Background Makerere University-Johns Hopkins University research collaboration (MU-JHU) conducted a VOICE study which was a phase 2B safety and effectiveness study of Tenofovir 1% gel, Tenofovir tablet and Truvada tablet for the prevention of HIV infection in women. The study encouraged women to disclose to their partners for support while using study products.
Methods Before and during recruitment, need for male involvement was emphasised. At screening and follow up visits, participants were informed about the importance of disclosing their participation to partners. Women were encouraged to invite their spouses to the clinic to know about the study and also receive HIV and syphilis testing. Men were invited verbally through their spouses; given reading materials to give to their partners before inviting them. Later, an invitation letter was developed inviting male partners to the clinic but given to those who opted for it. Male partners who came to the clinic were periodically invited for meetings to brainstorm issues about the study and general health.
Results Out of 322 participants, 140 accepted to take letters, 67men turned up to the clinic, and 52 men tested for syphilis and HIV. 5 male partners’ meetings were held and many concerns, which rotated around safety and effectiveness, were resolved, among which; whether it is safe for them to stop using a condom since their partners are on study products and whether the products will not affect their manhood.
Lessons learnt Male Partners who turned up to the clinic were very supportive in reminding their partners clinic appointments and product use for better adherence. Increased disclosure among discordant couples, and helped treating sexually transmitted infections.
Conclusion Male Involvement in microbicide studies is of utmost importance. Men need a proactive approach to get involved in clinic activities to support spouse in adherence and avoiding STD/STI re-infection.
- male involvement in microbicide studies
- testing for STI in trials
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