Buprenorphine Implementation at Syringe Services Programs To Reduce Overdoses: A Type 1 Hybrid Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 512
- 试验地点
- 16
研究概览
简要总结
This study is testing whether offering buprenorphine treatment directly at syringe service programs (SSPs) helps more people start and stay in treatment for opioid use disorder (OUD) than referring them to community buprenorphine treatment providers. Buprenorphine is a medication that helps reduce opioid cravings and withdrawal symptoms.
The study compares two ways of connecting people to treatment:
Referral to a community treatment provider (usual care before the new program begins).
Onsite, low-threshold buprenorphine treatment at the SSP, which allows participants to start medication quickly and without having to establish care at another provider.
Participants will be adults who have opioid use disorder and are SSP clients. Each SSP will begin offering the new onsite buprenorphine program at different times during the study. Researchers will collect information before and after the new program begins to see how it affects treatment engagement and health outcomes.
The study will also examine how easy or difficult it is for SSPs to start and run the new program, how acceptable it is to staff and participants, and whether it is cost-effective.
The overall goal is to find better ways to expand access to life-saving opioid treatment in community-based settings.
详细描述
This is a Type 1 hybrid effectiveness-implementation study designed to evaluate the impact and feasibility of implementing low-threshold buprenorphine (BUP) treatment at syringe service programs (SSPs) in order to improve access to and retention in medications for opioid use disorder (MOUD) treatment among people with moderate to severe opioid use disorder (OUD). The study seeks to understand whether the low-threshold approach improves participant-level outcomes and how SSPs can successfully implement and sustain this model.
Study Design
The study uses a cluster randomized stepped wedge design, in which eight SSPs will be randomly and sequentially assigned to begin implementing the low-threshold BUP program until all sites have transitioned from the referral condition to the intervention condition. This design allows each site to serve as its own control and ensures equitable access to the intervention over time. The stepped wedge design also facilitates examination of temporal effects, while accounting for differences in local environments and SSP readiness for implementation.
Participants will be recruited across the eight SSPs in different geographic regions of the United States. SSPs will be selected to represent a range of community types (urban, suburban, and rural) and to reflect varying policy environments related to MOUD access.
Study Rationale and Background
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 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
- •≥ 18 years old;
- •Meet DSM-5 criteria for moderate or severe OUD;
- •Interest in receiving buprenorphine treatment;
- •Speaks English or Spanish;
- •Currently an SSP client at the time of enrollment;
- •Ability to provide informed consent.
排除标准
- •Current use of prescribed opioid agonist treatment, as assessed by self-report, at the time of enrollment;
- •Unstable mental health or medical condition that requires an immediate clinical evaluation or higher level of care;
- •Allergy to buprenorphine;
- •Currently detained in jail, prison, residential substance use treatment facility, or other overnight facility as required by court of law. or have pending legal action that could prevent participation on study activities.
研究组 & 干预措施
Treatment As Usual (TAU)
Participants enrolled before the intervention is implemented at each syringe service program (SSP) will receive standard of care, consisting of referral to community-based buprenorphine treatment providers. SSP staff will offer information and referral support but will not provide on-site buprenorphine treatment or prescribing.
干预措施: Standard of Care Referral (Other)
Low-threshold Buprenorphine (LTB)
After implementation at each SSP site, participants will have access to on-site, low-threshold buprenorphine treatment integrated into SSP services. This model focuses on minimizing barriers to treatment initiation and retention and includes , flexible policies and procedures and collaboration with a peer outreach worker.
干预措施: Low Threshold Buprenorphine (Behavioral)