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

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).

Timeline

Start

2019-06-20

Primary completion

2024-04-10

Completion

2024-04-10

Publications

• Chai PR, Lee JS, Goodman GR, Albrechta H, Hokayem J, Loo L, Mohamed Y, Glynn TR, Rosen RK, Mayer KH, Boyer EW, Alpert P, Buffkin E, Carnes C, O'Cleirigh C. PrEPSteps: A Pilot Randomized Controlled Trial to Assess the Feasibility and Acceptability of a Digital Pill-Based PrEP Adherence Intervention in Men Who Have Sex with Men with Substance Use Disorder. AIDS Behav. 2026 Feb 2:10.1007/s10461-026-05049-x. doi: 10.1007/s10461-026-05049-x. Online ahead of print.

Drugs

Indications