Peer support to improve HIV treatment adherence in high-risk populations
Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 186 (estimated) |
| Ages | 18 Years to 88 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 2 sites (Washington D.C., District of Columbia and 1 other locations) |
| Trial ID | NCT06501781 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to the study medications will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Washington D.C., District of Columbia and 1 other locations
- 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
- Study coordinator: Elana Rosenthal, MD
- Email: erosenthal@ihv.umaryland.edu
- Phone: 240-367-4157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.