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EXECUTIVE SUMMARY
Tuberculosis (TB) is a widely spread disease globally that causes millions of peoples death
worldwide. Treatment for TB is complex and usually involves taking several antibiotics at once
for a long time (sometimes up to two years). Considering the severity of the treatment regimen,
it becomes hard for the patients to adhere and complete proposed treatment and particularly for
those who are infected with drug-resistant strain of TB. Poor adherence to treatment remains
significant problem that prevents countries from obtaining high treatment success rates that is
essential for health systems to control the epidemic and decrease spread of the disease. A new
study from Georgia looks at adherence to treatment factors among drug resistant TB (DR-TB)
patients and provides evidence that may help policy-makers develop effective strategies for
improving treatment outcomes among DR-TB patients. The study findings might be helpful for
other countries in the region where TB burden is also high.

PROBLEM STATEMENT
Tuberculosis remains a global health challenge for the public health throughout the world.
According to the World Health Organization (WHO) statistics, in 2015, 10.4 million people fell
ill with TB of which 1.8 million died from the disease. TB has been a leading cause of death
among infectious diseases1.

In Georgia, the incidence rate of all forms of TB reached 74.7 per 100,000 population in 2015.
Even though Georgia has seen a decreasing trend of TB incidence for the past several years,
Drug Resistant TB (DR-TB) prevalence rate is still high. In 2015, 11.6% of the new cases of
pulmonary TB and 38.8% of previously treated cases accounted to be drug resistant2.

The rate of treatment interruption (patients who stopped taking treatment) among DR-TB
patients is high, which creates a risk of drug resistant TB spread.

1
Global Tuberculosis Report 2016, WHO
2
Statistical Yearbook Health Care in Georgia 2015, NCDC

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 ACKNOWLEDGEMENT

Policy Brief was developed by Lela Sulaberidze and Ivdity Chikovani.

Curatio International Foundation would like to express its gratitude

towards the National Center for Tuberculosis and Lung Diseases for
supporting the field work implementation for the study. The research
team would also like to thank all respondents who agreed to dedicate
their time and effort to the study.

The study was implemented under the TDR/WHO small grants

scheme financial support. The views expressed in the publication are
those of the authors and do not necessarily represent those of the
TDR/WHO.

All rights reserved. Results may be used or reproduced without obtaining prior
written permission from the authors but with appropriate citation.

Curatio International Foundation 2016

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 EPIDEMIOLOGICAL REVIEW
The number of TB cases has been decreased in Georgia for the past decade.

Figure 1: TB cases per 100,000 population, 2005-2015 yy.

All Cases New Cases

Source: Statistical Yearbook Health Care in Georgia 2015, NCDC

Georgia no longer belongs to the group of the countries with a high burden of DR-TB since
2016, however, DR-TB prevalence rate is still high among new and previously treated TB cases.

Figure 2: DR-TB prevalence in Georgia, 2005-2015 yy.

New Cases Previously treated cases

Source: Statistical Yearbook Health Care in Georgia 2015, NCDC

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DR-TB prevalence is higher in Georgia, compared to the countries in Central and Eastern Europe.

Figure 3: DR-TB prevalence among new and previously treated cases (%), 2015

New cases Previously treated cases

Source: Global Tuberculosis Report, 2016, WHO

Statistical Yearbook Health Care in Georgia 2015, NCDC

As for the treatment outcomes, it should be noted that treatment success rate among DR-TB
patients is not satisfactory enough in the country.

Figure 4: Treatment Success rate (%) among DR-TB patients, 2015

Source: Global Tuberculosis Report, 2016, WHO

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 The trend for the past several years shows that every third of DR-TB patients stopped treatment.

Figure 5: M/XDR-TB treatment outcome (%) 2011-2013yy cohorts

Treatment success Lost to follow-up Died Treatment failed Not evaluated

Source: National Center for Tuberculosis and Lung Diseases, 2015

ABOUT THE STUDY

In 2016 Curatio International Foundation conducted a qualitative study to investigate factors that
enhance or hinder treatment adherence among DR-TB patients.

The study was conducted in Tbilisi, Adjara and Samegrelo-Zemo Svaneti regions using in-depth
interviews with a randomly selected sample of TB patients and focus group discussions (FGD)
with health care providers. The target audience for the study was comprised with the following
types of patients and health personnel:

DR-TB patients, lost to follow-up from treatment

DR-TB patients who were currently receiving treatment but had difficulties to adhere to the
treatment regimen, so-called recalcitrant patients
DR-TB patients, who finished treatment successfully
Phtisiatrists, DOT1 -nurses, primary health care nurses providing DOT services in rural areas,
epi demiologists.

Set of in-depth interviews were provided also with the key informants. Data generated from the
interviews and FGDs were analysed using a conceptual framework that outlines a range of structural,
personal, social and health system factors affecting adherence to TB treatment2.

