The PrEP (Pre-exposure Prophylaxis) SMART Study (NCT04038060) | Clinical Trial Compass
CompletedNot Applicable
The PrEP (Pre-exposure Prophylaxis) SMART Study
South Africa360 participantsStarted 2019-05-16
Plain-language 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.
Who can participate
Age range18 Years – 25 Years
SexFEMALE
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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