MedTrace Logo

Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women

NCT05322629 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2025-11-03

No results posted yet for this study

Summary

To reach HIV-uninfected pregnant and breastfeeding women in South Africa, who are at very high risk of HIV, researchers will test a new and innovative package of interventions: 1) pre-exposure prophylaxis (PrEP), which is a daily antiretroviral pill that is both safe and effective for preventing HIV in pregnant and breastfeeding mothers and 2)) enhanced adherence counseling combined with differentiated deliver of community PrEP delivery for women who have difficulties with regular PrEP use.

Our study will be among the first ever to evaluate the efficacy and cost-effectiveness of a PrEP intervention among pregnant and postpartum women and will play a key role in informing maternal PrEP interventions to eliminate HIV acquisition and transmission to partners and their infants.

Conditions

Interventions

BEHAVIORAL

PrEP adherence biofeedback

Services for women in the intervention arm includes bio-feedback adherence counseling based on urine lateral flow assays of tenofovir to measure adherence with rapid PrEP delivery .

BEHAVIORAL

Standard of care counseling

Adherence counseling based on self report and following national guidelines

Sponsors & Collaborators

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

    collaborator NIH

  • University of Cape Town

    collaborator OTHER

  • University of California, Los Angeles

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2025-05-30
Completion
2025-12-31

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05322629 on ClinicalTrials.gov