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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 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.

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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.

Conditions Studied

HIV Infections Substance Use

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

FieldValue
Enrollment Target 186 participants
Start Date 2025-03-18
Est. Completion 2028-12
Phase NA

Sponsor

University of Maryland, Baltimore

560 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06501781

The ClinicalTrials.gov registry entry for NCT06501781 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 186 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 (58% lower). The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.