The PrEP (Pre-exposure Prophylaxis) SMART Study

University of Washington360 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

360

Conditions

HIV/AIDS

Interventions

WhatsApp GroupBEHAVIORAL

Participants will receive peer adherence support through WhatsApp groups

2-way SMSBEHAVIORAL

Participants will receive healthcare worker adherence support through 2-way SMS

Drug level feedbackBEHAVIORAL

Participants will receive adherence counseling based on tenofovir drug levels

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wits Reproductive Health and HIV Institute

Johannesburg, South Africa

Outcomes

Primary Outcomes

PrEP Adherence

Evaluation of the proportion of young women who adhere well to PrEP in each of the original intervention arms.

Time frame: 9 months

Secondary Outcomes

Probability of High PrEP Adherence at Nine Months

Estimated probability of high PrEP adherence (tenofovir diphosphate levels greater than or equal to 700 fmol/punch at 9 months) by embedded dynamic treatment strategy. This analysis employed a weighted and replicated approach to account for non-response, re-randomization, and overlap in intervention assignments (e.g., the same participants in the SMS intervention were represented twice in two of the four interventions). Weighting accounted for over-representation of people who responded, whereas replicating responder observations across the two embedded dynamic treatment strategies with the same first-line treatment accounted for one participant being able to be in two treatment strategies.

Time frame: 9 months

PrEP Discontinuation

Assessment of the timing of PrEP discontinuation in young women who discontinue PrEP, reported by original intervention arm.

Time frame: 9 months

Data from ClinicalTrials.gov

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