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The ENHANCE Project Toolkit

10. juli 2026 oppdatert av: University of Wisconsin, Madison

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

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53792
        • Rekruttering
        • UW School of Medicine and Public Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Pilot Participants
People who use opioid and/or stimulant drugs and are disconnected from harm reduction services.
Enhet: Connections mHealth Application
Mobile health app, bundled with other harm reduction internet and phone resources

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Acceptability of Intervention Measure (AIM)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in the Number of Risk Days from baseline to 6 months
Tidsramme: 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.
baseline, 6 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Wisconsin, Madison

Samarbeidspartnere

National Institute on Drug Abuse (NIDA)

Etterforskere

  • Hovedetterforsker: Ryan Westergaard, MD, PhD, MPH, UW School of Medicine and Public Health
  • Hovedetterforsker: Rachel Gicquelais, PhD, MPH, UW School of Medicine and Public Health

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

10. juni 2026

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

16. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juli 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2026-0408
  • Protocol Version 3/13/26 (Annen identifikator: UW- Madison)
  • R01DA057645-02 (U.S. NIH-stipend/kontrakt)
  • SMPH | Population Health (Annen identifikator: UW Madison)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

As part of a NIH-funded study which requires data sharing and open access commitments, data from this project will be shared with a national coordinating center and in an open-access data repository. Data shared with external research partners may contain limited identifiable information but will remain confidential and under the direction of an approved Data Use and Transfer Agreement (e.g. not public). Any data shared on public data repositories will be stripped of any potential identifiers.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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