NCT03583138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 11, 2018

Completed
Last Updated

May 27, 2020

Status Verified

May 1, 2020

Enrollment Period

1.5 years

First QC Date

March 19, 2018

Last Update Submit

May 22, 2020

Conditions

Human Immunodeficiency VirusAcquired Immunodeficiency SyndromeOpiate AddictionDrug Dependence

Keywords

HIVAIDSOpiate AddictionDrug DependenceBuprenorphine

Outcome Measures

Primary Outcomes (6)

  • VL <400

    Blood test for HIV viral load

    Month 0

  • CD4+ cell count

    Blood test for HIV CD4+ cell count

    Month 0

  • VL <400

    Blood test for HIV viral load

    6 months

  • CD4+ cell count

    Blood test for HIV CD4+ cell count

    6 months

  • VL <400

    Blood test for HIV viral load

    12 months

  • CD4+ cell count

    Blood test for HIV CD4+ cell count

    12 months

Secondary Outcomes (12)

  • HIV risk behaviors

    Month 0

  • HIV risk behaviors

    6 months

  • HIV risk behaviors

    12 months

  • Retention in HIV care

    Month 0

  • Retention in HIV care

    6 months

  • +7 more secondary outcomes

Other Outcomes (3)

  • Reincarceration

    Month 0

  • Reincarceration

    6 months

  • Reincarceration

    12 months

Study Arms (2)

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

buprenorphineDRUG

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

Also known as: Suboxone
Buprenorphine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • HIV+, confirmed by rapid HIV test
  • Meet DSM-IV criteria for opioid dependence
  • years or older
  • Have health insurance that is accepted at Lab Corp.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Howard University

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

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeOpioid-Related DisordersSubstance-Related Disorders

Interventions

BuprenorphineBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesNarcotic-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsNaloxoneDrug CombinationsPharmaceutical Preparations

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

July 11, 2018

Study Start

June 23, 2014

Primary Completion

December 15, 2015

Study Completion

June 30, 2017

Last Updated

May 27, 2020

Record last verified: 2020-05

Locations

US(1)