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NCT03402672 Clinical Trial

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

Substance Use Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03402672
Other study ID # 2017-1074-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2017
Est. completion date June 21, 2018

Study information
Verified date April 2019
Source University of Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date June 21, 2018
Est. primary completion date June 21, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

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.

Locations
Country Name City State
United States University of Cincinnati Addiction Sciences Division Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Feedback on AWAITS To assess the acceptability of the intervention Day 1
Secondary Acceptance of list of MAT providers Assess relative interest in MAT post-AWAITS Day 1
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