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

Completed

• Conditions: Human Immunodeficiency Virus; Drug Dependence; Acquired Immunodeficiency Syndrome; Opiate Addiction
• Interventions: Drug: buprenorphine

• Registration Number: NCT03583138
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-06-23
• Primary Completion: 2015-12-15
• Study Completion: 2017-06-30
• Study First Submitted: 2018-03-19
• Study First Submitted QC: 2018-06-26
• Study First Posted: 2018-07-11
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

Inclusion Criteria

1. HIV+, confirmed by rapid HIV test
2. Meet DSM-IV criteria for opioid dependence
3. 18 years or older
4. Have health insurance that is accepted at Lab Corp.

Exclusion Criteria

1. Are <18 years old;
2. Are HIV negative;
3. Are Unable to communicate in English;
4. Are not able to provide informed consent;
5. Do not meet DSM-IV criteria for opioid dependence;
6. Plan to leave the DC area

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Buprenorphine	buprenorphine	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.

Primary Outcome Measures

Name	Time	Method
VL <400	12 months	Blood test for HIV viral load
CD4+ cell count	12 months	Blood test for HIV CD4+ cell count

Secondary Outcome Measures

Name	Time	Method
HIV risk behaviors	12 months	Survey for HIV risks
Retention in HIV care	12 months	Survey data for retention
Opioid use	12 months	Measure of relapse to opioid use
Medically assisted therapy retention	12 months	Measure of length of time on Methadone or Buprenorphine

Trial Locations

Locations (1)

Howard University; 🇺🇸 Washington, District of Columbia, United States