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The Prevention Agent Pregnancy Exposure Registry, also known as EMBRACE (Evaluation of Maternal and Baby Outcome Registry After Chemoprophylactic Exposure) was a prospective observational cohort study of maternal exposures to investigational HIV prevention agents. 460 pregnant participants and 413 live infants were enrolled in the study. Participants were enrolled as early in pregnancy as possible to maximize data validity. The study population consisted of current or recent female participants identified as becoming pregnant during MTN microbicide or PrEP trials, or who have had planned exposures in pregnancy safety studies. This study included infants resulting from those pregnancies. This protocol assessed adverse pregnancy outcomes, evaluated growth parameters of infants during the first year of life, and collected information on the prevalence of major malformations in infants during the first year of life. The study also evaluated the prevalence and persistence of HIV drug resistance mutations in plasma among HIV-infected infants and provided a cohort of infants not exposed to active study agents during pregnancy. The protocol was amended in February 2014 with modifications made to the anticipated sample size, study duration, study objectives, and endpoints.

The status of MTN-016 participants enrolled from the following parent protocols is as follows:

  • MTN-002 protocol cohort completed follow-up on December 23, 2010
  • MTN-003 protocol cohort completed follow-up on December 9, 2013
  • MTN-008 protocol cohort completed follow-up on September 17, 2014
  • MTN-020 protocol cohort completed follow-up on January 6, 2017
  • MTN-025 protocol cohort completed follow-up on May 6, 2020

MTN-016/MTN-002 and MTN-008 cohort results of obstetric and infant outcomes were presented at the HIV Research for Prevention (HIVR4P) conference held on October 28-31, 2014 in Cape Town, South Africa. MTN-016/VOICE cohort results of pregnancy incidence and outcomes were presented at International AIDS Society (IAS) held on July 19-22, 2015 in Vancouver, Canada. MTN-016/ASPIRE cohort results of pregnancy incidence and outcomes were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) held on February 13-17, 2017 in Seattle, WA and the primary manuscript was published in Journal of Acquired Immune Deficiency Syndromes on December 15, 2018.

Protocol Chair(s)
Beigi, Richard (Protocol Co-Chair)
Kabwigu, Samuel (Protocol Co-Chair)
Protocol Title
HIV Prevention Agent Pregnancy Exposure Registry: EMBRACE Study
DAIDS Protocol ID
10737
Status
Closed to Follow Up
Study Type
Observational  
Safety
Countries
Malawi
South Africa
Uganda
United States
Zimbabwe
Population
Infants
Pregnant  
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

Prospective observational cohort investigation of prevention agent and control group exposures in pregnancy