Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Motivators and barriers affecting medication adherence and persistence
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, pre-exposure prophylaxis (PrEP) for HIV prevention, and/or hepatitis C treatment 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 site in Greensboro, 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, pre-exposure prophylaxis (PrEP) for HIV prevention and/or hepatitis C treatment 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, PrEP, and hepatitis C treatment as part of a comprehensive telemedicine-based harm reduction program among people who inject drugs using SSPs.
To assess feasibility and acceptability of implementing a telemedicine-based care harm reduction program among program implementers To assess feasibility and acceptability of participating in a telemedicine-based harm reduction program among users
The study population is people who inject drugs, specifically opioids, and who access services at an SSP in Greensboro, NC. The study team will enroll 30 people who inject drugs accessing the participating SSP. 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.
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
- 否
入选标准
- •18 years or older
- •Participant in SSP
- •History of self-report injection opioid use in the past 6 months
- •Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months
- •Not currently taking PrEP
- •HIV negative
- •Not pregnant
- •Either a history of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV* in the past 6 months
- •*Individuals are considered at risk of sexual acquisition of HIV if they answer yes to any of the items in the below question: In the last 6 months, have any of the following applied to you?
- •Traded sex for money or drugs
- •Had a sexual partner who is HIV positive
- •Did not consistently use condoms when having sex
- •Had a bacterial sexually transmitted infections (like gonorrhea, chlamydia, or syphilis)
- •No medical contraindications for these medications such as history of renal failure or bone diseases
排除标准
- •Have altered mental status in which participant cannot sign a consent form
- •Receive a positive pregnancy test (will be checked at screening visit)
- •Receive a positive HIV test at enrollment (will be checked at screening visit)
- •Have evidence of renal failure (will be checked at screening visit)
- •Have a history of hepatitis B (will be checked at screening visit)
- •Becoming incarcerated during the study
- •Additional considerations:
- •The following are not exclusion criteria for the study overall, but will affect which treatment(s) they can receive:
- •Are currently receiving some form of MOUD (buprenorphine, naltrexone, methadone) - this makes them ineligible for MOUD treatment through the study, but they can still receive PrEP and/or hepatitis C treatment
- •Have received treatment for hepatitis C prior to enrollment - this makes them ineligible for hepatitis C treatment through study, but they can still receive PrEP and/or MOUD
研究组 & 干预措施
Medication and telemedicine follow up
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
干预措施: Suboxone (Drug)
Medication and telemedicine follow up
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
干预措施: Truvada (Drug)
Medication and telemedicine follow up
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
干预措施: Mavyret (Drug)
结局指标
主要结局
Motivators and barriers affecting medication adherence and persistence
时间窗: 6 months
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Proportion who demonstrate no or minimal opioid use.
时间窗: 6 months
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Proportion who remain HIV negative.
时间窗: 6 months
Measured via negative HIV test.
Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
时间窗: 6 months
Measured via negative hepatitis C test.
Persistence in care
时间窗: 6 months
Defined as the proportion who remain on treatment.
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
时间窗: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Ease/difficulty of accessing the telemedicine video platform
时间窗: month 1
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Acceptability of medical care via a telemedicine video platform
时间窗: 6 month
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Participant satisfaction with the program
时间窗: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Participant perceived usefulness of the program
时间窗: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Motivators and barriers affecting program persistence
时间窗: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
次要结局
未报告次要终点