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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03512418 | Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps) | PHASE3 | COMPLETED | 30 | — | — | Jun 20, 2019 | Apr 10, 2024 | Sep 17, 2025 | 1 | United States |
Number of participants who were able to complete the trial and record adherence events using the digital pill system in the intervention arm.
| Arm | Type | Description |
|---|---|---|
| PrEPsteps | EXPERIMENTAL | Participants receive the digital pills with Truvada, plus the PrEPsteps intervention that is programmed at the randomization study visit (Study Visit 2). Participants will use PrEPsteps and the digital pill to measure Truvada adherence for months 1-3. |
| Control | ACTIVE_COMPARATOR | Participants receive digital pills with Truvada alone. Participants will use digital pills with Truvada for months 1-3. |
| Name | Type | Description |
|---|---|---|
| PrEPsteps | BEHAVIORAL | Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT). |
| Digital pill | DEVICE | The digital pill comprises a standard gelatin capsule with an integrated radiofrequency emitter that overencapsulates the desired medication (Truvada). When participants ingest the digital pill, the chloride ion gradient in the stomach activates the radiofrequency emitter which transmits direct evidence of medication ingestion to a wearable reader which relays this data to the participant's smartphone and cloud server. |
| Truvada | DRUG | Participants receive once daily Truvada as PrEP to prevent HIV. |
Inclusion Criteria: * Cisgender MSM * Moderate to severe non-alcohol substance use disorder * Self-reported missed PrEP doses (\> or equal to 2 doses in 1 week over past 3 months) * HIV negative * On PrEP or initiating PrEP * Has qualifying laboratory testing: Cr clearance, HBV, liver function test...