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MTN-015 was 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).  MTN-015 was designed to capture extensive prospective data on the clinical progression of HIV disease, virologic and immunologic responses following initiation of ART, and HIV-1 drug resistance profile among ART recipients at the time of virologic failure. This study also described post-seroconversion changes in participant sexual behaviors and partnership status. MTN-015 was 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 status of MTN-015 participants enrolled from the following parent protocols is as follows:

  • HPTN 035 protocol cohort completed follow-up on May 31, 2013
  • MTN-003 protocol cohort completed follow-up on June 30, 2014
  • MTN-020 protocol cohort completed follow-up on June 30, 2019
  • MTN-025 protocol cohort completed follow-up on June 30, 2019

MTN-015/HPTN-035 cohort results were presented at the Microbicides 2010 meeting and the primary manuscript was published in HIV Clinical Trials on July 28, 2016. MTN-015/VOICE cohort results were presented at the HIV Research for Prevention (HIVR4P) conference held on October 17-21, 2016 in Chicago, IL and the primary manuscript was published in PLoS One on June 28, 2017. MTN-015/ASPIRE cohort results were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) held on February 13-16, 2017 in Seattle, WA and the primary manuscript was published in Clinical Infectious Diseases on July 18, 2019.

Protocol Chair(s)
Riddler, Sharon (Protocol Chair)
Protocol Title
An Observational Cohort Study of Women following HIV-1 Seroconversion in Microbicide Trials
DAIDS Protocol ID
10529
Status
Closed to Follow Up
Study Type
Observational  
Safety
Countries
Malawi
South Africa
Uganda
Zimbabwe
Population
Women (cisgender women, non‐transgender women)
Funder(s)
Division of AIDS, US National Institute of Allergy and Infectious Diseases
US National Institutes of Health
Other Study Info

Multi-site prospective observational cohort study