CompletedPHASE3NCT05378399

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

Sponsor: Brigham and Women's Hospital

Trial Details

ConditionHIV Infections, Substance Use, Adherence, Medication, Adherence, Treatment
InterventionDescovy or Truvada; ID-Cap System; Beiwe
PhasePHASE3
StatusCompleted
Participants40
Est. Completion27 Feb 2026
Last Updated21 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

United States
View Registry Entry

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