Details
- Protocol Title
- HIV Prevention Agent Pregnancy Exposure Registry
- DAIDS Protocol ID
- 10737
- Status
- Enrolling
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
Sites
- Bothas Hill Clinical Research Site
- Pitt CRS
- Umkomaas Clinical Research Site
- Makerere University - Johns Hopkins University Research Collaboration
- Kamwala Health Centre
- Seke South Clinical Research Site
- Spilhaus Clinical Research Site
- R.K. Khan Hospital
- Zengeza 3 Clinic
- Isipingo CRS
- Overport CRS
- CAPRISA Aurum CRS
- RHRU Research and Training Centre CRS
- CAPRISA eThekwini CRS
- Verulam CRS
- Soweto MTN CRS
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.