan menjalani ART kurang dari enam bulan
6. Skrining positif terhadap gejala depresi atau faktor resiko psikososial.
Perempuan-perempuan tersebut diskrining untuk depresi melalui Pusat
Studi Epidemiologi Depresi Scale (CES-D) dan untuk faktor psikososial
menggunakan Kerentanan Psikososial Checklist (PSVC).
c. Comparator (C)
Jurnal utama yang berjudul MAHILA : A Protocol For Evaluating A
Nurse-Delivered m-Health Intervention For Women With HIV And Psychososcial
Risk Factors In India menjelaskan bahwa pengobatan ARV yang ditambah
dengan intervensi MAHILA ini akan lebih efektif dibandingkan dengan hanya
pengobatan ARV untuk meningkatkan kepatuhan penderita HIV dalam terapi
ARV. M-health (MAHILA) ini dapat diterima dengan baik oleh para perempuan
penderita HIV di India. Selain dapat meningkatkan kepatuhan pada terapi ARV,
intervensi tersebut juga dapat mengurangi masalah psikososial misalnya saja
gejala depresi. Dengan intervensi tersebut, para perawat dapat melakukan
tindakan pemantauan yang ketat terhadap penderita HIV tersebut, sehingga
kepatuhan dalam pengobatan dapat terkontrol. Penelitian tersebut juga
memberikan suatu kontribusi bagaimana intervensi mobile health dapat
memotivasi kesehatan dan perawatan diri pada perempuan dengan HIV. Selain
itu, penelitian tersebut juga akan membantu petugas kesehatan dalam
mengidentifikasi risiko bahwa kemungkinan besar perempuan HIV menghadapi
masalah psikososial seperti putus asa dengan penyakitnya dan kekerasan
pasangan. Hal ini tidak jauh berbeda dengan jurnal A Counselor In Your Pocket:

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Feasibility Of Mobile health Tailored Messages To Support HIV Medication
Adherence yang menjelaskan bahwa keluhan yang paling umum dari klien
selama masa perawatan orang dengan HIV/AIDS (ODHA) dan pengobatan ARV
adalah kebosanan. Maka pada jurnal tersebut dibentuk tim konselor sebagai
petugas kesehatan yang melakukan intervensi konseling dalam bentuk pesan
singkat (SMS) yang ditujukan kepada ODHA agar menerapkan perilaku
kepatuhan selama menjalani terapi ARV. Intervensi m-health ini juga
membutuhkan dukungan dari keluarga klien agar klien patuh dan ada yang
memberikan motivasi dalam menjalani terapi ARV tanpa merasa bosan yang
berkepanjangan.
Selain itu, intervensi ini juga dapat diterapkan pada wanita yang hamil dan
sedang mengandung anak untuk menjalani terapi ARV sebagai upaya prevensi
agar anak yang dilahirkan normal dan sehat. Pada jurnal The Effect Of An
Interactive Weekly Mobile Phone Messaging On Retention In Prevention Of
Mother To Child Transmission (PMTCT) Of HIV Program: Study Protocol For A
Randomized Controlled Trial (WELTEL PMTCT) dijelaskan pula bahwa pasangan
suami adalah sebagai media utama motivator klien ODHA yang hamil agar patuh
dalam pengobatan. Dengan memanfaatkan ponsel yang dapat terhubung dengan
petugas kesehatan dapat melindungi kerahasiaan serta sebagai pengingat sekaligus
sumber informasi jika terjadi permasalahan selama menjalani terapi ARV
tersebut. Jadi istri, suami, dan petugas kesehatan sebagai konselor dapat terhubung
dalam satu jaringan komunikasi.
d. Outcome
Hasil dari penelitian ini menjelaskan bahwa intervensi berbasis mobile
health dapat memotivasi pengobatan dan perawatan perempuan yang terinfeksi
HIV lebih baik lagi. Intervensi ini disampaikan oleh perawat non-spesialis yang
dapat meningkatkan akses keperawatan dan mendukung kepatuhan dan hasil
klinis perempuan dengan infeksi HIV yang tinggal di negara berpenghasilan
rendah dan menengah seperti India. Terapi ART disertai intervensi mobile health
juga terbukti lebih efektif dalam proses penyembuhan dibandingkan dengan hanya
melakukan terapi ART. Perawatan diri diantara perempuan yang terinfeksi HIV
dan memiliki depresi dan gangguan psikososial lainnya akan memberikan bukti

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penting bagi kegunaan, kelayakan, dan penerimaan intervensi ini. Hasil percobaan
ini akan sangat penting dalam menginformasikan intervensi m-Health di masa
depan untuk populasi ini dan untuk wanita dengan penyakit kronis lainnya.
2.2 Tinjauan Pustaka Penyakit
2.2.1 Definisi
HIV (Human Immunodeficiency Virus) adalah salah satu virus
yang menyerang kekebalan tubuh pada manusia dan sebagai akibatnya dapat
terjadi AIDS (Acquired Immune Deficiency Sindrome). Dalam tubuh manusia,
HIV menyerang salah satu jenis dari sel-sel darah putih yang berfungsi untuk
menangkal dan melindungi tubuh dari infeksi. CD4 dalam tubuh manusia akan
semakin berkurang dan menunjukkan bahwa limfosit juga berkurang. Nilai CD4
normal dalam tubuh manusia adalah 1400-1500, sedangkan pada orang yang
terinfeksi HIV yang system kekebalan tubuhnya terganggu, nilai CD4 semakin
lama akan semakin menurun. Bahkan beberapa kasus dijumpai nilai CD4
menunjukkan angka nol (KPA, 2007).
HIV adalah virus yang menjadi parasite dan merusak system imun
tubuh. Sedangkan AIDS adalah sekumpulan gejala penyakit yang disebabkan oleh
HIV itu sendiri (Brunner&Suddart, ed.8)
HIV adalah jenis parasit obligat yang hanya dapat hidup dalams el
yang hidup. Seseorang yang mengalami HIV dan tanpa melakukan pengobatan
maka semakin lama akan mengalami kondisi yang disebut dengan AIDS.
Umumnya, AIDS ditandai dengan adanya berbagai infeksi yang dikenal dengan
keadaan oportunistik (Zein, 2006)
2.2.2 Klasifikasi
Klasifikasi HIV menurut CDC pada remaja> 13 tahun berdasarkan
dua system, yakni dengan melihat supresi kekebalan tubuh yang dialami oleh
pasien serta dengan stadium klinis. Jumlah supresi kekebalan tubuh dapat
ditunjukkan dengan lofosit CD4. Tiga kisaran CD4 dan tiga kategorik lini untuk
HIV yakni:
1. Kategori 1 : 500 sel/
2. Kategori 2 : 200-499 sel/
3. Kategori 3 : < 200 sel/

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Tabel 2.2 Klasifikasi Klinis dan CD4 Pasien Remaja dan Orang Dewasa menurut
CDC
CD4 KategoriKlinis
Total % A B C (AIDS)
(Asimptomatik, (Simtomatik)
Infeksi Akut)
500 sel/ 29% A1 B1 C1
200-499 sel/ 14-28% A2 B2 C2
< 200 sel/ < 14% A3 B3 C3
Sumber: Depkes 2003
1. Kategori Klinis A
Meliputi infeksi HIV yang asimptomatik (tanpa gejala), limfatik generalisata yang
menetap, daninfeksi HIV akut primer dengan adanya riwayat infeksi HIV akut
atau dengan berbagai riwayat penyerta.
2. Kategori Klinis B
Terdiri atas kondisi simptomatik (disertai gejala) pada remaja dan orang dewasa
yang terinfeksi HIV dan tidak termasuk dalam kategori C dan memenuhi minimal
satu kriteria dari beberapa kriteria berikut:
a. Keadaan yang dihubungkan dengan infeksi HIV atau adanya kerusakan
kekebalan tubuh dengan perantara sel (cell mediated immunity)
b. Kondisi yang dianggap sudah memerlukan penanganan klinis atau
membutuhkan penataksanaan komplikasi HIV, contoh:
1. Angiomatosis basilaris
2. Kandidiasis orofaringeal
3. Kandidiasis vulvovaginal
4. Dysplasia leher Rahim
5. Demam 38.5o
6. Diare lebih dari satu bulan berturut-turut
7. Oral bairy leukoplakia
8. Herpes zoster
9. Purpura idiopatik trombositopenik
10. Listeriosis, dll

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3. Kategori Klinis C
Meliputi gejala yang ditemukan pada pasien dengan HIV. Pada tahapanini, pasien
yang terinfeksi HIV menunjukkan perkembangan infeksi dan keganasan yang
mengancam hidupnya seperti:
1. Kandidiasis bronki, trakea, paru
2. Kandidiasis esophagus
3. Kankerserviks
4. Retinitis virus sitomegalo
5. Ensevalopati yang berhubungan dengan HIV
6. Herpes simples, ulkus lama
7. Bronchitis, esophagitis atau pneumonia
8. Sarcoma Kaposi
9. Limfomaburkit
10. Mikobakterium jenis lain yang menyebar di paru, dll
2.2.3 Etiologi
Penyebab HIV adalah golongan retro virus yang disebut Human
Immunodeficiency Virus. Transmisi infeksi HIV dan AIDS terdapat lima fase,
yakni:
1. Periode jendela
Periode ini berlangsung selama empat minggu sampai enam bulan setelah
infeksi. Belum tampak gejala apapun pada pasien
2. Fase infeksi HIV primer akut
Pada fase ini, setelah munculnya gejala flu likes illness selama 1-2
minggu.
3. Infeksi asimptomatik
Fase ini berlangsung selama 1-15 minggu atau lebih tanpa adanya gejala.
4. Supresi imun simtomatik
Fase ini setelah lebih dari tiga tahun dengan gejala demam,
keringat malam hari, BB menurun, diare, neuropati, lemah, rash,
lesi mulut.
5. AIDS

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 Fase ini setelah 1-5 tahun dari kondisi AIDS yang pertama
ditegakkan. Infeksi oportunis berat dan ditemukan tumor pada
berbagai system tubuh.
Terdapat beberapa kelompok resiko tinggi yakni:
1. Lelaki homoseksual atau biseks.
2. Orang dengan obat-obatan melalui IV.
3. Melakukan seks dengan penderita HIV/AIDS
4. Penerima darah atau tranfusi dari penderita HIV/AIDS.
5. Bayi dari ibu atau ayah yang terinfeksi.
2.2.4 Manifestasi Klinis
WHO mengembangkan HIV hanya berdasarkan penyakit klinis dengan
mengelompokkan tanda gejala mayor dan minor. Seseorang yang memiliki 2
gejala mayor serta 2 gejala minor bias didiagnosis HIV tanpa melakukan
pemeriksaan lab atau dengan tes ELISA. Beberapa Negara memodifikasi criteria
menjadi 2 gejala mayor dan 3 gejala minor dengan factor resiko paparan HIV.
Berikut ini adalah pengelompokan tanda gejala:
A. Gejala mayor
1. Mengalami penurunan berat badan
2. Diare kronis
3. Demam berkepanjangan tanpa sebab
4. Tuberculosis
B. Gejala minor
1. Limfadenopati generalisata
2. Kandidiasis oral
3. Batukmenetap
4. Distress pernafasan (pneumonia)
5. Infeksiberulang
6. Infeksi kulit generalisata

2.2.5 Penatalaksanaan
A. Medis
1. Pengendalian oportunistik

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Bertujuan menghilangkan serta mengendalikan infeksi oportunistik dan sebagai
pemilihan dan anti sepsis. Tindakan yang aman untuk mencegah kontaminasi
bakteri dan komplikasi penyebab sepsis harus ditingkatkan dan dipertahankan
bagi pasien di perawatan kritis.
2. Terapi AZT (Azidotimidin)
FDA menyetujui penggunaan obat antiviral AXT yang efektif untuk penderita
AIDS. Obat ini menghambat replikasi antiviral HIV dan menghambat enzim
pembalik traskriptase. Obat ini sekarang tersedia dengan jumlah sel T4 >3 untuk
AIDS dansel T4 > 500 mm3 untuk pasien HIV positif asimptomatik.
3. Terapi antiviral baru
Beberapa dari obat antiviral yang baru bekerja dengan meningkatkan imun serta
menghambat replica dari virus serta memutus rantai reproduksi virus pada
prosesnya. Beberapa obat antiviral baru adalah :
a. Didanosine
b. Ribavirin
c. Diedoxycytidine
d. Recombinan SD4 dapat larut
4. Vaksin dan rekonstruksi virus
Upaya rekonstruksi vaksin dan imun dengan agen interveron. Perawat tim khusus
harus menggunakan keahlian penelitian serta keperawatannya untuk menunjang
pengobatan ini.
B. Non Medis
Diet
Menurut UGI, 2012 ada beberapa penatalakasanaan untuk penderita HIV/AIDS
salah satunya dengan diet. Tujuannya adalah untuk memberikan intervensi gizi
serta memenuhi kebutuhan energy dan semua zat gizi untuk pasien HIV/AIDS.
Diet AIDS ini diberikan hanya kepada pasien dengan:
a. Infeksi HIV asimptomatik
b. Infeksi HIV simptomatik
c. Infeksi HIV dengan gangguan syaraf
d. Infeksi HIV dengan TBC
e. Infeksi HIV dengan kanker dan HIV Wasting Syndrome

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Ada tiga macam diet AIDS yakni:
1. Diet AIDS 1
Makanan yang diberikan berupa cairan dan bubur susu setiap hari setiap 3 jam
dengan porsi kecil (sesuai kebutuhan pasien). Makanan lainnya yaitu makanan
sonde dengan menggunakan makanan enteral komersial energy dan protein tinggi.
Makanan ini cukup energy, zat besi, danvit.C
2. Diet AIDS 2
Diet ini diberikan sebagai perpindahan dari Diet AIDS 1 setelah tahap akut
teratasi. Makanan yang diberikan berupa makanan saring atau cincang setiap 3
jam sekali. Makanan ini nilai gizinya rendah dan juga membosankan. Untuk
mengimbanginya, diberikan makanan sonde.
3. Diet AIDS 3
Diet ini diberikan sebagai perpindahan dari Diet AIDS 2 atau pada pasien dengan
HIV asimptomatik. Bentuk makanan seperti biasa namun sedikit lunak. Diet ini
tinggi energy, protein, mineral dan vitamin. Bila masih menunjukkan penurunan
berat badan, maka dianjurkan makanan pendamping sonde.
2.3 Prosedur Penatalaksanaan Intervensi
Mobile health adalah sebuah inovasi baru dengan memanfaatkan
kemajuan teknologi. Tindakan ini diharapkan dapat mempengaruhi seluruh
lapisan masyarakat. Tujuan tindakan ini adalah untuk membantu mempermudah
masyarakat dalam mengecek dan mengetahui bagaimana kondisi tubuh dan
kesehatan mereka. Prosedur menggunaan m-health dalam masyarakat adalah
dengan salahsatunya melakukan kampanye kesehatan missal mengiriman pesan
singkat atau SMS yang berisi mengenai berbagai informasi tentang kesehatan,
salah satunya tentang bahaya HIV/AIDS. Mobile health ini juga bisa diakses
melalui telepon seperti dalam jurnal. Setiap pasien tentu saja dapat mengakses
layanan M-Health dalam jurnal adalah dengan memberikan peserta ponsel yang
hanyak bisa untuk menghubungi nomor penelitian dan dihubungi oleh nomor
yang disesuaikan. Peserta penelitian harus bersedia ditelfon setidaknya dua kali
dalam seminggu untuk empat minggu pertama, sekali seminggu untuk minggu
kelima sampai minggu ke 10 sampai dengan masa penelitian.selama melakukan
prosedur ini, perawat melakukan pendekatan pada pasien untuk melakukan

12
perawatan diri secara produktif. Pada penelitian ini dijelaskan bahwa panggilan
yang dilakuakn oleh perawat setidaknya dua kali seminggu selama 1-4 minggu.
Klien dapat berunding dengan perawat tentang hal-hal yang berhubungan dengan
kesehatan pada setiap panggilan yang dilakukan.Intervensi ini juga mendorong
untuk mengatasi perilaku perawatan diri (misalnya, kepatuhan terhadap
pengobatan). Selain itu, m-health dapat menyediakan sarana koordinasi layanan,
kotinuitas perawatan, dan pemantauan pasien. Tujuan secara umum adalah untuk
memastikan bahwa pasien yang menjalani yterapi ART mendapat dukungan dan
informasi akurat, pengetahuan, dan konteks situasional. hl ini dimaksutkan untuk
merangsang pengembangan pemecahan masalah dan mengelola hambatan umum
dan tanggapan emosional yang mengelilingi baik pengalama sulit saat didiagnosa
HIV dan pengalam sulit saat menjalani terapi ART. Komponen utama dari
intervensi meliputi :
1. Menyediakan pasien dengan program individual yang kongruen
dengan konteks sosial dan budaya pasien.
2. Sesi panggilan yang interaktif dan berpusat pada pasien.Perawat
mendengarkan aktif dan menggunakan pertanyaan dan probe
terbuka dengan mengarahkan teori. Komunikasi yang positif, tidak
menghakimi dan mendorong.
3. Isi panggilan adalah individual untuk kognitif peserta representasi,
kekhawatiran (misalnya,stigma/pengungkapan) dan konteks sosial
budaya.
4. Mengintegrasikan screening untuk depresi dan faktor resiko
lainnya secara bersamaan.
5. Memungkinkan pemecahan masalah proaktif untuk membantu
peserta dalam mengatasi faktor-faktor yang dapat menghambat dan
juga mempengaruhi keterlibatan mereka dalam pengobatan
6. Skrining untuk depresi dan resiko faktor psikososial .
7. Pengenalan dini dari hambatan dan arahan.
8. Menyediakan mediator (perawat studi) antara sistem kesehatan dan
peserta. Perawat memainkan peran mediasi.

