Clinical trial NCT01550341: HIV, Buprenorphine, and the Criminal Justice System
Official title: HIV, Buprenorphine, and the Criminal Justice System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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: George Mason University
name: Howard University
name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of STRIDE were changed as of July, 2014. The revised project, called STRIDE2, has a longitudinal, non-randomized, observational study design. The population under study consists of individuals living with HIV who are dependent on opioids.

Detailed description: Presented in the results section are the summary of outcomes from the STRIDE RCT that were collected prior to the change in study design. The STRIDE study became STRIDE2 (NCT03583138). Those individuals originally enrolled in the STRIDE RCT will be followed for 12 months.

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:

* HIV+
* Age ≥18 yrs
* Meets DSM-IV criteria for opioid dependence
* Has medical entitlements in DC
* Able to provide informed consent
* Able to communicate in English or Spanish

Exclusion Criteria:

* Being prescribed an opiate medication for a chronic pain condition or expressing the need to be placed on chronic pain medical conditions for a documented pain condition
* Currently receiving methadone dosing of over 30 mg per day and uninterested in changing to buprenorphine
* AST and ALT \>5x the upper limit of normal (AST≥175, ALT≥195)
* Pregnant or unwilling to use contraception (including OCPs, patch, Depo-Provera, condoms, etc.)
* Breastfeeding or unwilling to stop breastfeeding
* Subject is part of another pharmacological research study
* Liver dysfunction (acute hepatitis, liver failure or hepatic dysfunction)
* Suicidal ideation
* Hypersensitivity to buprenorphine

Primary outcomes:
measure: CD4 Count Absolute
timeFrame: Baseline
measure: CD4 Count Absolute
timeFrame: 6 Months
measure: CD4 Count Absolute
timeFrame: 12 Months
measure: CD4 Percent
timeFrame: Baseline
measure: CD4 Percent
timeFrame: 6 Months
measure: CD4 Percent
timeFrame: 12 Months
measure: Viral Load
timeFrame: Baseline
measure: Viral Load
timeFrame: 6 Months
measure: Viral Load
timeFrame: 12 Months
measure: Log Viral Load
timeFrame: Baseline
measure: Log Viral Load
timeFrame: 6 Months
measure: Log Viral Load
timeFrame: 12 Months
Secondary outcomes:
measure: Improved Opioid Treatment Outcomes
timeFrame: baseline, 3 months, 9 months, 12 months
measure: Improved Criminal Justice Outcomes
timeFrame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
Study officials:
affiliation: Yale University School of Medicine/AIDS Program
name: Frederick 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: