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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
CoMPASS Trial 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.Check my eligibility
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.See study design
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.
CoMPASS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Engagement in opioid use disorder-related care
Extra medical opioid use
HIV Risk Behaviors
+2 moreOther outcome measures
Sexually transmitted infection and HIV acquisition
CoMPASS 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.
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Who is running the clinical trial?
National Institute on Drug Abuse (NIDA)NIH
2,496 Previous Clinical Trials
2,623,379 Total Patients Enrolled
1 Trials studying HIV Prevention Program
50 Patients Enrolled for HIV Prevention Program
Yale UniversityLead Sponsor
1,870 Previous Clinical Trials
2,742,497 Total Patients Enrolled
3 Trials studying HIV Prevention Program
408 Patients Enrolled for HIV Prevention Program
E. Jennifer Edelman, MD, MHSPrincipal InvestigatorYale University
3 Previous Clinical Trials
380 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I am currently taking medication to prevent HIV.You engage in behaviors that put you at risk of getting HIV, such as sharing needles or having unprotected sex in the past 6 months.I am willing to fill out a survey online.I have no plans that would stop me from completing the study.You meet the criteria for opioid addiction as outlined in the DSM-5.I have kidney disease.You have used injected drugs in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual (TAU)
- Group 2: Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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