NCT03402672

Brief Summary

The purpose of this research study is to:

  1. 1.assess how participants like the AWAITS e-health application as measured by their feedback on the intervention
  2. 2.test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies.
  3. 3.assess the proportion of participants who accept a list of local treatment providers
  4. 4.test the impact of AWAITS 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
24

participants targeted

Target at below P25 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

Click on a node to explore related trials.

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
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2018

Completed
Last Updated

April 10, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

January 10, 2018

Last Update Submit

April 9, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT)

    To test the impact of AWAITS on knowledge about opioid overdose

    Day 1

Secondary Outcomes (2)

  • Feedback on AWAITS

    Day 1

  • Acceptance of list of MAT providers

    Day 1

Study Arms (1)

AWAITS

EXPERIMENTAL

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

Other: self-administered, e-health application

Interventions

AWAITS 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 when they were actively using. 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.

AWAITS

Eligibility Criteria

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

You may qualify if:

  • At least 18 years of age
  • Not enrolled in MAT per self-report
  • Self-reports illicit opioid use

You may not qualify if:

  • \. Does not acknowledge reviewing "Information Sheet for Research" within REDCap

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 DisordersDrug OverdoseSubstance-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersChemically-Induced DisordersMental DisordersPrescription Drug MisuseDrug Misuse

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 18, 2018

Study Start

November 8, 2017

Primary Completion

June 21, 2018

Study Completion

June 21, 2018

Last Updated

April 10, 2019

Record last verified: 2019-04

Locations