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NCT03842436 · ClinicalTrials.gov registry record · Phase 4
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT03842436: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT03842436 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03842436, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. Additionally, the investigators will measure adherence over time, as well as episodes of suboptimal PrEP adherence.
Primary Outcome
Participants' engagement with the digital pill system (DPS) was measured over the 90-day study period. The percentages for the total expected ingestions recorded by DPS each month were compared.
Interventions
- DRUG Truvada
- DEVICE Digital pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2020-04-22 |
| Phase | Phase 4 |
What the finished NCT03842436 record still lists
NCT03842436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Truvada is the first listed.
NCT03842436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03842436 about?
NCT03842436 is a clinical study titled "Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use". This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF...
What is the current status of trial NCT03842436?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2018-10-01. Estimated completion is 2020-04-22.
What interventions are being tested in trial NCT03842436?
The interventions under investigation include: Truvada (DRUG), Digital pill (DEVICE).
Who is sponsoring clinical trial NCT03842436?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03842436's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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