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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 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 16 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03842436
The ClinicalTrials.gov registry entry for NCT03842436 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Truvada is the first listed.
NCT03842436 reports 0 study locations.
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.
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