This trial will recruit syringe exchange participants with opioid use disorder in New York City and test whether starting buprenorphine treatment at the syringe exchange program is more effective than referral to a community health center for buprenorphine treatment.
In a 24 week randomized controlled trial based in a large urban area with high rates of opioid use disorder (OUD) and HIV, 250 out-of-treatment opioid users who utilize syringe exchanges will be recruited and randomize to receive an onsite treatment intervention (O-BMT) or enhanced referral to buprenorphine treatment. Over 2 weeks, participants in the O-BMT arm will see a buprenorphine provider twice, receive weekly blister packs of medication, and then their care will be transferred to a community health center for maintenance buprenorphine treatment. In the control arm, participants will receive enhanced referral to the community health center for maintenance buprenorphine treatment. Data collection will include urine drug tests, questionnaires, and medical and pharmacy record review. Key outcomes will include engagement in buprenorphine treatment, treatment outcomes, and programmatic costs. Buprenorphine diversion will be assessed by using electronic monitors that estimate medication adherence, testing urine samples for buprenorphine, and through sequential surveys regarding buying or selling illicit buprenorphine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
all participants will receive buprenorphine
Washington Heights CORNER Project
New York, New York, United States
New York Harm Reduction Educators
New York, New York, United States
BOOM!Health Harm Reduction Center
The Bronx, New York, United States
Buprenorphine Engagement
Buprenorphine engagement was defined as the number of participants having an active buprenorphine prescription at 30 days after randomization. Responses were tallied using a dichotomous (i.e., Yes/No) measure. Data are summarized by study arm.
Time frame: 30 days after randomization
Treatment Retention
Treatment retention was assessed by the number/percentage of participants who had a medical visit AND active buprenorphine prescription each month after buprenorphine initiation for 6 months. Results are summarized by study arm.
Time frame: 6 months
HIV Risk Behaviors
Change in HIV risk behaviors will be assessed using the HIV risk behavior survey. This survey, consisting of a dichotomous (yes/no) measure of injection risk, will be used based on self-report of at least one risk behavior (sharing syringes, not using bleach to clean syringes, sharing cookers, or front/back loading of syringes) reported during the interval. The number of participants demonstrating at least one risk behavior is during the 6 month interval is summarized by study arm.
Time frame: 6 months
Buprenorphine Diversion
Buprenorphine diversion will be defined as having at least one problem behavior: non-adherence to prescribed medication on electronic monitoring, self-reported diversion, or a urine sample consistent with diversion during the 6 month interval. This outcome measure is used to determine how many participants sell or give away prescribed medication. The number of participants with at least one problem behavior is summarized by study arm.
Time frame: 6 months
Incremental Cost-effectiveness Ratio (ICER)
The ICER will be calculated by dividing the incremental mean cost of the O-BMT arm relative to the control arm by the incremental mean effectiveness of the O-BMT arm relative to the control arm. The primary economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. ICER is a composite measure that incorporates QALYs (also reported as a separate outcome measure) and mean costs (also reported as a separate outcome measure).
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Time frame: 6 months
Quality-adjusted Life-years (QALYs) Gained
The main economic effectiveness outcome will be the quality-adjusted life-year (QALY), a measure that incorporates both duration and health-related quality-of-life and is recommended as the primary economic effectiveness measure. Mean years gained are summarized by study arm.
Time frame: 6 months
Mean Difference in Total Costs
Mean cost (in US dollars) of the O-BMT arm were compared to the control arm. The resource utilization and resulting cost of implementing and administering the O-BMT intervention were estimated using microcosting analysis and participant self-report. Mean costs (in US dollars) are summarized by study arm.
Time frame: 6 months
Time to First Buprenorphine Prescription
Time to first buprenorphine prescription is defined as the amount of time, in days, from when a participant enrolled in the study to receipt of first buprenorphine prescription. Results are summarized by study arm using basic descriptive statistics.
Time frame: 1 month
Number/Percentage of Participants Who Received Any Buprenorphine Prescription
The Number/percentage of participants who received any buprenorphine prescription is defined as the number/percentage of participants that filled at least one prescription for buprenorphine while enrolled in the study. Results are summarized by study arm.
Time frame: 6 months
Total Time Prescribed Buprenorphine
Total time prescribed buprenorphine is defined as the amount of time in days that participants were prescribed buprenorphine during the study period. Results are summarized by study arm using basic descriptive statistics.
Time frame: 6 months