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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT03583138

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), George Mason University (Other), Howard University (Other)

159

Enrollment

Location

36.2

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Opiate Addiction Drug Dependence	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 Design

Study Type:

Observational

Actual Enrollment :

159 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 23, 2014

Actual Primary Completion Date :

Dec 15, 2015

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

Arm	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 No buprenorphine

Arm

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

Outcome Measures

Primary Outcome Measures

VL <400 [Month 0]
Blood test for HIV viral load
CD4+ cell count [Month 0]
Blood test for HIV CD4+ cell count
VL <400 [6 months]
Blood test for HIV viral load
CD4+ cell count [6 months]
Blood test for HIV CD4+ cell count
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

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

Other Outcome Measures

Reincarceration [Month 0]
Measure of rearrest and reincarceration
Reincarceration [6 months]
Measure of rearrest and reincarceration
Reincarceration [12 months]
Measure of rearrest and reincarceration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Howard University	Washington	District of Columbia	United States	20060

Sponsors and Collaborators

Yale University
National Institute on Drug Abuse (NIDA)
George Mason University
Howard University

Investigators

Principal Investigator: Fredrick Altice, MD, Yale University School of Medicine/AIDS Program
Principal Investigator: Faye Taxman, PhD, George Mason University
Principal Investigator: William Lawson, MD, Howard University