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MTN 016 (EMBRACE)

Status
Ongoing
Phase
Open Label
Principal Investigator(s)
Richard Beigi
Objective

To learn whether using a vaginal microbicide or antiretroviral (ARV) tablets affects a woman’s pregnancy outcome and her baby's health and development.

Prevention Option(s)
Microbicides
PrEP
Observational
Prospective Cohort
Arms and Assigned Interventions
Description
Pregnant women exposed to an HIV prevention study agent during participation in an HIV prevention trial
Description
Infants born to women who are enrolled in MTN 016 where there exists maternal HIV prevention agent exposure
Results
Pregnancy and Infant Outcomes Among Women Using the Dapivirine Vaginal Ring in Early Pregnancy
Official Code
NCT01209754
Related Publications
Implementation of a prospective pregnancy registry for antiretroviral based HIV prevention trials
Trial Sponsors
MTN, NIAID, CONRAD, NICHD
October 2009
November 2020
Enrollment
873
1
Months
Population
Pregnant women
Sites

University of Alabama at Birmingham

Birmingham, Alabama
United States of America

University of Pittsburgh School of Medicine, Center for Family Planning Research

Pittsburgh, Pennsylvania
United States of America

UZ-UCSF HIV Prevention Trials Unit - Seke South

Chitungwiza
Zimbabwe

UZ-UCSF HIV Prevention Trials Unit - Spilhaus

Harare
Zimbabwe

UZ-UCSF HIV Prevention Trials Unit - Chitungwiza

Zengeza
Zimbabwe

Wits Reproductive Health and HIV Institute / University of the Witwatersrand

Hillbrow
South Africa

UNC Lilongwe CRS

Lilongwe
Malawi

Blantyre CRS

Malawi

eThekwini CRS

Durban, KwaZulu-Natal
South Africa

Botha's Hill CRS

Westville, KwaZulu-Natal
South Africa

Chatsworth CRS

Chatsworth, KwaZulu-Natal
South Africa

Isipingo CRS

Westville, KwaZulu-Natal
South Africa

Tongaat CRS

Tongaat, KwaZulu-Natal
South Africa

Umkomaas CRS

Umkomaas, KwaZulu-Natal
South Africa

Verulam CRS

Verulam, KwaZulu-Natal
South Africa

Soweto MTN CRS

Johannesburg, Gauteng
South Africa

Makerere University - Johns Hopkins University Research Collaboration

Kampala
Uganda