Evaluating an Intervention to Prevent Overdoses in Rural and Urban Counties
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 2,400
- 试验地点
- 2
- 主要终点
- Test the hypothesis that PWUD who receive FTS education and testing materials as part of an OEND program will have improved knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for lowering their risk of an opioid overdose.
研究概览
简要总结
The purpose of the study is to investigate the feasibility, acceptability, and associated benefits and harms of integrating FTS education and distribution into select Project DAWN sites in rural and urban communities in Ohio.
详细描述
Purpose: Opioid-related fatalities are a leading cause of death in Ohio and nationally, with an increasing number of overdoses attributable to fentanyl. Rapid fentanyl test strips (FTS) test for the presence of some types of fentanyl in urine samples and are increasingly being used to check illicit drugs for fentanyl before they are used. FTS use is a promising harm reduction strategy and research shows when people who use drugs (PWUD) receive a positive result, they are more likely to perform overdose risk reduction behaviors. However, access to FTS is limited, and there are barriers to the adoption of this intervention in some communities. This study will investigate FTS distribution and education as a harm reduction strategy to prevent overdoses among PWUD. Study findings will contribute valuable information about the feasibility and acceptability of integrating FTS drug checking into Project DAWN sites in rural and urban communities in Ohio and help us achieve our long-term goal of reducing overdose deaths.
Study Design: Project DAWN sites that volunteer to participate in the study will be randomly assigned to either the intervention or non-intervention arm of the study.
Clients in the intervention arm of the study will receive:
- One-on-one education on the purpose, benefits, and limitations of FTS testing
- A brief 20-minute fentanyl test strip educational intervention, including a 2-3-minute video and hands-on demonstrations on how to use FTS
- A supply of FTS upon enrollment and throughout the 2-year follow up period
Clients in the non-intervention arm of the study will receive:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Age 18 years or older
- •Visitor to a Project DAWN site in Ohio that does not currently distribute FTS and has agreed to participate in the study
- •Self-reported use of illicit drugs or prescription drugs purchased on the street within the past 6 months
- •Has a phone number or email address to allow for follow-up contact
- •Understands English (Based on the 2012-2016 American Community Survey, only 2.4% of Ohioans 5 years and older speak English less than "very well.")
排除标准
- •- None (must meet inclusion criteria)
研究组 & 干预措施
Intervention Arm
Each participant in the intervention arm will receive one-on-one education on the purpose, benefits, and limitations of fentanyl test strip (FTS) testing and undergo a brief 20-minute FTS educational intervention (including a 2-3-minute video and hands-on demonstrations on how to use FTS). They will also receive a supply of 10 FTS upon enrollment and continued supply upon request throughout the 2-year follow up period.
干预措施: Fentanyl Test Strips (Behavioral)
Non-Intervention Arm
Fentanyl test strip (FTS) education and a supply of FTS will be offered to participants in the non-intervention arm of the study during the final quarter of year 5.
结局指标
主要结局
Test the hypothesis that PWUD who receive FTS education and testing materials as part of an OEND program will have improved knowledge and self-efficacy regarding how to test drugs for fentanyl and strategies for lowering their risk of an opioid overdose.
时间窗: 6-month follow-up
All participants (in both the intervention and non-intervention arms) will complete a questionnaire at enrollment (for the intervention group, prior to the intervention) and again at 6 months. Both questionnaires (baseline and 6 months) will include the same questions about the participant's knowledge of and self-efficacy in reducing their risk of an opioid overdose by using FTS (Appendix). Participants will be compensated for their time with gift cards for completing the questionnaires.
Test the hypothesis that individuals who receive FTS education and testing materials as part of an OEND program will have a lower opioid overdose rate than individuals who receive OEND only ("usual practice").
时间窗: Quarter 3 of Year 5
Participants in the intervention arm will be contacted biweekly for 2 years and asked if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Intervention arm participants will be asked to notify the study team when they receive a positive FTS result. Participants in the non-intervention arm will be contacted biweekly up to a maximum of 2 years after enrollment to ask if they had an overdose in the past 2 weeks and, if so, what drug they were using at the time. Fatal overdoses among participants in the intervention and non-intervention arms of the study will be identified by reviewing death certificates issued by the Ohio Department of Health quarterly starting in Year 2. Participating Project DAWN sites will be asked to advise the study team if they become aware of any fatal overdoses among clients who are enrolled in the study.
Determine the perceived barriers and facilitating factors associated with incorporating FTS education and distribution in existing OEND programs in rural and urban counties.
时间窗: 6-month follow-up
Interview intervention arm sites about the acceptability of the program. Quantitative Data/Process Measures: * \# interested Project DAWN sites * \# Project DAWN sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTS education and testing materials at baseline * \# replacement FTS requested/distributed * total # FTS distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
次要结局
未报告次要终点
研究者
Nichole Michaels
Principal Investigator
Nationwide Children's Hospital