CClinicalTrials.gg
CompletedNCT03402672AWAITSUpdated Apr 10, 2019

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

An interventional study of self-administered, e-health application in Opioid-use Disorder, IV Drug Usage and Overdose, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.

Sponsored by University of Cincinnati · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Opioid-use Disorder
  • IV Drug Usage
  • Overdose
  • Drug Addiction
  • Substance Use Disorders
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Does not acknowledge reviewing "Information Sheet for Research" within REDCap
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    AWAITS

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

    Other: self-administered, e-health application

Interventions

  • Otherself-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.

05

What researchers measure

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

    Time frame: Day 1

Secondary outcomes

  1. Feedback on AWAITS

    To assess the acceptability of the intervention

    Time frame: Day 1

  2. Acceptance of list of MAT providers

    Assess relative interest in MAT post-AWAITS

    Time frame: Day 1

06

Study locations

1 site
  • University of Cincinnati Addiction Sciences Division
    Cincinnati, Ohio 45229, United States
07

Registry details

Key details

Study ID
NCT03402672
Lead sponsor
University of Cincinnati
Responsible party
Theresa Winhusen, PhD (Principal Investigator, University of Cincinnati) — Principal investigator
First posted
Jan 18, 2018
Start date
Nov 8, 2017
Primary completion
Jun 21, 2018
Completion
Jun 21, 2018
Last update
Apr 10, 2019

Study contacts

Theresa Winhusen, PhD
principal investigator · University of Cincinnati

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion