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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45229
- University of Cincinnati Addiction Sciences Division
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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treatment retention status after 3 months
Tijdsspanne: 3 months
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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treatment retention status after 6 months
Tijdsspanne: 6 months
|
To compare with retention rates for the overall MAT clinics and use in sample size
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6 months
|
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MAT Knowledge Assessment
Tijdsspanne: 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)
Tijdsspanne: Pre and Post Tests in E-Health App Day 1
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To test the impact of RETAIN on knowledge about HCV and HIV
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Pre and Post Tests in E-Health App Day 1
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Feedback on the RETAIN e-health application
Tijdsspanne: Day 1
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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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2017-1074-1
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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