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CompletedNCT03583138Updated May 27, 2020

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

An observational study in Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome and Opiate Addiction, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.

Sponsored by Yale University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
159
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Human Immunodeficiency Virus
  • Acquired Immunodeficiency Syndrome
  • Opiate Addiction
  • Drug Dependence

Keywords

  • HIV
  • AIDS
  • Opiate Addiction
  • Drug Dependence
  • Buprenorphine
03

In context

Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 159 is below the median of 236 across 355 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
159 participants (actual)
Patient registry
No

Groups and 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.

    Drug: buprenorphine

  • No buprenorphine

    No buprenorphine

Interventions

  • Drugbuprenorphine

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

    Also known as: Suboxone

06

What researchers measure

Primary outcomes

  1. VL <400

    Blood test for HIV viral load

    Time frame: Month 0

  2. CD4+ cell count

    Blood test for HIV CD4+ cell count

    Time frame: Month 0

  3. VL <400

    Blood test for HIV viral load

    Time frame: 6 months

  4. CD4+ cell count

    Blood test for HIV CD4+ cell count

    Time frame: 6 months

  5. VL <400

    Blood test for HIV viral load

    Time frame: 12 months

  6. CD4+ cell count

    Blood test for HIV CD4+ cell count

    Time frame: 12 months

Secondary outcomes

  1. HIV risk behaviors

    Survey for HIV risks

    Time frame: Month 0

  2. HIV risk behaviors

    Survey for HIV risks

    Time frame: 6 months

  3. HIV risk behaviors

    Survey for HIV risks

    Time frame: 12 months

  4. Retention in HIV care

    Survey data for retention

    Time frame: Month 0

  5. Retention in HIV care

    Survey data for retention

    Time frame: 6 months

  6. Retention in HIV care

    Survey data for retention

    Time frame: 12 months

  7. Opioid use

    Measure of relapse to opioid use

    Time frame: Month 0

  8. Opioid use

    Measure of relapse to opioid use

    Time frame: 6 months

  9. Opioid use

    Measure of relapse to opioid use

    Time frame: 12 months

  10. Medically assisted therapy retention

    Measure of length of time on Methadone or Buprenorphine

    Time frame: Month 0

  11. Medically assisted therapy retention

    Measure of length of time on Methadone or Buprenorphine

    Time frame: 6 months

  12. Medically assisted therapy retention

    Measure of length of time on Methadone or Buprenorphine

    Time frame: 12 months

Other outcomes

  1. Reincarceration

    Measure of rearrest and reincarceration

    Time frame: Month 0

  2. Reincarceration

    Measure of rearrest and reincarceration

    Time frame: 6 months

  3. Reincarceration

    Measure of rearrest and reincarceration

    Time frame: 12 months

07

Study locations

1 site
  • Howard University
    Washington, District of Columbia 20060, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03583138
Lead sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA), George Mason University, Howard University
Responsible party
Sponsor
First posted
Jul 11, 2018
Start date
Jun 23, 2014
Primary completion
Dec 15, 2015
Completion
Jun 30, 2017
Last update
May 27, 2020

Study contacts

Fredrick Altice, MD
principal investigator · Yale University School of Medicine/AIDS Program
Faye Taxman, PhD
principal investigator · George Mason University
William Lawson, MD
principal investigator · Howard University

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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