The PrEP (Pre-exposure Prophylaxis) SMART Study
Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design
2 other identifiers
interventional
360
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2019
CompletedFirst Submitted
Initial submission to the registry
June 19, 2019
CompletedFirst Posted
Study publicly available on registry
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2022
CompletedResults Posted
Study results publicly available
May 4, 2026
CompletedMay 4, 2026
April 1, 2025
2.5 years
June 19, 2019
December 14, 2023
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PrEP Adherence
Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms.
9 months
Secondary Outcomes (2)
Probability of High PrEP Adherence at Nine Months
9 months
PrEP Discontinuation
9 months
Study Arms (6)
WhatsApp Group
EXPERIMENTALParticipants will be assigned to participate in a WhatsApp Group
2-way SMS
EXPERIMENTALParticipants will be assigned to receive weekly 2-way SMS initiated by the study team
2-way SMS and monthly counseling sessions
EXPERIMENTALParticipants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
2-way SMS and drug level feedback
EXPERIMENTALParticipants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
WhatsApp Group and monthly counseling sessions
EXPERIMENTALParticipants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
WhatsApp Group and drug level feedback
EXPERIMENTALParticipants will be assigned to participate in a WhatsApp Group and drug level feedback
Interventions
Participants will receive peer adherence support through WhatsApp groups
Participants will receive healthcare worker adherence support through 2-way SMS
Participants will receive adherence counseling based on tenofovir drug levels
Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
Eligibility Criteria
You may qualify if:
- Female at birth
- Age 18-25 years
- Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening
- Literate in one or more of the study languages
- Willing and able to provide informed consent
- Able and willing to provide adequate locator information
- Regular access to a mobile phone with SMS and WhatsApp capacity
- Agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation
You may not qualify if:
- Planning to relocate in the next 12 months
- Has a job or other obligations that would require long absences from the area (\> 4 weeks at a time) for 12 months
- A reactive or positive HIV test at Enrollment
- Any reported PrEP use within the last 6 months
- Concomitant participation in a clinical trial using investigational agents, including placebo-controlled clinical trials using such agents
- Prior participation in the active arm, or current participation in any arm, of an HIV vaccine trial
- Positive pregnancy test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Mental Health (NIMH)collaborator
- University of Washingtonlead
- Wits Reproductive Health and HIV Institutecollaborator
Study Sites (1)
Wits Reproductive Health and HIV Institute
Johannesburg, South Africa
Related Publications (2)
Velloza J, Poovan N, Meisner A, Ndlovu N, Ndimande-Khoza N, Grabow C, Zwane P, Mbele S, Molefe M, Donnell D, Baeten JM, Hosek S, Celum C, Delany-Moretlwe S. Adaptive HIV pre-exposure prophylaxis adherence interventions for young women in Johannesburg, South Africa: a sequential multiple-assignment randomised trial. Lancet HIV. 2025 Feb;12(2):e105-e117. doi: 10.1016/S2352-3018(24)00268-6. Epub 2024 Dec 13.
PMID: 39681126DERIVEDVelloza J, Poovan N, Ndlovu N, Khoza N, Morton JF, Omony J, Mkwanazi E, Grabow C, Donnell D, Munthali R, Baeten JM, Hosek S, Celum C, Delany-Moretlwe S. Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: Study protocol for a sequential multiple assignment randomized trial. PLoS One. 2022 Apr 13;17(4):e0266665. doi: 10.1371/journal.pone.0266665. eCollection 2022.
PMID: 35417485DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Future work is needed to assess optimal approaches for implementing WhatsApp adherence clubs as an alternative support group model. Although the two-way SMS and WhatsApp support groups involved less participant burden and clinic-based procedures than the counseling interventions, they were still time-intensive for staff monitoring the messages. Future PrEP implementation programs considering these approaches will need to decide what level of messaging and phone-based follow-up is feasible.
Results Point of Contact
- Title
- Dr. Jennifer Velloza
- Organization
- University of California San Francisco
Study Officials
- PRINCIPAL INVESTIGATOR
Connie Celum, MD, MPH
University of Washington
- PRINCIPAL INVESTIGATOR
Sinead Delany-Moretlwe, MBChB, PhD
Wits Reproductive Health and HIV Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof of Medicine & Global Health, Adjunct Prof of Epidemiology
Study Record Dates
First Submitted
June 19, 2019
First Posted
July 30, 2019
Study Start
May 16, 2019
Primary Completion
October 27, 2021
Study Completion
January 25, 2022
Last Updated
May 4, 2026
Results First Posted
May 4, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
Data from the PrEP SMART Study will be available at the end of the project by contacting the Principal Investigators.