NCT03512418CompletedPhase 3
Development of Ingestible Biosensors to Enhance PrEP Adherence in Substance Users (PrEPSteps)
Source: ClinicalTrials.gov · Last updated 17 Sept 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 21 Mar 2018
- Start date
- 20 Jun 2019
- Primary completion date
- 10 Apr 2024
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- HIV
- NCT number
- NCT03512418
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 30
- From 20 Jun 2019 to the primary completion date, 10 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV positive
- History of Crohn's disease or ulcerative colitis
- History of gastric bypass, bowel stricture
- History of GI malignancy or radiation to abdomen
- Allergy to gelatin, silver or zinc (components of the digital pill)
Lab values
- Does not qualify for PrEP (abnormal liver function, or Cr Clearance \<60)
Other
- Non-English speaker
- Unable/unwilling to ingest a digital pill
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fenway Health Coordinator of this site? Confirm its status | Boylston | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.