iThrive WI - A Smartphone Intervention for Overdose and Risk and COVID-19 Among People Who Use Drugs
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention
研究概览
简要总结
This study will examine if the use of a smartphone application called Thrive4Life Connect can help people who use drugs lower their risk of overdose and learn more about COVID-19 vaccines. 60 participants will be enrolled and can expect to be on study for up to 6 months.
详细描述
The mobile health system used in this study, called Thrive4Life Connect, has been developed for use in harm reduction settings with prior funding from the National Institute on Drug Abuse. Thrive4Life Connect is based on the Addiction Comprehensive Health Enhancement Support System (A-CHESS) and facilitates brief, behavioral interventions targeting knowledge gaps, motivation, and social connectedness. This app is being used in another study at University of Wisconsin-Madison (registered to NCT04268173).
The proposed study will develop new intervention content for assessing and increasing vaccine confidence and lowering overdose risk. The feasibility and preliminary efficacy will be tested using a pilot, pre-post study design with 60 people who have injected drugs in the past week and used opioids in the past 30 days. The investigators will examine feasibility outcomes based on study recruitment, retention, and intervention completion. Changes in knowledge about COVID-19 and overdose, motivation to reduce risk, and behavioral outcomes including overdose risk behaviors and vaccine uptake will be examined to establish preliminary efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •18 years old or older
- •Willing to attend in person study encounters at any of the following Vivent Health locations: Milwaukee, Appleton, and Eau Claire
- •Used opioids to get high in the past 30 days
- •Injected drugs at least 2 times in the past 7 days
- •Express interest in reducing their overdose risk
排除标准
- •None in addition to the inclusion criteria
结局指标
主要结局
Content Completion Rate Assessed as Number of Participants Who Completed at Least 6 of the 12 Weeks of the Intervention
时间窗: up to 12 weeks
Study feasibility will be in part based on intervention content completion rates. The study will be considered feasible if participants complete any intervention content on at least 50% (i.e., 6) of the 12 weeks. We will report the number of participants who completed at least 6 of the 12 weeks.
次要结局
- Number of Days in the Past Month Endorsing Overdose Risk Behaviors(baseline, 3 months, 6 months)
- Change in COVID-19 Vaccination Rates From Baseline(baseline, 3 months, 6 months)