Status:
COMPLETED
The PrEP (Pre-exposure Prophylaxis) SMART Study
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Wits Reproductive Health and HIV Institute
National Institute of Mental Health (NIMH)
Conditions:
HIV/AIDS
Eligibility:
FEMALE
18-25 years
Phase:
NA
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) ...
Detailed Description
Women enrolled in the study will be randomized to standard of care adherence support (brief counseling) and either WhatsApp groups or weekly two-way SMS messages. Two months after PrEP initiation, ten...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2022
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT04038060
Start Date
May 16 2019
End Date
January 25 2022
Last Update
September 1 2023
Active Locations (1)
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1
Wits Reproductive Health and HIV Institute
Johannesburg, South Africa