MedTrace Logo

SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder

NCT05378399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-28

No results posted yet for this study

Summary

This is a single-arm, observational study of HIV-negative MSM with substance use disorder. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and study eligibility will be confirmed. Eligible participants will attend three additional visits over the course of the study - the Enrollment Visit (Visit 2), Month 1 Visit (Visit 3), and Month 2 Visit (Visit 4). Participants will take one PrEP digital pill per day, for 60 days total, while using the digital pill system (DPS) and Beiwe, a digital phenotyping app. On nonadherent days, participants will receive brief surveys prompting them to report the reasons for their missed dose, as well as their engagement in substance use and sexual activity. Timeline followback will be conducted at the Month 1 and Month 2 Visits to understand the context of any nonadherence. Qualitative user experience exit interviews and dried blood spots (DBS) will be conducted at the Month 2 Visit.

Conditions

  • HIV Infections
  • Substance Use
  • Adherence, Medication
  • Adherence, Treatment

Interventions

DRUG

Descovy or Truvada

Descovy or Truvada prescribed with digital pills for PrEP

DEVICE

ID-Cap System

Digital pills overencapsulating Descovy or Truvada for PrEP

DEVICE

Beiwe

Digital phenotyping app

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 Hopsital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-20
Primary Completion
2026-02-27
Completion
2026-02-27
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05378399 on ClinicalTrials.gov