HIV prevention program for people who inject drugs using a stepped care approach

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

This study tests a new 24-week program to help people who inject drugs and have opioid use disorder stick to their HIV prevention medication and reduce risky behaviors compared to standard treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 526 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Yale University (other)
• Locations: 6 sites (Bridgeport, Connecticut and 5 other locations)
• Trial ID: NCT04738825 on ClinicalTrials.gov

What this trial studies

This intervention involves a 24-week program designed to promote HIV risk reduction among individuals with opioid use disorder who have injected drugs. Participants will receive contingency management to encourage adherence to pre-exposure prophylaxis (PrEP) and access to support services. The study will compare the effectiveness of this approach against standard treatment, with a focus on sustained PrEP adherence and reduced HIV risk behaviors. Additionally, a process evaluation will be conducted to inform future implementation of the program in real-world settings.

Who should consider this trial

Good fit: Ideal candidates are individuals with opioid use disorder who have a history of injection drug use and meet PrEP eligibility criteria.

Not a fit: Patients currently prescribed PrEP or those who are pregnant, breastfeeding, or planning to conceive may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce HIV transmission rates among individuals with opioid use disorder who inject drugs.

How similar studies have performed: Other studies have shown promise in using contingency management for improving adherence to treatment in similar populations, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

Aims 1 and 2:

1. Receive or willing to receive care at one of the participating study sites
2. Have a recent negative HIV test with no concern for acute HIV
3. Report injection drug use in their lifetime
4. 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
5. Meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM5) criteria for opioid use disorder
6. Have a phone or use of a household member's phone
7. Provide written informed consent

Aim 3:

1. Currently employed at one of the participating study sites
2. Willing to complete a web-based survey

Exclusion criteria:

Aims 1 and 2:

1. Currently prescribed PrEP
2. Self-report or urine test confirming pregnancy, breastfeeding, or trying to conceive
3. Any plans that would preclude study completion (surgery, major medical treatment or conditions, incarceration, travel out of state or country.)
4. Inability to provide at least one collateral contact for a friend or family member.
5. Non-English speaking (for sites without Spanish-speaking staff)
6. Have kidney disease (a contraindication to PrEP)

Aim 3:

1. Non-English speaking

Where this trial is running

Bridgeport, Connecticut and 5 other locations

• Recovery Network of Programs, Inc — Bridgeport, Connecticut, United States (TERMINATED)
• Liberations Program, Inc — Bridgeport, Connecticut, United States (RECRUITING)
• Apex Community Care. Inc. — Danbury, Connecticut, United States (TERMINATED)
• Greater Hartford Harm Reduction Coalition- SWAN — New Haven, Connecticut, United States (RECRUITING)
• APT — New Haven, Connecticut, United States (RECRUITING)
• Stanley Street Treatment and Resource Center — Fall River, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: E. Jennifer Edelman, MD, MHS — Yale University
• Study coordinator: June-Marie C Weiss, MA, MEd

Conditions: Opioid-use Disorder, HIV Prevention Program, People who inject drugs, Pre-exposure prophylaxis, Medications for opioid use disorder, Opioid use disorder, HIV prevention