N/A
N=237
Testing an Integrated Bio-Behavioral Primary HIV Prevention Intervention Among High-Risk People Who Use Drugs
Risk Behavior · HIV/AIDS · Medication Adherence · Substance Abuse
Bottom Line
View on ClinicalTrials.gov: NCT03282890 ↗Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Pre-exposure Prophylaxis (PrEP) Adherence Behavior — 25.9; 22.8 score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CHRP-BB (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Connecticut
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-exposure Prophylaxis (PrEP) Adherence Behavior |
25.9; 22.8 | — |
| SECONDARY HIV Risk Reduction Behavior |
17.5; 16.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Meet DSM-V criteria for opioid-dependence and are enrolled in methadone maintenance drug treatment at the APT Foundation, Inc.
- Were confirmed to be HIV-negative and started on PrEP in the past week
- Report unsafe injection drug use practices or unprotected sex within the past 3 months
- Have a cell phone
- Are able to read and understand the questionnaires, ACASI, and informed consent form
- Available for the full duration of the study with no anticipated circumstances impeding participation (e.g., pending charges, jail term).
Exclusion Criteria
- Have an untreated bipolar or psychotic disorder
- Are actively suicidal or homicidal as assessed by trained research staff under the supervision of a licensed clinical psychologist
- Cannot speak English
Data sourced from ClinicalTrials.gov (NCT03282890). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.