NCT06501781 Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
| NCT ID | NCT06501781 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Maryland, Baltimore |
| Condition | HIV Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 186 participants in total. It began in 2025-03-18 with a primary completion date of 2028-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06501781 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 88 Years, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06501781 currently recruiting?
Yes, NCT06501781 is actively recruiting participants. Contact the research team at erosenthal@ihv.umaryland.edu for enrollment information.
Where is the NCT06501781 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States.
Who is sponsoring the NCT06501781 clinical trial?
NCT06501781 is sponsored by University of Maryland, Baltimore. The trial plans to enroll 186 participants.
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