Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05378399 | SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder | PHASE3 | COMPLETED | 40 | — | — | Dec 20, 2022 | Feb 27, 2026 | Apr 28, 2026 | 1 | United States |
Percentage adherence to PrEP and adherence patterns over the course of 60 days, as detected by the ID-Cap digital pill system (DPS).
Comparison of digital phenotyping data, as detected by Beiwe, on PrEP-adherent versus PrEP-nonadherent days, as detected by the digital pill system (DPS).
| Arm | Type | Description |
|---|---|---|
| Digital Pills and Beiwe | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Descovy or Truvada | DRUG | Descovy or Truvada prescribed with digital pills for PrEP |
| ID-Cap System | DEVICE | Digital pills overencapsulating Descovy or Truvada for PrEP |
| Beiwe | DEVICE | Digital phenotyping app |
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 ...