Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that
responds to real-time PrEP adherence and nonadherence detected through the use of a digital
pill. The PrEPSteps intervention will be developed and refined through a series of focus
groups. Participants will be screened at the Screening Visit, and, if eligible, will then
begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2,
participants will undergo randomization to using either PrEPSteps + the digital pill, or the
digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3
monthly study visits (Study Visits 3-5) where the investigators will assess digital pill
adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide
substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the
investigators will conduct a semi-structured qualitative interview with participants in the
PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to
understand the user response to PrEPSteps and the digital pill. All participants will
complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).
Phase:
Phase 3
Details
Lead Sponsor:
Fenway Community Health
Collaborators:
Brigham and Women's Hospital Gilead Sciences
Treatments:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination