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Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

NCT02732730 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2025-06-12

Study results available
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Summary

To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.

Conditions

Interventions

DRUG

Truvada

400 women who accept to initiate PrEP

BEHAVIORAL

Drug level counseling at Weeks 8 and 13

Women who are randomized to enhanced counselling will have adherence monitoring based on plasma TFV levels obtained 4 and 8 weeks after PrEP acceptance

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Gilead Sciences

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • HIV Prevention Trials Network

    lead NETWORK

Principal Investigators

  • Connie Celum, MD, MPH · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-12
Primary Completion
2018-10-25
Completion
2018-10-25

Countries

  • South Africa
  • Zimbabwe

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 NCT02732730 on ClinicalTrials.gov