SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 or older

• Cisgender male

• Has sex with men

• HIV negative

• On PrEP or initiating PrEP (including switching from 2-1-1 or on-demand PrEP dosing to once-daily dosing)

• Moderate risk score on ASSIST substance use screener (11-26 for alcohol, 4-26 for all other substances) or higher

• Qualifying laboratory testing for PrEP: Cr clearance in past 3 months, HBV vaccination, liver function tests

• Owns a smartphone with Android or iOS

Locations
United States
Massachusetts
Fenway Health
RECRUITING
Boston
Contact Information
Primary
Peter R Chai, MD MMS
pchai@fenwayhealth.org
617-732-5640
Backup
Georgia Goodman, BS
ggoodman@fenwayhealth.org
857-301-8820
Time Frame
Start Date: 2022-12-20
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 40
Treatments
Experimental: Digital Pills and Beiwe
Participants will take one PrEP digital pill per day, for 60 days total, while using the ID-Cap digital pill system and Beiwe digital phenotyping app.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Gilead Sciences, The Fenway Institute

This content was sourced from clinicaltrials.gov

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