Status:
RECRUITING
Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
HIV Infections
Substance Use
Eligibility:
All Genders
18-88 years
Phase:
NA
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 f...
Detailed Description
Background. Substance use continues to be a major driver of HIV acquisition and has been associated with suboptimal ART adherence, treatment interruption, and inability to achieve or maintain viral su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT06501781
Start Date
March 18 2025
End Date
December 1 2028
Last Update
October 31 2025
Active Locations (2)
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1
HIPS (Harm reduction drop-in center)
Washington D.C., District of Columbia, United States, 20002
2
Baltimore Safe Haven
Baltimore, Maryland, United States, 21218