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临床试验/NCT04268173
NCT04268173已完成不适用

Community-Based, Client-Centered Prevention Homes to Address the Rural Opioid Epidemic- Aim 3

University of Wisconsin, Madison7 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2020年3月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
343
试验地点
7
主要终点
Change in the Risk of HIV as Assessed by Risky Behavior Frequencies

研究概览

简要总结

The goal of this study was to effectively use a client-centered community-based intervention to engage people who inject drugs (PWIDs) in healthcare that helps reduce risky behaviors and lower infectious disease risks. Participants in the intervention group of this study received a 12-week intensive multilevel harm reduction case-management intervention at three rural Vivent Health offices. Service coordination aimed to reduce human immunodeficiency virus (HIV), hepatitis C virus (HCV), and overdose risks in PWIDs. Prevention Navigators (PNs) at each office helped to coordinate referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades.

详细描述

This project was conducted by an experienced, interdisciplinary team working across academic, public health, and non-government sectors. The main community partner Vivent Health, formerly known as the AIDS Resource Center of Wisconsin (ARCW), is a unique, state-wide organization that provides harm reduction services, including syringe services and confidential HIV and HCV testing, to clients at 10 fixed sites and numerous mobile units reaching all 72 Wisconsin counties. Based on the investigators' preliminary studies and prior collaborations, the investigators selected 6 counties in rural Wisconsin. The Client-Centered Prevention Home intervention model was implemented at 3 Vivent Health field offices in 3 of these counties, and 3 other counties served as "usual services," or control sites. Participants in the intervention underwent a 12-week intensive multilevel harm reduction case-management intervention geared towards coordinating referrals to reduce substance use disorder and increase engagement in the substance use disorder care cascades, and reduce vulnerability to HIV, STIs, and HCV and increase in engagement in the HIV, STI, and HCV care cascades. Participants in the intervention arm worked with Prevention Navigators to undergo a risk assessment and identify problems and create goals that they want to achieve. Each session after that was used to review the needs assessment and goals. During their last meeting, participants and prevention navigators developed a discharge plan that will enable the participants to work on their goals on their own. Participants at all six sites were offered rapid testing for HIV, HCV, and STIs, and fill out survey questionnaires to evaluate risk behaviors, intervention effectiveness, and general needs of the communities.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • has injected drugs in the past 30 days, resides in Wisconsin, over 18 years of age
  • able to read and write in English

排除标准

  • 未提供

结局指标

主要结局

Change in the Risk of HIV as Assessed by Risky Behavior Frequencies

时间窗: Pre-intervention, post intervention (3 months)

Participants were asked to gauge frequency of safe injection behaviors that reduce the risk of HIV. Participants will be asked how many times in the last 30 days they have practiced these behaviors. "In the last 3 months, how often have you shared needles with someone else, used a syringe more than once, used equipment you knew wasn't clean, or received equipment from a potentially unsafe source?" Responses were coded 0="never" and 1="at least once"

Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Frequency of "Yes" Answers

时间窗: Pre-intervention, post intervention (3 months)

Following questions will be asked with yes or no answers. In the past 3 months, have you gotten buprenorphine maintenance medication-like Suboxone or Subutex-from a doctor or program? Responses were coded as 0 = "No" and 1 = "Yes." Summary statistics presented as "mean" below represent the proportion responding yes.

Change in the Addiction Treatment Accessibility and Utilization as Assessed by Change in Likert Scale

时间窗: Pre-intervention, post intervention (3 months)

The following question was asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree: If I wanted to start medical treatment for opioid or heroin addiction, I could easily get buprenorphine or Suboxone or Subutex. The outcome is represented as the mean response in each intervention group (min 0, max 4)

Change in the Risk of HIV as Assessed by Change in Likert Scale

时间窗: Pre-intervention, post intervention (3 months)

Following questions will be asked to gauge ease of accessing clean injecting equipment to assess how risky the participants behaviors are in relation to HIV transmission. "It's easy for me to get new, clean syringes or needles." Questions will be answered on a scale of 0 to 4, with 0=strongly disagree and 4=strongly agree. An increase in the Likert scale among intervention participants is associated with increased access to HIV prevention compared to the controls.

Change in the Risk of Drug Overdose as Assessed by Change in Likert Scale

时间窗: Pre-intervention, post intervention (3 months)

Following question will be asked on a scale of 0 to 4, where 0=strongly disagree and 4=strongly agree "If I wanted the overdose reversal drug naloxone or Narcan, I could easily get it."

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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