The document summarizes main findings of the study and proposes recommendations for further
improvement of the system.

1
DOT - Directly Observed Therapy
2
Munro, S. A. et al (2007). Patient Adherence to Tuberculosis Treatment: A Systematic Review of Qualitative
Re search. PLoS Medicine, 4(7), e238. http://doi.org/10.1371/journal.pmed.0040238

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Study conceptual framework

STUDY FINDINGS
The study revealed different types of factors affecting treatment adherence among DR-TB
patients in Georgia. The findings are grouped into structural, social, personal and health system
factors according to the study conceptual framework.

Structural Factors
Some social and economic factors prevent patients from completing the treatment. Despite the
fact that the treatment is free, some patients cannot find time for it because of their work. If a
patient has to choose between employment and treatment, preference is given to employment.

...I stopped the treatment because I am the only man in the family. I have two
sisters who are single and I cannot leave my family members hungry. I had to
work but it is very difficult to combine work and treatment at the same period...

A lost to follow-up patient

There exist some conflict between the Labor Code and TB treatment regimen. Working hours of
employed patients and difficulty in obtaining sick leave for treatment do not allow them to
comply with the treatment regimen. In addition to this, some patients do not disclose their
disease to the employers because of stigma or fear to lose their jobs. Therefore, it is difficult
for such patients to combine the work and treatment regimens and they are forced to abandon
treatment.

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 On the other hand, communication with colleagues helps patients to overcome treatment
related adverse events. As successfully treated TB patients reported they paid less attention to the
unpleasant feelings caused by the TB drugs during work, which helped them to cope with such
factors.

Due to financial problems low economic status patients face difficulties in terms of performing
additional tests and purchasing medications required for side effects management.

The monetary incentive system works well among the patients, especially for those who are
under economic constraints.

Of course side effects mean additional expenses because you have to buy
additional medications. Although this voucher creates additional motivation
because some people have no money at all and this helps

A patient who has successfully completed TB treatment

Besides the monetary voucher drug resistant tuberculosis patients also receive a voucher that
covers their transport costs. The amount covered by the transport voucher equals the public
transportation cost to visit a DOT center. The voucher was also found to be positively
influencing adherence to treatment.

Social factors
Support from family and society is crucial during the treatment as patients report. Conversations
with family members and friends help patients not to feel alone, not to loose hope, be less
irritated and do not miss visits at DOT centers.

...Support from family members is very important. You feel that you are not
alone. Sometimes I was too lazy to go to the DOT center but my wife insisted and
forced me
A patient who successfully completed the treatment

Lack of attention from family and friends negatively affects adherence to treatment. When a
family member is actively involved in the treatment process and supervises the patients visits,
the patient has more responsibility towards himself and his family and tries to fulfil visits.
Patients who have family support are usually those who successfully accomplish treatment.

Decisions made by the majority of patients are greatly influenced by peer experiences. The
majority of patients reported that their decision to continue receiving medicines was a result of
negative consequences of abandoning treatment, which they had seen among other patients.
Successful treatment stories and peers experience on different coping strategies with side
effects had positive influence on treatment adherence.

For example, I was looking for patients who had finished treatment wonder-
ing how they felt and how much time had passed since their treatment

A patient who successfully completed the treatment

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Peers influence turned out to be negative when patients shared information on how to avoid
receiving some medicines and different methods of deceiving health personnel.

Although stigma has never been named as the main reason for treatment interruption among
respondents, some patients reported that they concealed information about their illness and
tried to avoid communication with other people.

Personal factors
Service providers inform patients about the disease, special characteristics of the treatment
regimen and possible occurrence of side effects on a regular basis. Almost all patients
confirmed that they received detailed information about TB from health personnel. Although,
information deficit was revealed with lost to follow-up and recalcitrant patients: one fourth of
these patients reported that they missed visits to the DOT center or stopped treatment because
TB symptoms disappeared or they felt much better. There were also some cases when patients
interrupted the treatment and then resumed it after deterioration of the heath condition.

...I stopped the treatment a year ago and have not visited the TB hospital to
receive medicine ever since. Physically I was feeling well so I decided that
medicine was no longer needed...

A lost to follow-up patient

Patients who had successfully finished TB treatment reported that one of the main motivators
for them to complete treatment was their family. These patients had correct understanding of
risks associated with untreated Tuberculosis, so they tried to complete the treatment in order to
protect their family members and friends.

Health system factors

Free treatment and TB program management

The opportunity of receiving treatment free of charge was viewed as a huge benefit provided to
the patients by the National TB Program. Many people emphasized that they received
expensive treatment free of charge within this program.

