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Acceptability of Tenofovir Gel as a Vaginal Microbicide Among Women in a Phase I Trial: A Mixed-Methods Study
Objectives: In this phase I safety trial of tenofovir gel, a candidate vaginal microbicide for human immunodeficiency virus (HIV) prevention, a mixed-methods design was used to gather acceptability data among women participants. The impact of acceptability factors on use of the gel and the relationship between qualitative and quantitative acceptability data are explored.
Methods: Participants included low-risk, HIV-uninfected, and clinically stable HIV-infected women. Participants were enrolled into cohorts stratified by HIV serostatus, sexual activity, gel concentration, and frequency of use. Quantitative data were collected via interviewer-administered structured questionnaires. Qualitative data were collected via semistructured small group discussions.
Results: Although 94% of participants stated they would “probably” or “definitely” use tenofovir gel, a range of responses emerged on multiple domains relevant to microbicide acceptability during the qualitative discussions. Lubrication, leakage, sexual pleasure, and the possibility of covert use were central to women's qualitative assessments of tenofovir gel.
Conclusions: Quantitative results indicate that tenofovir vaginal gel was acceptable to almost all users, while qualitative findings indicate that acceptability is complex, varies among users, and is likely shaped by a variety of contextual factors that manufacturers will need to consider to optimize use-effectiveness. Because of the differences in the qualitative and quantitative responses, the authors argue that future trials of candidate microbicides should include strategic collection of mixed-methods microbicide acceptability data
Impact of targeted counseling on reported vaginal hygiene practices and bacterial vaginosis: the HIV Prevention Trials Network 035 study
We describe the impact of intense counseling to reduce vaginal hygiene practices and its effect on bacterial vaginosis (BV)
Effects of partnership change on microbicide gel adherence in a clinical trial (HPTN 035).
Use of HIV prevention methods may vary for women by types of sexual partners. In a microbicide safety and effectiveness trial (HPTN 035) differences in adherence to a microbicide study gel were compared between women with new versus ongoing partnerships over time. 1,757 women in the three HPTN 035 trial's arms completed the Follow-up Partner Status (FPS) questionnaire at their last study visit. Women married at baseline were asked if they had the same husband, new husband or new partner. Unmarried women were asked if they had changed partners or married. Self-reported gel adherence during the last sex act was compared at each quarterly visit between women with ongoing versus new partners. High gel adherence was compared with low gel adherence (85-100 vs. <85 % of last vaginal sex acts reported with gel use, respectively) in multivariable models to assess associations with partner change. Overall 7 % of women (n = 123) reported a new partner and 41 % (51) of those reported a new husband. Median gel adherence was reported to be 100 % in women with ongoing partners and 75 % for women with new partners (p < 0.001). In women reporting no gel use in their last sex act, only 12.5 % of the women with a new partner and none of those with an ongoing partner reported using condoms (p < 0.001). Fewer women with new partners reported using both the gel and condom during the last sex act as compared to women with ongoing partners (median 50 vs. 71.4 %, p < 0.001). After adjusting for age, site, education level, and sexual frequency, women with ongoing partners were more likely to report high gel adherence than those with new partners (AOR 2.5, 95 % CI 1.6, 3.9). This pattern persisted when gel use over time was compared between women with new versus ongoing partners. In the HPTN 035 trial, women with new partners had higher HIV incidence and reported less gel use and higher condom use. Specific counseling and support are needed to help women use potential HIV prevention methods, including microbicides, when they are changing partners