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

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ClinicalTrials.gov Identifier: NCT03411265
Recruitment Status : Enrolling by invitation
First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Theresa Winhusen, University of Cincinnati

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
Opioid-Related Disorders Opioid-use Disorder Drug Addiction Substance Use Disorders Other: self-administered, e-health application Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : November 8, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. treatment retention status after 3 months [ Time Frame: 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 [ Time Frame: 6 months ]
    To compare with retention rates for the overall MAT clinics and use in sample size

  2. MAT Knowledge Assessment [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03411265


Locations
United States, Ohio
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

Responsible Party: Theresa Winhusen, Principal Investigator, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03411265     History of Changes
Other Study ID Numbers: 2017-1074-1
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

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
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders