The ENHANCE Project Toolkit
Mobile Health Strategies to Support Longitudinal Engagement in Comprehensive, Community-based Prevention Services for People Who Use Drugs (Aim 3)
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Research Team
- 電話番号：(608) 572-3514
- メール：enhance@medicine.wisc.edu
研究場所
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Wisconsin
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Madison、Wisconsin、アメリカ、53792
- 募集
- UW School of Medicine and Public Health
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：デバイスの実現可能性
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Pilot Participants
People who use opioid and/or stimulant drugs and are disconnected from harm reduction services.
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Mobile health app, bundled with other harm reduction internet and phone resources
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
時間枠：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
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up to 6 months
|
|
Intervention Appropriateness Measure (IAM)
時間枠：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.
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up to 6 months
|
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Feasibility of Intervention Measure (FIM)
時間枠：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.
|
up to 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in the Number of Risk Days from baseline to 6 months
時間枠：baseline, 6 months
|
This data will be collected using the Overdose Risk Behavior Scale (ORBS) instrument which provides a comprehensive index of proximal opioid-related overdose risks.
At baseline and study completion, participants will complete the ORBS assessment.
The ORBS assessment will be administered to assess the potential effect of the intervention on the frequency of overdose risk behaviors.
The average change in the self reported risk days on this instrument from baseline to six months will be reported as the outcome.
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baseline, 6 months
|
協力者と研究者
捜査官
- 主任研究者：Ryan Westergaard, MD, PhD, MPH、UW School of Medicine and Public Health
- 主任研究者：Rachel Gicquelais, PhD, MPH、UW School of Medicine and Public Health
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026-0408
- Protocol Version 3/13/26 (その他の識別子：UW- Madison)
- R01DA057645-02 (米国 NIH グラント/契約)
- SMPH | Population Health (その他の識別子：UW Madison)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。