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RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing (RETAIN)

9. april 2019 opdateret af: Theresa Winhusen, PhD, University of Cincinnati

Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing Through Active Patients Sharing Experiences and the Provision of Information About Infections -an electroNic-health Application

The purpose of this research study is to:

  1. assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
  2. test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
  3. assess treatment retention rates in patients completing the RETAIN intervention.
  4. test the impact of RETAIN on knowledge about HCV/HIV
  5. test the impact of RETAIN on interest in being tested for HCV/HIV

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The pre-post study of RETAIN will: 1) assess the acceptability of RETAIN as measured by participant feedback about the intervention; 2) test the impact of RETAIN on knowledge about MAT, as measured by the MAT Knowledge Assessment; 3) assess MAT retention rates in patients completing the RETAIN intervention; 4) test the impact of RETAIN on knowledge about HCV/ HIV; 5) test the impact of RETAIN on interest in being tested for HCV/HIV.

The acceptability of RETAIN will be assessed with a feedback form which includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it. The average (and standard deviation) for the rated helpfulness of the intervention will be derived and the qualitative data about what they liked most and least about the intervention and suggestions for improvement will be tabulated. Pre-/post-changes in the percent of correct knowledge assessment items (i.e., about MAT and HCV/HIV) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The 3- and 6-month retention rates for RETAIN participants will be compared, using Fisher's exact tests, to the overall treatment retention rates at 3- and 6- months for the UC Health MAT clinics as determined by the retrospective chart review.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

40

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
        • University of Cincinnati Addiction Sciences Division

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. At least 18 years of age

  2. Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;

    Exclusion Criteria:

  3. Does not sign the "short form" consent form

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: RETAIN
Participants who meet criteria will receive the RETAIN self-administered, e-health application intervention.
Andet: self-administered, e-health application
RETAIN is a self-administered, e-health application and includes short videos in which patients who are successfully engaged in MAT discuss what they wish they had known about MAT and its benefits when they started treatment. The intervention is designed to maximize "scalability" - the administration would entail handing an electronic device (e.g., tablet, laptop, etc.) to an individual who would then self-administer the intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
treatment retention status after 3 months
Tidsramme: 3 months
To compare with retention rates for the overall MAT clinics and use in sample size calculations for potential follow-on trial
3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
treatment retention status after 6 months
Tidsramme: 6 months
To compare with retention rates for the overall MAT clinics and use in sample size
6 months
MAT Knowledge Assessment
Tidsramme: Pre and Post Tests in E-Health App Day 1
To test the impact of RETAIN on knowledge about MAT
Pre and Post Tests in E-Health App Day 1
The Injection-Related Infection and Treatment Survey (I-RITS)
Tidsramme: Pre and Post Tests in E-Health App Day 1
To test the impact of RETAIN on knowledge about HCV and HIV
Pre and Post Tests in E-Health App Day 1
Feedback on the RETAIN e-health application
Tidsramme: Day 1
feedback includes questions about how helpful the intervention was (scale of 1-4), what the patient liked most and least about the intervention, and any suggestions for improving it.
Day 1

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Cincinnati

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. november 2017

Primær færdiggørelse (Faktiske)

6. september 2018

Studieafslutning (Faktiske)

6. september 2018

Datoer for studieregistrering

Først indsendt

10. januar 2018

Først indsendt, der opfyldte QC-kriterier

24. januar 2018

Først opslået (Faktiske)

26. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2017-1074-1

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Opioid-relaterede lidelser

Kliniske forsøg med self-administered, e-health application

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Malawi

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner