DOI 10.1007/s10461-009-9655-6
BRIEF REPORT
Introduction
In 2007, women accounted for 46% of the 33.2 million
people living with human immunodeficiency virus (HIV).
The estimated number of people newly infected with HIV
in 2007 was 2.5 million.[1] Male and female condoms
remain the only methods proven to reduce risk of sexually
transmitted diseases (STDs) and HIV, but negotiating their
use is not always possible. [2, 3] Researchers believe that
the use of a vaginal microbicide could substantially reduce
the number of new cases of STD/HIV. Numerous research
studies have examined the perceived acceptability of gel
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Methods
This study was a qualitative assessment of the acceptability
and function of a non-woven substrate (modified tampon)
used to dispense water or lime juice solutions.
The researchers collected information through use of indepth telephone interviews with a 16-woman subset of the
47 women who completed the Contraceptive Research
and Development Program (CONRAD) sponsored study
6-Day Safety Trial of Intravaginal Lime Juice (in 3 concentrations) versus Water, Applied Twice Daily. [7] Participation in this sub-study was voluntary and women were
enrolled from each of the four study groups (three lime
juice concentrations and water) until four women from
each group were interviewed. Eligible women were
required to use their assigned solution of lime juice or
water as a douche and in the saturated tampon, be at least
18 years old, have used at least one of the saturated,
modified tampons and have provided oral informed consent. Women completing only the douching condition of
the aforementioned lime juice study were not eligible to
participate. Participants were enrolled from two clinical
study sites: East Virginia Medical School (EVMS), Norfolk, VA, and the Magee Womens Hospital (MWH),
Pittsburgh, PA.
The primary objective of this sub-study was to determine the feasibility and potential acceptability of using a
non-woven textile material (similar to the wetted tampon)
to deliver drugs intra-vaginally. Further, we described a
device prototype during the interview process and participants were asked their opinions about using such a device.
After oral informed consent, researchers from Family
Health International (FHI) interviewed the 16 women
individually by telephone. The interviews were conducted
using a semi-structured survey instrument that included
fixed-response questions linked to open-ended questions
and probes. The survey instrument was designed to move
toward more precise questioning as information emerged
throughout the interview. Women were interviewed within
one week of last study product use and each interview
lasted approximately 45 min. The interviews were taped
and transcribed verbatim.
Prior to participant recruitment, this sub-study was
reviewed and approved by the ethics committees of
CONRAD (East Virginia Medical School) and FHIs Protection of Human Subjects Committee (PHSC).
Data Analysis
Demographic data were entered into a Microsoft Excel
spreadsheet and quantified. Qualitative data analysis was
performed manually. We used the research questions from
the survey instrument to group the data and then looked for
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similarities and differences in responses among participants. There were two sources of data: the transcripts from
the audiotapes and notes from each interview. A codebook
was developed and periodically reviewed to ensure consistency of coded definitions. Two people coded each
transcript and the field notes. Differences in coding decisions were negotiated and reconciled. Coded comments
were sorted by main and emergent themes and quantified.
Though seven main themes were identified, data were
reduced to commonly cited ideas/opinions and essential
points of interest relevant to the issue of acceptability of a
non-woven device. Five key themes emerged: ease of
insertion; ease of removal; comfort in use; leakage/messiness; and, physical effects. The interviewers discussed
impressions/opinions about participant responses to assist
in the evaluation and interpretation of the data.
Results
Ten sexually-active participants were recruited from MWH
and six from EVMS. Participants ranged in age from 20 to
49 years (mean = 34). Twelve were Caucasian and four
were African-American. Nine were married and seven
were single. The length of their relationships ranged from
less than 1 year to more than 22 years. Only one participant had less than 12 years of education, the remaining
reporting between two and 4 years of college. Their
occupations were: nurses; social worker; sales representatives; administrative assistants; students; a homemaker and
a domestic worker. Since the investigators found that
women in the 50 and 100% lime juice groups reported
irritation more frequently than those in the water and 25%
Table 1 Number of
participants experiencing
problems/difficulties by
category and future positive
interest in using a device for
vaginal drug delivery
Category*
25%
n=3
50%
n=4
100%
n=5
Total
n = 16
Difficult insertion
Difficult removal
Applicator problem
0
1
0
0
1
1
1
1
2
3
10
STI/HIV
10
Contraception
Yeast treatment
13
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603
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Discussion
Half of the women enrolled reported some discomfort or
adverse medical events associated with use of the wetted,
modified tampon. One woman in the water group complained
about tampon heaviness after insertion of the saturated
tampon. The remaining women complained about device
heaviness and discomfort (adverse events) associated with
use of the higher concentrations of lime juice (50 or 100%).
None expressed difficulties or problems using tampons during menstruation. When asked, the women attributed the
discomfort or adverse medical events to the combination of
the lime juice, the tampon, and the extended wear time
(610 h) of the device. Since 16 of 17 reports of discomfort
and adverse medical events occurred in the 50 and 100% lime
juice groups, and women did not report similar events during
the douching phase of study, it is likely that the tampon and
extended contact with a high concentration of an acidic
solution irritated the vaginal epithelium. Hemmerling, et al.
conducted the first safety study of diluted lime juice to assess
its potential as a candidate microbicide. [8] In that study, 10
and 20% concentrations of lime juice were delivered to the
vagina through a fully saturated tampon. Twenty-five sexually abstinent women participated. They were instructed to
use their randomly assigned dosage daily, during a 14-day
study period. Results showed that a 20% concentration of
lime juice exhibited an acceptable safety profile; however,
there was concern that use of lime juice at that concentration
would not be effective in killing HIV. Further, higher concentrations ([50%) may be toxic to tissue.
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Conclusions
The experience with the wetted tampons used in this
study, though different in construction from our proposed
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