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The PrEP (Pre-exposure Prophylaxis) SMART Study

NCT04038060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-04

Study results available
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Summary

The PrEP SMART study is testing a stepped model of scalable adherence support strategies in South African young women who initiate PrEP using a SMART (sequential multiple assignment randomized trial) design.

Conditions

Interventions

BEHAVIORAL

WhatsApp Group

Participants will receive peer adherence support through WhatsApp groups

BEHAVIORAL

2-way SMS

Participants will receive healthcare worker adherence support through 2-way SMS

BEHAVIORAL

Drug level feedback

Participants will receive adherence counseling based on tenofovir drug levels

BEHAVIORAL

Monthly counseling sessions

Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence

Sponsors & Collaborators

  • Wits Reproductive Health and HIV Institute

    collaborator OTHER

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Washington

    lead OTHER

Principal Investigators

  • Connie Celum, MD, MPH · University of Washington

  • Sinead Delany-Moretlwe, MBChB, PhD · Wits Reproductive Health and HIV Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2021-10-27
Completion
2022-01-25

Countries

  • South Africa

Study Locations

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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 NCT04038060 on ClinicalTrials.gov