MTN-035 was a multi-site, randomized-sequence (1:1:1:1:1:1), three-period, open-label crossover study. The study evaluated the safety, acceptability and tolerability of and adherence to three placebo dosage forms (insert, douche, suppository) when each was applied rectally and used prior to RAI over a 4-week-long period. The study enrolled 217 healthy, HIV-uninfected men (cisgender and transgender) and transgender women (TGW) who are 18-35 years of age and who report engaging in RAI. Participants were randomized equally across six application sequences which determine the order each dosage form was used. Each dosage form was used for approximately four weeks, and there was be a 1-week washout period between each dosage form application period. It is hypothesized that the placebo rectal insert, the placebo rectal douche, and the placebo rectal suppository will be safe, acceptable and tolerable to participants, and that adherence will be high.
The study completed follow-up on July 27, 2020. Primary results are expected to be available soon.
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health