Role of men in a phase III vaginal microbicide trial in SW Uganda.
Issues: Vaginal microbicides in HIV prevention are intended to increase the choices of safer sexual practices among couples. We assessed the role that men are playing in an ongoing phase III microbicide trial in rural Uganda. The trial is part of the Microbicide Development Programme (MDP), a collaboration of African and UK research institutions. Description: HIV-1 negative women living in HIV discordant and some in HIV-negative concordant couple relationships were invited to participate in a phase III microbicide trial. Study information was provided to both partners. Informed consent was obtained from both partners prior to enrollment. In-depth interviews (IDIs) and focus group discussions (FGDs) were conducted among men and women to assess compliance with gel and condom use, decision making patterns, and to explore how supportive men were. 100 IDIs (50 with women and 50 with men) and 11 FGDs (8 with women; 3 with men) were conducted. Data were analyzed using NVIVO 2. Both women and men thought it important to discuss sexual matters with their partners as this enhances communication and may help prevent HIV infection. All women informed their partner whenever they intended to use the gel. All women reported support from their partner. Some men even reminded them to insert the gel. The main reason given was that study information had been provided to both partners at the beginning of the trial. Couples generally made decisions jointly on the use of gel and condoms, but occasionally women took the decision on gel and simply informed their partner. Conclusion: In this trial of a vaginal microbicide gel, we observe generally excellent support of female participants by their partners. We think that this was achieved through strong involvement of men both at enrolment and follow-up. Men's role seems to be essential for the success of microbicide trials.
Kawuma, R. Role of men in a phase III vaginal microbicide trial in SW Uganda. Presented at 2008, New Delhi, India, 24-27 February 2008. (2008)