search
Back to results

AWAITS: A Web-based E-health Application for Active Illicit Opioid Users (AWAITS)

Primary Purpose

Opioid-use Disorder, IV Drug Usage, Overdose

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
self-administered, e-health application
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid-use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years of age
  2. Not enrolled in MAT per self-report
  3. Self-reports illicit opioid use

Exclusion Criteria:

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

Sites / Locations

  • University of Cincinnati Addiction Sciences Division

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AWAITS

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feedback on AWAITS
To assess the acceptability of the intervention
Acceptance of list of MAT providers
Assess relative interest in MAT post-AWAITS

Full Information

First Posted
January 10, 2018
Last Updated
April 9, 2019
Sponsor
University of Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT03402672
Brief Title
AWAITS: A Web-based E-health Application for Active Illicit Opioid Users
Acronym
AWAITS
Official Title
A Web-based E-health Application for Active Illicit Opioid Users Providing Information About Overdose and Infection Risk Factors and Encouraging HCV/HIV Testing and Medication Assisted Treatment Seeking
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
June 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to: assess how participants like the AWAITS e-health application as measured by their feedback on the intervention test the impact of AWAITS on knowledge about opioid overdose and risk-reduction strategies. assess the proportion of participants who accept a list of local treatment providers test the impact of AWAITS on interest in being tested for HCV/HIV.
Detailed Description
The pre-post study of AWAITS will: 1) assess the acceptability of AWAITS as measured by participant feedback about the intervention; 2) test the impact of AWAITS on knowledge about opioid overdose, as measured by the OOTAS; 3) assess the proportion of participants who accept a list of local MAT treatment providers; and 4) test the impact of AWAITS on interest in being tested for HCV/HIV. The acceptability of AWAITS 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 overdose and MAT) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The proportion of participants accepting a list of local MAT treatment providers will be calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, IV Drug Usage, Overdose, Drug Addiction, Substance Use Disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AWAITS
Arm Type
Experimental
Arm Description
Participants who meet criteria will receive the AWAITS self-administered, e-health application intervention.
Intervention Type
Other
Intervention Name(s)
self-administered, e-health application
Intervention Description
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.
Primary Outcome Measure Information:
Title
3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT)
Description
To test the impact of AWAITS on knowledge about opioid overdose
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Feedback on AWAITS
Description
To assess the acceptability of the intervention
Time Frame
Day 1
Title
Acceptance of list of MAT providers
Description
Assess relative interest in MAT post-AWAITS
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Not enrolled in MAT per self-report Self-reports illicit opioid use Exclusion Criteria: 3. Does not acknowledge reviewing "Information Sheet for Research" within REDCap
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati Addiction Sciences Division
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

AWAITS: A Web-based E-health Application for Active Illicit Opioid Users

We'll reach out to this number within 24 hrs