Microbicide Trials Network

MTN-016

Details

Protocol Title: 
HIV Prevention Agent Pregnancy Exposure Registry
DAIDS Protocol ID: 
10737
Status: 
Enrolling

Protocol Chair(s)

Richard Beigi (Protocol Co-Chair)
Samuel Kabwigu (Protocol Co-Chair)

Description

Sponsors:

Division of AIDS, US National Institute of Allergy and Infectious Diseases

US National Institutes of Health

Study design:

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

Other Study Info

EMBRACE is a prospective observational cohort investigation of exposures to study agents under investigation for HIV prevention. Participants will be offered enrollment in the Registry after it is determined that there has been an exposure to a study agent during pregnancy. Participants will be enrolled as early in pregnancy as possible to maximize the validity of the data. The study population will consist of female participants who are identified as becoming pregnant during microbicide or PrEP trials, or who have had planned exposures in pregnancy safety studies as well as their babies resulting from these pregnancies. This study will only enroll babies who have not yet reached their 1 year birth date.