The PrEP (Pre-exposure Prophylaxis) SMART Study

Not Applicable

Completed

Interventions: Behavioral: WhatsApp Group
Behavioral: 2-way SMS
Behavioral: Drug level feedback
Behavioral: Monthly counseling sessions

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.

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, tenofovir drug levels will be measured to determine if participants have achieved high adherence based on their initial randomization. Women with high adherence (i.e., TFV-DP \>/=500 fmol/punch from dried blood spots \[DBS\]) will continue with the adherence support to which they were initially randomized. Participants with low adherence (i.e., TFV-DP \<500 fmol/punch from DBS) will continue initial randomization (WhatsApp or two-way SMS) plus be randomized to more one of two more intensive adherence support interventions - continued monthly visits with adherence and problem-focused counseling at months 3-8 or quarterly visits between months 3-9 with feedback about adherence based on drug levels at months 3 and 6.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
WhatsApp Group	WhatsApp Group	Participants will be assigned to participate in a WhatsApp Group
2-way SMS	2-way SMS	Participants will be assigned to receive weekly 2-way SMS initiated by the study team
2-way SMS and monthly counseling sessions	2-way SMS	Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
WhatsApp Group and drug level feedback	WhatsApp Group	Participants will be assigned to participate in a WhatsApp Group and drug level feedback
WhatsApp Group and drug level feedback	Drug level feedback	Participants will be assigned to participate in a WhatsApp Group and drug level feedback
2-way SMS and drug level feedback	2-way SMS	Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
2-way SMS and drug level feedback	Drug level feedback	Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback
2-way SMS and monthly counseling sessions	Monthly counseling sessions	Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions
WhatsApp Group and monthly counseling sessions	WhatsApp Group	Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions
WhatsApp Group and monthly counseling sessions	Monthly counseling sessions	Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions

Primary Outcome Measures

Name	Time	Method
PrEP Adherence	9 months	Evaluation of the proportion of young women who adhere well to PrEP in each of the intervention arms.

Secondary Outcome Measures

Name	Time	Method
PrEP persistence	12 months	Assessment of the proportion of young women who achieve high adherence.
Intervention satisfaction	12 months	Qualitative exploration of women's satisfaction with their assigned intervention(s).
Correlates of PrEP adherence	12 months	Assessment of the correlates of PrEP adherence, after adjusting for study arm.
PrEP discontinuation	12 months	Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP.
PrEP decision making	12 months	Qualitative exploration of the factors that influence women's decisions to adhere to PrEP.

Locations (1): Wits Reproductive Health and HIV Institute
🇿🇦
Johannesburg, South Africa