13
 BAB 3. PEMBAHASAN

HIV menjadi salah satu masalah baik di tingkat nasional maupun

internasional. Hal ini dikarenakan HIV meluas dengan cepat dan menjadi epidemi
di seluruh dunia. Penyakit infeksi HIV sejak kemunculannya hingga kini terus
menyebabkan berbagai permasalahan kesehatan. Permasalahan kesehatan yang
dimaksud adalah masih tingginya transmisi infeksi, angka kesakitan, serta angka
kematian akibat HIV. HIV dapat menimbulkan penderitaan, baik dari segi fisik
maupun dari segi mental. Di India Sekitar 2,9 juta penduduk adalah orang dengan
HIV/AIDS (ODHA). Penderita HIV rentan terhadap berbagai masalah psikososial
yang membatasi akses dan kepatuhan terhadap pengobatan. Stres psikososial-
spiritual pasien HIV akan mempercepat kejadian AIDS dan bahkan meningkatkan
angka kematian. Salah satu upaya yang dapat dilakukan untuk menanggulangi
penyakit HIV yaitu dengan terapi antiretroviral (ARV). Pada tahun 2014, sekitar
14,9 juta orang yang 13,5 juta diantaranya tinggal di negara berpenghasilan
rendah dan menengah yang terjangkit virus HIV menerima terapi ARV, dan untuk
mendapatkan hasil terapi ARV yang efektif, maka dibutuhkan kepatuhan minum
obat yang optimal agar memperoleh hasil yang baik. Oleh karena itu terdapat
beberapa faktor pendukung dalam kepatuhan dalam terapi ARV bagi penderita
HIV. Faktor pendukung kepatuhan terapi ARV yaitu sebagai berikut :
1. Motivasi Diri
- Tidak ingin putus obat dengan alasan ingin sehat, bertahan hidup dan sudah
pernah melihat teman yang sakit karena putus obat ARV sampai kondisi
fisiknya menurun.
- Menjadi patuh minum obat karena pernah merasakan sakit dan kondisi fisik
menurun hingga dirawat di rumah sakit setelah pernah putus obat ARV.
2. Dukungan dari keluarga
- Selalu mengingatkan minum obat dan mengantar berobat
- Memberikan motivasi dan penguatan kondisi serta memberikan motivasi
untuk mau minum obat setiap hari
- Mengingatkan untuk tetap beribadah, bahkan meningkatkan kedekatan
kepada Allah

14
3. Dukungan dari suami
- Saling mengingatkan untuk minum obat
- Sama-sama mengingatkan pasangan untuk minum obat misalnya
menggunakan alarm
4. Dukungan dari teman dekat
- Menjalin komunikasi untuk terus mengingatkan jadwal minum obat
5. Dukungan Petugas Kesehatan
- Peran petugas kesehatan adalah penting karena petugas kesehatan yang paling
mengerti apa saja keluhan mereka selama minum obat.
Berdasarkan penelitian pada jurnal tersebut, India telah mengalami
penurunan sekitar 19% pada kasus HIV, akan tetapi Negara tersebut memiliki
jumlah tertinggi ketiga dari estimasi pasangan yang hidup dengan HIV di dunia,
diantaranya 39% adalah mayoritas perempuan yaitu sekitar 0,82 juta perempuan
di India menderita HIV. Beberapa perempuan di India menghadapi berbagai
hambatan situasional dan psikososial yang mungkin dapat mempengaruhi
kepatuhan mereka dalam pengobatan khususnya terapi ARV. Oleh karena itu,
dalam jurnal tersebut dijelaskan salah satu intervensi untuk menanggulangi sikap
kepatuhan yang sangat minim pada perempuan India dalam pengobatan dengan
terapi ARV yaitu menggunakan intervensi m-health atau biasa disebut dengan
mobile health. M-health atau mobile health merupakan suatu program yang
memakai teknologi informasi dan komunikasi (information and communication
technology/ ICT) misalnya saja komputer, telepon seluler, dan komunikasi satelit
yang digunakan untuk layanan dan informasi kesehatan. Telepon seluler adalah
salah satu teknologi tercepat yang dapat menyebarkan seluruh informasi di dunia,
dan sekarang dipakai lebih dari sekadar menelepon. Pada tahun 2005, WHO
mengusulkan penggunaan telepon seluler (m-Health) untuk memperbaiki mutu
pemberian layanan kesehatan khususnya di tingkat layanan kesehatan primer
(primary healthcare/PHC), serta juga membangun kemampuan petugas kesehatan
yang sumber dayanya rendah di negara tersebut. Telepon seluler dapat diakses
bahkan di tempat paling terpencil di dunia meskipun tidak mendapatkan akses air
bersih, tidak ada dokter atau pusat kesehatan. Beberapa manfaat yang ingin

15
diwujudkan oleh para petugas kesehatan melalui intervensi m-health ini yaitu
sebagai berikut :
a. Mendukung kepatuhan dalam pengobatan terapi ARV pada penderita HIV
b. Mengirim pesan pencegahan dan kesehatan dasar lain
c. Mendukung petugas kesehatan melakukan tugasnya, menghemat waktu
dan meningkatkan efisiensi layanan operasional
d. Memperbaiki efisiensi pengumpulan data dan analisis layanan
penatalaksanaan
Dalam penelitian tersebut, intervensi dilakukan dengan uji coba terkontrol,
dimana 120 perempuan terinfeksi HIV diambil secara acak untuk pengobatan
ARV sebagai kelompok kontrol dan ditambah dengan intervensi m-health
(MAHILA) sebagai kelompok eksperimen.
Intervensi tersebut adalah menggunakan intervensi konseling berbasis
ponsel, prosedurnya yaitu dilakukan dengan menggunakan teks berbasis pengingat
yang dikirimkan melalui ponsel para klien. Pesan tersebut berisi pengingat obat-
obatan apa saja dan juga mengatasi masalah faktor psikososial daripada klien
tersebut yang mempengaruhi perilaku kepatuhan dalam pengobatan. Intervensi
konseling MAHILA ini dapat juga memberikan pengetahuan kepada klien,
meningkatkan dukungan, serta memberikan pemecahan masalah klien yang
menjalani pengobatan ARV agar patuh dalam perawatan dan pengobatan.
Pada jurnal dijelaskan bahwa pengobatan ARV yang ditambah dengan
intervensi MAHILA ini akan lebih efektif dibandingkan dengan hanya pengobatan
ARV untuk meningkatkan kepatuhan penderita HIV dalam terapi ARV. M-health
(MAHILA) ini dapat diterima dengan baik oleh para perempuan penderita HIV di
India. Selain dapat meningkatkan kepatuhan pada terapi ARV, intervensi tersebut
juga dapat mengurangi masalah psikososial misalnya saja gejala depresi. Dengan
intervensi tersebut, para perawat dapat melakukan tindakan pemantauan yang
ketat terhadap penderita HIV tersebut, sehingga kepatuhan dalam pengobatan
dapat terkontrol. Penelitian tersebut juga memberikan suatu kontribusi bagaimana
intervensi mobile health dapat memotivasi kesehatan dan perawatan diri pada
perempuan dengan HIV. Selain itu, penelitian tersebut juga akan membantu
petugas kesehatan dalam mengidentifikasi risiko bahwa kemungkinan besar

16
perempuan HIV menghadapi masalah psikososial seperti putus asa dengan
penyakitnya dan kekerasan pasangan.
Pada jurnal A Counselor In Your Pocket: Feasibility Of Mobilehealth
Tailored Messages To Support HIV Medication Adherence dijeaskan bahwa
keluhan yang paling umum dari klien selama masa perawatan orang dengan
HIV/AIDS (ODHA) dan pengobatan ARV adalah kebosanan. Maka pada jurnal
tersebut dibentuk tim konselor sebagai petugas kesehatan yang melakukan
intervensi konseling dalam bentuk pesan singkat (SMS) yang ditujukan kepada
ODHA agar menerapkan perilaku kepatuhan selama menjalani terapi ARV.
Intervensi m-health ini juga membutuhkan dukungan dari keluarga klien agar
klien patuh dan ada yang memberikan motivasi dalam menjalani terapi ARV
tanpa merasa bosan yang berkepanjangan.
Intervensi ini juga dapat diterapkan pada wanita yang hamil dan sedang
mengandung anak untuk menjalani terapi ARV sebagai upaya prevensi agar anak
yang dilahirkan normal dan sehat. Pada jurnal The Effect Of An Interactive Weekly
Mobile Phone Messaging On Retention In Prevention Of Mother To Child
Transmission (PMTCT) Of HIV Program: Study Protocol For A Randomized
Controlled Trial (WELTEL PMTCT) dijelaskan pula bahwa pasangan suami
adalah sebagai media utama motivator klien ODHA yang hamil agar patuh dalam
pengobatan. Dengan memanfaatkan ponsel yang dapat terhubung dengan petugas
kesehatan dapat melindungi kerahasiaan serta sebagai pengingat sekaligus
seumber informasi jika terjadi permasalahan selama menjalani terapi ARV
tersebut. Jadi istri, suami, dan petugas kesehatan sebagai konselor dapat terhubung
dalam satu jaringan komunikasi.
Penerapan sistem intervensi konseling menggunakan mobile health ini
bagi penderita HIV di Indonesia sangat mungkin sekali karena banyaknya
masyarakat yang menggunakan telepon seluler sudah hampir menjangkau
ditempat terpencil sekalipun, sehingga dapat mendukung program ini. Selain itu,
program ini membutuhkan tenaga atau personel sebagai konselor yang dapat
memantau program untuk edukasi bagi pasien HIV serta kepatuhan dalam
pengobatan, tetapi tentunya tenaga ini harus terlatih dan manajemennya harus baik
pula agar outcome daripada perawatan serta pengobatan dapat tercapai dengan

17
maksimal. Pemerintahpun harus memikirkan layanan telekomunikasi khusus
untuk pasien HIV yang dihubungkan dengan sistem layanan di rumah sakit atau
layanan kesehatan primer seperti puskesmas, sehingga memudahkan bagi
penderita HIV untuk menerima layanan seperti pengobatan ataupun terkait
komplikasi dari penyakit yang dideritanya, serta dapat menggunakan fasilitas
layanan tersebut untuk mengutarakan masalah yang dihadapinya sebagai bentuk
konseling melalui telepon seluler serta peningkatan koping klien agar tidak terjadi
masalah psikososial selama masa perawatan dan pengobatan berjalan. Intervensi
ini tidak hanya ditujukan kepada klien namun juga kepada keluarganya agar
senantiasa mengawasi serta memberikan motivasi kepada klien agar berperilaku
patuh dalam menjalani perawatan dan pengobatan di rumah. Prosedurnya
mungkin bisa diterapkan pada suami atau istri klien dimana sebagai orang yang
paling dekat dengan klien, agar petugas kesehatan sebagai alarm pengingat jadwal
ODHA untuk mengkonsumsi obat ARV tersebut serta memberikan konseling
apabila ada hambatan masalah pada klien dan keluarganya.

18
 BAB 4. PENUTUP

4.1 Kesimpulan
HIV/AIDS adalah suatu penyakit autoimun yang menyerang sistem
pertahanan tubuh penderita yang belum ada obatnya dan belum ada vaksin yang
bisa mencegah serangan virus HIV. Namun harapan hidup klien ODHA dapat
ditingkatkan dengan pemberian terapi antiretrovial (ARV). Dalam pengobatan
ARV seringkali klien merasa jenuh dan keterlibatan keluarga masih rendah.
Sehingga dalam jurnal dilakukan penelitian upaya pelayanan kesehatan oleh
petugas sebagai konselor yang dihubungkan dengan media komunikasi berbasis
ponsel (m-health) sebagai upaya peningkatan kesehatan ODHA yaitu dengan
media intervensi konseling agar klien meningkatkan kepatuhan selama masa
perawatan dan pengobatan serta keluarga dapat memberikan motivasi sekaligus
pengawas ODHA dalam menjalani perawatan dan pengobatan.

4.2 Saran
Menurut penulis, masih banyak orang dengan HIV/AIDS di Indonesia
yang tidak menjalani terapi antiretrovial (ARV) karena kurangnya petugas
kesehatan untuk mengawasi klien dalam masa pengobatan. Maka dari itu,
intervensi konseling berbasis ponsel ini dapat digunakan oleh petugas kesehatan
khususnya perawat sebagai konselor di instansi kesehatan atau rumah-rumah sakit
di Indonesia. Intervensi ini dapat dimanfaatkan sebagai bentuk manajemen
pengendalian penyakit menular HIV/AIDS agar klien patuh dalam menjalani
pengobatan dan menekan depresi akibat masalah psikososial klien dengan
keluarga maupun masyarakat sekitarnya dengan metode konseling berbasis ponsel
yang dihubungkan langsung antara klien, keluarga dan petugas kesehatan.

19
 DAFTAR PUSTAKA

Awiti, Patricia Opondo, et al. The Effect of An Interactive Weekly Mobile Phone
Messaging on Retention in Prevention Of Mother to Child Transmission
(PMTCT) of HIV Program: Study Protocol For A Randomized Controlled
Trial (WELTEL PMTCT). BMC Medical Informatics and Decision Making
16:86 (online).
http://bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-
016-0321-4 (diakses pada 14 November 2016)

BBC Indonesia. 2016. Ribuan Orang di India Terinfeksi HIV karena transfusi
darah.(online).
http://www.bbc.com/indonesia/majalah/2016/05/160531_majalah_india_hiv
(diakses pada 17 November 2016)

Cook, Paul F, et al. 2015. A Counselor In Your Pocket: Feasibility of Mobile

Health Tailored Messages to Support HIV Medication Adherence. Patient
Preference and Adherence 2015:9 13531366 (online)
https://www.dovepress.com/a-counselor-in-your-pocket-feasibility-of-
mobile-health-tailored-messa-peer-reviewed-fulltext-article-PPA (diakses
pada 14 November 2016)
http://eprints.undip.ac.id/43845/3/ELIZABETH_FAJAR_P.P_G2A009163_bab_2
_KTI.pdf (diakses pada 18 November 2016)
Nursalam dan Kurniawati, Ninuk D. 2007. Asuhan Keperawatan pada Pasien
Terinfeksi HIV/AIDS. Jakarta: Salemba Medika.
UNAIDS. 2016. GLOBAL AIDS UPDATE (online).
http://www.who.int/hiv/pub/arv/global-aids-update-2016-pub/en/ (diakses
pada 17 November 2016)

Reynolds, Nancy R, et al. 2016. MAHILA: A Protocol For Evaluating A Nurse-

Delivered Mhealth Intervention For Women With HIV And Psychosocial
Risk Factors In India. BMC Health Services Research 16:352 (online).
https://www.dovepress.com/a-counselor-in-your-pocket-feasibility-of-
20
 mobile-health-tailored-messa-peer-reviewed-article-PPA (diakses pada 2
November 2016)
Smeltzer , Bare. 2001. Buku Ajar Keperawatan Medikal Bedah Brunner dan
Suddart, Edisi 8. Jakarta: EGC

21
Reynolds et al. BMC Health Services Research (2016) 16:352
DOI 10.1186/s12913-016-1605-1

STUDY PROTOCOL Open Access

MAHILA: a protocol for evaluating a nurse-

delivered mHealth intervention for women
with HIV and psychosocial risk factors in
India
Nancy R. Reynolds1*, Veena Satyanarayana2, Mona Duggal3, Meiya Varghese4, Lauren Liberti1, Pushpendra Singh5,
Mohini Ranganathan6, Sangchoon Jeon1 and Prabha S. Chandra4*

Abstract
Background: Women living with HIV are vulnerable to a variety of psychosocial barriers that limit access and
adherence to treatment. There is little evidence supporting interventions for improving access and treatment
adherence among vulnerable groups of women in low- and middle-income countries. The Mobile Phone-Based
Approach for Health Improvement, Literacy and Adherence (MAHILA) trial is assessing the feasibility, acceptability and
preliminary efficacy of a novel, theory-guided mobile health intervention delivered by nurses for enhancing self-care
and treatment adherence among HIV-infected women in India.
Methods/Design: Women (n = 120) with HIV infection who screen positive for depressive symptoms and/or other
psychosocial vulnerabilities are randomly assigned in equal numbers to one of two treatment arms: treatment as
usual plus the mobile phone intervention (experimental group) or treatment as usual (control group). In addition to
treatment as usual, the experimental group receives nurse-delivered self-care counselling via mobile phone at fixed
intervals over 16 weeks. Outcome measures are collected at baseline and at 4, 12, 24 and 36 weeks post-baseline.
Outcomes include antiretroviral treatment adherence, HIV-1 RNA, depressive symptoms, illness perceptions, internalized
stigma and quality of life.
Discussion: The MAHILA trial will provide information about how a mobile health counselling intervention delivered
by non specialist nurses may improve access to care and support the adherence and clinical outcomes of women with
HIV infection living in low- and middle-income countries such as India.
Trial registration: NCT02319330 (First received: July 30, 2014; Last verified: January 2016)
Keywords: HIV, Women, Mental health, mHealth, Antiretroviral adherence, LMIC

