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

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

The purpose of this research study is to:

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

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Overdose; Opioid-use Disorder; Drug Addiction; IV Drug Usage
• Intervention / Treatment: Other: self-administered, e-health application

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • University of Cincinnati Addiction Sciences Division

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback on AWAITS	To assess the acceptability of the intervention	Day 1
Acceptance of list of MAT providers	Assess relative interest in MAT post-AWAITS	Day 1

Collaborators and Investigators

• Sponsor: University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): June 21, 2018
• Study Completion (Actual): June 21, 2018

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 10, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Narcotic-Related Disorders; Substance-Related Disorders; Disease; Opioid-Related Disorders; Drug Overdose
• Other Study ID Numbers: 2017-1074-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No