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

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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; Human Immunodeficiency Virus; Opiate Addiction; Drug Dependence
• Intervention / Treatment: Drug: buprenorphine

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 Type: Observational
• Enrollment (Actual): 159

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20060
      • Howard University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: buprenorphine; To provide buprenorphine for 12 months for those who are interested in receiving it.; Other Names: Suboxone
No buprenorphine

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reincarceration	Measure of rearrest and reincarceration	Month 0
Reincarceration	Measure of rearrest and reincarceration	6 months
Reincarceration	Measure of rearrest and reincarceration	12 months

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); Howard University; George Mason University
• Investigators: Principal Investigator: Fredrick Altice, MD, Yale University School of Medicine/AIDS Program

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2014
• Primary Completion (ACTUAL): December 15, 2015
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: March 19, 2018
• First Submitted That Met QC Criteria: June 26, 2018
• First Posted (ACTUAL): July 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: HIV; AIDS; Buprenorphine; Opiate Addiction; Drug Dependence
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes; Opioid-Related Disorders; Behavior, Addictive; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine
• Other Study ID Numbers: 1011007631b; R01DA030768 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes