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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.

Protocol Chair(s)
Bauermeister, Jose (Protocol Chair)
Protocol Title
Acceptability, Tolerability, and Adherence of Three Rectal Microbicide Placebo Formulations among HIV Seronegative Cisgender Men, Transgender Men and Transgender Women Who Engage in Receptive Anal Intercourse
DAIDS Protocol ID
38459
Status
Pending
Formulation
Douche
Rectal Insert
Rectal Suppository
Drug
Placebo
Study Focus/Product Administration
Rectal
Study Type
Behavioral
Safety
Countries
Malawi
Peru
South Africa
Thailand
United States
Population
Men (cisgender men, non‐transgender men)   
Transgender men
Transgender women
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US Eunice Kennedy Shriver National Institute of Child Health and Human Development
US National Institute of Mental Health
US National Institutes of Health