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Contingency Management for HIV Prevention (CoMPASS Trial)

N/A

Recruiting

Led By E. Jennifer Edelman, MD, MHS

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Non-English speaking

Currently prescribed PrEP

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether contingency management and stepped care can promote HIV prevention among people with opioid use disorder who inject drugs, as well as evaluate the real-world implementation of CoMPASS.

Who is the study for?

This trial is for individuals with opioid use disorder who inject drugs and are at risk for HIV. They must meet PrEP eligibility, have a recent negative HIV test, own or share a cell phone, and be willing to complete surveys. Exclusions include non-English speakers without translation support, kidney disease, current PrEP users, pregnant or breastfeeding women, and those unable to finish the study.

What is being tested?

The study tests CoMPASS—a program combining contingency management with support services—to improve adherence to PrEP among people who inject drugs. It's a 24-week intervention followed by a year of monitoring their health outcomes and evaluating how well the program works in real-world settings.

What are the potential side effects?

While specific side effects aren't listed here as it focuses on adherence to existing treatments (PrEP), common side effects of PrEP can include nausea, headache, stomach pain, weight loss and sometimes more serious effects like liver or kidney problems.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not speak English.

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I am currently taking medication to prevent HIV.

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I have kidney disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Engagement in opioid use disorder-related care

Extra medical opioid use

HIV Risk Behaviors

+2 more

Other study objectives

Sexually transmitted infection and HIV acquisition

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)Experimental Treatment1 Intervention

Participants randomized to Compass will also receive a health handout on HIV risk reduction approaches. They will also 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).

Group II: Treatment as Usual (TAU)Active Control1 Intervention

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. They will receive standard care as provided by the community-based organization and by their medical provider.

0 / 3Eligibility criteria met