SmartSteps: A Context-Aware, Pre-Exposure Prophylaxis Adherence Intervention for Individuals With Substance Use Disorder
Sponsor: Brigham and Women's Hospital
Trial Details
| Condition | HIV Infections, Substance Use, Adherence, Medication, Adherence, Treatment |
| Intervention | Descovy or Truvada; ID-Cap System; Beiwe |
| Phase | PHASE3 |
| Status | Completed |
| Participants | 40 |
| Est. Completion | 27 Feb 2026 |
| Last Updated | 21 July 2026 |
Primary Outcome
PrEP Adherence Patterns; Correlation of PrEP Adherence with Digital Phenotyping Patterns
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: 1. Age 18 or older 2. Cisgender male 3. Has sex with men 4. HIV negative 5. On PrEP or initiating PrEP (including switching from 2-1-1 or "on-demand" PrEP dosing to once-daily dosing) 6. Moderate risk score on ASSIST substance use screener (11-26 for alcohol, 4-26 for all other substances) or higher 7. Qualifying laboratory testing for PrEP: Cr clearance in past 3 months, HBV vaccination, liver function tests 8. Owns a smartphone with Android or iOS Exclusion Criteria: 1. Does not speak English 2. History of Crohn's disease or ulcerative colitis 3. History of gastric bypass or bowel stricture 4. History of GI malignancy or radiation to abdomen 5. Allergy to gelatin, silver, or zinc (components of digital pill) 6. Allergy to PrEP 7. Not willing to operate DPS or Beiwe app
Trial Sites
Countries
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