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CompletedNCT03411265RETAINUpdated Apr 10, 2019

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

An interventional study of self-administered, e-health application in Opioid-Related Disorders, Opioid-use Disorder and Drug Addiction, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by University of Cincinnati · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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.

02

Conditions studied

  • Opioid-Related Disorders
  • Opioid-use Disorder
  • Drug Addiction
  • Substance Use Disorders
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  1. Does not sign the "short form" consent form
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    RETAIN

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

    Other: self-administered, e-health application

Interventions

  • Otherself-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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. treatment retention status after 6 months

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

    Time frame: 6 months

  2. MAT Knowledge Assessment

    To test the impact of RETAIN on knowledge about MAT

    Time frame: Pre and Post Tests in E-Health App Day 1

  3. The Injection-Related Infection and Treatment Survey (I-RITS)

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

    Time frame: Pre and Post Tests in E-Health App Day 1

  4. 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.

    Time frame: Day 1

06

Study locations

1 site
  • University of Cincinnati Addiction Sciences Division
    Cincinnati, Ohio 45229, United States
07

Registry details

Key details

Study ID
NCT03411265
Lead sponsor
University of Cincinnati
Responsible party
Theresa Winhusen, PhD (Principal Investigator, University of Cincinnati) — Principal investigator
First posted
Jan 26, 2018
Start date
Nov 8, 2017
Primary completion
Sep 6, 2018
Completion
Sep 6, 2018
Last update
Apr 10, 2019

Study contacts

Theresa Winhusen, PhD
principal investigator · University of Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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