The ENHANCE Project Toolkit

Официальное название

Mobile Health Strategies to Support Longitudinal Engagement in Comprehensive, Community-based Prevention Services for People Who Use Drugs (Aim 3)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Connections mHealth Application
  Mobile health app, bundled with other harm reduction internet and phone resources

Первичные конечные точки

• Acceptability of Intervention Measure (AIM) [Срок оценки: up to 6 months]
• Intervention Appropriateness Measure (IAM) [Срок оценки: up to 6 months]
• Feasibility of Intervention Measure (FIM) [Срок оценки: up to 6 months]

Вторичные конечные точки (1)

• Change in the Number of Risk Days from baseline to 6 months [Срок оценки: baseline, 6 months]

Критерии участия

Inclusion Criteria (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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• UW School of Medicine and Public Health — Madison

Идентификаторы

NCT: NCT07649278 · 2026-0408 · R01DA057645-02 · SMPH | Population Health · Protocol Version 3/13/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