Background prognosis of people living with HIV, deficits in adher-

There have been dramatic improvements in access to
life-saving combination antiretroviral therapy (cART). In
2014, 14.9 million people living with the human immuno-
deficiency virus (HIV) were receiving cART globally, 13.5
million of whom live in low- and middle-income countries
(LMICs) [1]. While cART has markedly improved the
* Correspondence: nancy.reynolds@yale.edu; chandra@nimhans.ac.in
1
Division of Acute Care/Health Systems, School of Nursing, Yale University,
400 West Campus Drive, West Haven, CT 06516, USA
4
Department of Psychiatry, National Institute of Mental Health and Neuro
Sciences, Hosur Road, Bengaluru 560029, India
Full list of author information is available at the end of the article
ence to the spectrum of HIV care pose significant bar-
riers to its long term success [24]. Effective cART
requires optimal adherence to maintain suppression of
viral replication with non-adherence resulting in treat-
ment failure, disease progression and/or the emergence
of drug resistance [46].
Although India has seen a 19 % decline in new HIV in-
fections, the country has the third highest number of esti-
mated people living with HIV in the world (~2.1 million)
[7, 8], of whom, 39 % are women [9]. This amounts to
approximately 0.82 million women, given the large

2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Reynolds et al. BMC Health Services Research (2016) 16:352
population of the country. There is a growing body of
evidence indicating that women in India are vulner-
able to poor HIV prevention and treatment outcomes
[1018]. Women in India face a variety of inter-
related situational and psychosocial barriers that may
limit their access to HIV care and adherence to cART
over time including low literacy, stigma, discrimin-
ation and low social support [1921]. Depression, a
prominent predictor of poor adherence to cART [2226],
is also prevalent among women living with HIV in
India in whom it is largely under diagnosed and under-
treated [27, 28].
Good adherence is critical in HIV prevention and
treatment success, yet little attention has been given to
the development of interventions focused on women liv-
ing with HIV and depression or other psychosocial risk
factors for nonadherence. Interventions that improve
adherence and reduce the barriers that women face in
adhering to cART are urgently needed. Our preliminary
work indicates that a theory-guided phone intervention
originated in the U.S. is well suited to the Indian context
given the widespread use of mobile phone technology
[29]. This multi-dimensional, patient-centered approach
builds patient-provider rapport, establishes sources of sup-
port, and enables and empowers problem solving to ad-
dress situational and psychosocial barriers to care [29].
Other HIV adherence interventions using mobile health
(mHealth) approaches in LMICs have mainly relied on
text-based reminders [3033]. Women with low literacy
skills may find text message based interventions challen-
ging. Further, these messages serve mainly as memory
prompts to take the medications and do not address psy-
chosocial factors that influence adherence behaviour [32].
Following initial formative work to refine the mobile
phone-based adherence intervention for delivery in India,
we trained non specialist nurses to deliver the interven-
tion. We are now evaluating whether the low cost,
mHealth counselling intervention is an effective, feasible
and acceptable way to improve the treatment outcomes of
women in India who are affected by HIV with and inter-
related mental health and psychosocial risk factors. Here
we describe the protocol of the ongoing randomized, sin-
gle blind (rater), controlled trial. The SPIRIT guidelines
were adhered to for the reporting of this manuscript.
Methods
Study aim and design
The MAHILA project is being conducted through a
Collaborative Research Partnership between investiga-
tors at the National Institute of Mental Health and
Neuro Sciences (NIMHANS) and Yale University. The
study is designed to evaluate the feasibility, acceptability,
fidelity and preliminary efficacy of a standardized mobile
phone intervention in a randomized, controlled pilot
Page 2 of 9
study in which 120 HIV-infected women are randomized
to treatment as usual (TAU) alone or TAU plus the
mHealth (delivered over 16 weeks). After baseline assess-
ment, women are randomly assigned to treatment condi-
tion in a 1:1 allocation and outcomes (adherence, HIV-1
RNA plasma [viral load], mental health) are evaluated at
4, 12, 24 and 36 weeks post-randomization (see Fig. 1).
The primary hypothesis is that TAU plus the mobile
phone intervention will be more effective than TAU in
improving adherence to cART and clinical outcomes at
24 weeks post-randomization. Other hypotheses are
that the mobile phone intervention will be feasible and
acceptable to women living with HIV, fidelity of the
intervention will be maintained, and the intervention
will improve HIV adherence by concurrently addressing
prominent barriers (e.g., depressive symptoms) and im-
proving knowledge, support and problem solving for
better engagement in care and adherence.
Study setting
The Mobile Phone-Based Approach for Health Improve-
ment, Literacy and Adherence (MAHILA) project is con-
ducted at the government-sponsored HIV treatment clinic
(ART Centre) of the Belgaum Medical College Hospital, in
the state of Belgaum, Karnataka and at NIMHANS,
Bengaluru, South India. Recruitment of participants and
data collection is conducted by trained project staff at the
ART Centre in Belgaum. The mobile phone intervention
is delivered by trained non specialist nurses at NIMHANS.
Delivery of the intervention from a central site allows for
prevention of within site dispersion of intervention con-
tent to the control group and it enables close monitoring
of the fidelity of intervention delivery by the project inves-
tigators with mental health expertise at NIMHANS. These
non specialist nurses are trained as part of this study on
the clinical and psychosocial aspects of HIV/AIDS, basics
of mental health screening, phone based counseling and
the self-care intervention in four separate workshops.
Belgaum is situated in North-West Karnataka and shares
its borders with two neighbouring states Maharashtra
and Goa. It is the largest district in the state with a popula-
tion of 4.8 million [34]. The district has the highest overall
HIV prevalence (1.43 %) in the state of Karnataka with
prevalence greater in rural than urban areas [35].
High rates of migration and a tradition called the Devdasi
system is prevalent in several parts of the district [36].
Devadasi is a religious practice whereby parents marry a
daughter to a deity or a temple. While the Devadasi prac-
tice has a long tradition in parts of India, many devadasis
today become religiously sanctioned prostitutes [3739].
Sample size and eligibility criteria
One hundred and twenty participants will be enrolled,
with 60 in each treatment arm. This sample size is
Reynolds et al. BMC Health Services Research (2016) 16:352
Fig. 1 MAHILA flowchart
consistent with developmental research with the primary
aim of assessing the feasibility, acceptability and prelim-
inary efficacy of a new behavioral intervention [40]. It is
also large enough to allow for a diverse set of participant
characteristics representative of the target population.
To be eligible, a woman must be 1) able to give in-
formed consent, 2) able and willing to be contacted by
mobile phone, 3) 18 years of age or older, 4) speak
Kannada, English or Hindi, 5) HIV+ and taking cART
for less than six months, and 6) screen positive for depres-
sive symptoms or psychosocial risk factors. Women are
screened for depression with the Centre for Epidemiologic
Page 3 of 9
Studies Depression Scale (CES-D) [41] and for psycho-
social risk factors with the Psychosocial Vulnerability
Checklist (PSVC). The PSVC was developed by the re-
searchers based on a review of studies among women with
HIV, especially in LMICs [26, 28, 42, 43]. It consists of 14
items which assess level of financial strain, social support,
violence, substance abuse, mental health problems and
suicide ideation.
Women are excluded from participation if they have
any condition that, in the opinion of the site investigator,
would compromise their ability to participate. Women
who screen positive for active suicidal ideation are also
Reynolds et al. BMC Health Services Research (2016) 16:352
excluded. All women with > 16 CES-D or active suicidal
thoughts are referred for treatment per a standardized,
written protocol.
Recruitment, enrollment and randomization
Potential participants are invited to participate by a
study team member in the ART Centre in Belgaum, who
then explains the study, obtains informed consent and
screens them for eligibility. Eligible participants then
complete the baseline assessments.
Each participant is provided with a basic mobile
phone. This mobile phone is used for proactive delivery
of the intervention to participants in the TAU + mobile
phone arm. To enhance methodological rigor, mobile
phones are also distributed to the participants in the TAU
arm to avoid a placebo effect and for ethical reasons: for
instance, the phone may be used by participants in either
arm to call the study nurse ad hoc for health-related
advice or assistance. It is also used by study staff for
purposes of establishing contact or collecting data if ne-
cessary. The mobile phones are provided with Sub-
scriber Identity Module (SIM) cards under a Closed
User Group (CUG) connection, in which the partici-
pant can make calls to the CUG number of the study
nurse and can receive calls from the same number. The
subscription is paid for by the project on a monthly
basis. This approach ensures that the phone is not used
for personal calls and it overcomes the difficulty of pro-
viding regular top ups of phone currency.
Participants are randomized to a treatment condition
following the baseline assessment in a 1:1 allocation
ratio to one of the two treatment arms. Computer-gen-
erated, block randomization is used to ensure balanced
representation in the two treatment arms. Sequentially
numbered opaque sealed envelopes serve as the allocation
concealment method. The Belgaum study staff are blinded
from the randomization assignment. Once a new par-
ticipant is enrolled, the Belgaum staff notify the project
coordinator who is located in the project research office
at NIMHANS. The project coordinator initiates the
randomization procedures and hand delivers notifica-
tion of randomization assignment to the study nurses
who then make contact with the participant by mobile
phone and inform them of the treatment assignment.
Study interventions
Control group TAU All participants receive TAU as
prescribed by the Indian National ART guidelines [44].
In addition, referral to psychiatric care is made by pro-
ject staff for depressive symptoms or suicidal thoughts at
baseline and follow-up assessments. Further, as noted
above, all participants may initiate ad hoc contact with a
study nurse to confer about health-related matters. The
time, date, and content of any calls initiated by the
Page 4 of 9
patient are documented by the nurse on a project form
for analysis. Time matched attention in both arms is not
possible given the individualized approach with variable
frequency and length of the intervention calls for each
participant.
Experimental group TAU plus nurse-delivered
mobile phone intervention The mobile phone inter-
vention is delivered proactively by nurses via mobile
phones at a convenient time identified by the participant
for up to 16 weeks. Calls are made by the nurse at base-
line and at least two times per week during weeks 14,
once a week during weeks 5 to 10, and then at weeks 14
and 16. More frequent calls can be made at the discre-
tion of the nurse or if initiated by the participant as in
the TAU arm. Up to 6 attempts are made by the nurse
for each scheduled contact. As noted above, participants
also have the option of initiating calls to confer with the
nurse on health-related matters between scheduled calls
(date, length and content of each call are recorded by
the nurse). A script is used to guide delivery of the critical
elements of the manualized mobile phone intervention,
but the duration and content is individualized to each
participant.
The multi-component mobile phone intervention was
developed through a series of studies guided by applica-
tion of the Leventhal self-regulatory model of illness be-
havior to HIV [29]. It has been tested in the U.S. and
adapted for delivery to women in India during Phase 1
of project MAHILA. At the core of the approach is a
trained nurse who contacts patients proactively by mobile
phone at regular intervals. A structured, patient-centered,
counseling approach is used to engage and develop the
individuals capacity for productive self-care behavior.
Self-care behavior of the individual living with a chronic
illness is essential to the effectiveness of medical treat-
ments since most of the day-to-day management takes
place outside of health care settings. A host of research
conducted by Leventhal and others has shown that the
way in which individuals interpret or make sense of their
illness (illness representation) drives the selection of cop-
ing/self-care behaviors (e.g., adherence to medication)
[4551]. Illness representations are highly individual, in-
fluenced by a host of internal and external information
that are often ambiguous, fluctuate daily, and are affected
by situational variation. They may or may not be com-
patible with medical norms and influence how new
health information is processed and acted upon; any
health information provided will interact and be accepted
or rejected based on the patients pre-existing illness rep-
resentations. Thus, a central element of this mobile phone
intervention is assessing how the patient comprehends
her illness in the context of her life circumstances and
past experiences. Areas of risk and strengths are identified,
Reynolds et al. BMC Health Services Research (2016) 16:352
corresponding health information and support is provided
and skills developed that are individualized to the patients
schema and situational context. The premise is that in so
doing the content is viewed as more meaningful and is more
readily integrated into the individuals cognitive schema and
acted upon in problem solving efforts to manage barriers
and emotional responses that surround both the primary dif-
ficult experience of living with an illness condition in the
context of the individuals situational challenges. Further, the
phone contact provides a means of facilitating coordination
of services, continuity of care, and patient monitoring.
The overarching objective is to ensure that the patient
in the TAU + mobile phone arm is provided with accur-
ate information and support, individualized to patients
knowledge level and situational context. This is intended
to stimulate development of a perceptual schema and
skills to engage resources and problem solve to manage
common barriers and emotional responses that surround
both the primary difficult experience of living with HIV
and taking antiretroviral therapy in the context of situ-
ational demands and challenges (e.g., stigma/disclosure,
competing demands/priorities (e.g., family/child care), side
effects, depressive symptoms, social support). A combin-
ation of strategies are used. The five-step process begins
with an assessment of the patients representation of HIV
and medication, areas of risk are identified, and corre-
sponding, key health information and affective support are
provided in accordance with the participants priorities
and contextualized to the patients schema and situational
context to build knowledge and skills to problem solve to
sustain adherence/self-care behavior as indicated. Appro-
priate referrals are generated as indicated.
The key components of the intervention include: (1)
providing the patient with an individualized program
that is congruent with patients social and cultural con-
text; (2) integrating screening for depression and other
concurrent risk factors; (3) enabling proactive problem
solving to aid participants in overcoming factors that
may impede their engagement in treatment; (4) improv-
ing early recognition of barriers and referrals; and, (5)
providing a mediator (the study nurse) between the health
system and the participants. For example, the study nurse
will screen for the presence or worsening of depression
and facilitate the engagement of the participants in appro-
priate mental health care by: (a) providing information
contextualized to the cognitive representation and con-
cerns (e.g., stigma/disclosure) of the patient; (b) schedul-
ing of appointments; (c) follow-up. This provides an
opportunity for continuity and coaching through threats
to treatment adherence that may manifest over time. The
sessions are interactive and patient-centered. The nurse
listens actively and uses theory-directed open-ended
questions and probes. Communication is positive, non-
judgmental and encouraging (See summary Table 1).
Page 5 of 9
Fidelity To ensure treatment fidelity, the nurses are pro-
vided with Android smart phones so that the intervention
sessions can be recorded using an application. With the
consent of participants, the Android application is enabled
to record any incoming or outgoing calls made on the
phone which are saved on a secure laptop that is password
protected. The recorded calls are checked randomly by
the study principal investigators and the study nurses are
provided with feedback and guidance on the content and
delivery of counseling sessions as needed.
Measures
All study assessments (baseline and 4, 12, 24 and
36 weeks post-randomization) are conducted by trained
study staff who are blind to treatment allocation. Assess-
ments are typically conducted in person in the Belgaum
ART Centre, but there is some allowance for mobile
phone-based follow-up assessments in cases where par-
ticipants are unable to return to the study site. The data
from the forms can be exported in different formats,
such as Microsoft Excel file format (.xls) for further
processing.
Adherence is measured with the AIDS Clinical Trails
Group (ACTG) Adherence Questionnaire [52]. The ques-
tionnaire queries the patient on the number of doses
missed of an ART medication during each of the 4 days
before a clinic visit (e.g., How many doses did you miss
yesterday, the day before yesterday, 3 days ago, and 4 days
ago?). It has been used widely in the U.S. and India and
has shown good validity and reliability [53].
Plasma HIV-1 RNA concentration is used as the clin-
ical criterion and primary outcome variable. Plasma HIV
RNA concentration is measured in copies per millilitre
(Roche Amplicor HIV-1 Monitor Test). The threshold
for detectability of HIV viral load 50 copies/mL.
Table 1 Summary of key elements of the mobile phone
intervention
Key elements
1. Proactive, nurse-delivered calls by mobile phone at time convenient
to the participant;
2. Call sessions are interactive and patient-centered. The nurse listens
actively and uses theory-directed open-ended questions and probes.
Communication is positive, non-judgmental and encouraging.
3. Content of calls is individualized to the participants cognitive
representations, concerns (e.g., stigma/disclosure) and sociocultural
context;
4. Screening for depression and other concurrent psychosocial risk
factors;
5. Early recognition of barriers and referrals - Coaching through threats
to care that may manifest over time;
6. Building of problem solving skills to aid participants in overcoming
factors that may impede their engagement in treatment;
7. The nurse plays a mediating role between the health system and
the participant. Enhanced continuity of care.
Reynolds et al. BMC Health Services Research (2016) 16:352
Depression is measured with the Centre for Epidemio-
logic Studies Depression Scale (CES-D) [41, 54]. CES-D
( = 0.88-0.91) is a 20 item screening tool for depressive
symptomatology. All items are rated using a 4 point or-
dinal scale with the responses based on occurrence of
symptoms in the past one week.
Illness representation is measured with the Brief Illness
Perception Questionnaire (IPQ-B), a 9-item questionnaire
designed to rapidly assess cognitive and emotional repre-
sentations of illness [55]. The IPQ-B uses a single-item
scale approach to assess perception on a 010 response
scale, with higher scores representing more threatening
illness perceptions. The scale has demonstrated good
test-retest reliability (Pearson correlations 0.24-0.73)
and moderate to good correlations when tested for con-
current validity (Pearson correlations 0.320.63).
Symptom Distress is measured with the HIV Symptom
Index, a 20-item valid and reliable ( = 0.92) measure of
overall HIV symptom frequency and level of bother-
someness [56].
Stigma is measured with a 10-item measure of internal-
ized stigma. The scale was adapted from the Stigma Scale
which was developed in South India and measures enacted,
felt normative and internalised stigma [57]. Internalised
stigma experienced by respondents is measured on a 4
point scale running from 0 (not at all) to 3 (a great deal).
Quality of life is measured with the World Health
Organization (WHO) Quality of Life (QOL) HIV short
version (WHOQOL-HIV BREF), a multidimensional 31
item instrument used to assess quality of life of persons
with HIV [58]. WHOQOL-HIV BREF has been used and
validated in the Indian HIV population [5961].
Feasibility, acceptability, and fidelity of the intervention
and study protocol are measured with protocol specific
tools. The assessment includes: 1) The ratio of eligible
study participants to those enrolled; 2) Number of sched-
uled study visits completed at 4, 12, 24, and 36 weeks; 3)
Attrition between baseline and follow-up; 4) Reason for pre-
mature drop-out; 5) Number of phone calls that were made
on schedule; 6) Level of participation in intervention sessions
including the total number sessions, number of sessions
completed without break offs, number of break offs,
length (minutes) of sessions; 7) Congruence of topic/
content discussed on calls with protocol; 8) Patient and
study nurse satisfaction with intervention content,
mode of delivery, and protocol; and, 9) Adverse events.
A study-specific intervention assessment tool is used to
evaluate content fidelity and quality of the interaction and a
log is maintained that details technical challenges faced by
the team (e.g., problems related to mobile phone, SIM card).
Data storage and monitoring
A web-accessible and interactive database system is used
for the storage and exploration of the study data. The
Page 6 of 9
data collection framework uses an open-source relational
database management system, MySql, at the back-end
and Python-Django at the front end with a MVC
(Model-View-Controller) architecture. The MVC archi-
tecture makes it easy to develop new functionalities and
extend the capabilities of the framework. In the front-end
we have created forms for collecting the baseline and fol-
low-up data. The use of a data-collection framework of-
fers many advantages over conventional paper-based
forms. For example, sharing data across partners is easier
and the forms have a feature of preliminary validation, i.e.,
a user must enter values which are in the valid range
otherwise the form refuses to accept the input.
All study participants are assigned unique study identi-
fiers that appear on all data collection instruments,
tapes, documents, and files. Data collection instruments
and the study database contain no client identifying in-
formation or record of HIV status and are stored in a
secure, double-locked cabinet. Personal information
needed for tracking and informed consent are stored
separately from other data in double-locked, fireproof,
water resistant safe in the ART Centre. No identifying
information will leave the clinic or be entered into the
project database.
Data are entered into study-specific laptops. Microsoft
Access is used for storage and management. The master
study dataset is stored on a dedicated Windows file ser-
ver that can only be accessed by authorized study staff.
All data are password protected.
A Data Safety and Monitoring Board (DSMB) has been
constituted to review the progress and safety of study
procedures and address unanticipated problems involv-
ing risks to subjects or other serious adverse events. The
DSMB meets every three months.
Statistical analysis
Data will be described using univariate analysis (distribu-
tions, frequencies, and means). The intervention assign-
ment will be examined in relation to HIV-1 plasma and
cART adherence. Analyses will be intention-to-treat. As
this is a small sample size we will only be able to evalu-
ate parsimonious models to explore effect of the inter-
vention, and not include all mediating and potentially
confounding variables. Generalized estimating equations
(GEEs) will be used to model adherence rates to account
for the multiple measurements of each subject and allow
all subjects, regardless of the number of visits, to be in-
cluded in the analysis. Analyses also will be conducted
within-person, comparing baseline to follow-up session
responses. As GEEs require strong assumptions regarding
missing data (missing completely at random), analyses will
be repeated using the subset of subjects with complete
data.
Reynolds et al. BMC Health Services Research (2016) 16:352
Discussion
To our knowledge, the current study is the first clinical
trial to examine the effects of a nurse delivered mobile
phone based self-care intervention for women with HIV
infection who have depression or psychosocial risk fac-
tors in a LMIC [32]. Results from this study will inform
the development of interventions for achieving improved
clinical benefits and recommendations for mHealth ser-
vice delivery, from the clinic to national and international
policy levels. Findings will also contribute to understand-
ing how mobile technology interventions motivate better
health and self-care among women with HIV. Further-
more, in addition to outcome data, respondent and pro-
vider satisfaction that are collected as part of this study
protocol may provide guidance to HIV and mHealth ex-
perts who are seeking to evaluate mobile phone programs
for HIV prevention, care, and treatment.
The protocol focuses on mHealth impact on psycho-
logical behavioral and physical health; assesses imple-
mentation issues unique to mHealth interventions; and
also looks at the gender intentionality of the intervention,
all of which are priorities for evidence generation in the
area of mobile phones for health among women in
LMICs. The study will also help us in identifying any risks
that women might face related to the mobile intervention
such as disclosure issues, any increase in stigma or escal-
ation of partner violence.
There are a few study limitations worth noting. Self-
reported adherence to cART has notable limitations
[6265]. We have, however, measured HIV-1 RNA in
plasma which is the gold standard for monitoring the
efficacy of HIV treatment and measuring the validity of
adherence reports. If a patients virus is known to be
sensitive to current therapy, a detectable viral load likely
represents poor adherence [66]. The health behavior con-
structs we are assessing have not often been evaluated in
mobile phone interventions, but prior research and focus
group data from other projects suggests that the proposed
constructs are affected by mHealth programs [29, 67, 68].
In addition, we will not be able to control external factors
that may confound study results, such as medication sup-
plies or health system challenges, weather, civil or political
influences, or other health programs occurring in study
communities during the intervention period, although we
will document these contextual factors to help with inter-
pretation of findings.
The study has several strengths. It is the first trial
using a mHealth non text based intervention among
women with HIV infection in a LMIC; biases and con-
tamination have been minimised by adequate allocation
concealment and by ensuring that the teams of assessors
and interventionists are in two different geographical lo-
cations. The intervention itself is theory driven and is
based on the self-regulatory model of ART adherence
Page 7 of 9
[29]. Both groups of women have been given mobile
phones to ensure blinding and remove any effect of
owning a phone rather than receiving an intervention.
Adequate training and supervision is provided to the
nurses including a periodic review of call recordings by
the investigators to ensure fidelity. Standard operating
procedures have been developed for women who report
mental health problems, suicidality or domestic violence.
Any adverse effects or difficulties related to the inter-
vention will be recorded. Multiple outcomes including
adherence, mental health outcomes, quality of life and
biological parameters of disease progression (e.g., HIV-1
RNA) are measured. An important outcome that has not
been studied in previous trial will include respondent and
provider satisfaction with the intervention.
Conclusions
This nurse led mobile phone intervention for improved
self-care among women with HIV infection who have
depression and/or psychosocial vulnerabilities will provide
important evidence for the usefulness, feasibility and ac-
ceptability of this novel intervention. Results of this trial
will be important in informing future mHealth interven-
tions for this population and for women with other
chronic medical illness in LMICs.
Abbreviations
ACTG, AIDS clinical trials group; ART centre (antiretroviral centre) - a
government-sponsored HIV treatment clinic; cART, combination antiretroviral
therapy; CES-D, centre for epidemiologic studies depression scale; CUG,
closed user group;.xls - microsoft excel file format; DSMB, data safety and
monitoring board; GEEs, generalized estimating equations; HIV, human
imuunodeficiency virus; HIV-1 RNA plasma (viral load) - a quantitative
measurement of viremia; ICMR, Indian council of medical research; IPQ-B,
brief illness perception questionnaire; IRB/ECs, institutional review board or
ethics committees; LMICs, low- and middle-income countries; mHealth,
mobile health, a term used for the practice of medicine and other health
care services supported by mobile devices; MVC (Model-View-Controller), a
software architectural pattern mostly (but not exclusively) for implementing
user interfaces; MySql, an open-source relational database management system;
NIMHANS, national institute of mental health and neuro sciences; PSVC,
psychosocial vulnerability checklist; SIM card, subscriber identity module
card is a portable memory chip used in cell phones; TAU, treatment as
usual; WHOQOL-HIV BREF, world health organization quality of life HIV
short measure
Acknowledgements
The authors thank the study participants for their contribution to the research, as
well as current and past research staff, especially the nursing interventionists Ms.
Pushpa L., Ms. Savitha K. S. and Ms. Anto Rashmi, and staff at the ART centre, Dr.
Shanta Desai (Senior Medical officer), Dr. Attiq Rehaman (Medical officer) and Ms.
Swapna Hulasogi (Counsellor).
Funding
The study was supported by the US National Institutes of Health (R21MH100939),
the Indian Council of Medical Research (HIV/INDOUS/152/9/2012-ECD-II), and the
ITRA project, funded by DEITy, India (Ref. No. ITRA/15(57)/Mobile/HumanSense/01).
Availability of data and materials
Not applicable.
Reynolds et al. BMC Health Services Research (2016) 16:352
Authors contributions
NR, MD, PC, MR, VS, SJ and PS designed the study. NR and PC are the
principal investigators. NR, MD (NIH), PC (ICMR), and PS (DEITy) obtained the
funding. SJ provides statistical support, MD and PS provide technological
support, and NR, PC and VS support the intervention and fidelity. NR and LL
are the main coordinators of the study in the U.S. PC, VS, MV and MD are
the main coordinators of the study in India and conduct and provide on-site
oversight. NR, PC and MV wrote the initial manuscript. All authors provided
comments on the drafts and have read and approved the final version.
Competing interests
The author(s) declare that they have no competing interests.
Consent for publication
Not applicable.
Ethics approval and consent to participate
The protocol was approved by the Institutional Review Boards/Ethics
Committees (IRB/ECs) at NIMHANS, Yale University and the Indian Council of
Medical Research (ICMR); each participant provides written informed consent
prior to participant enrollment. To ensure that the study minimises risks to
the respondents several safeguards are taken including a detailed consent
process that involves explaining risks of having a mobile phone (such as
questions from husband and family; inadvertent disclosure). Written Standard
Operating Procedures are in place to guide staff on necessary actions if
women report suicidality, serious mental health concerns and/or interpersonal
violence. Adverse events that are judged to be related or possibly related to
study participation are documented and reported to the IRB/ECs according to
their individual requirements and to the DSMB (see above).
A password is provided to the participant to ensure that the phone calls are
being attended only by the respondent and the respondent is required to
say the password before each telephonic session is initiated. In addition, calls
are made only at respondents convenience.
A nutritious snack is offered to participants at each data collection visit and
any additional travel expenses are covered by the project.
Author details
1 among previously married women in India. AIDS Care. 2012;24(9):110310.
Division of Acute Care/Health Systems, School of Nursing, Yale University,
400 West Campus Drive, West Haven, CT 06516, USA. 2Department of Clinical
Psychology, National Institute of Mental Health and Neuro Sciences,
Bengaluru 560029, India. 3Post Graduate Institute of Medical Education and
Research, Chandigarh, India. 4Department of Psychiatry, National Institute of
Mental Health and Neuro Sciences, Hosur Road, Bengaluru 560029, India.
5 among HIV-infected heterosexualsa report from India. J Psychosom Res.
Indraprastha Institute of Information Technology (IIIT-D), B-304, Academic
Block, Okhla Phase III, New Delhi 110020, India. 6Department of Psychiatry,
Yale University, School of Medicine, 300 George Street, New Haven, CT
06511, USA.
Received: 19 January 2016 Accepted: 29 July 2016
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Patient Preference and Adherence Dovepress
open access to scientific and medical research

