The ENHANCE Project Toolkit
Mobile Health Strategies to Support Longitudinal Engagement in Comprehensive, Community-based Prevention Services for People Who Use Drugs (Aim 3)
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Research Team
- Telefonnummer: (608) 572-3514
- E-Mail: enhance@medicine.wisc.edu
Studienorte
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Wisconsin
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Madison, Wisconsin, Vereinigte Staaten, 53792
- Rekrutierung
- UW School of Medicine and Public Health
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Machbarkeit des Geräts
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Acceptability of Intervention Measure (AIM)
Zeitfenster: 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
|
up to 6 months
|
|
Intervention Appropriateness Measure (IAM)
Zeitfenster: 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.
|
up to 6 months
|
|
Feasibility of Intervention Measure (FIM)
Zeitfenster: 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.
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up to 6 months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in the Number of Risk Days from baseline to 6 months
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Ryan Westergaard, MD, PhD, MPH, UW School of Medicine and Public Health
- Hauptermittler: Rachel Gicquelais, PhD, MPH, UW School of Medicine and Public Health
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-0408
- Protocol Version 3/13/26 (Andere Kennung: UW- Madison)
- R01DA057645-02 (US NIH Stipendium/Vertrag)
- SMPH | Population Health (Andere Kennung: UW Madison)
Plan für individuelle Teilnehmerdaten (IPD)
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Beschreibung des IPD-Plans
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
Arzneimittel- und Geräteinformationen, Studienunterlagen
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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