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Microbicide Disclosure to Partners Did & Results of CAPRISA 004
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1st International Workshop on HIV and Women, January 10-11, 2011, Washington, DC
Mark Mascolini
Most women in a substudy of the CAPRISA 004 microbicide trial told sex partners they were in the trial and using a vaginal gel that might protect them from HIV [1]. Gel disclosure rates did not differ between women who became infected with HIV during the South African trial and those who did not. One third of women in this substudy did not tell their partners they were using a gel.
CAPRISA 004, a double-blind, randomized trial, compared 1% tenofovir vaginal gel with placebo in 889 sexually active, HIV-negative women in urban and rural KwaZulu-Natal, South Africa [2]. Women were advised to apply the gel before and after sex. HIV incidence was 38% lower among tenofovir gel users than in placebo users. Among women who used the gel more than 80% of the time, HIV incidence was 54% lower in tenofovir users than in placebo users.
Because adherence to gel use had such a strong positive impact on risk of acquiring HIV, it is important to understand whether disclosure of gel use by women to their partners affects adherence and HIV infection risk.
This case-control substudy conducted during CAPRISA 004 involved 72 women who became infected despite using the microbicide and an unmatched comparison group of 205 microbicide users who did not pick up HIV. Substudy participants completed an in-depth adherence and microbicide acceptability assessment including both quantitative and qualitative components. The primary goal of the substudy was to examine the quantitative association between partner disclosure of trial participation and participant HIV status, but most of the data presented at this workshop were from the qualitative questions.
Rates of disclosure to at least one sexual partner did not differ between HIV-positive cases (75%) and HIV-negative controls (76%) (odds ratio 0.95, 95% confidence interval 0.51 to 1.78). Among the 277 substudy participants, 165 (60%) discussed with the investigators whether they told their sex partners they were participating in the trial. Of these 165 women, 113 (68.5%) disclosed gel use to their partner and 52 (31.5%) did not.
Among the 113 women who told their partners about their trial involvement, only 7 (6%) reported partner-related difficulties in using the gel. Seventy-four of these 113 women (65%) said their partners had supportive or neutral attitudes about gel use. Some partners helped by reminding women to use the gel during sex. Women who disclosed trial participation to partners were able to use the gel during unplanned sexual encounters with their partners.
Among the 52 women who did not tell partners about their trial participation, 17 (33%) reported partner-related difficulties in using the gel, mainly an unwillingness to apply the gel in their partner's presence. As a result, these women did not use the gel during unexpected sexual encounters. They reported difficulties in hiding the gel from their partners and concern that their partner would feel the gel's coldness or wetness. Eleven of these 52 women (21%) said they were afraid to tell their partner about using the gel because they thought their partner would get angry and leave or would not use a condom if the woman used the gel. However, only one woman reported that a partner would not put on a condom after the woman applied the gel.
"As future microbicide trials and roll-out studies are planned in this population," the CAPRISA team concluded, "it will be important to consider the incorporation of a component to help overcome barriers to trial participation disclosure and difficulties with gel use such as partner education, couples counseling, or interpersonal communication skills development." They recommended that effective rollout of microbicides in the community should target both men and women.
References
1. Succop S, MacQueen K, van Loggerenberg F, Majola N, Abdool Karim Q, Abdool Karim S. Trial participation disclosure in the CAPRISA 004 tenofovir gel trial. 1st International Workshop on HIV and Women. January 10-11, 2011. Washington, DC. Abstract O_05.
2. Abdool Karim Q, Abdool Karim SS, Frohlich JA, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329:1168-1174.
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