Long-term follow-up of HIV seroconverters in microbicide trials – rationale, study design, and challenges in MTN-015
Year: 2016
Type: article
Abstract: BACKGROUND: As the effect of biomedical prevention interventions on the natural history of HIV-1 infection in participants who seroconvert is unknown, the Microbicide Trials Network (MTN) established a longitudinal study (MTN-015) to monitor virologic, immunological, and clinical outcomes, as well as behavioral changes among women who become HIV-infected during MTN trials. We describe the rationale, study design, implementation, and enrollment of the initial group of participants in the MTN seroconverter cohort. METHODS: Initiated in 2008, MTN-015 is an ongoing observational cohort study enrolling participants who acquire HIV-1 infection during effectiveness studies of candidate microbicides. Eligible participants from recently completed and ongoing MTN trials are enrolled after seroconversion and return for regular follow-up visits with clinical and behavioral data collection. Biologic samples including blood and genital fluids are stored for future testing. RESULTS: MTN-015 was implemented initially at six African sites and enrolled 100/139 (72%) of eligible women who seroconverted in HIV Prevention Trials Network protocol 035 (HPTN 035, conducted by the MTN). The median time from seroconversion in HPTN 035 to enrollment in MTN-015 was 18 months. Retention was good with >70% of visits completed. Implementation challenges included regulatory reviews, translation, and testing of questionnaires, and site readiness. CONCLUSIONS: Enrollment of HIV-seroconverters into a longitudinal observational follow-up study is feasible and acceptable to participants. Data and samples collected in this protocol will be used to assess safety of investigational HIV microbicides and answer other important public health questions for HIV infected women.
Source: HIV Clinical Trials
Authors: Sharon A. Riddler, Marla Husnik, Pamina M. Gorbach, Lisa Levy, Urvi Parikh, Edward Livant, Arendevi Pather, Bonus Makanani, Felix Muhlanga, Margaret Kasaro, Francis Martinson, Vanessa Elharrar, Jennifer E. Balkus, on Behalf of the MTN-015 Protocol Team for the Microbicide Trials Network
Institutions: University of Pittsburgh, Fred Hutch Cancer Center, University of California, Los Angeles, Family Health International 360, Magee-Womens Research Institute, South African Medical Research Council, Johns Hopkins University, Queen Elizabeth Central Hospital, University of Zimbabwe, University of California, San Francisco, University of Zimbabwe-University of California San Francisco, Centre for Infectious Disease Research in Zambia, Kamuzu Central Hospital, National Institutes of Health
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Awards: Statistical and Data Management Center (SDMC): Microbicide Trials Network, Leadership and Operations Center (LOC): Microbicide Trials Network, Aptamer Microbicide Development Program (MDP), Laboratory Center (LC): Microbicide Trials Network, UZ-UCSF CTU, The Johns Hopkins University-Blantyre Clinical Trials Unit, University of North Carolina Global HIV Prevention and Treatment Clinical Trials Unit, Wits HIV Research Group CLINICAL TRIAL UNIT (CTU) reapplication
OpenAlex ID: W2489186328