RecruitingNot ApplicableNCT04738825

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

Sponsor

Yale University

Enrollment

526 participants

Start Date

Oct 4, 2021

Study Type

INTERVENTIONAL

Conditions

Opioid-use Disorder HIV Prevention Program

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. .

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a stepped-care program to help people who inject drugs stay on PrEP — a daily pill that prevents HIV infection. The program combines incentives for good medication adherence with support services. **You may be eligible if...** - You have injected drugs at some point in your life - You have recently tested negative for HIV and do not suspect you were recently exposed - You meet the criteria to start PrEP (either you share needles/drug equipment, or you have had condomless sex or a sexually transmitted infection in the past 6 months) - You meet the diagnostic criteria for opioid use disorder - You are willing to receive care at one of the participating study sites **You may NOT be eligible if...** - You are currently HIV-positive - You do not meet PrEP eligibility criteria - You are unable to attend study visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALContingency 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).