Open Access Full Text Article Original Research

A counselor in your pocket: feasibility of mobile

health tailored messages to support HIV
medication adherence
This article was published in the following Dove Press journal:
Patient Preference and Adherence
23 September 2015
Number of times this article has been viewed

Paul F Cook 1 Purpose: Medication adherence is a major challenge in HIV treatment. New mobile technologies
Jane M Carrington 2 such as smartphones facilitate the delivery of brief tailored messages to promote adherence.
Sarah J Schmiege 1 However, the best approach for tailoring messages is unknown. Persons living with HIV (PLWH)
Whitney Starr 3 might be more receptive to some messages than others based on their current psychological
Blaine Reeder 1 state.
Methods: We recruited 37 PLWH from a parent study of motivational states and adherence.
1
University of Colorado College of
Nursing, Aurora, CO, USA; 2University Participants completed smartphone-based surveys at a random time every day for 2 weeks,
of Arizona College of Nursing, Tucson, then immediately received intervention or control tailored messages, depending on random
AZ, USA; 3University of Colorado assignment. After 2 weeks in the initial condition, participants received the other condition in a
School of Medicine, Aurora, CO, USA
crossover design. Intervention messages were tailored to match PLWHs current psychological
state based on five variables control beliefs, mood, stress, coping, and social support. Control
messages were tailored to create a mismatch between message framing and participants cur-
rent psychological state. We evaluated intervention feasibility based on acceptance, ease of
use, and usefulness measures. We also used pilot randomized controlled trial methods to test
the interventions effect on adherence, which was measured using electronic caps that recorded
Video abstract pill-bottle openings.
Results: Acceptance was high based on 76% enrollment and 85% satisfaction. Participants
found the hardware and software easy to use. However, attrition was high at 59%, and usefulness
ratings were slightly lower. The most common complaint was boredom. Unexpectedly, there
was no difference between mismatched and matched messages effects, but each group showed
a 10%15% improvement in adherence after crossing to the opposite study condition.
Conclusion: Although smartphone-based tailored messaging was feasible and participants had
clinically meaningful improvements in adherence, the mechanisms of change require further
study. Possible explanations might include novelty effects, increased receptiveness to new
information after habituation, or pseudotailoring, three ways in which attentional processes
can affect behavior.
Keywords: adherence, communication, feasibility, HIV, technology
Point your SmartPhone at the code above. If you have a
QR code reader the video abstract will appear. Or use:
http://youtu.be/7tbYkroHe-w
Introduction
Nonadherence to prescribed medications is a significant barrier to treatment of many
chronic diseases, and nowhere is this more important than in antiretroviral therapy
Correspondence: Paul F Cook (ART) for human immunodeficiency virus (HIV) infection. Adherence is most com-
University of Colorado College of
Nursing, Campus Box C288-04, Aurora,
monly defined in terms of the percentage of prescribed doses of medication that
CO 80045, USA a person actually takes.1 Persons living with HIV (PLWH) face particularly great
Tel +1 303 724 8537
Fax +1 303 724 8560
challenges because of the level of adherence required. Adherence of at least 80% is
Email paul.cook@ucdenver.edu acceptable for most chronic diseases such as diabetes and hypertension.2 However,

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http://dx.doi.org/10.2147/PPA.S88222
Patient Preference and Adherence 2015:9 13531366 1353
2015 Cook et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution Non Commercial (unported,v3.0)
License. The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further
permission from Dove Medical Press Limited, provided the work is properly attributed. Permissions beyond the scope of the License are administered by Dove Medical Press Limited. Information on
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Cook et al
PLWH are asked to maintain adherence levels of 95%
or higher because better clinical outcomes, including fewer
hospitalizations, fewer opportunistic infections, and higher
virologic suppression rates are associated with these higher
adherence levels.3
Varied interventions have been tested to improve
PLWHs adherence, but the success of these interventions
is highly variable.4 Tailoring messages to match patients
demographic and psychological characteristics is one strategy
that may increase the efficacy of adherence interventions:
Noar et al5 found in a meta-analysis of tailored print mes-
sages that 1) tailoring messages based on a theory is more
effective than tailoring on surface message features alone;
2) tailoring on four to six theory-based characteristics at
once has better results than tailoring on either more than
six or less than four variables; and 3) specific theory-based
strategies are effective, including tailoring on variables such
as perceived control (self-efficacy), social support, type of
coping strategy used, and level of motivation for change.
More frequent or ongoing messaging has also been recom-
mended as a way to enhance the efficacy of behavior change
interventions for PLWH.6
Mobile technology has grown in popularity and acces-
sibility, especially in the minority and lower-income groups
that are most heavily affected by HIV,7 and presents exciting
new opportunities for intervention. Technology-based adher-
ence interventions can have a broad reach and are potentially
more cost-effective than in-person counseling methods8
despite having slightly weaker overall effect sizes.6 To date,
most technology-based interventions to promote healthier
behavior have offered either nontailored reminders,9 or text
messages that are personalized by a human counselor using
clinical judgment.10 However, technology also makes it rela-
tively easy for investigators to automatically tailor messages
via an algorithm, using variables such as those identified
by Noar et al5 to optimize impact. Two recent studies11,12
have moved in this direction: in both studies, participants
selected a relevant barrier to adherence and then received a
message that was randomly selected from a pool of appropri-
ate content based on the selected barrier and other baseline
participant characteristics. One of these intervention stud-
ies showed positive effects on adherence,11 while the other
found no relationship between tailored message satisfaction
and adherence.12
Another appealing feature of mobile technology is the
ability to tailor messages based on an individuals psycho-
logical state at a particular point in time, rather than mes-
sages tailored to context-independent baseline variables
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as in past research. 11,12 Momentary states PLWHs
point-in-time thoughts, emotions, and motivation in the
context of their everyday lives have been identified as
predictors of their immediate behavior, and have different
relationships to behavior than the same variables measured
retrospectively.13,14 For example, mood, stress, and motiva-
tion are momentary state variables that fluctuate from one
point in time to another. With mobile technology it might
be possible to use momentary states as a basis for tailored
adherence messages. This type of personalized counseling
approach delivering different messages to different people
at different times is congruent with the current movement
toward personalized medicine in health care.15
Theoretical model and tailored message
development
For the current study, we developed a novel intervention in
which PLWH completed daily surveys about their momen-
tary states on a smartphone, and then immediately received
a message tailored based on their survey responses. First,
participants identified one of ten barriers to adherence that
they considered most relevant to them. Participants were
asked to identify a potential barrier regardless of whether
they were currently adherent, based on the idea that even
currently adherent patients can become nonadherent if bar-
riers increase. The list of barriers was generated with HIV
primary care experts, and ten base messages addressing those
barriers were created. These included statements such as,
Talk to your providers about any side effects, and, Keep
taking medication even when using alcohol or other drugs.
The note to Table 1 includes a complete list of barriers.
The ten base messages were designed to be as tailoring-
neutral as possible: that is, they were short, factual statements
presenting accurate information about ART adherence without
framing the message on any theory-relevant dimensions. Using
a computer algorithm, the message was then simultaneously
tailored along five separate dimensions. Specific tailoring vari-
ables were selected based on a model of momentary states and
behavior that was developed in our prior research16 and that
was tested in a project serving as a parent study for the current
investigation (Cook, unpublished data, 2012). Within each of
the five tailoring domains, two versions of a statement linked to
that domain were created as part of each of the ten messages,
based on relevant theories of health behavior (Table 1).
The theoretical model underlying the intervention
suggests that adherence behavior is based primarily on a
participants motivational state; the tailored messages were
therefore intended to work at the level of motivation by
Patient Preference and Adherence 2015:9
Dovepress Mobile health tailored messages for HIV medication adherence

