NCT04738825Active, not recruiting
Promoting HIV Risk Reduction Among People Who Inject Drugs: A Stepped Care Approach Using Contingency Management With PrEP Adherence and Support Services
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
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. .
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 526 (estimated)
- First submitted
- 29 Jan 2021
- Start date
- 4 Oct 2021
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Yale University
- Diseases
- HIV
- NCT number
- NCT04738825
What you commit to
- Study type: Interventional
- Planned participants: 526
- From 4 Oct 2021 to the primary completion date, 31 Jul 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.)
- Have kidney disease (a contraindication to PrEP)
- Aim 3:
- 1\. Non-English speaking
Other
- Aims 1 and 2:
- Currently prescribed PrEP
- Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive
- Inability to provide at least one collateral contact for a friend or family member.
- Non-English speaking (for sites without Spanish-speaking staff)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liberations Program, Inc Coordinator of this site? Confirm its status | Bridgeport | United States | Unknown status |
| Recovery Network of Programs, Inc Coordinator of this site? Confirm its status | Bridgeport | United States | Unknown status |
| Apex Community Care. Inc. Coordinator of this site? Confirm its status | Danbury | United States | Unknown status |
| Stanley Street Treatment and Resource Center Coordinator of this site? Confirm its status | Fall River | United States | Unknown status |
| Connecticut Harm Reduction Alliance (GHHRC and SWAN) Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| The APT Foundation (Legion and Long Wharf) Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.