UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

PHASE4RecruitingINTERVENTIONAL
Enrollment

621

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Pre-exposure ProphylaxisHIV PreventionPregnancy Related
Interventions
DRUG

Initiating daily oral PrEP during pregnancy

Group 1a will include pregnant women who initiate oral PrEP when already pregnant, at enrollment into the study.

DRUG

Already using daily oral PrEP at the time of pregnancy diagnosis

Group 1b will include women already using daily oral PrEP at the time of pregnancy diagnosis and enrollment in the study.

DRUG

Initiating injectable PrEP during pregnancy

Group 2a will include pregnant women who initiate injectable PrEP (CAB-LA) when already pregnant, at enrollment into the study.

DRUG

Already using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis

Group 2b will include women using injectable PrEP (CAB-LA) at the time of pregnancy diagnosis and enrollment into the study.

Trial Locations (1)

Unknown

RECRUITING

Bwaila Distict Hospital, Lilongwe

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

collaborator

United States President's Emergency Plan for AIDS Relief

FED

collaborator

Ministry of Health, Malawi

OTHER_GOV

lead

University of North Carolina, Chapel Hill

OTHER