Onsite Buprenorphine Treatment at Syringe Exchange Programs

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Buprenorphine Treatment at Syringe Exchanges to Reduce Opioid Misuse and HIV Risk

Conditions
-----------------
Opiate Addiction

Intervention / Treatment
-----------------
* Behavioral: Onsite treatment
* Behavioral: Enhanced referral
* Drug: Buprenorphine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years opioid use disorder interest in buprenorphine treatment motivation for opioid use disorder treatment willingness to accept community health center referral syringe exchange participant Exclusion Criteria: receiving opioid agonist treatment in the past 30 days (confirmed by New York Prescription Drug Monitoring Program); inability to provide informed consent unstable mental illness (e.g., suicidality, psychosis, etc.) severe alcohol use disorder or benzodiazepine use disorder by the Diagnostic and Statistical Manual of Mental disorders, Fifth Edition (DSM-5) criteria hypersensitivity to buprenorphine or naloxone. pregnancy (confirmed via urine testing)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized 1:1 to receive the O-BMT intervention or enhanced referral
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: O-BMT (onsite treatment)<br>Over 2 weeks at the syringe-exchange program, 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 | Behavioral: Onsite treatment<br>* 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.<br>Drug: Buprenorphine<br>* all participants will receive buprenorphine<br>|
| Active Comparator: Enhanced Referral<br>In the control arm, participants will receive enhanced referral to a community health center for maintenance buprenorphine treatment | Behavioral: Enhanced referral<br>* Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment<br>Drug: Buprenorphine<br>* all participants will receive buprenorphine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Buprenorphine Engagement | Having an active buprenorphine prescription at 30 days after randomization | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Retention | Having a medical visit and active buprenorphine prescription each month after buprenorphine initiation | 6 months | 
| HIV risk behaviors | Change in HIV risk behaviors we will be assessed using the HIV risk behavior survey. A dichotomous measure (yes/no) of injecting 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). | 6 months | 
| Diversion | 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. | 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. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opioid use disorder, syringe exchange, HIV risk reduction