NCT04738825

Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 526 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The proposed study will be a 24-week intervention with a 12-month follow-up period to evaluate the impact of contingency management with stepped care to pre-exposure prophylaxis (PrEP) adherence and support services (CoMPASS) to promote HIV prevention among individuals with opioid use disorder who have injected drugs in their lifetime. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .

Detailed description

Consistent with a Hybrid Effectiveness-Implementation Type 1 design, this is a multi-site randomized clinical trial designed to evaluate the effectiveness of Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS) vs. treatment as usual (TAU) on HIV risk reduction among individuals with opioid use disorder (OUD) who have injected drugs in their lifetime. The study will be conducted in community-based settings serving individuals with opioid use disorder to assess the effectiveness of CoMPASS on promoting: sustained PrEP adherence (primary outcome) and HIV risk behaviors, engagement in opioid use disorder-related care, opioid use (secondary outcomes); and sexually transmitted infections and HIV (exploratory). Participants randomized to CoMPASS will first receive contingency management and have the potential to earn prizes for making progress towards initiation of and consistent adherence to HIV pre-exposure prophylaxis (PrEP) and engagement in OUD-related care. Individuals who do not demonstrate PrEP adherence (based on self-report, confirmed by urine testing for tenofovir metabolites at week 12), will be "stepped up" to PrEP Adherence and Support Services (PASS). The intervention is 24 weeks in duration. Participants randomized to TAU will receive a health handout on HIV risk reduction approaches, including PrEP and OUD-related care, and where to access such services. To inform future implementation efforts, factors relevant for scale-up in parallel (e.g., completion of study visits, attitudes regarding the intervention among front-line staff) will be assessed.

Conditions

• Opioid-use Disorder
• HIV Prevention Program

Interventions

Type	Name	Description
BEHAVIORAL	Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)	Participants will receive contingency management sessions (n=9). Participants who do not demonstrate PrEP adherence by week 12 will be "stepped up" to receive PrEP adherence and support services (n=5).

Timeline

• Start date: 2021-10-04
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2021-02-04
• Last updated: 2025-06-13

Locations

6 sites across 1 country: United States