Harm Reduction Services

Study Overview
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Brief Summary
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The purpose of this study is to assess whether an integrated harm reduction intervention (IHRI), compared to harm reduction (HR) services as usual, will improve harm reduction service utilization among Black and Latinx people who use drugs (PWUD).

Official Title
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Culturally Response Integrated Harm Reduction Services for Black and Latinx People Who Use Drugs

Conditions
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Drug Use, Substance Abuse, Mental Illness

Intervention / Treatment
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* Behavioral: Integrated Harm Reduction Intervention (IHRI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age self-identified as misusing opioids +/- other substances (stimulants) in the past 30 days, confirmed by interview using DSM-5 criteria English or Spanish speaking able to provide informed consent. Exclusion Criteria: inability to provide informed consent or participate in the study procedures as proposed in the consent active suicidal or homicidal ideation or an unstable psychotic disorder (schizophrenia, schizoaffective disorder) or mood disorder (bipolar disorder, severe major depressive disorder) an unwillingness to be randomized. are prisoners

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IHRI<br>Integrated harm reduction intervention (IHRI) program tailored specifically for highly marginalized Black and Latinx people who use drugs (PWUDs). The IHRI lasts 8 weeks in duration, with the first 4 weeks consisting of weekly education lessons provided by the IHRI care coordinator. The subsequent 4 weeks will involve individualized identification of vulnerabilities in the social determinants of health (SDOH) for the purposes of making informed referrals to relevant partnering social service organizations. Participants will also be exposed to service encounters through mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution. | Behavioral: Integrated Harm Reduction Intervention (IHRI)<br>* 8-week program targeting areas rooted in the 8 principles of harm reduction. Includes weekly education lessons and informed referrals to social service organizations.<br>|
| No Intervention: HR SAU<br>Harm reduction services as usual (HR SAU). Participants will be exposed to service encounters through the mobile vans in which staff offer information to PWUD on syringe exchange, clean user kits, naloxone use, and fentanyl strip distribution. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who Attend At least 1 Harm Reduction (HR) Session after Introductory HR Session | Measure of engagement. | Up to Week 8 | 
| Percentage of Participants who Attend at least 3 HR Sessions in Total | Measure of engagement. | Up to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Number of Days of Opioid/Other Stimulant Use | Number of days of opioid/other stimulant use will be calculated using the timeline follow back method, which asks participants to estimate how many days over the previous 30 days that they used opioids/other stimulants. | Baseline, Week 8 | 
| Change from Baseline in Overdose Risk Assessment Tool Score | 20-item assessment of overdose risk. Each item prompts a Yes or No response. If the response is Yes, a score is assigned for that item. If the answer is No, no score is assigned for that item. The total score is the sum of responses and ranges from 0 to 42; lower scores indicate low risk, higher scores indicate higher risk. A decrease in scores indicates risk of overdose decreased during the observatioN period. | Baseline, Week 8 | 
| Change from Baseline in Brief Quality of Life Scale Score | 12-item assessment of quality of life. Each item is ranked on a 5-point Likert scale ranging from 0 (do not agree at all) to 4 (agree completely). The total score is the sum of responses and ranges from 0 to 48; higher scores indicate higher quality of life. An increase in scores indicates quality of life increased during the observation period. | Baseline, Week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Use, Harm Reduction, Latinx/Hispanix, Black/African American, Cocaine, Opioids, Methamphetamines