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NCT05378399 · ClinicalTrials.gov registry record · Phase 3
SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder
A Phase 3 study of HIV Infections and Substance Use, sponsored by Brigham and Women's Hospital.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05378399: Recruiting Phase 3 study of HIV Infections and Substance Use, sponsored by Brigham and Women's Hospital.
NCT05378399 is a Phase 3 study of HIV Infections and Substance Use that is actively recruiting participants, run by Brigham and Women's Hospital. The registered enrollment target is 40 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05378399, a Phase 3 study of HIV Infections and Substance Use, is actively recruiting participants, sponsored by Brigham and Women's Hospital.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm, observational study of HIV-negative MSM with substance use disorder. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and study eligibility will be confirmed. Eligible participants will attend three additional visits over the course of the study - the Enrollment Visit (Visit 2), Month 1 Visit (Visit 3), and Month 2 Visit (Visit 4). Participants will take one PrEP digital pill per day, for 60 days total, while using the digital pill system (DPS) and Beiwe, a digital phenotyping app. On nonadherent days, participants will receive brief surveys prompting them to report the reasons for their missed dose, as well as their engagement in substance use and sexual activity. Timeline followback will be conducted at the Month 1 and Month 2 Visits to understand the context of any nonadherence. Qualitative user experience exit interviews and dried blood spots (DBS) will be conducted at the Month 2 Visit.
Primary Outcome
Percentage adherence to PrEP and adherence patterns over the course of 60 days, as detected by the ID-Cap digital pill system (DPS).
Conditions Studied
Interventions
- DRUG Descovy or Truvada
- DEVICE ID-Cap System
- DEVICE Beiwe
Study Locations (1)
Massachusetts
- Fenway Health - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-12-20 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
What NCT05378399 shows while recruiting
NCT05378399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (91% lower).
The record links to 4 conditions, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Descovy or Truvada is the first listed.
NCT05378399 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05378399 about?
NCT05378399 is a clinical study titled "SmartSteps: A Context-Aware, PrEP Adherence Intervention for Individuals With Substance Use Disorder". This is a single-arm, observational study of HIV-negative MSM with substance use disorder. Those who meet pre-screening criteria will attend a Screening Visit (Visit 1), where the informed consent process will be conducted and study eligibility will be confirmed. Eligible participants will attend th...
What is the current status of trial NCT05378399?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2022-12-20. Estimated completion is 2026-03-31.
What conditions does trial NCT05378399 study?
This clinical trial studies the following conditions: HIV Infections, Substance Use, Adherence, Medication, Adherence, Treatment.
What interventions are being tested in trial NCT05378399?
The interventions under investigation include: Descovy or Truvada (DRUG), ID-Cap System (DEVICE), Beiwe (DEVICE).
Who is sponsoring clinical trial NCT05378399?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05378399 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05378399's enrollment target sits among peer trials
40 390th of 542 higher than 139 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV Infections 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.
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