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NCT04523519 · ClinicalTrials.gov registry record · Phase 4
PrEP Intervention for People Who Inject Substances and Use Methamphetamine
A Phase 4 study of HIV Infections, sponsored by San Francisco Department of Public Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT04523519 is a Phase 4 study of HIV Infections that is actively recruiting participants, run by San Francisco Department of Public Health. The registered enrollment target is 140 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04523519, a Phase 4 study of HIV Infections, is actively recruiting participants, sponsored by San Francisco Department of Public Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who inject methamphetamine adhere to PrEP. We will randomize 140 adults who use methamphetamine, are HIV-negative, and have recently engaged in a sexual HIV risk behavior to VDOT-CM or counseling alone for 24 weeks. The study aims are to (1) determine the efficacy of VDOT-CM compared to counseling alone for PrEP adherence, (2) evaluate the acceptability of PrEP and adherence support strategies among the cohort, and (3) compare injection or chemsex and sexual HIV risk behavior before and during PrEP use. We hypothesize that participants randomized to VDOT-CM will have superior adherence to PrEP. We also hypothesize that participants will describe barriers to and facilitators of PrEP adherence, and those who are randomized to VDOT-CM will consider it an acceptable PrEP adherence support strategy. Finally, we do not expect to find increased injection, chemsex, or sexual risk behaviors for HIV among study participants after they begin taking PrEP.
Conditions Studied
Interventions
- BEHAVIORAL Video directly observed therapy with contingency management
- BEHAVIORAL Integrated Next-Step Counseling
Study Locations (1)
California
- San Francisco Department of Public Health - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2025-05 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04523519
The ClinicalTrials.gov registry entry for NCT04523519 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (69% lower). The listed sponsor is San Francisco Department of Public Health, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Video directly observed therapy with contingency management is the first listed.
NCT04523519 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04523519 about?
NCT04523519 is a clinical study titled "PrEP Intervention for People Who Inject Substances and Use Methamphetamine". In this study, "PrEP Intervention for people who Inject Substances and Use Methamphetamine" (PRIME), we propose to assess if using video directly observed therapy with real-time contingency management (VDOT-CM) may help people assigned male sex at birth who inject methamphetamine adhere to PrEP. We ...
What is the current status of trial NCT04523519?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2021-04-30. Estimated completion is 2025-05.
What conditions does trial NCT04523519 study?
This clinical trial studies the following conditions: HIV Infections.
What interventions are being tested in trial NCT04523519?
The interventions under investigation include: Video directly observed therapy with contingency management (BEHAVIORAL), Integrated Next-Step Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT04523519?
This trial is sponsored by San Francisco Department of Public Health, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04523519 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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