Table 1 Message tailoring dimensions

Construct What is assessed Difference between Specific matching prediction Average construct
to determine tailored message and relevant theory of health validity rating of ten
tailoring versions behavior tailored messages
Control High vs low sense Emphasis on reasons for Problem-solving focus adherence for M =3.58 (SD =0.19)
beliefs of control over change (think about) high control beliefs; reasons for change
problems vs actions to take (do) better for low control beliefs (Prochaska
and DiClementes transtheoretical model33)
Mood Level of positive Focus on feared outcomes Feared consequences adherence M =3.86 (SD =0.31)
emotional arousal (permanent vs short-term), for high (positive) mood; lower-fear
(high vs low) and use of affect-inducing words presentation better for low (negative)
mood (Leventhals illness perception
model34)
Situational Level of current Deep focus (content) vs surface For high stress, surface focus M =3.69 (SD =0.29)
stress stress (high vs low) focus (vivid images, expert adherence; content focus better for low
from multiple quotes, personal relevance) stress when people process information
sources more deeply (Lazarus and Folkmans
coping theory35)
Coping Approach (domain Emphasis on benefits of behavior Gain frame adherence for high M =3.91 (SD =0.12)
of gains) vs avoidance change vs costs of not changing (active) coping; loss frame better for low
(domain of losses) behavior (passive) coping (Kahneman and Tverskys
prospect theory36)
Social Perceived current Focus on self vs others in Other-focus adherence if support M =3.72 (SD =0.26)
support social support (+) reasons for behavior change is seen as high; self-focus better if support
and stigma (-) is low (Bronfenbrenners socio-ecological
model37)
Notes: Construct validity ratings were made by 15 independent experts in health behavior change research, using a scale from 1= not relevant to 4= very relevant and
succinct. Ratings were averaged across experts, and across ten different base messages corresponding to different barriers to adherence. Experts also gave a rating of
3.84 points for the messages overall integration and consistency, and 3.89 points for their relevance to ART adherence and clinical utility, on the same 4-point scale. The
ten barriers identified through consultation with HIV primary care experts in a previous stage of development were: 1) low perceived importance of treatment, 2) lack of
confidence in treatment, 3) adverse effects of treatment, 4) feeling healthy, 5) feeling sick, 6) lack of financial resources, 7) treatment complexity, 8) stigma, 9) alcohol or
other drug use, and 10) forgetting.
Abbreviations: vs, versus; M, mean; SD, standard deviation; HIV, human immunodeficiency virus.

synchronizing message wording with momentary psychologi-
cal states. Messages were not designed to modify PLWHs
momentary states directly, but rather were presented in a way
that was hypothesized to make messages more acceptable to
people in specific states. For instance, when PLWH reported
high levels of perceived control, they were predicted to attend
more to internal motivators, eg, Taking care of your health
is something very important that you can do for yourself. By
contrast, PLWH reporting lower levels of perceived control
were hypothesized to respond better to external reasons for
behavior change, eg, People are counting on you to take the
best care of your health that you can.
To validate final messages, we used a five-step content
validity process described by Lynn:17 1) relevant content
domains were identified by the first author (ie, control beliefs,
mood, stress, coping, and social support); 2) a group of 15
experts (five or more experts are recommended) generated
possible message wordings for all five tailoring dimensions;
3) individual statements were combined into usable forms by
the principal investigator (PI); 4) seven experts (three or more
experts are recommended) judged the resulting statements
on each of the original domains; and 5) the same experts
judged the overall integration and consistency of the com-
plete messages, their relevance to ART adherence, and their
clinical utility. Results of this content validation process are
also shown in Table 1. All individual items were rated above
3.5 on Lynns 4-point scale; Lynn suggested that items with
scores of 3 or higher have acceptable content validity.17
Design and study aims
Our primary aim in the current study was to test the feasibility
of tailored messages matched to momentary states as a way
to improve PLWHs ART adherence. Feasibility testing is
an important step in the development of new technologies.
Any new technology can be characterized as either emerging,
promising, or effective in single or multiple contexts.18 Based
on the literature review presented above, although reminder
messages are likely to be effective to at least a moderate
degree in improving adherence, technology for systematically
tailoring messages is still at the emerging stage. Necessary

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Cook et al
further development steps include discovery, feasibility
testing with end-users, and efficacy testing to determine the
potential benefits of a technology-based intervention. During
feasibility testing, researchers measure participants accep-
tance of the new technology, their perceptions of its ease of
use, and their willingness to adopt this type of technology if
it were widely available. Feasibility testing is related to the
treatment delivery and receipt steps of intervention fidelity
assessment.19
In this study, we measured feasibility based on acceptance
of the intervention including recruitment and attrition, and by
participant self-report on perceived ease of use of the daily
surveys, and perceived usefulness of the new technology.
Ease of use and usefulness are orthogonal dimensions of
peoples experiences with technology, and both contribute
to a technologys ultimate adoption in practice.20 Ease of use
is defined as whether a technology is simple and convenient,
while perceived usefulness is defined as whether a technology
has potential benefits.21
As a secondary aim, we also conducted a pilot random-
ized controlled trial (RCT) using an experimental crossover
design to test the tailored messages effects on adherence.
Although pilot studies do not necessarily produce reliable
estimates of an interventions effects, they can be useful
in identifying its more or less useful aspects and can guide
revisions to make the intervention more efficacious in future
full-scale RCTs.22
Methods
Participants
This study gained ethical approval from the Colorado
Multiple Institutional Review Board and all participants
provided written informed consent. Participants were
37 PLWH recruited from a larger observational parent study
of momentary state predictors of ART adherence behavior,
who were receiving HIV care at the Infectious Disease Group
Practice at the University of Colorado Hospital, Aurora CO,
USA. The studys inclusion and exclusion criteria were
1) documented HIV infection and current ART treatment
based on medical records; 2) ability to speak, read, and write
English; 3) age over 18 years and less than 81 years old; and
4) no current substance abuse, cognitive impairment, psy-
chiatric or medical disorder, or other condition (as evaluated
by the participants HIV primary care clinician) that would
substantially interfere with study participation. Participants
were recruited during the second half of the parent study
from April 2013 through May 2014, and the current, second-
ary study ended as planned. Not all of the 87 parent-study
participants were recruited due to the more limited scope and
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shorter recruitment duration of the current study; however,
during the time the current study was recruiting, all PLWH
who completed the parent study were invited to participate.
There were no additional selection criteria beyond those
originally used in the parent study. Study flow is shown in
the CONSORT diagram in Figure 1.
Participants average age was M =42.6 years (standard
deviation [SD] =7.98 years), and 22% (8/37 participants) were
women. Of the 37 participants, 51% were minority group
members, including six Latino/Latina participants, eight
AfricanAmericans, three Native Americans, and two other
non-White participants. The majority of participants (22/37
participants, or 59%) were gay, lesbian, bisexual, or trans-
gender (GLBT), with the remaining 15 participants (41%)
identifying as heterosexual. Participants had M =13.0 years
of education on average (SD =2.16 years), equivalent to some
college, although a few participants had either less than a high
school education or a graduate degree. Participants average
level of ART adherence during the parent study was 80.0%
(SD =21.8%), and just over half of the participants (19/37
participants, or 51%) had an overall adherence level during
the parent study that was below the minimum recommended
level of 95%.
Sample representativeness
Compared to national epidemiology, our current sample
included a higher percentage of White men who have sex
with men and better-educated patients but the level of
diversity was high compared to the Western US region.
Because of the potential for sampling bias when participants
are recruited from a larger parent study, we tested for any
demographic differences between PLWH who participated
in this secondary tailored messaging pilot study and PLWH
who did not participate (either because of refusal or because
they ended the parent study before this secondary pilot study
began). We found no differences between participants and
nonparticipants in terms of age, sex, race/ethnicity, sexual
orientation, or years of education (all P-values .0.13), sug-
gesting an absence of sampling bias.
Baseline differences between groups
Table 2 shows participant demographics by group. As
is common in small studies, there were some failures of
randomization. Specifically, participants in the AB order
group (matched messages first) were more likely to be
women and less likely to be GLBT than participants in the
BA order group (mismatched messages first). These two
variables are related, because most women in the study
were heterosexual, while the largest subgroup of GLBT
Patient Preference and Adherence 2015:9
Dovepress Mobile health tailored messages for HIV medication adherence

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Figure 1 CONSORT diagram showing recruitment, enrollment, and retention.

Abbreviations: PLWH, persons living with HIV; HIV, human immunodeficiency virus; MEMS, medication event monitoring system; CONSORT, Consolidated Standards of
Reporting Trials.

participants consisted of patients who were men who have
sex with men. Sex was therefore included as a covariate in
subsequent analyses, but sexual orientation was not included,
because of multicollinearity between these two variables.
There were no baseline differences between groups on
other important covariates like age, race/ethnicity, or years
of education. There was a nonsignificant but still relatively
large difference in baseline ART adherence, 72% in the
AB order group versus 87% in the BA order group. There
was also a nonsignificant but still potentially meaningful

Table 2 Participant demographics by order of study conditions

Variable AB condition order BA condition order Significant difference? Yes/no
(matched first) (mismatched first)
Age, years M =43.7 (SD =5.87) M =41.8 (SD =9.23) No: t(30) =0.71, P=0.48, d =0.25
Sex 35% women (6/17) 10% women (2/20) Yes: 2=4.59, P=0.03, =0.37
Race/ethnicity 47% non-White (8/17) 55% non-White (11/20) No: 2=0.003, P=0.06, =0.01
3 Latino/Latina 3 Latino/Latina
2 AfricanAmerican 6 AfricanAmerican
1 Native American 2 Native American
2 other ethnicity
Sexual orientation 29% GLBT (5/17) 85% GLBT (17/20) Yes: 2=10.5, P=0.001, =0.56
Years of education M =12.9 (SD =1.45) M =13.0 (SD =2.54) No: t(27) =0.11, P=0.92, d =0.04
Baseline MEMS M =72% (SD =22%) M =87% (SD =20%) No: t(25) =1.85, P=0.08, d =0.64
adherence (%)
Abbreviations: MEMS, medication event monitoring system; SD, standard deviation; GLBT, gay, lesbian, bisexual, or transgender; M, mean.

