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

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 20, 2019

Primary Completion Date

April 10, 2024

Study Completion Date

April 10, 2024

Conditions
HIV InfectionsSubstance Use Disorders
Interventions
BEHAVIORAL

PrEPsteps

Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).

DEVICE

Digital pill

The digital pill comprises a standard gelatin capsule with an integrated radiofrequency emitter that overencapsulates the desired medication (Truvada). When participants ingest the digital pill, the chloride ion gradient in the stomach activates the radiofrequency emitter which transmits direct evidence of medication ingestion to a wearable reader which relays this data to the participant's smartphone and cloud server.

DRUG

Truvada

Participants receive once daily Truvada as PrEP to prevent HIV.

Trial Locations (1)

02215

Fenway Health, Boylston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

collaborator

The Fenway Institute

OTHER

collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Brigham and Women's Hospital

OTHER