MTN-035 is a multi-site, randomized (1:1), open label crossover study. The study will evaluate the acceptability of and adherence to a placebo rectal insert and to a placebo rectal douche when each is used pericoitally prior to RAI over a 4-week-long period. The study population will consist of healthy, HIV-uninfected men who are 18-29 years of age and have sex with men (MSM) and healthy, HIV-uninfected transgender women who are 18-29 years of age who engage in RAI. Participants will be randomized to use either a rectal insert or a rectal douche during the first 4 weeks before switching to the other product for another 4 weeks. It is hypothesized that both the placebo rectal insert and the placebo rectal douche will be acceptable and that adherence will be high.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health