Opioid-use DisorderAWAITSNCT03402672
AWAITS: A Web-based E-health Application for Active Illicit Opioid Users
A study testing self-administered, e-health application in people with Opioid-use Disorder and IV Drug Usage, run by University of Cincinnati at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, IV Drug Usage, Overdose
- What is being tested?
- self-administered, e-health application
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 21 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Not enrolled in MAT per self-report
- Self-reports illicit opioid use
Who cannot join
- 3. Does not acknowledge reviewing "Information Sheet for Research" within REDCap
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Addiction Sciences Division
Cincinnati, Ohio, 45229
About this study
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
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.
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.
- Being tested
- self-administered, e-health application
- Medical subject headings
- Opioid-Related Disorders, Drug Overdose, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-administered, e-health applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AWAITS | Experimental | Participants who meet criteria will receive the AWAITS self-administered, e-health application intervention. Receives: Other: self-administered, e-health application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (2)
Feedback on AWAITS
To assess the acceptability of the intervention
Measured: Day 1
Acceptance of list of MAT providers
Assess relative interest in MAT post-AWAITS
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start8 Nov 2017
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Theresa Winhusen, PhD, University of Cincinnati
- Investigators
- Theresa Winhusen, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402672
- Sponsor's protocol ID
- 2017-1074-2
- Acronym
- AWAITS
- Status last verified
- Apr 2019
- First submitted
- 10 Jan 2018
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03402672
- Acronym / sponsor ID
- AWAITS / 2017-1074-2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AWAITS | Experimental | Other: self-administered, e-health applicationParticipants who meet criteria will receive the AWAITS self-administered, e-health application intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Not enrolled in MAT per self-report
- Self-reports illicit opioid use
Key exclusion criteria (1 listed)
- 3. Does not acknowledge reviewing "Information Sheet for Research" within REDCap
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-administered, e-health applicationAWAITS 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. | Other | AWAITS |
Primary outcome
3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT)
Time frame: Day 1
To test the impact of AWAITS on knowledge about opioid overdose
2 secondary outcomes
Feedback on AWAITS
Time frame: Day 1
Acceptance of list of MAT providers
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theresa Winhusen, PhD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-administered, e-health application in people with Opioid-use Disorder and IV Drug Usage, run by University of Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3 sections of the OOTAS (signs of overdose, how to respond to an overdose, and MAT) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2019.