NCT03386578View on ClinicalTrials.gov

Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum

PHASE2CompletedINTERVENTIONAL
Enrollment

780

Participants

Timeline

Start Date

July 3, 2018

Primary Completion Date

October 25, 2023

Study Completion Date

February 24, 2024

Conditions
HIV Infections
Interventions
DRUG

Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)

200 mg/300 mg of FTC/TDF administered orally as a fixed-dose combination tablet once daily

BEHAVIORAL

Behavioral HIV risk reduction package

Included cohort-appropriate SMS messages.

BEHAVIORAL

Enhanced adherence support

Included two-way SMS messaging and tailored counseling with drug level feedback.

Trial Locations (7)

2001

Wits RHI Shandukani Research Centre CRS, Johannesburg

Unknown

Blantyre CRS, Blantyre

Baylor-Uganda CRS, Kampala

MU-JHU Care Limited CRS, Kampala

St Mary's CRS, Saint Mary's

Seke North CRS, Chitungwiza

Harare Family Care CRS, Harare

Sponsors

Collaborators (1)

Gilead Sciences
All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03386578 - Evaluating the Pharmacokinetics, Feasibility, Acceptability, and Safety of Oral Pre-Exposure Prophylaxis for HIV Prevention During Pregnancy and Postpartum | Biotech Hunter | Biotech Hunter