Actively Recruiting
Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
Led by University of Maryland, Baltimore · Updated on 2025-10-31
186
Participants Needed
2
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able and willing to sign informed consent
- HIV negative with a negative HIV antibody/antigen test and meeting CDC criteria for PrEP, or HIV positive with a positive antibody/antigen test
- Meeting treatment indications based on Cabotegravir-LA (HIV negative) or Cabotegravir and Rilpivirine-LA (HIV positive) prescribing information
- Moderate substance use defined as WHO-ASSIST score 4 for certain drugs (cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids) or 11 for alcohol
You will not qualify if you...
- Contraindications to Cabotegravir-LA (HIV negative) or Cabotegravir and Rilpivirine-LA (HIV positive) use based on prescribing information or other medical/psychiatric conditions interfering with participation
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
HIPS (Harm reduction drop-in center)
Washington D.C., District of Columbia, United States, 20002
Actively Recruiting
2
Baltimore Safe Haven
Baltimore, Maryland, United States, 21218
Actively Recruiting
Research Team
E
Elana Rosenthal, MD
CONTACT
E
Emade Ebah Edongole, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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