跳至主要内容
临床试验/NCT05872386
NCT05872386进行中(未招募)不适用

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

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年6月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
buprenorphine uptake

研究概览

简要总结

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. This study innovatively develops and tests 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. The investigators 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.

详细描述

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 the investigator's 2019 study on Homelessness in Public Spaces: An Assessment at the San Diego Central Library. Libraries have already taken extraordinary measures to help unstably housed patrons with OUD. The San Diego Central Library trained 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, the investigator's 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 the investigators' 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, the study combines qualitative and quantitative methodologies to address three specific aims:

  1. Develop "Bupe by the Book" (BBB) within TAM: Through formative research using intervention mapping, the investigators 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.
  2. Determine the feasibility of BBB: Estimate the expected level of treatment uptake and adherence. The investigators 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. The study hypothesizes that the BBB vs. control group, will have higher uptake and longer adherence to treatment.
  3. Evaluate the acceptability of BBB: Identify program components that could be improved to enhance adherence and patient satisfaction. Research staff 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, the investigators 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

Telehealth

Experimental

Intervention arm

干预措施: Buprenorphine uptake/retention via Telehealth (Behavioral)

Treatment as Usual

Experimental

Treatment as usual (in-person at clinic)

干预措施: Control group (Behavioral)

结局指标

主要结局

buprenorphine uptake

时间窗: within first 2 weeks

participants will pick up prescriptions and take them

buprenorphine adherence

时间窗: 8-12 weeks

participants will adhere to prescription by taking buprenorphine for \> 1 times and ideally for at least 8 weeks

次要结局

  • adherence to appointments(1-12 weeks)
  • telebupe feasibility(1-12 weeks)
  • Opioid use/overdose and other substance use(1,2,4,8,and 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lianne Urada

Associate Professor

University of California, San Diego

研究点 (1)

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