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

Not Applicable

Recruiting

• Conditions: Opioid-use Disorder; HIV Prevention Program
• Interventions: Behavioral: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)

• Registration Number: NCT04738825
• Lead Sponsor: Yale University

Brief Summary

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 inject drugs. In parallel, the investigators will conduct an implementation focused process evaluation to inform real-world implementation of CoMPASS. .

Detailed Description

Consistent with a Hybrid Effectiveness-Implementation Type 1 design, this is a multi-site randomized clinical trial designed to evaluate the effectiveness of Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS) vs. treatment as usual (TAU) on HIV risk reduction among individuals with opioid use disorder (OUD) who inject drugs. The study will be conducted in community-based settings serving individuals with opioid use disorder to assess the effectiveness of CoMPASS on promoting: sustained PrEP adherence (primary outcome) and HIV risk behaviors, engagement in opioid use disorder-related care, opioid use (secondary outcomes); and sexually transmitted infections and HIV (exploratory). Participants randomized to CoMPASS will first receive contingency management and have the potential to earn prizes for making progress towards initiation of and consistent adherence to HIV pre-exposure prophylaxis (PrEP) and engagement in OUD-related care. Individuals who do not demonstrate PrEP adherence (based on self-report, confirmed by urine testing for tenofovir metabolites at week 12), will be "stepped up" to PrEP Adherence and Support Services (PASS). The intervention is 24 weeks in duration. 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.

To inform future implementation efforts, factors relevant for scale-up in parallel (e.g., completion of study visits, attitudes regarding the intervention among front-line staff) will be assessed.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-04
• Study Start: 2021-10-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15
• Primary Completion: 2025-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 526

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)	Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)	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).

Primary Outcome Measures

Name	Time	Method
Sustained PrEP adherence	24 weeks	Determined by tenovifir-diphosphate levels by dried blood spot testing.

Secondary Outcome Measures

Name	Time	Method
HIV Risk Behaviors	24 weeks	Self-reported HIV risk behaviors
Sustained PrEP adherence	12 weeks	Determined by tenovifir-diphosphate levels by dried blood spot testing. .
Recent PrEP adherence	12 weeks	Self-report adherence confirmed by the presence of tenofivir in urine sample.
Extra medical opioid use	24 weeks	Self reported extra medical opioid use
Engagement in opioid use disorder-related care	24 weeks	Self report of engagement in opioid use disorder-related care

Trial Locations

Locations (6)

APT; 🇺🇸 New Haven, Connecticut, United States

Recovery Network of Programs, Inc; 🇺🇸 Bridgeport, Connecticut, United States

Liberations Program, Inc; 🇺🇸 Bridgeport, Connecticut, United States

Apex Community Care. Inc.; 🇺🇸 Danbury, Connecticut, United States

Greater Hartford Harm Reduction Coalition- SWAN; 🇺🇸 New Haven, Connecticut, United States

Stanley Street Treatment and Resource Center; 🇺🇸 Fall River, Massachusetts, United States