Mobile Health Strategies to Support Longitudinal Engagement in Comprehensive, Community-based Prevention Services for People Who Use Drugs (Aim 3)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
This study will examine the feasibility, appropriateness, and acceptability of a bundle of smartphone-based tools for lowering overdose risk. 40 participants will be enrolled and can expect to be on study for up to 9 months.
详细描述
As a pilot study, this study is not designed to rigorously evaluate the effect of the intervention (i.e., health-related biomedical or behavioral outcome) on participants. Rather, the sample size will allow determination of feasibility, acceptability, appropriateness, and secondarily, will allow quantification of preliminary effect size to aid in future trial planning. After enrolling in the study, participants will receive a mobile phone with an unlimited data plan. After receiving the phone, participants will receive a brief orientation to a bundle of phone and internet-based overdose prevention tools. This includes overdose crisis hotlines, mail-order overdose prevention supplies, and a mobile health app that has been adapted for people who use drugs to support self-determined motivation for reaching goals through educational content, social engagement, and peer-to-peer support. Each month for 6 months, participants will also complete a 20-30 minute survey evaluating the primary and secondary outcomes (described below) and use of each phone and internet-based tool that is part of the enhanced harm reduction bundle. 25 participants will also be invited to complete a 45-60 minute semi-structured in-depth interview about their experience participating in the study and use of the phone- and internet-based tools. Primary analyses will seek to describe the feasibility, acceptability, and appropriateness of the overdose prevention service model. Secondarily, changes in overdose risk behaviors and experiences over the 6-month study period relative to baseline will be analyzed.
Primary Objective: to evaluate feasibility, appropriateness, and acceptability of an enhanced harm reduction service model incorporating internet and/or mobile health tools to reduce overdose risk for people who use opioid and/or stimulant drugs.
Secondary Objective: to understand overdose risk behaviors before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •(Pilot Participant):
- •Be at least 18 years old
- •Be able to read and write in English
- •Report drug use in the past 30 days, defined as
- •Any use of illicit stimulants, opioids, OR
- •Use of prescription opioids by a route other than "by mouth/swallowed"
- •Additionally report recent drug use of at least twice in the past 7 days
- •Have NOT used any of the following harm reduction services in the past 6 months:
- •In-person community-based prevention services for people who use drugs
- •Overdose crisis hotlines
- •Online mail-order prevention supply delivery
- •Apps for supporting addiction treatment or recovery
- •Inclusion Criteria (Peer Mentor Participant):
- •Be at least 18 years old
- •Be able to read and write in English
- •Have served as a member of the existing Community Leadership Team.
排除标准
- •Are under the age of 18
- •Have impaired decision making capacity at the time of screening
- •Do not have the ability to participate in screening and enrollment activities in any one of the following ways:
- •Traveling to their nearest participating Vivent Health health center
- •Coordinating a visit with the Vivent Health harm reduction mobile unit
- •Accessing and completing the online screening survey on a personal wifi/internet enabled device
研究组 & 干预措施
Pilot Participants
People who use opioid and/or stimulant drugs and are disconnected from harm reduction services.
干预措施: Connections mHealth Application (Device)
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: up to 6 months
The Acceptability of Intervention Measure (AIM) measures intervention acceptability with 4 items ranked on a 5-point Likert-type scale. Participants will be asked the 4-item questionnaire for each tool offered in the bundle (3). Scores are averaged across the measure for each tool and subsequently scores for individual tools will be summed to generate a composite acceptability score of the program. Scores can range from 3-15, with higher scores meaning higher acceptability of the intervention
Intervention Appropriateness Measure (IAM)
时间窗: up to 6 months
The Intervention Appropriateness Measure (IAM) measures intervention appropriateness with 4 items ranked on a 5-point Likert-type scale. Participants will be asked the 4-item questionnaire for each tool offered in the bundle (3). Scores are averaged across the measure for each tool and subsequently scores for individual tools will be summed to generate a composite appropriateness score of the program. Scores can range from 3-15, with higher scores meaning higher appropriateness of the intervention.
Feasibility of Intervention Measure (FIM)
时间窗: up to 6 months
The Feasibility of Intervention Measure (FIM) measures intervention feasibility with 4 items ranked on a 5-point Likert-type scale. Participants will be asked the 4-item questionnaire for each tool offered in the bundle (3). Scores are averaged across the measure for each tool and subsequently scores for individual tools will be summed to generate a composite feasibility score of the program. Scores can range from 3-15, with higher scores meaning higher feasibility of the intervention.
次要结局
- Change in the Number of Risk Days from baseline to 6 months(baseline, 6 months)