Microbicide Trials Network

MTN-035

Details

Protocol Title: 
Acceptability, Tolerability and Adherence of Two Rectal Placebo Products among HIV Seronegative Men and Transgender Women
DAIDS Protocol ID: 
38459
Status: 
In Development

Protocol Chair(s)

Jose Bauermeister (Protocol Chair)

Description

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.