Bupe by the Book (BBB)

Study Overview
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Brief Summary
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Public libraries nationwide are facing an on-premise opioid overdose crisis. Many persons with opioid use disorder (OUD) remained unhoused and profoundly hard to reach. To our knowledge, our study will be the first to develop and test a telemedicine intervention delivered through public libraries to increase unstably housed individuals' access to bupe treatment that would prevent overdoses from occurring in the first place.We will conduct a 12-week pilot 2-arm randomized controlled trial (RCT) (n=40). Research staff will recruit library patrons and randomize them to weekly telehealth at the library or in-person clinic control arms across two participating libraries in San Diego.

Detailed Description
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Libraries have become places of refuge for unstably housed individuals with OUD. Two overdoses a day occurred just outside the library, according to focus group participants in our 2019 study on Homelessness in Public Spaces: An Assessment at the San Diego Central Library. Libraries have already taken extraordinary measures to help their homeless patrons with OUD. The San Diego Central Library trained their security staff to carry Narcan to save patrons who overdose in their bathrooms. To deal with daily patron mental health crises, libraries now have social workers, nurses, and peer homeless outreach staff on-site. Buprenorphine bupe is a highly effective medical treatment for OUD. However, our preliminary work shows that unstably housed persons with OUD at libraries perceive lack of bupe access due to transportation and medical coverage issues as barriers to treatment. Bupe by the Book (BBB), in collaboration with our established local partners, San Diego Public Libraries and Father Joe's Village Health Center (FJV), will innovatively adapt FJV's already successful same-day, free tele-bupe treatment to library settings where OUD patrons are already. BBB will be a groundbreaking 12-week intervention that leverages the library's resources to facilitate low-barrier tele-bupe care via local clinic providers without requiring access to a clinic. By testing BBB uptake and retention in libraries, this study will inform how unstably housed persons and others can receive bupe care in innovative ways with minimal clinical/non-clinical requirements (e.g., low-barrier induction), changing the landscape radically for implementing bupe. Using a mixed methods approach, we will combine qualitative and quantitative methodologies to address three specific aims: Develop Bupe by the Book (BBB) within TAM: Through formative research using intervention mapping, we will conduct a series of 8 focus groups across 4 libraries to: a) assess perceptions of key stakeholders such as local residents, businesses, library staff/security, outreach workers, tele-bupe providers, and unstably housed persons with OUD about BBB's potential, b) develop a feasible plan with stakeholder input, and c) identify facilitators and modifiable barriers to implementation. Determine the feasibility of BBB: Estimate the expected level of treatment uptake and adherence. We will conduct a 12-week pilot 2-arm randomized controlled trial (RCT) (n=40). Research staff will recruit library patrons and randomize them to weekly telehealth at the library or in-person clinic control arms across two participating libraries in San Diego. A health provider at FJV will then screen participants in person for eligibility for same-day bupe induction. BBB's effects on bupe induction and adherence to prescribed doses will be based on self-reported measures at 1-,2-,4-,8-, 12- weeks follow-ups with study staff, and weekly drug screenings and prescription pickups. We hypothesize that the BBB vs. control group, will have higher uptake and longer adherence to treatment. Evaluate the acceptability of BBB: Identify program components that could be improved to enhance adherence and patient satisfaction. We will conduct structured interviews with BBB patients, health providers, and library staff to gain insight into the patients' experiences after receiving BBB. In line with NIDA's 2020 Strategic Plan (Objective 3.4. Develop and test strategies for effectively and sustainably implementing evidence-based treatments), the proposed study addresses long-standing barriers to bupe uptake/adherence. By utilizing multiple library sites, we will render tele-bupe reproducible for other libraries nationwide facing opioid overdoses. This work will pave the foundation for a larger RCT in a subsequent R01 to evaluate the efficacy of utilizing public settings to treat substance use disorders and reduce opioid-related deaths.

Official Title
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Bupe by the Book: Developing and Testing a Tele-Buprenorphine Intervention in Public Libraries With Unstably Housed Persons With Opioid Use Disorder

Conditions
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Telehealth at the Library, Treatment as Usual Control Group at Father Joe's Villages Health Center (a FQHC)

Intervention / Treatment
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* Behavioral: Buprenorphine uptake/retention via Telehealth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All participants interested in OUD treatment will be eligible for study screening regardless of OUD and treatment history. However, they cannot already be on bupe with an active medical prescriber unless they can no longer stay with that provider. We will accommodate participants with disabilities. The FJV medical provider will determine if bupe is appropriate for the individual and able to proceed in BBB. Exclusion Criteria: Persons with comorbidities or polysubstance use that needs a different level or type of care from bupe will not be enrolled in either study arm. Participants ineligible for FJV or the libraries will be ineligible for this study.

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will conduct a 12-week pilot 2-arm randomized controlled trial (RCT) (n=40-60). Research staff will recruit library patrons and randomize them to weekly telehealth at the library or in-person clinic control arms across two participating libraries in San Diego.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth<br>Intervention arm | Behavioral: Buprenorphine uptake/retention via Telehealth<br>* Bupe by the Book (BBB) will randomly assign library patrons with opioid use disorder to a telehealth or treatment as usual control group to receive buprenorphine (aka, Suboxone) treatment from Father Joe's Villages Health Center for those who desire it.<br>* Other names: Suboxone;|
| Experimental: Treatment as Usual<br>Treatment as usual (in-person at clinic) | Behavioral: Buprenorphine uptake/retention via Telehealth<br>* Bupe by the Book (BBB) will randomly assign library patrons with opioid use disorder to a telehealth or treatment as usual control group to receive buprenorphine (aka, Suboxone) treatment from Father Joe's Villages Health Center for those who desire it.<br>* Other names: Suboxone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| buprenorphine uptake | participants will pick up prescriptions and take them | within first 2 weeks | 
| buprenorphine adherence | participants will adhere to prescription by taking buprenorphine for at least 8 weeks | 8-12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adherence to appointments | adherence to appointments | 1-12 weeks | 
| telebupe feasibility | adherence to telehealth | 12 weeks | 
| Opioid use/overdose and other substance use | weekly oral cheek swab drug screenings and fentanyl self-tests and self-report from surveys | 1,2,4,8,and 12 weeks |