Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials
Year: 2017
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Safety data on pregnancy and fetal outcomes among women in HIV prevention trials are urgently needed to inform use of effective antiretroviral agents for HIV prevention. We describe an effective, efficient, and novel method to prospectively collect perinatal safety data concurrent with on-going parent clinical trials. METHODS: The Microbicide Trials Network (MTN)-016 study is a multinational prospective pregnancy exposure registry designed to capture pregnancy and neonatal outcomes. Studies currently contributing data to this registry included phase I and II safety trials with planned exposures to candidate HIV prevention agents, as well as phase IIB and III efficacy trials capturing data on pregnancy and infant outcomes following inadvertent fetal exposure during study participation. RESULTS: To date, participants from two phase I studies and two effectiveness trials have participated in MTN-016, resulting in 420 pregnant women and 381 infants enrolled. Infant retention has been high, with 329 of 381 (86%) infants completing the 12-month follow-up visit. CONCLUSION: In a research setting context, it is feasible to establish and implement a prospective, multinational HIV chemoprophylaxis pregnancy registry that will generate pregnancy exposure data in a robust fashion.
Source: HIV Clinical Trials
Institutions: University of Zimbabwe, University of California, San Francisco, University of Zimbabwe-University of California San Francisco, Johns Hopkins University, University of Washington, Fred Hutch Cancer Center, Makerere University, Family Health International 360, National Institutes of Health, United States Department of State, UPMC Health System, Magee-Womens Hospital, University of Pittsburgh Medical Center
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funders: U.S. Department of State, University of Alabama, University of New England, National Institutes of Health, National Institute of Mental Health, National Institute of Allergy and Infectious Diseases, National Institute of Child Health and Human Development, Eunice Kennedy Shriver National Institute of Child Health and Human Development
OpenAlex ID: W2777129343