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

RecruitingNAAges 18 Years - 88 YearsAllUniversity of Maryland, Baltimore
NCT06501781 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 me

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📋 Eligibility rules (as published)
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
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What it tests

  • Peer Activate-LAI
  • Standard of Care HIV treatment or prevention with LAI-PrEP/ART
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Where

2 sites
HIPS (Harm reduction drop-in center)
Washington D.C., United States
Baltimore Safe Haven
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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