Clinical trial NCT03583138: HIV, Buprenorphine, and the Criminal Justice System (STRIDE2)
Official title: Project STRIDE2 - Seek/Test/Retain: PLWHA and Opioid Users in Washington, DC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome
Opiate Addiction
Drug Dependence
Keywords: HIV
AIDS
Opiate Addiction
Drug Dependence
Buprenorphine
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: George Mason University
name: Howard University
First posted: 2018-07-11
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: VL <400
timeFrame: Month 0
measure: CD4+ cell count
timeFrame: Month 0
measure: VL <400
timeFrame: 6 months
measure: CD4+ cell count
timeFrame: 6 months
measure: VL <400
timeFrame: 12 months
measure: CD4+ cell count
timeFrame: 12 months
Secondary outcomes:
measure: HIV risk behaviors
timeFrame: Month 0
measure: HIV risk behaviors
timeFrame: 6 months
measure: HIV risk behaviors
timeFrame: 12 months
measure: Retention in HIV care
timeFrame: Month 0
measure: Retention in HIV care
timeFrame: 6 months
measure: Retention in HIV care
timeFrame: 12 months
measure: Opioid use
timeFrame: Month 0
measure: Opioid use
timeFrame: 6 months
measure: Opioid use
timeFrame: 12 months
measure: Medically assisted therapy retention
timeFrame: Month 0
measure: Medically assisted therapy retention
timeFrame: 6 months
measure: Medically assisted therapy retention
timeFrame: 12 months
Other outcomes:
measure: Reincarceration
timeFrame: Month 0
measure: Reincarceration
timeFrame: 6 months
measure: Reincarceration
timeFrame: 12 months
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
Study officials:
affiliation: Yale University School of Medicine/AIDS Program
name: Fredrick Altice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: George Mason University
name: Faye Taxman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Howard University
name: William Lawson, MD
role: PRINCIPAL_INVESTIGATOR
References: