- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03411265
RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing (RETAIN)
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:
- assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
- test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
- assess treatment retention rates in patients completing the RETAIN intervention.
- test the impact of RETAIN on knowledge about HCV/HIV
- test the impact of RETAIN on interest in being tested for HCV/HIV
Studieoversigt
Status
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
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- University of Cincinnati Addiction Sciences Division
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- At least 18 years of age
Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;
Exclusion Criteria:
- Does not sign the "short form" consent form
Studieplan
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 |
|---|---|
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Eksperimentel: RETAIN
Participants who meet criteria will receive the RETAIN self-administered, e-health application intervention.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
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3 months
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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
|
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MAT Knowledge Assessment
Tidsramme: Pre and Post Tests in E-Health App Day 1
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To test the impact of RETAIN on knowledge about MAT
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Pre and Post Tests in E-Health App Day 1
|
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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
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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.
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Day 1
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2017-1074-1
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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