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

Primary Purpose

Opioid-Related Disorders, Opioid-use Disorder, Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
self-administered, e-health application
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-Related Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Cincinnati Addiction Sciences Division

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RETAIN

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

treatment retention status after 6 months
To compare with retention rates for the overall MAT clinics and use in sample size
MAT Knowledge Assessment
To test the impact of RETAIN on knowledge about MAT
The Injection-Related Infection and Treatment Survey (I-RITS)
To test the impact of RETAIN on knowledge about HCV and HIV
Feedback on the RETAIN e-health application
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.

Full Information

First Posted
January 10, 2018
Last Updated
April 9, 2019
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03411265
Brief Title
RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing
Acronym
RETAIN
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
September 6, 2018 (Actual)
Study Completion Date
September 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-Related Disorders, Opioid-use Disorder, Drug Addiction, Substance Use Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RETAIN
Arm Type
Experimental
Arm Description
Participants who meet criteria will receive the RETAIN self-administered, e-health application intervention.
Intervention Type
Other
Intervention Name(s)
self-administered, e-health application
Intervention Description
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.
Primary Outcome Measure Information:
Title
treatment retention status after 3 months
Description
To compare with retention rates for the overall MAT clinics and use in sample size calculations for potential follow-on trial
Time Frame
3 months
Secondary Outcome Measure Information:
Title
treatment retention status after 6 months
Description
To compare with retention rates for the overall MAT clinics and use in sample size
Time Frame
6 months
Title
MAT Knowledge Assessment
Description
To test the impact of RETAIN on knowledge about MAT
Time Frame
Pre and Post Tests in E-Health App Day 1
Title
The Injection-Related Infection and Treatment Survey (I-RITS)
Description
To test the impact of RETAIN on knowledge about HCV and HIV
Time Frame
Pre and Post Tests in E-Health App Day 1
Title
Feedback on the RETAIN e-health application
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Addiction Sciences Division
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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