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Cook et al
difference in the number of study observations completed in
each of the two conditions, as reported below in the findings
about acceptance. Despite the lack of statistical significance,
we included these potential confounds as covariates in our
outcome analysis.
Procedures
Baseline data collection
A research assistant met individually with each participant
in a consultation room at the clinic where the participant
regularly received HIV care. Each participants most recent
CD4 and viral load laboratory test results, which were usu-
ally collected within the past 3 months as per standard of
care, were extracted from clinic charts with the participants
authorization. As part of the parent study, each participant
had already received a smartphone, had completed baseline
questionnaires, and had provided demographic informa-
tion. During their participation in the parent study, PLWH
had also completed 3 months of daily smartphone-based
surveys about their control beliefs, mood, stress, coping,
social support, and motivation, and had stored their ART
medication in medication event monitoring system (MEMS)
pill bottles that electronically monitored bottle openings
as a measure of adherence. Surveys were completed once
daily, at random times determined by the software. The
parent study involved assessment only; no tailored mes-
sages were delivered.
Randomization
Group assignment was generated using simple randomization
by the research assistant at the time the participant completed
the parent study. For the first 2 weeks, participants were
randomized to receive either matched messages (AB mes-
sage order) or mismatched messages (BA message order).
Participants then crossed over to the other study condition
(mismatched or matched) to complete surveys and to receive
the other type of messages for a final 2 weeks before a
concluding in-person study visit. As in the parent study,
participants were paid US $25 for the in-person visit. The
investigators also paid for another month of data service on
the participants smartphone so that he or she could continue
to complete surveys and receive tailored messages. Par-
ticipants were blind to their initial group assignment and to
which intervention condition was considered the active one,
although they were informed as part of the studys consent
process that there would be 2 weeks of messages matched to
their survey responses and 2 weeks that were mismatched.
The research assistant who administered questionnaires also
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generated the allocation sequence, resulting in a single-blind
study.
Message delivery
During the current secondary intervention study, participants
continued answering surveys on their smartphones for another
4 weeks, again once daily at times randomly determined by
the software. The same survey questions were used as in the
parent study. However, at this point, tailored messages were
generated by an algorithm in the survey software based on the
participants responses, and were delivered immediately after
completion of the daily survey. The survey was completed
on a Samsung phone (Samsung Electronics Co, Ltd, Suwon,
South Korea) with an Android operating system (Google, Inc,
Mountain View, CA, USA) and pre-installed Apptive (Austin,
TX, USA) software to deliver the daily tailored messages. The
intervention message appeared as an alert on the device, which
also retained all other telephone and data capabilities. Each
message contained a URL to an online survey that opened in
the smartphones built-in web browser. Web-based surveys
were completed online using SurveyMonkey (Palo Alto, CA,
USA), and survey questions asked about the participants
current medication adherence and motivation to take ART
medication; in addition, questions on five theoretically rel-
evant aspects of participants daily experiences were used
to tailor intervention messages, as described in Table 1. The
researchers pre-programmed tailored messages in Survey-
Monkey using the softwares decisional logic capabilities to
either match or mismatch message text to participants survey
responses, depending on which study condition the participant
was assigned to at that point in time.
Tailored messaging intervention
Each time an intervention was delivered, the participant was
first asked to select one of ten possible barriers to adher-
ence. The participant then received a tailored text message
addressing the barrier he or she had selected. A single base
message for the selected barrier was tailored based on a theo-
retical model of momentary state influences on behavior, as
described in the Introduction section. A cut-off score was
used for each of the momentary state subscales to classify
participants as either high or low with respect to each of
the five variables. Separate components of the message were
then tailored based on each of the five variables. Figure 2
shows sample messages that are matched and mismatched
based on a particular set of momentary states, and identifies
the message components that were tailored based on each of
the five measured variables. With two versions for each of
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Patient description: Imagine that a participant has decided to
stop taking medication, and her survey results show low control
beliefs, positive mood, high stress, active coping, and high
social support. The same participant would receive the following
message in a matched week:
IMPORTANT MESSAGE: A vacation from meds is no
vacation for you! Its not easy to take medication every
MATCHED
day. Taking all of your HIV medication is essential to
prevent getting sicker. People are counting on you to
take the best care of your health that you can. Think
about what makes ithard for you to take medication right
now, and tell your health care providers.
The same participant, with the same set of momentary states,
would receive the following message instead in a mismatched
messaging (control group) week:
HIV medications work best when taken at least
95% of the time. You can take control of your health.
MISMATCHED
Skipping doses or taking a break from HIV medication
can make your HIV worse. Taking care of your health
is something very important that you can do for
yourself. Keep taking your medication! Dont stop or skip
without talking to your health care providers first.
This message is predicted to be less acceptable to participants
with the same set of momentary states, who will be more likely
to discount the information. The second message might still
improve adherence, but is expected to have a weaker effect
than the theory-matched message.
Key to tailored message components:
Bold = tailored for stress level (high stress = more dramatic or
emotional, low stress = more factual)
Italics = tailored for control beliefs (high control = action focus,
low control = support focus)
Small caps = tailored for coping (high coping = gain-focused,
low coping = focus on avoiding loss)
Underline = tailored for mood (four options, nested within coping
messages: positive mood = more fear-arousing message framing,
negative mood = less fear-arousing message framing)
Bold italics = tailored for social support (high support = other-
focused, low support = self-focused)
Figure 2 Example of tailored messaging intervention.
Abbreviation: meds, medications.
five momentary state variables for each of ten barriers, the
tailoring intervention had a total of 320 possible message
variations (2510) in each study condition.
Mismatched message control group
During the 2 weeks when they were assigned to the mis-
matched message control condition (either before or after the
crossover, depending on random assignment), participants
again completed daily surveys about their momentary states
and barriers to adherence, but this time they received a mes-
sage that was systematically tailored in the opposite way
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Mobile health tailored messages for HIV medication adherence
from what we theoretically predicted would most facilitate
participants use of the message. Thus, we expected any
given message wording to facilitate adherence under some
psychological conditions (when it was a matched message)
but not others (when it was mismatched). Because matched
and mismatched messages were identical in length, delivery
method, amount of tailoring, and factual content, we expected
the mismatched-message condition to provide a relatively
strong control for pseudotailoring effects that have been
documented in the literature.23 Pseudotailoring is a phenom-
enon in which participants respond better to a message if
they believe it has been generated especially for them. Such
messages may seem more salient to the participant, but do
not contain active ingredients based on relevant theory.
Mismatched messages are equivalent to matched messages
in terms of their potential for pseudotailoring effects, but
because they are tailored in exactly the opposite way from
what theory predicts should be effective, they should have
weaker effects on behavior. In the current study, we com-
pared messages that were either completely matched or
completely mismatched on five dimensions simultaneously,
which did not allow us to identify the effects of individual
message components, but did provide the strongest com-
parison possible.
Measures
Primary outcomes: feasibility of new technology
Because the primary aim of this study was to examine fea-
sibility of the new smartphone-based tailored messaging
intervention, the primary outcome measures focused on
acceptance, ease of use, and perceived usefulness, which
are constructs of the technology acceptance model.21 At the
end of the parent study, participants completed a self-report
technology acceptance questionnaire about acceptance of the
daily smartphone-based survey. By that point in time, they
had been using the technology to complete daily surveys
for 12 weeks, but had not received any tailored messages.
Acceptance was measured with a single question: What
number best represents your attitude toward the smartphone
survey tool?. Answers were measured on a 0100 scale with
reference points at 0= completely unacceptable, 50= neutral,
and 100= completely acceptable. Our analysis of acceptance
also considered study enrollment and attrition data as indirect
behavioral evidence of acceptance.
To measure ease of use, the technology acceptance ques-
tionnaire also included a series of items developed by a nurse
informaticist, (Dr. Jane Carrington) on concepts including
overall ease of use, consistency, efficiency, memorability
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Cook et al
of the items, level of language used, perceived cognitive
load, format in which information was presented, errors,
and overall performance of the device. These items were
subjected to exploratory factor analysis using data from the
parent study, and the initial pool of 24 items was reduced
to a 12-item ease of use scale (Cronbachs alpha =0.96)
representing general satisfaction with the technology, the
survey questions, the smartphone hardware, and the tailored
messages For example, one question asked, Did using the
survey feel natural to you?. Response choices ranged from
exceptionally unnatural to exceptionally natural.
Finally, participants completed a tailored messaging
survey at the end of the intervention phase, which asked
them more specific usefulness questions about the tailored-
messaging intervention and their willingness to use this
technology for adherence support. Sample items included,
If you had it to do over again would you still enroll in this
study? and, Would you recommend a similar program to
a friend who was taking the same medication?. One ques-
tion about personalization of the survey items was dropped
because it did not load with the others; Cronbachs alpha was
0.72 for the resulting seven-question scale. Two items about
participants behavioral intentions were also examined indi-
vidually. Finally, three open-ended questions on this survey
asked participants if any messages seemed wrong, offensive,
or unhelpful, what changes to the messages they would sug-
gest, and what other feedback participants could offer.
Manipulation check on the tailored
messaging intervention
A separate question on the tailored messaging survey asked
whether participants noticed any differences between the
intervention and control messages. We believed that our
tailoring strategy was relatively subtle and that participants
would be unable to notice a major difference, which is
important because participants otherwise might not have
found the matched and mismatched messages to be equally
credible or because noticeable differences might have led to
pseudotailoring effects. Three additional questions similarly
asked whether the participant noticed any difference in how
personalized the messages were, in how helpful the messages
were, or in how much the participant liked the messages.
Secondary outcome: effect of the intervention on
adherence
For our secondary aim, we measured adherence using MEMS
caps, electronic devices that record actual pill bottle openings
in real time.1 MEMS are regarded as a relatively objective
measure, have low reactivity after a 6-week initial run-in
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(completed during the parent study), and capture real-time
data about adherence.24
Data analysis
For the first aim, we examined descriptive statistics and
visualized data on the feasibility domains of acceptance,
ease of use, and perceived usefulness. Data were relatively
complete for the acceptance and ease-of-use self-report mea-
sures, and complete for the behavioral acceptance measures
of enrollment and attrition, but the usefulness measure was
administered only at the end of the crossover condition,
resulting in a high proportion of missing data due to attrition.
Descriptive analyses for Aim 1 used available observations
only with no adjustment for missing data.
For the second aim, we first examined descriptive results
on the manipulation check items, with the goal of testing
whether participants found the matched and mismatched
messages equally credible. We next tested for any between-
group differences in baseline demographic characteristics that
might indicate failures of randomization. Finally, we analyzed
MEMS data across groups and over time using a 22 repeated-
measures analysis of variance (ANOVA). We expected to
find an interaction between initial group assignment (matched
versus mismatched) and time showing that matched messages
improved adherence more than mismatched messages did
within each experimental group. We did not expect a main
effect of condition, because all participants eventually received
both interventions. The analysis controlled for participants
baseline adherence, and for the number of days of tailored
messages actually received in case there were dose-response
effects. No power analysis was completed for the current
preliminary study, because effect size estimation rather than
statistical significance testing was the primary goal; sample
sizes of 30 or greater are generally considered adequate for
this type of pilot study.25 The MEMS measure had some miss-
ing data, 33% of observations in the AB group and 37% of
observations in the BA group. While this amount of missing
data is slightly outside the 30% level at which missing data can
be imputed without bias,26 MEMS observations appeared to be
missing at random with respect to participant demographics
or baseline adherence. Therefore, missing data points were
handled using multiple imputation prior to analysis.
Results
Aim 1: feasibility of the tailored messaging
intervention
Acceptance
The recruitment process suggested high acceptance based on
the 76% enrollment rate among PLWH who were offered the
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chance to participate (37/49 patients; Figure 1). This high
level of acceptance must be considered in context, because
participants had already been involved in a previous study
and were receiving a month of smartphone data service as
an incentive for participation. However, participants also
rated the intervention very acceptable based on a 0100
visual analogue scale (mean (M) =85%; SD =17.9%) with
no ratings below 50%. Table 3 shows self-reported accep-
tance results, together with scores on the ease of use and
perceived usefulness measures. In exploratory correlations
with participant demographics, we found no relationship
between acceptance and either participants sex or minority
race/ethnicity (all P-values .0.33), but there was a signifi-
cant negative relationship between the overall acceptance
rating and participants age (r=0.66; P=0.02), meaning that
older adults found the tailored messaging intervention less
acceptable than younger adults did.
We examined attrition from the study (also shown in
Figure 1), including the number of tailored messages actually
received, as an additional behavioral measure of acceptance.
All participants received at least one tailored text message.
The average number of messages received by participants
was higher during the 14 days they received matched mes-
sages (M =10.7 messages; SD =12.7 messages, versus M =6.0
messages; SD =8.6 messages) during the 14 days they spent
in the mismatched study condition. Although this differ-
ence was not statistically significant (P=0.48), it might
suggest better acceptance of the matched messages than of
the mismatched messages. Additionally, 22/37 participants
failed to complete the second (crossover) part of the study,
an attrition rate of 59%. These participants generally failed
to return for scheduled appointments and did not complete
end-of-study paperwork or respond to multiple outreach
attempts. No participants reported leaving the study because
of difficulty using the technology. This high attrition rate
should again be considered in the context of the parent study,
where participants had already been completing surveys
on a smartphone for 3 months at the time they enrolled in
this secondary study. Therefore, participants perceptions
Table 3 Summary statistics for self-report feasibility measures
Variable N Possible range
Acceptance 14 0100
Ease of use 25 17
Usefulness 5 04
Would do it again 5 04
Would recommend to a friend 5 04
Notes: N varies by analysis because the technology acceptance questionnaire was completed by participants at the end of the baseline phase for the first two measures (with
some missing data on the acceptance item), and the tailored messaging survey was completed at the end of the intervention phase, with sample size affected by attrition.
Results on the perceived usefulness measures are therefore less reliable.
Abbreviations: SD, standard deviation; N, number of responses; M, mean.
Patient Preference and Adherence 2015:9
Mobile health tailored messages for HIV medication adherence
of burden may have been higher in our sample than would
otherwise have been the case.
Ease of use
The ease-of-use measure had a mean rating of 5.96 out of
7possible points (SD =1.06 points), showing relatively high
satisfaction with the ease of receiving and understanding text
messages about adherence. The ease-of-use scale had no cor-
relation with participants sex or minority race/ethnicity (all
P-values .0.17), but did have a significant negative correla-
tion with participants age (r=-0.48; P=0.03), meaning that
older participants found the daily surveys harder to use.
Usefulness
On the tailored messaging survey, participants gave the inter-
vention a rating of 2.85 points (SD =0.32 points) out of 4pos-
sible points, indicating that it generally or mostly met their
needs. Two items about participants behavioral intentions
were also examined individually. On these items, participants
also indicated a relatively high level of willingness to receive
this type of support message if they could do it over again
(M =3.00 points; SD =0.00 points), and an even higher level
of willingness to recommend the survey and messages to a
friend who was taking similar medication (M =3.40 points;
SD =0.55 points). On open-ended feedback items, partici-
pants said that all text messages were appropriate and accept-
able. Results on these usefulness measures were limited by
attrition as shown in Figure 1, because these items were not
completed until the end of the study. Importantly, there were
no adverse events reported during the study, suggesting little
potential for harm even when messages were systematically
mismatched to participants survey responses.
Manipulation check: lack of perceived
differences between study conditions
As expected, participants perceived few differences between
the intervention and control conditions, with 20% saying
there were no differences between the first 2 weeks and
second 2 weeks of the tailored-messaging intervention, 40%
M (SD) Minimum Maximum
85.3 (17.9) 49 100
5.96 (1.06) 3.24 7.00
2.79 (0.23) 2.50 3.13
3.00 (0.00) 3.00 3.00
3.40 (0.55) 3.00 4.00
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Cook et al
saying there was a small difference that was barely notice-
able, and the remaining 40% saying there was a noticeable
difference but not a large or important one. These findings
suggest that the message framing intervention was relatively
subtle, as intended. Similarly, 80% of respondents said that
both sets of messages related equally well to their needs
across the matched and mismatched conditions, with the
remaining 20% saying that neither set of messages seemed
to relate well to their needs. These responses also suggested
a lack of perceived differences between message types.
When asked how much they liked the tailored messages,
60% of participants again said there was no difference
between study conditions, with 20% reporting a noticeable
difference and another 20% saying there was a large and
important difference in how much they liked the messages.
Finally, when asked how helpful the messages were, 20%
said there was no difference, and 40% said there was only
a small difference in helpfulness of the tailored messages
across study conditions. On this item, however, 40% of
participants did rate the difference in helpfulness between
study conditions as noticeable. No participants chose the
most extreme category stating that differences in helpfulness
were large and important. Unfortunately, due to the way these
questions were worded (ie, Did you notice a difference?),
it was not possible to determine which set of messages the
participants considered more acceptable or helpful. At first
glance, an assumption might be that participants preferred
the matched messages, but the adherence results below could
lead one to question this assumption.
Aim 2: effect of the intervention
onadherence
After controlling for baseline adherence level, sex, and the
number of days with a study observation, there was a sta-
tistically significant effect of time in the repeated-measures
ANOVA (multivariate F (1, 20) =5.50; P=0.03; 2=0.16). This
result indicates that both groups adherence improved from
the initially assigned messaging condition to the crossover
condition, regardless of the order in which the two condi-
tions were presented AB or BA (Figure 3). The expected
interaction between initial group assignment and time
was nonsignificant, and the observed effect size was small
(multivariate F (1, 20) =0.18; P=0.68; 2=0.005). There was
also no overall difference between experimental conditions
(F (1, 20) =0.17; P=0.90; 2=0.0005). The most plausible threat
to validity in this analysis was attrition: because relatively few
participants completed the crossover phase, it seemed possible
that participants who remained were simply more adherent
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Estimated marginal means
Order of
85%
groups
Adherence based on MEMS
AB
BA
83%
80%
78%
75%
73%
Initial group as Second (crossover)
randomly assigned group
Study phase
Figure 3 Change in adherence over time.
Notes: AB order = matched, then mismatched messages; BA order = mismatched,
then matched messages. Covariates in the model are evaluated at the following
average values: sex =0.72 (1= male, 0= female); baseline MEMS =0.8354; number of
days with observations =7.48 days.
Abbreviation: MEMS, medication event monitoring system.
overall, a nonrandom source of attrition that would call into
question our use of imputation for missing data. We checked
for this possibility in a sensitivity analysis that used only cases
with complete data for both the intervention and crossover
phases, and found an identical pattern of results: there was no
difference between matched and mismatched messages, but
there was an overall increase in adherence from the originally
assigned intervention (regardless of which one was assigned)
to the crossover phase. Additionally, there was no difference
in baseline adherence between patients who remained in the
study (M =81.8%) and those who dropped out prematurely
(M =80.0%; t(25) =0.16, P=0.88). Findings from these analy-
ses gave us greater confidence in the obtained results.
Discussion
The current study was designed to evaluate feasibility of a
novel text-messaging intervention to promote ART adherence
based on PLWHs psychological state at the time the message
was received. The intervention was feasible based on accep-
tance (as shown by a 76% enrollment rate and a 0100 visual
analogue scale rating of 85%) and participants high ratings
of ease of use for the daily surveys. Perceived usefulness was
slightly lower, with ratings between a little bit and mostly
useful on a 4-point scale, so there appeared to be room for
improvement in terms of making the intervention appealing
Patient Preference and Adherence 2015:9
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to PLWH. The usefulness findings were more tentative,
because they were based on a questionnaire completed at the
end of the study when results were affected by attrition. Never-
theless, perceived usefulness affects peoples sustained use of
a new technology over time,27 so the slightly lower usefulness
ratings suggested a need to make the intervention more appeal-
ing in order to maximize its chances for successful adoption
in practice. On the other hand, there were no comments sug-
gesting problems with the message content, and no adverse
events even when messages were systematically mismatched
to PLWHs momentary states. Participants reported occasional
problems using the hardware and software; in particular, lim-
ited battery life and a tendency to miss messages when the
phone was powered down were common reported problems.
The main concern appeared to be that the technology could
be made more exciting or engaging to promote repeated use
over time, not that there was anything specifically unaccept-
able about the tailored messaging intervention.
The present study had a relatively high rate of attrition, and
it is unknown whether the same usefulness considerations led
participants to discontinue. We checked baseline adherence as
a potential confound, and there was no evidence that partici-
pants decision to leave the study was related to their overall
level of medication adherence. Anecdotally, the most com-
mon complaint was simply that surveys and messages were
too repetitive, that the intervention became boring over time,
and that participants wanted more variety. This might relate
to the fact that participants perceived few differences among
tailored messages, even between the completely matched
and completely mismatched message conditions. It is also
possible that some participants actually had limited variety
in the messages received: although there were 320 possible
messages overall, if participants reported essentially the same
momentary states and selected the same adherence barrier
each day, they would have received the same or almost the
same message each time. Alternately, participants might have
abandoned the intervention as a result of alert fatigue, which
could be addressed by delivering less frequent messages.
The current pilot RCT results in aim 2 showed no differ-
ence between the matched and mismatched message conditions
overall, with an effect size very close to zero after controlling
for covariates. This result implied that tailoring messages
based on relevant theory did not have a strong effect, contrary
to both our expectations and prior meta-analytic findings.5
Only a few prior studies11,12 have utilized tailored messages
that are systematically tailored based on algorithms, but the
available evidence for this type of intervention is mixed, and
the current study seemed to suggest no benefit of systematic
Patient Preference and Adherence 2015:9
Mobile health tailored messages for HIV medication adherence
tailoring. However, we did observe an unexpected but signifi-
cant improvement in adherence at the time of the crossover
between groups, regardless of whether participants crossed
from intervention to control or the reverse. The improvement
was equivalent to about a 15 percentage point gain in adher-
ence, which is a potentially clinically meaningful effect. This
surprising finding requires further exploration.
One possible explanation is a novelty effect; educational
technology researchers have long known that simply intro-
ducing a different element can cause people to attend to their
environment more carefully, regardless of what the difference
entails.28 Therefore, simply noticing that the messages had
changed might have been enough to make participants attend
to their content more closely and to follow advice contained
in the messages. This type of effect has been documented in
one other intervention using electronic tailored messaging
to improve health behavior, where both the intervention and
control groups showed improvement.29 One argument against
this interpretation is that participants noticed few differences
between the original study condition and the crossover condi-
tion, so they might not have noticed that the second condition
was novel or different compared to the first. A variation on this
idea is that repetitive messages might actually lull people into
a more receptive state, a principle used in clinical hypnosis.30
Such effects might arise even if participants did not consciously
notice a difference in message content. This explanation is
potentially supported by the complaint that messages were
boring or repetitive; although repetition of the same message
reduces attention, it may also make novel or different messages
more salient.31 Pseudotailoring effects23 are a third possible
explanation if participants believed the second condition was
better matched to their individual needs simply because they
had been answering surveys longer by that time. Again, the
fact that participants noticed few differences between study
conditions might be an argument against this interpretation.
Study limitations
There were minor failures of randomization in this small-N
pilot study, which we addressed in the analysis by controlling
for baseline between-group differences. There might have
been differences in other unmeasured variables even though
random assignment was used. Missing data were another
concern, and slightly exceeded the level at which imputation
is bias-free; nevertheless, modern data imputation procedures
are considered to provide more accurate parameter estimates
than traditional case-deletion missing data strategies, even
when some bias may be present.26 We therefore imputed
missing data despite this limitation, an approach supported
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Cook et al
by the fact that MEMS values appeared to be missing at
random with respect to baseline participant characteristics,
including initial adherence.
Selection bias was a potential concern, because partici-
pants were recruited from a previous study and had completed
3 months of prior daily surveys; however, there were no
demographic differences between PLWH who started the par-
ent study and those who continued into the current secondary
intervention pilot study. Perhaps the greatest remaining meth-
odological limitation in the present study was the high rate of
attrition between the initially assigned experimental condition
and the crossover condition, which may reduce confidence in
our results on usefulness and adherence. However, acceptance
and ease-of-use ratings were completed at the baseline time
point and were not affected by attrition, and we conducted a
sensitivity analysis using complete cases to verify that improve-
ments in adherence were not an artifact of attrition. All of these
limitations could be addressed in a future full-scale RCT.
Implications for practice and research
Although a smartphone-delivered tailored messaging interven-
tion was feasible for improving adherence in PLWH, it did not
show evidence of efficacy in the way that we expected. The
results demonstrated that daily tailored messages can improve
adherence, but the way in which they do this is still an open
question. The current intervention was designed to assess
momentary states and to use information about them to affect
participants motivation, but not to modify the underlying
states directly. There is some evidence that momentary states
do predict adherence behavior in PLWH,16 so these states may
yet be a viable target for intervention. An alternative approach
might be to design tailored messages that directly modify
momentary states, rather than trying to use momentary states
as a way to indirectly affect motivation. Such a strategy might
lead to greater differences in message content to reduce par-
ticipants sense of boredom and to generate stronger effects.
Second, analyses currently underway from the parent
study suggest that motivation does play a mediating role
between other momentary states and behavior. It might be
possible to retain motivation as the target for a daily text-
messaging intervention, but to do so in a different way.
For instance, the variables of importance, confidence, and
readiness are often identified as aspects of motivation in
motivational interviewing, and these are alternative dimen-
sions that could be used to tailor daily adherence messages.32
This strategy would allow us to retain the principle of work-
ing at the level of motivation that guided the current study,
but to implement this principle in a different way.
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Dovepress
A third development option might be to abandon the
motivational model, but capitalize on the novelty effect
produced when messages differ from one another over
time. This strategy would mean providing PLWH with a
wide range of interesting messages to keep their attention,
with the idea that simple variations might be more useful
than algorithm-driven matching of messages to participant
characteristics. Such a strategy could incorporate additional
features of currently available smartphone technology,
such as YouTube videos, audio clips, interactive graphics,
or gamification strategies like contests, badges, and leader
boards. The more characteristics of a message that change
at once, the weaker the ability to identify active ingredients
or to control for potential pseudotailoring effects,5 but this
methodological concern might be secondary to the clinical
need for a more efficacious version of the intervention. Modi-
fying other characteristics of the intervention such as dose
(message length or level of detail) and frequency (number
of messages per day), or including suggestions that address
practical barriers to care such as transportation, might also
contribute to a stronger effect.
Conclusion
Smartphone-based tailored messages are an appealing mobile
health modality that can potentially address limitations of
prior adherence interventions. Tailored messages can address
theoretically relevant psychological variables that are assessed
in the moment, and can deliver information that is potentially
more relevant to the immediate context of PLWHs daily lives.
In the current study, we successfully delivered tailored mes-
sages to PLWH over a period of 4 weeks. PLWH were willing
to participate in the intervention, gave it high ratings for accep-
tance and ease of use, and gave it moderately high ratings for
perceived usefulness. These factors could likely be improved
by varying message content and/or format to maintain par-
ticipants interest, strategies that might also reduce attrition.
Tailored messages have the potential to improve adherence to
a clinically meaningful degree, although theory-based tailoring
did not appear to be the active ingredient, and the mechanisms
by which smartphone-delivered messages actually affect
PLWHs adherence behavior are still unclear.
Acknowledgments
This research was supported by an intramural grant from
the University of Colorado College of Nursing, and by
grant number 1R21NR012918 from the National Institute
of Nursing Research. The authors wish to thank Ms Laurra
Aagaard for assistance with recruitment and follow-up,
Patient Preference and Adherence 2015:9
Dovepress
and staff at the University of Colorado Hospital Infectious
Disease Group Practice for their support of this study.
Disclosure
In the past 12 months, Dr Cook has received grant support
from Merck & Co Inc, from the Colorado Health Founda-
tion, and from several US Federal Government agencies,
and has served as a consultant for Takeda Inc, the Opto-
metric Glaucoma Society, and Academic Impressions Inc.
Dr Carrington has received grant support from the US
National Institutes of Health. The authors report no other
conflicts of interest in this work.
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Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
DOI 10.1186/s12911-016-0321-4

