NCT05378399CompletedPhase 3
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 12 May 2022
- Start date
- 20 Dec 2022
- Primary completion date
- 27 Feb 2026
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- HIV
- NCT number
- NCT05378399
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 40
- From 20 Dec 2022 to the primary completion date, 27 Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Does not speak English
- Not willing to operate DPS or Beiwe app
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fenway Health Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.