HIV, Buprenorphine, and the Criminal Justice System

Study Overview
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Brief Summary
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The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

Detailed Description
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Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months. STRIDE2 will assist in identifying and monitoring individuals' HIV risk behaviors and provide resources to seek treatment for their HIV care and substance use. The goal of STRIDE2 is to examine if there are differences in HIV, drug use, and other outcomes between individuals receiving treatment versus individuals actively using, not actively using and not in treatment, and individuals on Methadone, Suboxone, or in some other treatment.

Official Title
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HIV, Buprenorphine, and the Criminal Justice System

Conditions
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Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, Opiate Addiction, Drug Dependence

Intervention / Treatment
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* Drug: Buprenorphine/naloxone
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV+ Age ≥18 yrs Meets DSM-IV criteria for opioid dependence Has medical entitlements in DC Able to provide informed consent Able to communicate in English or Spanish Exclusion Criteria: Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine AST and ALT >5x the upper limit of normal (AST≥175, ALT≥195) Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.) Breastfeeding or unwilling to stop breastfeeding Subject is part of another pharmacological research study Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction) Suicidal ideation Hypersensitivity to buprenorphine

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: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Buprenorphine<br> | Drug: Buprenorphine/naloxone<br>* 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.<br>* Other names: Suboxone;|
| Placebo Comparator: Placebo<br> | Drug: Placebo Oral Tablet<br>* 2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 Count Absolute | CD4 Count Absolute | Baseline | 
| CD4 Count Absolute | CD4 Count Absolute | 6 Months | 
| CD4 Count Absolute | CD4 Count | 12 Months | 
| CD4 Percent | CD4 Percent | Baseline | 
| CD4 Percent | CD4 Percent | 6 Months | 
| CD4 Percent | CD4 Percent | 12 Months | 
| Viral Load | Viral Load | Baseline | 
| Viral Load | Viral Load | 6 Months | 
| Viral Load | Viral Load | 12 Months | 
| Log Viral Load | Log Viral Load | Baseline | 
| Log Viral Load | Log Viral Load | 6 Months | 
| Log Viral Load | Log Viral Load | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Opioid Treatment Outcomes | Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year. | baseline, 3 months, 9 months, 12 months | 
| Improved Criminal Justice Outcomes | Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit. | baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Opiate Addiction, Drug Dependence, Buprenorphine