Opioid-Related DisordersRETAINNCT03411265
RETAIN: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing
A study testing self-administered, e-health application in people with Opioid-Related Disorders and Opioid-use Disorder, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research study is to: 1. assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention. 2. test the impact of RETAIN on knowledge about medication-assisted treatment(MAT). 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-Related Disorders, Opioid-use Disorder, Drug Addiction
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2017to 6 Sep 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
- Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;
Who cannot join
- Does not sign the "short form" consent form
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: Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing Through Active Patients Sharing Experiences and the Provision of Information About Infections -an electroNic-health Application
The purpose of this research study is to:
- assess how well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
- test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
- assess treatment retention rates in patients completing the RETAIN intervention.
- test the impact of RETAIN on knowledge about HCV/HIV
- test the impact of RETAIN on interest in being tested for HCV/HIV
Read the detailed description
The pre-post study of RETAIN will: 1) assess the acceptability of RETAIN as measured by participant feedback about the intervention; 2) test the impact of RETAIN on knowledge about MAT, as measured by the MAT Knowledge Assessment; 3) assess MAT retention rates in patients completing the RETAIN intervention; 4) test the impact of RETAIN on knowledge about HCV/ HIV; 5) test the impact of RETAIN on interest in being tested for HCV/HIV.
The acceptability of RETAIN 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 MAT and HCV/HIV) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The 3- and 6-month retention rates for RETAIN participants will be compared, using Fisher's exact tests, to the overall treatment retention rates at 3- and 6- months for the UC Health MAT clinics as determined by the retrospective chart review.
- Being tested
- self-administered, e-health application
- Medical subject headings
- Opioid-Related Disorders, 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
RETAIN 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 and its benefits when they started treatment. 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 |
|---|---|---|
| RETAIN | Experimental | Participants who meet criteria will receive the RETAIN 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.
treatment retention status after 3 months
To compare with retention rates for the overall MAT clinics and use in sample size calculations for potential follow-on trial
Measured: 3 months
Secondary outcomes (4)
treatment retention status after 6 months
To compare with retention rates for the overall MAT clinics and use in sample size
Measured: 6 months
MAT Knowledge Assessment
To test the impact of RETAIN on knowledge about MAT
Measured: Pre and Post Tests in E-Health App Day 1
The Injection-Related Infection and Treatment Survey (I-RITS)
To test the impact of RETAIN on knowledge about HCV and HIV
Measured: Pre and Post Tests in E-Health App Day 1
Feedback on the RETAIN e-health application
feedback 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.
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 posted26 Jan 2018
- Study start8 Nov 2017
- Primary completion6 Sep 2018
- Study completion6 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- 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
- 40 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
- NCT03411265
- Sponsor's protocol ID
- 2017-1074-1
- Acronym
- RETAIN
- 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
- Retaining Opioid Users Entering Medication Assisted Treatment and Encouraging HCV/HIV Testing Through Active Patients Sharing Experiences and the Provision of Information About Infections -an electroNic-health Application
- ClinicalTrials.gov ID
- NCT03411265
- Acronym / sponsor ID
- RETAIN / 2017-1074-1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 6 Sep 2018 (actual)
- Study completion
- 6 Sep 2018 (actual)
- First posted
- 26 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 well individuals entering medication assisted treatment like the RETAIN e-health application as measured by their feedback on the intervention.
- test the impact of RETAIN on knowledge about medication-assisted treatment(MAT).
- assess treatment retention rates in patients completing the RETAIN intervention.
- test the impact of RETAIN on knowledge about HCV/HIV
- test the impact of RETAIN on interest in being tested for HCV/HIV
Detailed description
The pre-post study of RETAIN will: 1) assess the acceptability of RETAIN as measured by participant feedback about the intervention; 2) test the impact of RETAIN on knowledge about MAT, as measured by the MAT Knowledge Assessment; 3) assess MAT retention rates in patients completing the RETAIN intervention; 4) test the impact of RETAIN on knowledge about HCV/ HIV; 5) test the impact of RETAIN on interest in being tested for HCV/HIV.
The acceptability of RETAIN 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 MAT and HCV/HIV) and interest in HCV/HIV testing will be analyzed using a Wilcoxon signed-rank test. The 3- and 6-month retention rates for RETAIN participants will be compared, using Fisher's exact tests, to the overall treatment retention rates at 3- and 6- months for the UC Health MAT clinics as determined by the retrospective chart review.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RETAIN | Experimental | Other: self-administered, e-health applicationParticipants who meet criteria will receive the RETAIN 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 (2 listed)
- At least 18 years of age
- Starting MAT with methadone or suboxone or in MAT for less than 2 weeks;
Key exclusion criteria (1 listed)
- Does not sign the "short form" consent form
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 applicationRETAIN 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 and its benefits when they started treatment. 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 | RETAIN |
Primary outcome
treatment retention status after 3 months
Time frame: 3 months
To compare with retention rates for the overall MAT clinics and use in sample size calculations for potential follow-on trial
4 secondary outcomes
treatment retention status after 6 months
Time frame: 6 months
MAT Knowledge Assessment
Time frame: Pre and Post Tests in E-Health App Day 1
The Injection-Related Infection and Treatment Survey (I-RITS)
Time frame: Pre and Post Tests in E-Health App Day 1
Feedback on the RETAIN e-health application
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-Related Disorders and Opioid-use Disorder, 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 2 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?
treatment retention status after 3 months (time frame: 3 months). 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.