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

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583138
• Other study ID #: 1011007631b
• Secondary ID: R01DA030768
• Status: Completed
• Start date: June 23, 2014
• Est. completion date: June 30, 2017

Study information

• Verified date: May 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 30, 2017
• Est. primary completion date: December 15, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Behavior, Addictive
• Drug Dependence
• HIV Infections
• Human Immunodeficiency Virus
• Immunologic Deficiency Syndromes
• Opiate Addiction
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Drug:
• buprenorphine
To provide buprenorphine for 12 months for those who are interested in receiving it.

Locations

Country	Name	City	State
United States	Howard University	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	George Mason University, Howard University, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reincarceration	Measure of rearrest and reincarceration	Month 0
Other	Reincarceration	Measure of rearrest and reincarceration	6 months
Other	Reincarceration	Measure of rearrest and reincarceration	12 months
Primary	VL <400	Blood test for HIV viral load	Month 0
Primary	CD4+ cell count	Blood test for HIV CD4+ cell count	Month 0
Primary	VL <400	Blood test for HIV viral load	6 months
Primary	CD4+ cell count	Blood test for HIV CD4+ cell count	6 months
Primary	VL <400	Blood test for HIV viral load	12 months
Primary	CD4+ cell count	Blood test for HIV CD4+ cell count	12 months
Secondary	HIV risk behaviors	Survey for HIV risks	Month 0
Secondary	HIV risk behaviors	Survey for HIV risks	6 months
Secondary	HIV risk behaviors	Survey for HIV risks	12 months
Secondary	Retention in HIV care	Survey data for retention	Month 0
Secondary	Retention in HIV care	Survey data for retention	6 months
Secondary	Retention in HIV care	Survey data for retention	12 months
Secondary	Opioid use	Measure of relapse to opioid use	Month 0
Secondary	Opioid use	Measure of relapse to opioid use	6 months
Secondary	Opioid use	Measure of relapse to opioid use	12 months
Secondary	Medically assisted therapy retention	Measure of length of time on Methadone or Buprenorphine	Month 0
Secondary	Medically assisted therapy retention	Measure of length of time on Methadone or Buprenorphine	6 months
Secondary	Medically assisted therapy retention	Measure of length of time on Methadone or Buprenorphine	12 months