STUDY PROTOCOL Open Access

The effect of an interactive weekly

mobile phone messaging on retention
in prevention of mother to child
transmission (PMTCT) of HIV program:
study protocol for a randomized
controlled trial (WELTEL PMTCT)
Patricia Opondo Awiti1*, Alessandra Grotta2, Mia van der Kop3,4,5, John Dusabe1, Anna Thorson1,
Jonathan Mwangi1, Rino Belloco2, Richard Lester6, Laura Ternent7, Edwin Were8 and Anna Mia Ekstrm1

Abstract
Background: Improving retention in prevention of mother to child transmission (PMTCT) of HIV programs is
critical to optimize maternal and infant health outcomes, especially now that lifelong treatment is immediate
regardless of CD4 cell count). The WelTel strategy of using weekly short message service (SMS) to engage patients in
care in Kenya, where mobile coverage even in poor areas is widespread has been shown to improve adherence to
antiretroviral therapy (ART) and viral load suppression among those on ART. The aim of this study is to determine the
effect of the WelTel SMS intervention compared to standard care on retention in PMTCT program in Kenya.
Methods: WelTel PMTCT is a four to seven-centers, two-arm open randomized controlled trial (RCT) that will be
conducted in urban and rural Kenya. Over 36 months, we plan to recruit 600 pregnant women at their first antenatal
care visit and follow the mother-infant pair until they are discharged from the PMTCT program (when infant is aged
24 months). Participants will be randomly allocated to the intervention or control arm (standard care) at a 1:1 ratio.
Intervention arm participants will receive an interactive weekly SMS How are you? to which they are supposed to
respond within 24 h. Depending on the response (ok, problem or no answer), a PMTCT nurse will follow-up and triage
any problems that are identified.
The primary outcome will be retention in care defined as the proportion of mother-infant pairs coming for infant HIV
testing at 24 months from delivery. Secondary outcomes include a) adherence to WelTel; (b) adherence to antiretroviral
medicine; (c) acceptance of WelTel and (d) cost-effectiveness of the WelTel intervention.
Discussion: This trial will provide evidence on the effectiveness of mHealth for PMTCT retention. Trial results and the
cost-effectiveness evaluation will be used to inform policy and potential scale-up of mHealth among mothers living
with HIV.
Trial registration: ISRCTN98818734; registered on 9th December 2014
Keywords: Mobile health (m-health), Retention, HIV/PMTCT, Antiretroviral therapy (ART), Kenya

* Correspondence: Patricia.Awiti@ki.se
1
Department of Public Health Sciences, Karolinska Institutet, 171 77
Stockholm, Sweden
Full list of author information is available at the end of the article

