Acceptability of PrEP for HIV prevention among women at high risk for HIV.

OBJECTIVE: To assess the acceptability of a daily pill for prevention of HIV acquisition among 400 Ghanaian women in the oral tenofovir disoproxil fumarate (TDF) clinical trial. METHODS: Structured questionnaires were conducted with women enrolled in the trial at enrollment and at each of the 12 monthly follow-up visits. Growth curve analysis was used to examine adherence patterns over time. Qualitative interviews were carried out with a subsample of the clinical trial population, and thematic analysis was applied to these data. RESULTS: Overall, acceptability of the pill was good. Adherence remained > 82% throughout the 12-month trial. Consistent access to the pill and study assignment were both associated with adherence. Most reported problems diminished over time as women became accustomed to the pill and developed strategies to incorporate pill taking into their daily routines. CONCLUSIONS: If daily preexposure prophylaxis (PrEP) for HIV is found to be efficacious and has as few physical side effects as TDF, acceptability of this method among women in the study population may not be problematic. However, future studies must develop better acceptability measures, in order to more fully address the relationship among adherence, safety, and effectiveness.

Changes in sexual risk behavior among participants in a PrEP HIV prevention trial.

BACKGROUND: One of the concerns raised regarding the introduction of any new HIV-prevention measure, such as PrEP, is the potential for risk disinhibition or sexual risk compensation. The oral tenofovir HIV prevention trial has been the subject of international discussion in this regard. METHODS: This article maps the changes in sexual risk behavior among women participating in the oral tenofovir HIV prevention trial in Ghana. Content-driven, thematic analysis was carried out on qualitative data obtained from in-depth interviews with study participants. Growth curve analysis was the primary method used to document trends over time in self-reported sexual behavior collected monthly. RESULTS: Overall, the study found that sexual risk behavior did not increase during the trial. Number of sexual partners and rate of unprotected sex acts decreased across the 12-month period of study enrollment. Certain subgroups of women, however, exhibited different growth curves. Data indicate that the HIV prevention counseling associated with the trial was effective. CONCLUSIONS: Counseling during the trial was effective. Different types of counseling and messaging may be needed for different subgroups within a population. These findings also have implications for required sample sizes for future HIV prevention trials where seroconversion is the main outcome.

Pregnancy prevention practices among women with multiple partners in an HIV prevention trial.

BACKGROUND: Women enrolled in microbicide and pre-exposure prophylaxis (PrEP) HIV prevention trials are not allowed to continue use of study products when pregnant because of fetal safety concerns. High pregnancy rates among women in trials can undermine statistical measures of safety and effectiveness. METHODS: Women enrolled in a PrEP trial in Ghana, Nigeria, and Cameroon had an overall pregnancy rate of 52 per 100 person-years of observation. In-depth interviews were conducted with 67 women who were asked to describe any changes made in their pregnancy prevention practices after enrolling in the trial. RESULTS: Most women (n = 44, 65%) reported changing pregnancy prevention practices after enrolling in the trial. Twice as many reported using condoms for pregnancy prevention after enrollment (n = 56, 84%) than before (n = 27, 40%). Cluster analysis identified site-specific patterns. Nigerian women tended to report using condoms for dual protection before and after trial enrollment. Cameroonian women tended to rely on natural methods before and after trial enrollment. Ghanaian women tended to switch from hormonal methods to condoms. CONCLUSIONS: The role of condoms in HIV prevention trials must not be diminished. Their use-effectiveness for contraception is likely too low for microbicide and PrEP trial needs, however. HIV prevention trials with women should be appropriately staffed to provide effective contraceptive counseling and, if needed, direct provision of contraceptives. This must be done without undermining women's reproductive rights.

Fear, hope and social desirability bias among women at high risk for HIV in West Africa.

BACKGROUND: Self-reports are widely used for measuring behaviour in HIV research and prevention, yet the accuracy of these measures has been shown to be questionable in many cases. Social desirability bias (SDB) is one of the key factors identified as affecting self-report accuracy. METHODS: Using in-depth interviews, we examined SDB from the perspective of 60 women at high risk for HIV in two West African countries: Ghana and Nigeria. We solicited suggestions for reducing SDB in the context of HIV research and prevention, and asked for feedback regarding methods currently being employed to reduce SDB. RESULTS: Themes pertaining to fear and a desire to have a better life were pervasive throughout the data. Thematic structure was similar between sites and age groups, although younger women tended to be more concerned about the interview context. CONCLUSIONS: Vulnerability of a population should be considered when asking sensitive questions. Audio-computer-assisted self-interviews may not be appropriate for vulnerable populations in developing countries, particularly for older respondents.