SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
Status:
Not yet recruiting
Trial end date:
2024-08-30
Target enrollment:
Participant gender:
Summary
This is a single-arm, observational study of HIV-negative MSM with substance use disorder.
Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the
informed consent process will be conducted and study eligibility will be confirmed. Eligible
participants will attend three additional visits over the course of the study - the
Enrollment Visit (Visit 2), Month 1 Visit (Visit 3), and Month 2 Visit (Visit 4).
Participants will take one PrEP digital pill per day, for 60 days total, while using the
digital pill system (DPS) and Beiwe, a digital phenotyping app. On nonadherent days,
participants will receive brief surveys prompting them to report the reasons for their missed
dose, as well as their engagement in substance use and sexual activity. Timeline followback
will be conducted at the Month 1 and Month 2 Visits to understand the context of any
nonadherence. Qualitative user experience exit interviews and dried blood spots (DBS) will be
conducted at the Month 2 Visit.
Phase:
Phase 3
Details
Lead Sponsor:
Fenway Community Health
Collaborators:
Brigham and Women's Hospital Gilead Sciences
Treatments:
Emtricitabine tenofovir alafenamide Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination