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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Opioid-use Disorder, HIV Prevention Program

Intervention / Treatment
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* Behavioral: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 the past 6 months 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 cell phone or use of a household member's cell phone Provide written informed consent Aim 3: Currently employed at one of the participating study sites Willing to complete a web-based survey Exclusion criteria: 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: 1. Non-English speaking

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Aims 1 and 2: Randomized controlled trial to evaluate the effectiveness of contingency management with stepped care to PrEP adherence and support services (Compass) compared to treatment as usual. Aim 3: Implementation-focused process evaluation to gain information on implementation of the intervention from perspectives of participants as well as front-line providers and staff
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment as Usual (TAU)<br>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. | |
| Experimental: Contingency Management with stepped care to PrEP Adherence and Support Services (CoMPASS)<br>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). | Behavioral: Contingency Management with stepped care to PrEP adherence and support services (CoMPASS)<br>* Participants will 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained PrEP adherence | Determined by tenovifir-diphosphate levels by dried blood spot testing. | 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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People who inject drugs, Pre-exposure prophylaxis (PrEP), Medications for opioid use disorder, Opioid use disorder, HIV prevention