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

NCT ID: NCT03411265

Last Updated: 2019-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-08

Study Completion Date

2018-09-06

Brief Summary

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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

Detailed Description

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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.

Conditions

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Opioid-Related Disorders Opioid-use Disorder Drug Addiction Substance Use Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RETAIN

Participants who meet criteria will receive the RETAIN self-administered, e-health application intervention.

Group Type EXPERIMENTAL

self-administered, e-health application

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Theresa Winhusen, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theresa Winhusen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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University of Cincinnati Addiction Sciences Division

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2017-1074-1

Identifier Type: -

Identifier Source: org_study_id

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