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NCT06501781 · ClinicalTrials.gov registry record · NA
Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
A NA study of HIV Infections and Substance Use, sponsored by University of Maryland, Baltimore.
- Recruiting
- Registry status
- NA
- Development phase
- 186
- Enrollment target
- 2
- Study locations
NCT06501781: Recruiting NA study of HIV Infections and Substance Use, sponsored by University of Maryland, Baltimore.
NCT06501781 is a NA study of HIV Infections and Substance Use that is actively recruiting participants, run by University of Maryland, Baltimore. The registered enrollment target is 186 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (58% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06501781, a NA study of HIV Infections and Substance Use, is actively recruiting participants, sponsored by University of Maryland, Baltimore.
- RECRUITING
- Registry status
- NA
- Development phase
- 186 participants
- Enrollment target
- 2
- Study locations
Study Summary
This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to: Aim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory) Aim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation. Aim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives. This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention.
Primary Outcome
Defined as receiving all 6 LAI maintenance doses within the +/-7 day window. Unit of Measure: Binary (Yes/No)
Conditions Studied
Interventions
- BEHAVIORAL Peer Activate-LAI
- OTHER Standard of Care HIV treatment or prevention with LAI-PrEP/ART
Study Locations (2)
District of Columbia
- HIPS (Harm reduction drop-in center) - Washington D.C.
Maryland
- Baltimore Safe Haven - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2025-03-18 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT06501781 shows while recruiting
NCT06501781 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions - of which Peer Activate-LAI is the first listed.
NCT06501781 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT06501781 about?
NCT06501781 is a clinical study titled "Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)". This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) fo...
What is the current status of trial NCT06501781?
This trial is currently recruiting. It is a NA study. The enrollment target is 186 participants. The study started on 2025-03-18. Estimated completion is 2028-12.
What conditions does trial NCT06501781 study?
This clinical trial studies the following conditions: HIV Infections, Substance Use.
What interventions are being tested in trial NCT06501781?
The interventions under investigation include: Peer Activate-LAI (BEHAVIORAL), Standard of Care HIV treatment or prevention with LAI-PrEP/ART (OTHER).
Who is sponsoring clinical trial NCT06501781?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06501781 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06501781's enrollment target sits among peer trials
186 185th of 542 higher than 357 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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