Phase 3
N=30
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
HIV Infections · Substance Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03512418 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire — 14; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- PrEPsteps (Behavioral); Digital pill (Device); Truvada (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Adherence Intervention Qualitative and Quantitive Questionnaire |
14; 14 | — |
| SECONDARY Potential of PrEPsteps to Improve Adherence |
86; 72 | — |
| SECONDARY Number of People Who Found the Digital Pill Acceptable to Use Within the Intervention Arm |
14 | — |
Summary
This study will deploy a novel, personalized, smartphone-based intervention (PrEPSteps) that responds to real-time PrEP adherence and nonadherence detected through the use of a digital pill. The PrEPSteps intervention will be developed and refined through a series of focus groups. Participants will be screened at the Screening Visit, and, if eligible, will then begin using the digital pill system at Study Visit 1 for 2 weeks. At Study Visit 2, participants will undergo randomization to using either PrEPSteps + the digital pill, or the digital pill alone to measure PrEP adherence, for 90 days. Participants will then complete 3 monthly study visits (Study Visits 3-5) where the investigators will assess digital pill adherence, conduct manual pill counts, obtain dried blood spots to confirm adherence, provide substance use disorder counseling, and obtain urine drug screens. At Study Visit 5, the investigators will conduct a semi-structured qualitative interview with participants in the PrEPsteps arm, which will be grounded in the Technology Acceptance Model, in order to understand the user response to PrEPSteps and the digital pill. All participants will complete the final follow-up assessment 3 months after Study Visit 5 (Study Visit 6).
Eligibility Criteria
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 tests
- Owns a smartphone with Android or iOS
- Age 18 or older
Exclusion Criteria
- Non-English speaker
- HIV positive
- History of Crohn's disease or ulcerative colitis
- History of gastric bypass, bowel stricture
- History of GI malignancy or radiation to abdomen
- Unable/unwilling to ingest a digital pill
- Allergy to gelatin, silver or zinc (components of the digital pill)
- Does not qualify for PrEP (abnormal liver function, or Cr Clearance <60)
Data sourced from ClinicalTrials.gov (NCT03512418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.