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

Substance Use Disorders Clinical Trial

— RETAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411265
• Other study ID #: 2017-1074-1
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: September 6, 2018

Study information

• Verified date: April 2019
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 6, 2018
• Est. primary completion date: September 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
United States	University of Cincinnati Addiction Sciences Division	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	treatment retention status after 6 months	To compare with retention rates for the overall MAT clinics and use in sample size	6 months
Secondary	MAT Knowledge Assessment	To test the impact of RETAIN on knowledge about MAT	Pre and Post Tests in E-Health App Day 1
Secondary	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
Secondary	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