Providing Comprehensive Harm Reduction Via Telemedicine for PWID Using Syringe Services Programs: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months
研究概览
简要总结
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP sites in Charlotte and Wilmington, North Carolina (NC); follow-up visits will be conducted via telemedicine.
详细描述
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, and pre-exposure prophylaxis (PrEP) for HIV prevention for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The study objectives are the following:
- To assess uptake and persistence to bup/nx and PrEP as part of a comprehensive harm reduction program among people who inject drugs using SSPs.
- To assess feasibility and acceptability of implementing a telemedicine-based MOUD and PrEP program
The study population is people who inject drugs, specifically opioids, and who access services at SSPs in Charlotte and Wilmington, NC. The study team will enroll 20 PWID accessing the participating SSPs in Charlotte and Wilmington, NC (10 from each site). Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.
Data collection
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •History of self-report injection opioid use in the past 6 months
- •Participate in SSPs,
- •HIV negative
- •Willing to take bup/nx and PrEP for 6 months
- •No medical contraindications for these medications
- •Not pregnant
- •18 years or older
- •Not currently taking PrEP
- •Not currently taking any form of MOUD
- •History of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV (such as engaging in sex work or men who have sex with men) in the past 6 months
排除标准
- •Positive pregnancy test including during the course of the study
- •Positive HIV test at enrollment
- •Altered mental status in which participant cannot sign a consent form
- •Renal insufficiency/failure
- •Hepatitis B surface antigen positive
- •Becoming incarcerated during the study
研究组 & 干预措施
Medication and telemedicine follow up
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
干预措施: Suboxone (Drug)
Medication and telemedicine follow up
All participants are provided with Suboxone and/or PrEP and follow up visits will be conducted via telemedicine
干预措施: PrEP (Drug)
结局指标
主要结局
Number of Participants Who Demonstrate no or Minimal Opioid Use at 3 Months
时间窗: 3 months
Defined as self-reported opioid use in prior month
Number of Participants Who Demonstrate no or Minimal Opioid Use at 6 Months
时间窗: 6 months
Defined as self-reported opioid use in prior month.
Persistence in Care at 3 Months
时间窗: 3 months
Defined as the number of participants who remain on treatment (MOUD or PrEP).
Number of Participants Who Remain HIV Negative at 3 Months
时间窗: 3 months
Measured via negative HIV test.
Number of Participants Who Remain HIV Negative at 6 Months
时间窗: 6 months
Measured via negative HIV test.
Persistence in Care at 6 Months
时间窗: 6 months
Defined as the number of participants who remain on treatment (MOUD or PrEP).
次要结局
未报告次要终点