NCT03411265

Brief Summary

The purpose of this research study is to:

  1. 1.assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
  2. 2.test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
  3. 3.assess treatment retention rates in patients completing the RETAIN intervention.
  4. 4.test the impact of RETAIN on knowledge about HCV/HIV
  5. 5.test the impact of RETAIN on interest in being tested for HCV/HIV

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

January 10, 2018

Last Update Submit

April 9, 2019

Conditions

Outcome Measures

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

    3 months

Secondary Outcomes (4)

  • treatment retention status after 6 months

    6 months

  • MAT Knowledge Assessment

    Pre and Post Tests in E-Health App Day 1

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

    Pre and Post Tests in E-Health App Day 1

  • Feedback on the RETAIN e-health application

    Day 1

Study Arms (1)

RETAIN

EXPERIMENTAL

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

Other: self-administered, e-health application

Interventions

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.

RETAIN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;

You may not qualify if:

  • Does not sign the "short form" consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Addiction Sciences Division

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Opioid-Related DisordersSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Theresa Winhusen, PhD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 26, 2018

Study Start

November 8, 2017

Primary Completion

September 6, 2018

Study Completion

September 6, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations