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

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

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

Study Overview

• Status: Completed
• Conditions: Opioid-Related Disorders; Substance Use Disorders; Opioid-use Disorder; Drug Addiction
• Intervention / Treatment: Other: self-administered, e-health application

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
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment retention status after 6 months	To compare with retention rates for the overall MAT clinics and use in sample size	6 months
MAT Knowledge Assessment	To test the impact of RETAIN on knowledge about MAT	Pre and Post Tests in E-Health App Day 1
The Injection-Related Infection and Treatment Survey (I-RITS)	To test the impact of RETAIN on knowledge about HCV and HIV	Pre and Post Tests in E-Health App Day 1
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.	Day 1

Collaborators and Investigators

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): September 6, 2018
• Study Completion (Actual): September 6, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders
• Other Study ID Numbers: 2017-1074-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No