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

NCT06501781 | Recruiting DMC

• 1 other identifier: HP-00110311
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• LAI-PrEP/ART Complete Adherence

  Defined as receiving all 6 LAI maintenance doses within the +/-7 day window. Unit of Measure: Binary (Yes/No)

  12 months

Study Arms (2)

Peer Activate-LAI

EXPERIMENTAL

Peer Activate-LAI, is a peer recovery specialist-delivered (PRS) behavioral activation (BA) and problem solving intervention aimed at improving adherence to LAI-PrEP/ART. BA was originally developed as an efficacious treatment for depression, with accumulating empirical support for SUD outcomes, including SUD treatment retention and HIV medication adherence, particularly when integrated with problem solving strategies. BA offers important advantages compared to other psychosocial interventions by being feasible and potentially sustainable for PRS delivery, appropriate for low-income individuals with OUD and other non-opioid SUD, and focused on building positive reinforcement in the current environment through engagement in adaptive, valued behaviors.

Behavioral: Peer Activate-LAI; Other: Standard of Care HIV treatment or prevention with LAI-PrEP/ART

Enhanced Treatment As Usual

ACTIVE COMPARATOR

Participants in the Enhanced Treatment As Usual (ETAU) arm receive access to standard clinical care, including access to a clinician with expertise in HIV and PrEP, opportunity for co-located treatment of OUD, and STI testing and treatment, and general peer support. Enhanced treatment includes reminder phone calls and facilitated referrals to psychosocial, housing, financial benefits and legal services.

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

Interventions

Peer Activate-LAI BEHAVIORAL

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).

Peer Activate-LAI

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

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

Enhanced Treatment As Usual; Peer Activate-LAI

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Able and willing to sign informed consent
• HIV status:
• HIV negative with a negative HIV antibody/antigen test and meeting CDC(center for disease control and prevention) criteria for PrEP HIV positive with a positive antibody/antigen test
• Meeting indications for treatment based on Cabotegravir-LA (HIV negative) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV positive) prescribing information
• Moderate substance use, defined as a (World Health Organization Alcohol, Smoking and Substance Involvement Screening Test) WHO-ASSIST score of ≥4 for certain drugs (cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids) or ≥11 for alcohol

You may not qualify if:

• Contraindications to Cabotegravir-LA (HIV-) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV+) use based on prescribing information or other medical/psychiatric conditions that may interfere with study participation
• Pregnant or breastfeeding

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

HIPS (Harm reduction drop-in center)

Washington D.C., District of Columbia, 20002, United States

RECRUITING

Baltimore Safe Haven

Baltimore, Maryland, 21218, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Elana Rosenthal, MD

CONTACT

240-367-4157; erosenthal@ihv.umaryland.edu

Emade Ebah Edongole, RN

CONTACT

202-655-6229; eebah@ihv.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor MD

Model Details: A pilot study to evaluate the feasibility and effectiveness of a peer-delivered intervention for LAI-PrEP/ART adherence among predominately Black substance-using populations.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 15, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)