2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
Background
HIV and maternal and newborn health in Kenya
Identification and rollout of the most cost-effective in-
terventions to eliminate HIV infections and AIDS death
among women and children is a key priority for Kenya.
According to the AIDS Response Progress Report 2014,
the number of people living with HIV (PLHIV) in Kenya
has increased by 15 % over the last 4 years, reaching 1.6
million cases in 2013, with an estimated incidence of100
000 new HIV infections in 2014 [1]. Women represent
about 57 % of all PLHIV in Kenya and close to 1 %
(101,000) of all Kenyan children are living with HIV, cor-
responding to 10 % of all PLHIV [1]. As many as 11 000
Kenyan children were estimated to be newly infected in
2013, mainly through mother to child transmission
(MTCT). Thus, Kenyas commitment to eliminate
MTCT of HIV by 2015 will not be achieved, but im-
provements have been made. Over the last decade, the
number of HIV-infected pregnant women in need for
PMTCT in Kenya has also declined, albeit too slowly,
from 98,000 in 2004 to 79,000 in 2013 [1]. Since 2013,
Kenya has adopted PMTCT Option B+, the World
Health Organization guideline recommending all preg-
nant women living with HIV receive immediate HIV
treatment for life regardless of immune defense (CD4
count), a strategy called PMTCT Option B+ [2].
Antiretrovirals (ARVs) during pregnancy, delivery and
breastfeeding, and for the infant 6 weeks post-delivery
can reduce the risk of transmission from 35 % to <2 %
in low-income countries [3]. Key strategies to finally
eliminate MTCT include increased knowledge of
PMTCT, increased involvement from the male partner,
universal attendance of antenatal care (ANC) by preg-
nant women, universal testing of pregnant women for
HIV and provision of ARVs from early pregnancy
throughout the breastfeeding period, and facility delivery
[4]. Kenyas progress on these goals is uneven. While the
proportion of pregnant women tested for HIV has in-
creased from 68 to 92 % in the last 5 years [1], only 5 %
of male partners accompanied their pregnant partner to
ANC [1]. PMTCT coverage (the number of pregnant
women living with HIV started on ARVs before delivery)
declined in Kenya from 86 % in 2010 to 73 % in 2013,
i.e. 58,000 out of 79,000 pregnant women living with
HIV were offered PMTCT services [1]. This was partly
due to the multiple challenges of implementing Option
B+, which is much more resource demanding.
Only 50 % in need of PMTCT were given ARVs
within 6 weeks of their HIV diagnosis [1], a service
delay that may cause avoidable MTCT. Only 45 % of
all HIV-exposed infants were tested for HIV, i.e. the
majority of children were lost to follow up leading to
preventable child deaths [1]. Because of these short-
comings, the proportion of HIV-exposed children who
Page 2 of 8
became HIV-infected has halted at 14 % in the last
3 years. If Kenya is to achieve the global target of
eliminating MTCT of HIV, initially aimed for 2015,
this trend needs to be reversed through new and
more effective interventions.
Mobile phone use for information and health service
strengthening in Kenya
The rapid expansion in mobile phone technology in
Africa has created new opportunities for information
sharing and service delivery where other infrastruc-
ture, such as cable connectivity and constant electri-
city supply is inadequate. In 2013, 82 % of Kenyan
households owned a mobile phone [5], reaching
100 % of 2029 year-olds i.e. the age-period when
most women give birth [6]. In fact, Kenya has the
worlds highest proportion of cell phone owners
(80 %) who use mobile banking, and 60 % of Kenyans
living on less than $2,50 i.e. under the poverty line,
have mobile phones [6].
Mobile technology for health (mHealth) is increas-
ingly being used to overcome shortcomings in infor-
mation systems, laboratory equipment and human
resource capacity in low-income countries. Within
maternal and child health care (MCH), mobile tech-
nology has been used to link ANC with pregnant
women and new mothers [7], to remind community
health workers in rural areas [8] and to submit sur-
veillance reports on disease outbreaks and delivery of
services [9]. Other uses of mHealth include registra-
tion of records [10] and monitoring of drug procure-
ments [11, 12].
Several trials have highlighted the potential of mHealth
to improve HIV services e.g. in adherence to ART, reten-
tion in ART care, and even for receipt of laboratory HIV
test results [1315]. A recent Cochrane review, which
included the WelTel RCT in Kenya found compelling
evidence that weekly text messages to non-pregnant
HIV infected patients are effective [16] in improving
ART adherence.
Whether a weekly interactive SMS intervention (the
WelTel model) improves adherence and retention in
PMTCT care and encourages life-long ARVs is un-
known. The situation for pregnant women living with
HIV in a country like Kenya is often highly complicated.
Many women do not feel comfortable disclosing their
HIV status to a partner or family members in fear of be-
ing stigmatized and socially isolated [17], which greatly
influences adherence to ART and PMTCT. Furthermore,
most women are newly diagnosed with HIV during preg-
nancy, often asymptomatic and have little time to adjust
to the idea of living with HIV before they must start on
ARVs. Our previous research shows that competing bur-
dens, including breadwinning responsibilities, stigma,
Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
feelings of guilt and fear of transmitting HIV to the
baby, fear of abandonment and violence from the male
partner also affects womens capacity to adhere to
PMTCT [18].
The WelTel trial remains the only SMS adherence
intervention study with the lowest risk of bias ranking.
The WelTel service has other advantages in that it is
low cost since it uses SMS to check-in on patients, can
work with minimal literacy since problems can be
followed up with voice calls and extends into the popu-
lation that do not own their own phones since shared
access is sufficient, and by being open-ended check-ins
allows almost any problem to be triaged. We will assess
the effectiveness, including evaluation of costs of weekly
interactive SMS reminders to improve the retention of
pregnant women and mother-infant pairs in PMTCT
care in Kenya. Ultimately this will result in better
PMTCT coverage and reduced infant HIV infections.
Research hypothesis
The weekly interactive mobile phone SMS (WelTel) is
an effective as well as cost-effective method to improve
the retention of women living with HIV and their new-
borns in PMTCT care (women living with HIV and their
HIV exposed infants who successfully complete the pro-
gram when infant is aged 24 months).
Study objectives
Primary objective
To determine effectiveness of the WelTel SMS inter-
vention on retention of women living with HIV and
their newborns in PMTCT care in urban and rural
Kenya.
Secondary objectives
1. To assess adherence to the WelTel SMS
intervention among pregnant women and newly
delivered mothers living with HIV.
Fig. 1 WelTel PMTCT trial design
Page 3 of 8
2. To determine adherence to single components
of PMTCT among pregnant women and newly
delivered mothers living with HIV (ARVs,
facility-based delivery, early infant HIV testing and
exclusive breastfeeding).
3. To explore facilitators for and barriers to using
WelTel SMS in order to inform any improvements
on the model for PMTCT among pregnant women
and newly delivered mothers living with HIV as well
as PMTCT staff.
4. To evaluate costs from a payers perspective, of the
WelTel SMS for retaining women living with HIV
and HIV-exposed infants in clinical follow-up until
24 months post-delivery (discharge from PMTCT).
Methods/design
Trial design
The WelTel PMCT study is a 47 center two-arm open
randomized controlled trial in which the intervention is
allocated in a 1:1 ratio (Fig. 1 trial design).
Study setting
The study is in western Kenya and involves 47 facilities
that are among over 192 facilities providing PMTCT ser-
vices located in the catchment of Academic Model Provid-
ing Access to Health Care (AMPATH) a large HIV
Comprehensive Care Program run under the auspices of
Moi University School of Medicine, located in Eldoret.
These facilities implement Option B+ regimen of PMTCT.
The approximate coverage of mobile phones in western
Kenya is around 78 % [19]. The research setting has been
carefully selected to represent urban and rural mixes that
have high antenatal HIV percentage prevalence (1015 %),
about twice that of the national prevalence of 6 %.
Study population
The study population will consist of: (i) pregnant
women living with HIV aged 18 and over presenting
at ANC for a first visit in the current pregnancy at
Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
the selected clinics; and (ii) newborns delivered to
these women living with HIV. Women who will be
pregnant and will be diagnosed with HIV infection
will be referred to a male or female research assistant
to complete a checklist for eligibility. Determination
of HIV infection will be based on two repeated Deter-
mine or Colloidal Gold tests for women newly diag-
nosed during the current pregnancy, or, based on
referral from the comprehensive care clinic for those
with known HIV infection and on antiretroviral ther-
apy (ART) or pre-ART). Individuals must fulfill all
the inclusion criteria, provide consent to participate
and complete an interviewer-administered question-
naire before they are randomized to either the control
and intervention groups.
Inclusion criteria
1. Women aged 18 years or above
2. Evidence of pregnancy
3. Evidence of HIV infection
4. Resident of the PMTCT clinic catchment area and
plans to remain residents from recruitment until
24 months after delivery
5. Willing to be followed-up from recruitment until
24 months after delivery
6. Owning a mobile phone or having access to a
mobile phone
7. Able to text message in Kiswahili or have someone
in close contact that they trust to read and respond
to a text message
Fig. 2 WelTel SMS intervention
Page 4 of 8
8. Willing to receive text messages from the PMTCT
clinic staff
9. Able and willing to provide informed consent
Intervention
Participants in the intervention group will register their
phone numbers in the WelTel system (online or via
SMS) and then receive a weekly short text message
question in Kiswahili Mambo? (Kiswahili for How are
you?) asking about their general wellbeing (Fig. 2). The
message will be sent on a fixed day of the week and will
allow the patient to respond within 24 h either that they
are well for example ok or sawa or that they have a
problem (for example problem or shida). A female
study coordinator will be in charge of centrally monitor-
ing the WelTel SMS platform, which automatically
sends the messages and registers responses from the par-
ticipants and categorizes them. All participants who re-
spond problem or who do not respond will be directly
linked to a regular PMTCT nurse at the womans clinic
to assist with identified problems. Problems that cannot
be immediately resolved by the nurse follow routine pro-
cedures at the clinic and are normally referred to the
PMTCT clinical officer at the respective facility who will
then decide if the patient needs to visit the facility or
should receive a follow up phone call. The study coord-
inator will follow up with the respective PMTCT nurses
to record action taken, which is entered directly into the
WelTel platform logs as notes. Patients who will not re-
spond to the SMS within 24 h will be traced (first by
telephone then at households) within the defaulter
Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
tracing outreach program in routine PMTCT care. At
enrollment, the participants will be informed that the
weekly SMS support service does not replace routine
clinic services, and that all appointments made by
PMTCT staff should be honored and all emergencies
should be handled by usual means. A WelTel SMS plat-
form technician will handle all technical problems that
may arise.
Outcomes
Primary outcome
Retention in PMTCT care is defined as the proportion
of women living with HIV and their HIV-exposed infants
that remain in care until infants are aged 24 months
measured from when the pair is enrolled in the program
from the womans first visit at ANC until 24 months
after birth.
Secondary outcomes
1. Adherence to the WelTel SMS intervention
measured as the proportion of women living with
HIV who do not respond to the SMS within 7 days.
2. Adherence to (i) ARVs measured as the proportion
of women living with HIV who do not respond to
the SMS within 7 days when suspected to be out of
ARVs (i.e. failure to pick up ARVs that can cover her
absence); (ii) facility-based delivery measured as the
proportion of women who deliver in hospital;
(iii) early infant HIV testing defined as the proportion
of HIV-exposed infants who are tested for HIV within
8 weeks of birth measured as HIV exposed infants
with known HIV status at age 10weeks and (iii)
exclusive breastfeeding defines as feeding the
HIV-exposed infant only milk from the mothers
breast.
3. Participant perceived facilitators and barriers of the
WelTel SMS intervention (assessed as perceived
reasons and challenges of use as well as suggestions
to possible solutions).
4. Cost compared with (i) effectiveness (levels of
retention) from a payers perspective and (ii) quality
of life (differences in pregnant womens QALYs
between the two trial arms.
Sample size
The primary outcome of the study is defined as the pro-
portion of mother-newborn retained in PMTCT care at
24 months; assuming i) a power of 80 %, ii) a two-sided
test (alpha = 0.05), iii) and based on prior knowledge, a
proportion retained in the control group of about 30 %,
a sample size of 300 participants in each arm for a total
of 600 subjects, with 5 % dropout rate (i.e. women who
decide to withdraw from the study) in both the control
Page 5 of 8
and intervention arms was estimated to detect a 11 %
difference (the smallest detectable difference) in the
primary outcome between the intervention and con-
trol arms that is the difference that it would be im-
portant to detect is 11 %, computed as the
proportion retained in the intervention arm minus
the proportion retained in the control arm i.e. the
proportion retained in the intervention group minus
the proportion retained in the control group. Calcula-
tions were performed using Stata 14.1.
Recruitment
A PMTCT nurse at the selected clinics will inform all
consecutive pregnant women identified as living with
HIV at their first ANC visit about the study. The
PMTCT nurse will then refer these clients to the re-
search assistant who will assess their eligibility and
provide detailed information about the study. Individ-
uals who are eligible will be invited to participate in
the study and the research assistant will seek their
consent.
Participants in the intervention arm who own or have
access to mobile phones will be registered directly onto
the WelTel platform with their phone number.
Randomization and allocation
Eligible and consenting patients will be randomized to
the intervention and control arms using a 1:1 allocation
ratio. To ensure balance between the arms throughout
the trial, we adopted a permuted-block randomization
scheme. The block size will be concealed until the trial
is over. Randomization will be performed separately at
each clinic. We will use opaque sealed envelopes to as-
sign participants to the intervention and control arms.
The randomization list was be generated at the Karo-
linska Institutet (Stockholm, Sweden) by an independent
statistician.
Baseline
An interviewer- facilitated baseline questionnaire will be
administered after recruitment and allocation. Questions
record information on participants social and demo-
graphic characteristics; time of HIV diagnosis, time on
ARV, disclosure of HIV status, HIV care and social sup-
port, mobile phone use as well as costs for accessing
care.
Follow up
Follow up visits will occur at 6 and 24 months postpar-
tum, at which time research assistant will administer the
follow-up questionnaire. The follow up questionnaire
will capture information on participants missed appoint-
ments, engagement with health workers and satisfaction
with care, mobile phone access and using the WelTel
Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
intervention, and health related status/quality of life
using the EuroQol 5-dimensional (EQ-5D) utility scores
and twelve item short form survey (SF-12) standardized
tools.
To investigate quality of life, we will first develop a pa-
tient generated index (PGI) to identify areas in the
womens lives that are affected by their HIV infection
during pregnancy and nursing period; periods when the
risk of transmitting HIV is high. A PGI is an individual-
ized patient reported instrument that allows the re-
spondent to state, weight and rate areas of importance
to the patients lives that are affected by their illness.
The PGI will also enable the investigators to assess the
validity of the EQ5D and SF12 in this population and
context.
Data collection and management
All outgoing and incoming text messages will be auto-
matically recorded on the WelTel platform. The plat-
form also captures all of the problems noted by
participants, instances of non-response, and actions
taken in relation to participants problem responses and
non-responses. Platform data will be backed up every
7 days.
All questionnaires will be paper-based and the data
manager will then enter data into a database at the cen-
tral office on an ongoing basis. A data manager will
check the forms for completeness and quality will be
verified by re-checking a random sample of 10 % of the
data. Any problems that arise will be resolved promptly.
Participant files will be stored in a locked office at the
trial sites.
Data on attendance, HIV care clinical indicators like
viral load and CD4 cell count as well as treatment regi-
men will be collected medical records. We will also col-
lect information on demographic characteristics (age,
education level, marital status and parity) of all screened
patients/potential trial participants.
Qualitative research using in depth interviews will
also be performed to discover how and why the inter-
vention works to improve retention in PMTCT program.
Purposive sampling will be used to identify participants
for qualitative interviews. Face-to-face interactions will
be used to build trust during the interview process and
to enhance free interaction between the researcher and
the participants [20]. All conversations will be recorded
with permission from the respondents and the inter-
views will be performed at a place and in a language pre-
ferred by the respondent.
All qualitative research tools will be developed in
English, then translated to Kiswahili, and then back
translated to English. The interview guide will be avail-
able in both languages.
Page 6 of 8
Analysis
Statistical methods
Baseline participants characteristics will be reported sep-
arately by treatment arm. Baseline characteristics in-
clude: age, parity (nulliparous versus previous birth),
marital status (single, married or cohabiting, divorced/
widowed), ARV exposure (experienced vs. naive), dur-
ation of known HIV diagnosis (newly vs. previously diag-
nosed), age (1829, 3039, 4049, 50 years of age),
phone ownership (owned vs. shared), level of education
(none, primary, secondary, post-secondary), distance
from clinic (1 h vs. >1 h), number of children born
after HIV diagnosis, on ARV at enrolment (yes, no), time
on ARV at enrolment (6 months, 712 months,
13 months) and HIV status disclosure (yes, no). We
will report the mean (standard deviation [SD]) or me-
dian (first quartile, third quartile) for continuous vari-
ables, and count and percentages for categorical
variables. All analyses are by intention-to-treat i.e.
according to the study group to which women were
originally allocated regardless of subsequent intervention
received and per protocol. Other more statistical
methods will be used to take into account switching.
For the primary outcome, we will compare the
proportion of mothers living with HIV and their HIV-
exposed infants in the program at 24 months post-
birth in the intervention vs. control arm using both
parametric (Chi-Square) and exact (Fisher) statistical
tests. Secondary outcomes will also be compared
between arms, with t-tests for normally distributed
variables, Mann Whitney-U tests for non-normally
distributed variables, and Chi-Square and Fisher exact
tests for categorical variables. The relative risk (RR)
for PMTCT retention with 95 % confidence intervals
will be computed and the number needed to treat to
prevent one non-retained mother-infant pair will also
be estimated. Concerning the secondary outcomes,
average treatment effects (ATE) will be computed for
continuous outcomes and RRs for categorical out-
comes. For both primary and secondary outcomes,
log-linear or linear regression models will be used to
provide effect estimates adjusted for potential imbal-
ances in baseline participants characteristics, if re-
quired. We will repeat the analysis of primary and
secondary outcomes within such subgroups (in rela-
tion to socio-demographics) to assess the homogen-
eity of the intervention effect across pre-determined
subgroups of patients. Stratified RRs and ATEs will
be computed. Regression models, which include the
intervention allocation and subgroup-defining vari-
ables and their interaction, will be applied to assess
effect modification across groups; all statistics tests
will be run based on two side p-values and values
<0.05 will be considered statistically significant. All
Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
statistical analyses will be again performed with Stata
version 14.1 (Stata Corporation, College Station, TX,
USA).
Qualitative process evaluation
Qualitative data will be analyzed using content analysis,
guided by Graneheim and Lundman [21]. First, the tran-
scribed material is read a number of times to get a gen-
eral sense of the material by a group of researchers.
Using the open code software for qualitative research,
meaning units, which are key phrases in the text, are
identified, condensed and outlined. Codes will then be
ascribed to each meaning unit. The codes will be com-
pared and grouped into sub-categories. This comparison
will be performed consistently to identify emerging cat-
egories that will be further compared, re-organized and
merged into sub-themes and one overarching theme.
The coding and analysis process will be deductive in na-
ture and involve key members of the research team.
Economic evaluation
We will perform an economic evaluation to assess Wel-
Tel SMS from a healthcare payer perspective. The pri-
mary outcome of the cost effective analysis (CEA) will
be the incremental cost per additional mother-infant
pairs that remain in PMTCT until infant is aged
24 months. A secondary outcome is averted infant HIV-
infections at cessation of breastfeeding. For the cost-
utility analysis the outcome will be quality adjusted life
years (QALYs), based on responses to the SF-12 and
EQ5D. For both analyses (CEA and CUA) we will report
the incremental cost-effectiveness ratios (ICERs) that
will be computed as the ratio of the incremental costs to
provide WelTel SMS over usual care and incremental
effects e.g. cost per additional mother-infant pairs that
remain in PMTCT until infant is aged 24 months, cost
averted infant HIV-infections at cessation of breastfeed-
ing and cost per QALY.
A secondary analysis will also consider the incremental
cost per averted deaths by bringing infants lost to follow
up back and enabling treatment. Thus, we will deter-
mine ICER for cost per averted deaths. Deterministic
sensitivity analysis will be to address uncertainty.
Discussion
This trial provides an opportunity to test whether the
WelTel SMS intervention is effective in improving re-
tention in PMTCT care. Further, we will be able to de-
termine whether the interactive WelTel text-messaging
intervention, by engaging patients with the PMTCT
clinic on a weekly basis, is a cost-effective way to im-
prove retention in this critical stage of care, potentially
helping to eliminate pediatric HIV infections.
Page 7 of 8
Abbreviations
AIDS, acquired immune deficiency syndrome; ANC, antenatal care; ART,
antiretroviral therapy; ARVs, antiretroviral drugs; CEA, cost effectiveness
analysis; CUA, cost utility analysis; HIV, human immunodeficiency virus;
ICERs, incremental cost effectiveness ratios; IDIs, in-depth interviews; IREC,
Institutional review and ethics committee; MCH, maternal and child health;
MTCT, mother to child transmission; PIP, partners in prevention Moi
University; PLHIV, people living with HIV; PMTCT, prevention of mother to
child transmission; QALYs, quality-adjusted life years; RCT, randomised clinical
trial; RR, relative risk; SMS, short message service; UNAIDS, Joint United
Nations programme on AIDS; WelTel SMS, Weekly mobile phone short
message service
Acknowledgements
We thank the patients who participated in pre-testing the data collection
tools, the staff at Partners in Prevention (PIP) Moi University for organizing
field logistics for the trial. Special thanks go to WelTel Kenya for providing
reduced costs, software and technical support.
Funding
The Swedish Research Council (Vetenskaprdet) supported the trial protocol
reported in this publication. The funder had no role in the design of the
study and will not have any role during its execution, analyses, interpretation
of data, or decision to submit results. The content of this publication is solely
the responsibility of the authors and does not necessarily represent the
official views of the Swedish Research Council.
Availability of data and material
There is no data shared in this protocol. However, any data collected will be
available for others interested in the area of research.
Authors contributions
PA is a co-investigator and leads the trial implementation. She is part of the
team that conceived the study; contributed to study design and also leads
coordinates fieldwork for the trial implementation. AT is part of the team that
conceived the study and also contributed in study design. AME is the lead
investigator, conceived the study and also contributed to the study design.
JD contributed to the study design and field implementation. M van der K
contributed to study design and drafting of the manuscript. EW is a
co-investigator and contributed to study design. RL contributed to the study
design of the trial. LT contributed to the economic evaluation and study
design. AG contributed to the statistical aspects and study design of the
trial. RB contributed to statistical aspects of the trial. JM contributed to
study design of the trial. All authors contributed to the development study
protocol and approved the final manuscript.
Authors information
Anna Thorson, Anna Mia Ekstrm, Edwin Were, Richard Lester and
Jonathan Mwangi are clinicians working with the management of HIV
infections as well as public health issues of HIV. Patricia Awiti is a
sociologist and public health researcher working with issues of HIV and
women and child health including reproductive health. Mia van der
Kop is an epidemiologist working with HIV issues among others.
John Dusabe is an environmental scientists and public health researcher.
Richard Lester, Mia van der Kop and John Dusabe are experienced in
designing and implementing mHealth interventions. Laura Ternent is an
economist with experiences of performing costing of evaluations within
health sector. Alessandra Grotta and Rino Bellocco are statisticians and
experienced in performing clinical trials. Most authors have experiences
of working in low-income countries in Africa.
Competing interests
Richard T Lester is the founder and paid consultant for the WelTel
International mHealth Society, a non-profit non-governmental mHealth
organization with the goal of scaling up evidence-based mHealth solutions
and is funded in part by Grand Challenges Canada. For the remaining
authors no conflicts of interest were declared.
Consent for publication
Not applicable.
Awiti et al. BMC Medical Informatics and Decision Making (2016) 16:86
Ethics approval and consent to participate 5.
The original study protocol, consent forms and data collection tools were
approved by the Moi University Institutional Research and Ethics Committee
(IREC 1292) in Kenya. Any modifications to the original trial protocol,
including the data collection tools, will be submitted as amendments 6.
to the institutional review boards, and requisite approvals obtained.
Ethical approval will be renewed annually. 7.
Ethical considerations and consent to participate
Strict criteria for obtaining informed consent have been established for 8.
health behavior research. Informed consent will be sought in writing and all
content pertaining to voluntary participation and description of the trial will
be presented in English and Kiswahili. Research team members are sensitive
to the fact that of potential participants may be newly diagnosed with HIV 9.
at the time of enrolment. They will give all eligible participants that are
newly diagnosed until their next clinic appointment to decide whether
to enroll in the study. The risk of breach of confidentiality resulting from 10.
the text messaging intervention will be minimized since the content of
the text message will not include language related to HIV. In addition,
the research phone number will not be displayed on the participants
cell phone when a text is received unless the participant actively installs 11.
a true caller software that reveals the number from which an SMS or
call originates.
Each participant will be assigned a unique study ID (the outpatient number
with additional serialization that denote participation codes), which will be 12.
used in all subsequent data collection and analyses. This ID number will not
be released to individuals outside of the core research team.
13.
Harms
In this trial all expected adverse events include those directly involved with
the intervention such as unintended HIV infection disclosure and to a lesser
extent disagreement relating to privacy in a relationship. Potential harms will 14.
be discussed during the consent process and also outlined are channels for
dealing with such events. A study coordinator will be in charge of
documenting all adverse events as per the requirements of the ethics review
board.
15.
Dissemination
All findings will be published in peer-reviewed journals. Additional dissemination
will occur in conferences, workshops and specified feedback sessions planned at
16.
mid and end of the trial targeting involved staff, participants and local and
national stakeholders including providers and policymakers.
17.
Author details
1 in Kenya: how fears of stigma and discrimination affect uptake and
Department of Public Health Sciences, Karolinska Institutet, 171 77
Stockholm, Sweden. 2Department of Medical Epidemiology and Statistics,
18.
Karolinska Institutet, 171 77 Stockholm, Sweden. 3Division of Infectious
diseases, University of British Columbia, Vancouver, Canada. 4Division of
Global Health, University of British Columbia, Vancouver, Canada.
5 Breastfeeding and Their Views on Option B+ in Dar es Salaam, Tanzania.
Department of Public Health Sciences, 171 77 Stockholm, Sweden.
6 PLoS One. 2014;9(1):e85310.
Department of Medicine, University of British Columbia, Vancouver, Canada.
7 19.
Newcastle University, Tyne and Wear NE1 7RU, UK. 8Department of
Reproductive Health, Moi University, P.O.BOX 390030100, Eldoret, Kenya.
20.
Received: 13 January 2016 Accepted: 8 June 2016
21.
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