HIV, Buprenorphine, and the Criminal Justice System (STRIDE2)

Study Overview
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Brief Summary
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STRIDE2 is a longitudinal, non-randomized study of individuals living with HIV who are dependent on opioids. This study is funded by the National Institute on Drug Abuse (R01DA030768, Altice, PI; Taxman & Lawson, Co-PIs) and is being conducted by George Mason University, Yale University, and Howard University.

Detailed Description
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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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Project STRIDE2 - Seek/Test/Retain: PLWHA and Opioid Users in Washington, DC

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

Intervention / Treatment
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* Drug: buprenorphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV+, confirmed by rapid HIV test Meet DSM-IV criteria for opioid dependence 18 years or older Have health insurance that is accepted at Lab Corp. Exclusion Criteria: Are <18 years old; Are HIV negative; Are Unable to communicate in English; Are not able to provide informed consent; Do not meet DSM-IV criteria for opioid dependence; Plan to leave the DC area

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Buprenorphine<br>Participants are eligible for the study if they are 18 years of age or older, HIV+, meet DSM-IV criteria for opioid dependence, have health insurance accepted at Lab Corp, are able to read and understand English, and live in Washington, DC and plan to remain in DC. The intervention is to provide buprenorphine for 12 months for those who are interested in receiving it. | Drug: buprenorphine<br>* To provide buprenorphine for 12 months for those who are interested in receiving it.<br>* Other names: Suboxone;|
| No buprenorphine<br>No buprenorphine | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VL <400 | Blood test for HIV viral load | Month 0 | 
| CD4+ cell count | Blood test for HIV CD4+ cell count | Month 0 | 
| VL <400 | Blood test for HIV viral load | 6 months | 
| CD4+ cell count | Blood test for HIV CD4+ cell count | 6 months | 
| VL <400 | Blood test for HIV viral load | 12 months | 
| CD4+ cell count | Blood test for HIV CD4+ cell count | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV risk behaviors | Survey for HIV risks | Month 0 | 
| HIV risk behaviors | Survey for HIV risks | 6 months | 
| HIV risk behaviors | Survey for HIV risks | 12 months | 
| Retention in HIV care | Survey data for retention | Month 0 | 
| Retention in HIV care | Survey data for retention | 6 months | 
| Retention in HIV care | Survey data for retention | 12 months | 
| Opioid use | Measure of relapse to opioid use | Month 0 | 
| Opioid use | Measure of relapse to opioid use | 6 months | 
| Opioid use | Measure of relapse to opioid use | 12 months | 
| Medically assisted therapy retention | Measure of length of time on Methadone or Buprenorphine | Month 0 | 
| Medically assisted therapy retention | Measure of length of time on Methadone or Buprenorphine | 6 months | 
| Medically assisted therapy retention | Measure of length of time on Methadone or Buprenorphine | 12 months | 

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