The PrEP (Pre-exposure Prophylaxis) SMART Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design

Conditions
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HIV/AIDS

Intervention / Treatment
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* Behavioral: WhatsApp Group
* Behavioral: 2-way SMS
* Behavioral: Drug level feedback
* Behavioral: Monthly counseling sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Sequential multiple assignment randomized trial (SMART)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WhatsApp Group<br>Participants will be assigned to participate in a WhatsApp Group | Behavioral: WhatsApp Group<br>* Participants will receive peer adherence support through WhatsApp groups<br>|
| Experimental: 2-way SMS<br>Participants will be assigned to receive weekly 2-way SMS initiated by the study team | Behavioral: 2-way SMS<br>* Participants will receive healthcare worker adherence support through 2-way SMS<br>|
| Experimental: 2-way SMS and monthly counseling sessions<br>Participants will be assigned to receive weekly 2-way SMS initiated by the study team and monthly counseling sessions | Behavioral: 2-way SMS<br>* Participants will receive healthcare worker adherence support through 2-way SMS<br>Behavioral: Monthly counseling sessions<br>* Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence<br>|
| Experimental: 2-way SMS and drug level feedback<br>Participants will be assigned to receive weekly 2-way SMS initiated by the study team and drug level feedback | Behavioral: 2-way SMS<br>* Participants will receive healthcare worker adherence support through 2-way SMS<br>Behavioral: Drug level feedback<br>* Participants will receive adherence counseling based on tenofovir drug levels<br>|
| Experimental: WhatsApp Group and monthly counseling sessions<br>Participants will be assigned to participate in a WhatsApp Group and monthly counseling sessions | Behavioral: WhatsApp Group<br>* Participants will receive peer adherence support through WhatsApp groups<br>Behavioral: Monthly counseling sessions<br>* Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence<br>|
| Experimental: WhatsApp Group and drug level feedback<br>Participants will be assigned to participate in a WhatsApp Group and drug level feedback | Behavioral: WhatsApp Group<br>* Participants will receive peer adherence support through WhatsApp groups<br>Behavioral: Drug level feedback<br>* Participants will receive adherence counseling based on tenofovir drug levels<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Adherence | Evaluation of the proportion of young women who adhere well to PrEP in each of the intervention arms. | 9 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-exposure prophylaxis, young women, HIV infections/prevention, SMART design