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Completed

NCT Number: NCT03411265

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Cincinnati Addiction Sciences Division

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-administered, e-health application

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study 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

Acronym: RETAIN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2018
Registry last updated
Apr 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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