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

Sponsor

University of Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT03402672

Collaborator

(none)

Enrollment

Location

Arm

7.4

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid-use Disorder IV Drug Usage Overdose Drug Addiction Substance Use Disorders	Other: self-administered, e-health application	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 8, 2017

Actual Primary Completion Date :

Jun 21, 2018

Actual Study Completion Date :

Jun 21, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AWAITS Participants who meet criteria will receive the AWAITS self-administered, e-health application intervention.	Other: self-administered, e-health application 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.

Arm

Intervention/Treatment

Experimental: AWAITS

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

Other: self-administered, e-health application

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.

Outcome Measures

Primary Outcome Measures

3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT) [Day 1]
To test the impact of AWAITS on knowledge about opioid overdose

Secondary Outcome Measures

Feedback on AWAITS [Day 1]
To assess the acceptability of the intervention
Acceptance of list of MAT providers [Day 1]
Assess relative interest in MAT post-AWAITS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Cincinnati Addiction Sciences Division	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

University of Cincinnati

Investigators

Principal Investigator: Theresa Winhusen, PhD, University of Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Theresa Winhusen, PhD, Principal Investigator, University of Cincinnati

ClinicalTrials.gov Identifier:

NCT03402672

Other Study ID Numbers:

2017-1074-2

First Posted:

Jan 18, 2018

Last Update Posted:

Apr 10, 2019

Last Verified:

Apr 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Disease

Substance-Related Disorders

Opioid-Related Disorders

Drug Overdose

Study Results

No Results Posted as of Apr 10, 2019