Last updated on March 2020

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

Brief description of study

This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real time PrEP adherence and non adherence 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 a baseline assessment, they will then use the digital pill system for 2 weeks, then undergo randomization to using PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence. Participants will undergo 3 monthly study visits where the investigators will assess adherence, conduct pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling and obtain urine drug screens. At the final study visit, the investigators will conduct a semi-structured qualitative interview grounded in the Technology Acceptance Model to understand the user response to PrEPSteps and the digital pill.

Detailed Study Description

PrEPSteps is a novel, smartphone-based behavioral intervention that delivers PrEP adherence messages in response to detected PrEP ingestion via an innovative digital pill. PrEPSteps comprises 1) an adaptation of LifeSteps, an evidence-based medication adherence behavioral intervention, with smartphone-delivered booster sessions, 2) messages of contingent reinforcement and corrective feedback, and 3) stimulant use screening, brief assessment, and referral to treatment. In this K23, the investigators will first refine and inform the specification of PrEPSteps with a series of focus groups. The investigators will next test the feasibility, acceptability and potential for an effect of PrEPSteps to boost PrEP adherence in a pilot randomized controlled trial of men who have sex with men (MSM) with stimulant use. Finally, the investigators will conduct qualitative interviews among participants who used PrEPSteps to understand the participant response to living with the intervention.

Clinical Study Identifier: NCT03512418

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Fenway Health

Boylston, MA United States
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