Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : April 7, 2020
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
George Mason University
Howard University
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date March 19, 2018
First Posted Date July 11, 2018
Last Update Posted Date April 7, 2020
Actual Study Start Date June 23, 2014
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2018)
  • VL <400 [ Time Frame: Month 0 ]
    Blood test for HIV viral load
  • CD4+ cell count [ Time Frame: Month 0 ]
    Blood test for HIV CD4+ cell count
  • VL <400 [ Time Frame: 6 months ]
    Blood test for HIV viral load
  • CD4+ cell count [ Time Frame: 6 months ]
    Blood test for HIV CD4+ cell count
  • VL <400 [ Time Frame: 12 months ]
    Blood test for HIV viral load
  • CD4+ cell count [ Time Frame: 12 months ]
    Blood test for HIV CD4+ cell count
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2018)
  • HIV risk behaviors [ Time Frame: Month 0 ]
    Survey for HIV risks
  • HIV risk behaviors [ Time Frame: 6 months ]
    Survey for HIV risks
  • HIV risk behaviors [ Time Frame: 12 months ]
    Survey for HIV risks
  • Retention in HIV care [ Time Frame: Month 0 ]
    Survey data for retention
  • Retention in HIV care [ Time Frame: 6 months ]
    Survey data for retention
  • Retention in HIV care [ Time Frame: 12 months ]
    Survey data for retention
  • Opioid use [ Time Frame: Month 0 ]
    Measure of relapse to opioid use
  • Opioid use [ Time Frame: 6 months ]
    Measure of relapse to opioid use
  • Opioid use [ Time Frame: 12 months ]
    Measure of relapse to opioid use
  • Medically assisted therapy retention [ Time Frame: Month 0 ]
    Measure of length of time on Methadone or Buprenorphine
  • Medically assisted therapy retention [ Time Frame: 6 months ]
    Measure of length of time on Methadone or Buprenorphine
  • Medically assisted therapy retention [ Time Frame: 12 months ]
    Measure of length of time on Methadone or Buprenorphine
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2018)
  • Reincarceration [ Time Frame: Month 0 ]
    Measure of rearrest and reincarceration
  • Reincarceration [ Time Frame: 6 months ]
    Measure of rearrest and reincarceration
  • Reincarceration [ Time Frame: 12 months ]
    Measure of rearrest and reincarceration
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title HIV, Buprenorphine, and the Criminal Justice System (STRIDE2)
Official Title Project STRIDE2 - Seek/Test/Retain: PLWHA and Opioid Users in Washington, DC
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Human Immunodeficiency Virus
  • Acquired Immunodeficiency Syndrome
  • Opiate Addiction
  • Drug Dependence
Intervention Drug: buprenorphine
To provide buprenorphine for 12 months for those who are interested in receiving it.
Other Name: Suboxone
Study Groups/Cohorts
  • 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.
    Intervention: Drug: buprenorphine
  • No buprenorphine
    No buprenorphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 2, 2020)
159
Original Actual Enrollment
 (submitted: June 26, 2018)
112
Actual Study Completion Date June 30, 2017
Actual Primary Completion Date December 15, 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03583138
Other Study ID Numbers 1011007631b
R01DA030768 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Yale University
Study Sponsor Yale University
Collaborators
  • 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
PRS Account Yale University
Verification Date April 2020