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

Sponsor
University of Cincinnati (Other)
Overall Status
Completed
CT.gov ID
NCT03411265
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
9.9
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: self-administered, e-health application
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Nov 8, 2017
Actual Primary Completion Date :
Sep 6, 2018
Actual Study Completion Date :
Sep 6, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: RETAIN

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

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. treatment retention status after 3 months [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

  1. treatment retention status after 6 months [6 months]

    To compare with retention rates for the overall MAT clinics and use in sample size

  2. MAT Knowledge Assessment [Pre and Post Tests in E-Health App Day 1]

    To test the impact of RETAIN on knowledge about MAT

  3. The Injection-Related Infection and Treatment Survey (I-RITS) [Pre and Post Tests in E-Health App Day 1]

    To test the impact of RETAIN on knowledge about HCV and HIV

  4. Feedback on the RETAIN e-health application [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  1. Does not sign the "short form" consent form

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Cincinnati Addiction Sciences Division Cincinnati Ohio United States 45229

Sponsors and Collaborators

  • University of Cincinnati

Investigators

  • Principal Investigator: Theresa Winhusen, PhD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Theresa Winhusen, PhD, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT03411265
Other Study ID Numbers:
  • 2017-1074-1
First Posted:
Jan 26, 2018
Last Update Posted:
Apr 10, 2019
Last Verified:
Apr 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Disease
Substance-Related Disorders
Opioid-Related Disorders

Study Results

No Results Posted as of Apr 10, 2019