Clinical trial Recruiting at 2 sites Interventional Ages 18 to 88

Peer support to improve HIV treatment adherence in high-risk populations

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

Run by University of Maryland, Baltimore · NCT06501781 · Data updated 2026-11-12

This study is testing whether a peer support program can help Black individuals who use substances and are living with or at high risk for HIV stick to their long-acting injectable treatments better than standard care.

Quick facts

Study typeInterventional
Ages18 Years to 88 Years
SexAll
Enrollment186 (estimated)
SponsorUniversity of Maryland, Baltimore
Academic / other
Locations2 sites (Washington D.C., District of Columbia and 1 other locations)
StatusRecruiting
StartedMarch 18, 2025
Main results expectedDecember 30, 2028
Study endsJanuary 2029
Registry record updatedNovember 9, 2026
Trial IDNCT06501781 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals aged 18 and older who are either HIV negative and eligible for PrEP or HIV positive and eligible for ART, with moderate substance use.

Probably not a fit

Patients who are pregnant, breastfeeding, or have contraindications to the study medications will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates a peer-delivered intervention called Peer Activate-LAI aimed at improving adherence to long-acting injectable PrEP/ART among Black, substance-using individuals living with or at high risk for HIV. The study compares the effectiveness of this intervention against enhanced treatment as usual over a 12-month period, focusing on adherence rates and substance use. It also assesses the implementation of the intervention, including its feasibility and acceptability, using mixed methods to understand the impact of structural racism and discrimination on adherence. The trial involves 186 participants and aims to address significant barriers to HIV treatment in marginalized communities.

Why it matters

Potential benefit: If successful, this intervention could significantly improve HIV treatment adherence and health outcomes for high-risk populations.

How similar studies have gone: Other studies have shown promise in using peer support interventions to improve health outcomes in similar populations, indicating a potential for success in this approach.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • HIPS (Harm reduction drop-in center)
    Washington D.C., District of Columbia, United States
    Recruiting
  • Baltimore Safe Haven
    Baltimore, Maryland, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.