RecruitingNot ApplicableNCT06501781

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

Enrollment

186 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 88 Years

Plain Language Summary

Simplified for easier understanding

This study (PUSH) tests whether peer support — having a trained peer coach with lived experience — can help people who use substances (such as alcohol or drugs) stay on long-acting injectable HIV prevention or treatment medications. **You may be eligible if...** - You are 18 or older - You are HIV-negative and qualify for long-acting injectable PrEP (HIV prevention), OR you are HIV-positive and on a long-acting injectable HIV treatment regimen - You have moderate substance use (as measured by a standardized screening tool) - You are able and willing to give informed consent **You may NOT be eligible if...** - You have a medical or psychiatric condition that prevents safe use of the injectable medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPeer 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).

OTHERStandard 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

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NCT06501781


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