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RECRUITING
NCT06501781
NA

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

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 88 Years

Study Type

INTERVENTIONAL

Enrollment

186

Start Date

2025-03-18

Completion Date

2028-12

Last Updated

2025-10-31

Healthy Volunteers

Yes

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

Locations (2)

HIPS (Harm reduction drop-in center)

Washington D.C., District of Columbia, United States

Baltimore Safe Haven

Baltimore, Maryland, United States