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).

Conditions

• HIV Infections
• Substance 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.

Sponsors & Collaborators

• Gilead Sciences

  collaborator INDUSTRY

• The Fenway Institute

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Brigham and Women's Hospital

  lead OTHER

Principal Investigators

• Peter R Chai, MD, MMS · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-20

Primary Completion

2024-04-10

Completion

2024-04-10

FDA Drug

Yes

FDA Device

Yes

Countries

• United States

Study Locations