Evaluation of a Novel Intervention to Prevent Polysubstance Overdoses Involving Illicit Stimulants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 653
- 试验地点
- 1
- 主要终点
- Questionnaire
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 courts 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 court sites in rural and urban communities in Ohio and help study personnel achieve the long-term goal of reducing overdose deaths.
Study Design: Court 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
- Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed 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
- •Not incarcerated at time of study enrollment
- •Currently enrolled in one of the following Ohio drug courts: Criminal drug court, Veterans' court, Mental health court, Human trafficking court, Family treatment court, O.V.I. court or on probation with a participating court
- •Self-reported use of illicit stimulants in 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. Each participant will also receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period.
干预措施: Fentanyl Test Strips (Behavioral)
Non-Intervention Arm
Each participant will receive Opioid overdose education and a naloxone kit upon enrollment and re-supply of naloxone as needed throughout the 2-year follow up period. 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 3.
结局指标
主要结局
Questionnaire
时间窗: Quarter 3 of Year 3
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.
Key informant interviews
时间窗: Quarter 2 of Year 1
Key informant interviews will be conducted with court personnel and peer recovery mentors who are affiliated with the court sites to discuss and obtain feedback on the intervention design and research protocols. Key informants will be asked to provide feedback on participant recruitment strategies, discuss potential barriers to the program's success, and describe any concerns with the implementation plan. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Follow-up questionnaire
时间窗: Quarter 3 of Year 3
A follow-up questionnaire will occur with intervention arm site personnel to gauge satisfaction with the program and identify any concerns. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Interview
时间窗: 6-month follow-up
Intervention arm sites will be interviewed about the acceptability of the program. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Interview
时间窗: Quarter 2 of Year 3
Intervention arm site personnel will be interviewed to identify barriers and facilitating factors related to offering FTS education and distribution at OEND sites. Quantitative Data/Process Measures: * \# interested court sites * \# Court sites enrolled * \# potential participants who request to enroll * \# participants successfully enrolled * \# people who receive FTSED and OEND at baseline * \# replacement FTS and Naloxone kits requested/distributed * total # FTS and Naloxone kits distributed * proportion of participants in the intervention arm who complete the biweekly surveys * proportion of participants who complete the 6-month follow-up questionnaire
Questionnaire
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.
次要结局
未报告次要终点
研究者
Nichole Michaels
Principal Investigator
Nationwide Children's Hospital