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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03583138
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
George Mason University
Howard University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Opiate Addiction Drug Dependence Drug: buprenorphine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Decide to receive buprenorphine and those who elect not to receive it.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Project STRIDE2 - Seek/Test/Retain: PLWHA and Opioid Users in Washington, DC
Actual Study Start Date : June 23, 2014
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: 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.

No Intervention: No buprenorphine
No buprenorphine



Primary Outcome Measures :
  1. VL <400 [ Time Frame: Month 0 ]
    Blood test for HIV viral load

  2. CD4+ cell count [ Time Frame: Month 0 ]
    Blood test for HIV CD4+ cell count

  3. VL <400 [ Time Frame: 6 months ]
    Blood test for HIV viral load

  4. CD4+ cell count [ Time Frame: 6 months ]
    Blood test for HIV CD4+ cell count

  5. VL <400 [ Time Frame: 12 months ]
    Blood test for HIV viral load

  6. CD4+ cell count [ Time Frame: 12 months ]
    Blood test for HIV CD4+ cell count


Secondary Outcome Measures :
  1. HIV risk behaviors [ Time Frame: Month 0 ]
    Survey for HIV risks

  2. HIV risk behaviors [ Time Frame: 6 months ]
    Survey for HIV risks

  3. HIV risk behaviors [ Time Frame: 12 months ]
    Survey for HIV risks

  4. Retention in HIV care [ Time Frame: Month 0 ]
    Survey data for retention

  5. Retention in HIV care [ Time Frame: 6 months ]
    Survey data for retention

  6. Retention in HIV care [ Time Frame: 12 months ]
    Survey data for retention

  7. Opioid use [ Time Frame: Month 0 ]
    Measure of relapse to opioid use

  8. Opioid use [ Time Frame: 6 months ]
    Measure of relapse to opioid use

  9. Opioid use [ Time Frame: 12 months ]
    Measure of relapse to opioid use

  10. Medically assisted therapy retention [ Time Frame: Month 0 ]
    Measure of length of time on Methadone or Buprenorphine

  11. Medically assisted therapy retention [ Time Frame: 6 months ]
    Measure of length of time on Methadone or Buprenorphine

  12. Medically assisted therapy retention [ Time Frame: 12 months ]
    Measure of length of time on Methadone or Buprenorphine


Other Outcome Measures:
  1. Reincarceration [ Time Frame: Month 0 ]
    Measure of rearrest and reincarceration

  2. Reincarceration [ Time Frame: 6 months ]
    Measure of rearrest and reincarceration

  3. Reincarceration [ Time Frame: 12 months ]
    Measure of rearrest and reincarceration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03583138


Locations
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United States, District of Columbia
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
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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

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03583138    
Other Study ID Numbers: 1011007631b
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: June 2018

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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
Keywords provided by Yale University:
HIV
AIDS
Opiate Addiction
Drug Dependence
Buprenorphine
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Substance-Related Disorders
Opioid-Related Disorders
Behavior, Addictive
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists