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Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)

NCT06501781 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2025-10-31

No results posted yet for this 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

  • HIV Infections
  • Substance Use

Interventions

BEHAVIORAL

Peer Activate-LAI

Peer Activate-LAI is a Peer Recovery Specialist-delivered behavioral activation and problem solving intervention, based on our team's formative work. The intervention focuses on problem-solving skills to improve adherence to ART and/or PrEP both at the individual level and environmental barriers to care (i.e., transportation, housing).

OTHER

Standard of Care HIV treatment or prevention with LAI-PrEP/ART

Standard of care HIV treatment or prevention with LAI-PrEP/ART

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06501781 on ClinicalTrials.gov