MTN-015 is a multi-site, prospective, observational cohort study of women following HIV-1 seroconversion in microbicide trials of ARV-based microbicides or oral pre-exposure prophylaxis (PrEP). It is anticipated that approximately 500 women will be enrolled in this study. Further comparisons between participants assigned to an agent and participants assigned to a placebo include HIV disease progression over the total duration of follow-up, virologic and immunologic responses following initiation of ART, HIV-1 drug resistance profile among ART recipients at the time of virologic failure. This study will also describe post-seroconversion changes in participant sexual behaviors and partnership status.
MTN-015 is uniquely poised to capture extensive prospective data on the clinical progression of HIV disease and the prevalence of drug resistance mutations among seroconverters from studies examining various formulations of microbicides (film, gel, ring), as well as orally administered antiretroviral agents for HIV prevention.
The protocol was amended in May 2013 to clarify that participants will remain on-study for a minimum of 12 months after HIV-1 seroconversion and that follow-up may continue as long as funding resources permit or as determined by MTN leadership. MTN-015 participants enrolled from the HPTN 035 parent protocol completed follow up on 31 May 2013. MTN-015 participants enrolled from the MTN-003 parent protocol completed follow up on June 30, 2014.
US National Institutes of Health
Multi-site prospective observational cohort study