Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT03282890
Status
Completed

Conditions

  • HIV/AIDS
  • Medication Adherence
  • Risk Behavior
  • Substance Abuse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CHRP-BB — OTHER
    The CHRP-BB intervention is a theory-based, manual-guided, HIV risk reduction and PrEP adherence intervention. It is an integrated evidence-based intervention that uses a coping skills training approach to primary prevention and is delivered in a small group modality by two trained intervention facilitators using a motivational enhancement therapeutic style to address high risk drug- and sex-related HIV risk behaviors and PrEP adherence. Importantly, the CHRP-BB intervention includes specific behavioral and mHealth strategies designed and tested to accommodate difficulties stemming from moderate to severe neuro-cognitive impairment (NCI).

Study Details

This study will evaluate the efficacy and cost-effectiveness of CHRP-BB - an integrated bio-behavioral approach that incorporates the use of PrEP - with an evidence-based behavioral approach aimed at enhancing PrEP adherence and HIV risk reduction among high risk PWUD.

Key Dates

Start date
Nov 20, 2017
Status verified
Jul 2025
Primary completion
Oct 13, 2023
Completion
Oct 13, 2023

Study Design

Enrollment
237 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: CHRP-BB
    Patients assigned to the CHRP-BB will receive a weekly HIV risk reduction and PrEP adherence group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. It is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP-BB, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction and PrEP adherence. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).
  • No Intervention: Control Condition
    The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).

Primary Outcome Measure

Pre-exposure Prophylaxis (PrEP) Adherence Behavior [ Time Frame: This is measured immediately post-intervention, and then at 3-months, 6-months, and 9 months post-intervention. Results are reported in the table at 9-months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
APT FoundationNew HavenConnecticut06511-

Find similar trials in New Haven, CT

By condition
HIV
By specialty
Infectious disease
By research site
APT Foundation· New Haven, CT

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