Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
Running, not enrolling · Not applicable
Conditions studied: Opioid-use Disorder, HIV Prevention Program
In brief
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. .
Key facts
- Study ID
- NCT04738825
- Run by
- Yale University
- People needed
- 526
- Starts
- 2021-10-04
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aims 1 and 2:
- Receive or willing to receive care at one of the participating study sites
- Have a recent negative HIV test with no concern for acute HIV
- Report injection drug use in their lifetime
- Meet PrEP eligibility criteria by either a) sharing of injection or drug preparation equipment; b) sexual risk behaviors (i.e. condomless sex or STI) in the past 6 months
- Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder
- Have a phone or use of a household member's phone
- Provide written informed consent
- Aim 3:
- Currently employed at one of the participating study sites
- Willing to complete a web-based survey
You may not qualify if…
- Aims 1 and 2:
- Currently prescribed PrEP
- Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive
- Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.)
- Inability to provide at least one collateral contact for a friend or family member.
- Non-English speaking (for sites without Spanish-speaking staff)
- Have kidney disease (a contraindication to PrEP)
- Aim 3:
- Non-English speaking
Where it is running
- Recovery Network of Programs, Inc — Bridgeport, Connecticut, United States
- Liberations Program, Inc — Bridgeport, Connecticut, United States
- Apex Community Care. Inc. — Danbury, Connecticut, United States
- Connecticut Harm Reduction Alliance (GHHRC and SWAN) — New Haven, Connecticut, United States
- The APT Foundation (Legion and Long Wharf) — New Haven, Connecticut, United States
- Stanley Street Treatment and Resource Center — Fall River, Massachusetts, United States
Full record on ClinicalTrials.gov
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