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

Completed · Phase 3

Conditions studied: HIV Infections, Substance Use, Adherence, Medication, Adherence, Treatment

In brief

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.

Key facts

Study ID

NCT05378399

Run by

Brigham and Women's Hospital

People needed

40

Starts

2022-12-20

Expected to finish

2026-03-31

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Does not speak English
• History of Crohn's disease or ulcerative colitis
• History of gastric bypass or bowel stricture
• History of GI malignancy or radiation to abdomen
• Allergy to gelatin, silver, or zinc (components of digital pill)
• Allergy to PrEP
• Not willing to operate DPS or Beiwe app

Where it is running

• Fenway Health — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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