Pilot Test of a Community-based Buprenorphine Treatment Intervention

Study Overview
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Brief Summary
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The main goal of this study is to pilot test the community-based buprenorphine treatment (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk behaviors. Two groups of participants will be followed for 60 days, with 3 research visits. One group will be enrolled prior to the CBBT intervention (pre-intervention), and one group after the CBBT intervention (post-intervention). Data sources will include questionnaires, urine toxicology tests, and medical record data. Investigators hypothesize that compared to the participants in the pre-intervention group, participants in the post-intervention group will be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce high-risk HIV risk behaviors.

Official Title
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Development of a Community-based Buprenorphine Treatment Intervention

Conditions
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Opioid Dependence, Injection Drug Use

Intervention / Treatment
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* Behavioral: Community-based buprenorphine treatment (CBBT) intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years old English or Spanish fluency ever injected drugs not receiving buprenorphine treatment (no prescribed buprenorphine in the previous 6 months) clients of our collaborating community-based organization interested in buprenorphine treatment Exclusion Criteria: pregnant taking more than 60mg of methadone daily in the previous 30 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-intervention<br>Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention. | |
| Experimental: Post-intervention<br>Participants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention | Behavioral: Community-based buprenorphine treatment (CBBT) intervention<br>* Community-based buprenorphine treatment (CBBT) intervention consists of three components which are delivered to staff of syringe exchange programs, including: 1) providing buprenorphine education, 2) facilitating access to buprenorphine treatment, and 3) providing support to individuals who initiate buprenorphine treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initiation of buprenorphine treatment | Medical record information will be extracted to determine initiation of buprenorphine treatment, which will be defined as a visit with a medical provider in which buprenorphine is prescribed. | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid use | Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing). | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid dependence, Injection drug use, Buprenorphine, Opioid agonist treatment, Access to care, HIV risk behaviors, Opioids