Trials / Completed
CompletedNCT04038060
The PrEP (Pre-exposure Prophylaxis) SMART Study
Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (actual)
- Sponsor
- University of Washington · Academic / Other
- Sex
- Female
- Age
- 18 Years – 25 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | WhatsApp Group | Participants will receive peer adherence support through WhatsApp groups |
| BEHAVIORAL | 2-way SMS | Participants will receive healthcare worker adherence support through 2-way SMS |
| BEHAVIORAL | Drug level feedback | Participants will receive adherence counseling based on tenofovir drug levels |
| BEHAVIORAL | Monthly counseling sessions | Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence |
Timeline
- Start date
- 2019-05-16
- Primary completion
- 2021-10-27
- Completion
- 2022-01-25
- First posted
- 2019-07-30
- Last updated
- 2023-09-01
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT04038060. Inclusion in this directory is not an endorsement.