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Completed

NCT Number: NCT03583138

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

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.

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Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Drug Dependence Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders Narcotic-Related Disorders Opiate Addiction Opioid-Related Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Howard University

Washington D.C., District of Columbia, 20060, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

buprenorphine

Drug

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

Other names: Suboxone

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jul 11, 2018
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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