Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study)

PHASE4CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 23, 2019

Primary Completion Date

December 1, 2021

Study Completion Date

September 30, 2023

Conditions
Hiv
Interventions
DRUG

TDF-FTC

We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.

BEHAVIORAL

Counselling on PrEP in antenatal and postnatal care

Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.

Trial Locations (1)

Unknown

Gugulethu Midwife Obstetric Unit, Cape Town

All Listed Sponsors
collaborator

University of Cape Town

OTHER

collaborator

Desmond Tutu HIV Foundation

OTHER

lead

University of California, Los Angeles

OTHER

NCT03826199 - Evaluation of Pre-exposure Prophylaxis Cascade in Pregnant and Breastfeeding Women in Cape Town (Formative Study) | Biotech Hunter | Biotech Hunter