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

University of Maryland, Baltimore · NCT06501781

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–88 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
186
US sites recruiting
2
Study start
March 18, 2025
Record last updated
October 31, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

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

Conditions: HIV Infections; Substance Use

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Recruiting US locations

  • HIPS (Harm reduction drop-in center)

    Washington D.C., DC 20002

    Site contact: Phyllis Bijole Clinic Manager · 202.834.3289 · phyllis@hips.org

  • Baltimore Safe Haven

    Baltimore, MD 21218

    Site contact: Onyinyechi Ogbumbadiugha, MPH · (443)-635-4943 · oogbumbadiugha@ihv.umaryland.edu

Study contacts (from the official record)

  • Elana Rosenthal, MD · 240-367-4157 · erosenthal@ihv.umaryland.edu
  • Emade Ebah Edongole, RN · 202-655-6229 · eebah@ihv.umaryland.edu
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Peer Behavioral Activation Utilization to Improve Substance Use… (NCT06501781) | Bored Studies