Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fenway Community Health
• Collaborators: Brigham and Women's Hospital; Gilead Sciences
• Treatments: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Criteria

Inclusion Criteria:

• Cisgender MSM

• Moderate to severe non-alcohol substance use disorder

• Self-reported missed PrEP doses (> or equal to 2 doses in 1 week over past 3 months)

• HIV negative

• On PrEP or initiating PrEP

• Has qualifying laboratory testing: Cr clearance, HBV, liver function tests

• Owns a smartphone with Android or iOS

• Age 18 or older

Exclusion Criteria:

• Non-English speaker

• HIV positive

• History of Crohn's disease or ulcerative colitis

• History of gastric bypass, bowel stricture

• History of GI malignancy or radiation to abdomen

• Unable/unwilling to ingest a digital pill

• Allergy to gelatin, silver or zinc (components of the digital pill)

• Does not qualify for PrEP (abnormal liver function, or Cr Clearance <60)