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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
Howard University
Washington D.C., District of Columbia, United States
CD4 Count Absolute
CD4 Count Absolute
Time frame: Baseline
CD4 Count Absolute
CD4 Count Absolute
Time frame: 6 Months
CD4 Count Absolute
CD4 Count
Time frame: 12 Months
CD4 Percent
CD4 Percent
Time frame: Baseline
CD4 Percent
CD4 Percent
Time frame: 6 Months
CD4 Percent
CD4 Percent
Time frame: 12 Months
Viral Load
Viral Load
Time frame: Baseline
Viral Load
Viral Load
Time frame: 6 Months
Viral Load
Viral Load
Time frame: 12 Months
Log Viral Load
Log Viral Load
Time frame: Baseline
Log Viral Load
Log Viral Load
Time frame: 6 Months
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Log Viral Load
Log Viral Load
Time frame: 12 Months
Improved Opioid Treatment Outcomes
Monitor relapse to opioid use, retention on Buprenorphine or placebo, percent days using opioids, lower addiction severity, lower craving, between baseline and subsequent follow-up visits. Monitor urine toxicology screens on every visit for approximately one year.
Time frame: baseline, 3 months, 9 months, 12 months
Improved Criminal Justice Outcomes
Measure change in time to reincarceration,number of days reincarcerated, and crime days, between baseline and each monthly follow-up visit.
Time frame: baseline, wk 4, 9, 13, 18, 22, 27, 31, 36, 40, 45, 49, 52