Besides free health services and pharmaceuticals, all respondents reported that they received
medicines continuously at DOT centers without interruptions. Specialists and service providers
working in this area indicate that TB program is well managed throughout the country. They
positively assess existence of properly running laboratory system, uninterrupted supply of
pharmaceuticals and good program monitoring system.

Service providers expressed dissatisfaction with their limited involvement in the decision making
process. As for the patients involvement in the decision making process, it must be noted that
patients did not even expect they should participate in the process.

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 Health Personnel
The majority of patients reported the positive role of the health personnel during treatment
period. Great attention from doctors and nurses and support at TB treatment facilities were
emphasized by the patients when describing interaction with health personnel. Attentive and
compassionate health personnel significantly influence the patients behavior and stimulates
them to complete treatment.

Physicians and nurses were positively disposed towards patients. They were
equally attentive to everyone and they motivated us to take drugs. They often
talked to us and supported us in everything. Nurses play a rather big role in the
treatment process; they provide moral support and additional consultations

A patient who has successfully completed TB treatment

FGDs with specialists revealed lack of young specialists working in this field. As a result, the
level of accepting and introducing innovations is low. Low salaries and health risks accompanied
with TB service delivery decrease the interest of young health personnel to work in this field.

Personnels Financial Motivation

Service providers complain about low salaries which is below the average salary level in
Georgia. According to the service providers, their only stimulus is professional motivation. In the
frame of National TB Program, a doctors minimum monthly remuneration equals to 360 GEL
and 280 GEL for DOT-nurses. A doctors salary is considerably lower than a primary healthcare
nurses salary. This definitely reduces doctors motivation.

Salaries are rather low. It is rather bad that primary healthcare nurses have
a salary of GEL 450, while doctors receive only GEL 360. This is a demotivating
factor for us

Phthisiatrists FGD

The same problem was identified in case of epidemiologists. They talked about an overloaded
work volume and complained about inadequate financing of their efforts.

The research also demonstrated that service providers do not have full financial support
necessary for the performance of their obligations within the program. Doctors and nurses have
to cover communication expenses with patients out of their own pockets, which is not a small
share of their monthly salary. At the same time, frequent communication positively influences
the patients adherence to treatment behavior.

When a patient does not come to take a medicine, we have to find out where
he is and why he has not come. We spend our salary to top up the mobile phone
account because we have to communicate with patients over the phone all the
time

Doctors and nurses FGD

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Epidemiologists are responsible to work with lost to follow-up patients in the frame of the
National TB Program. The research demonstrated that this part of the program does not work
effectively. In order to reach lost to follow-up patients, epidemiologists mostly use phone call
communication because transportation costs are not reimbursed for them.

... It would be good if I could make repeated calls to convince them; if there
were incentives; if we were given money for transportation, for example GEL 10.
In this case we would manage to return lost to follow-up patients in treatment...

Epidemiologists FGD

Besides low remunerations, the Program currently does not have any incentive mechanisms
(financial or other) for service providers to stimulate their work.

There is not even a small gift for us for a cured patient. World TB Day in the
past, where Phtisiatrists from Georgia used to meet each other, exchange
information during the dinner in the evening. This was some kind of expression
of gratitude, there is nothing like that nowadays

Regional Phtisiatrists FGD

Geographic Distribution and Infrastructural Conditions of TB treatment Facilities

Integration of the services into the primary healthcare system increased geographic access to
services for rural population. But in Tbilisi, both patients and specialists reported about existence
of a geographic barrier to access services. Transportation of patients to DOT centers is a problem
because there are only four DOT centers in Tbilisi, that are not evenly distributed in the city.

... Even though we reimburse them for their travel expenses under the Global
Fund project, spending 3-4 hours every day to reach the TB treatment
facility and return back is a problem for patients; moreover, only MDR
patients get compensation...

A field specialist

The patients living in regions face geographic barrier of access to services in terms of
management of side effects. They often have to go to Tbilisi to receive these services. In
addition to this, existing infrastructural problems and poor sanitary conditions at inpatient
hospitals in regions result in geographic access barrier for patients as they seek to get inpatient
service in Tbilisi, where conditions are satisfactory.

Noteworthy that DOT centers also have infrastructural problems. E.g.: regional facilities do not
have enough space for provision of high quality ambulatory services. Despite the fact that the
condition of integrated facilities was improved, they often do not meet international standards for
service delivery, such as constant natural or artificial ventilation and ultraviolet lights in doctors
rooms.

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 Due to the inadequate space or poor sanitary conditions of ambulatory facilities, patients do not
have an opportunity to talk to each other and share experiences that would help them to
overcome difficulties. As it has already been mentioned above, sharing of personal experiences
has a positive impact on the treatment process.

Conditions should be improved to encourage a patient to enter the TB

facilities. I used to go home right after taking the medicine. I did not want to stay
there and talk to other patients

A lost to follow-up patient

The challenges of DOT

Patients point out difficulties associated with DOT regimen. Pill burden is emphasized as one of
the main challenges of concomitant treatment by the patients. They find it difficult to take a high
number of pills at the health care facility for a long time on a daily basis.

Although DR-TB patients under treatment receive transportation voucher to visit treatment
facilities, patients involved in a new scheme of treatment also complain about visiting TB
treatment facilities 2 times a day. Under the new scheme of treatment patients receive TB drug
infusions, which should take place in hospital settings.

It is not difficult to take medicines in the morning but when I come here in
the evening then I feel sick. I have to come here twice a day and I drive here. My
father and my friends accompany me sometimes

A recalcitrant patient

The impact of Side-effects and system-level gaps in side effects management

Occurrence of side effects, frequency and their management play an important role on treatment
adherence. Almost all patients involved in the study reported having treatment related physical
and/or mental side effects. A big proportion of lost to follow-up patients attributed non-adherence
to experiencing side effects.

Initially, after taking drugs I used to recover more easily. Doctors gave me
everything included in the program against vomiting, liver-protectors - but
eventually I felt very bad and nothing helped me to recover

A lost to follow-up patient

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According to experts explanations, effective management of side effects caused by TB drugs
requires specific knowledge of different systems by health personnel. Several drugs are
financed by the National TB Program for side-effects management for DR-TB patients, but
besides this there are some investigations and specialists consultations patients with
side-effects seek to attend. Patients living in Tbilisi have better access to such services due to
their proximity to the National Center for Tuberculosis and Lung Diseases (NCTLD), where such
services are available. The Center has different specialists such as cardiologist, neurologist,
psychiatrist, gastroenterologist, endocrinologist, etc. who are involved in the management of
side effects. Moreover, patients living in Tbilisi are better informed and use the universal health
coverage program services rather than patients living in rural places. In regions, patients either
visit such kind of specialists directly or get services in Tbilisi, that are associated with additional
expenses.

Most of patients reported having problems like anxiety, insomnia, depression etc., the
management of which requires involvement of a psychologist/psychiatrist. Service providers
and field exerts also emphasize the need of psychological support strengthening countrywide.
Such services similarly to other specialists services are provided in Tbilisi National Center
however are not readily available for majority of patients who need such care.

...Patients need psychological support. Sometimes he is so exhausted that does

not want to take a medicine any more

A spouse of a recalcitrant patient

Some of patients become rather reserved and find it harder to deal with this
psychologically, such people need to be supported by a psychologist

A patient who has successfully completed the treatment

Risks Associated with TB Service provision

In 2011 the vertical management of TB services underwent changes. As part of the reform
integrated model of TB Services was introduced meaning that private primary care providers in
regions were imposed to carry out TB services. As field specialists report, regulations does not
guarantee that private providers would maintain service uninterrupted provision as the
obligations are valid until 2018.The situation is exacerbated by lack of motivation of service
providers at the institutional and personal levels to maintain TB services. In particular, it has
become evident that managers/owners of health facilities are not interested in implementing
unprofitable TB services and service providers have low motivation to improve performance
since there are no mechanisms that link performance to the payment.

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 RECOMMENDATIONS

The study made it clear that the structural, social, individual factors as well as health
system factors are closely interlinked and mutually influence each other. Therefore, a
successful strategy to deal with the factors negatively affecting adherence to TB
treatment must be based on multi-sectoral approach to tackle with existing difficulties.
The recommendations given below are based on the study outcomes.

Legal/regulatory changes:

The Labor Code provision on temporary disability term must be

reviewed taking into account the needs for TB treatment

Regulations need to be developed/refined in order to ensure continuity

of services rendered by private service providers

Involvement of peer educators in the treatment process is important

to enable sharing of their personal experience with other patients using
different strategies (peer-to-peer groups, social media etc.)

Improvement of the communication messages through emphasizing

treatment adherence barriers

Ensuring increased participation of patients and service providers in

the decision making processes

Ensuring increased motivation of service providers by introducing

results-based financing mechanisms:
Providing incentives for health personnel
Providing institutional incentives for health facilities

Increasing the efficiency of tracing lost to follow-up patients

through operational costs reimbursement and epidemiologists financial motivation

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 Opening additional DOT centers in Tbilisi and integration in the primary
healthcare services in order to improve geographic access

Timely introduction of global innovations in the country with the aim to

simplify DOT regimen

Improvement of access to side effect management:

Use of Telemedicine to reduce geographical and financial barriers,

save patients time and improve quality of services

Integrate mental health services into the primary healthcare

Reimburse expenses on medications for socially vulnerable patients

Motivating young professionals to enter the TB field by reducing financial

barriers on postgraduate studies.

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