N/A
Completed N=360
The PrEP (Pre-exposure Prophylaxis) SMART Study
HIV/AIDS
Source: ClinicalTrials.gov NCT04038060 ↗
Enrolled (actual)
360
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: PrEP Adherence — 34; 32 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PrEP Adherence |
34; 32 | — |
| SECONDARY Probability of High PrEP Adherence at Nine Months |
0.25; 0.27; 0.24; 0.24 | — |
| SECONDARY PrEP Discontinuation |
19; 18 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04038060). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.