Hepatitis CNCT03320889
Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
A study testing Educational Intervention in people with Hepatitis C, run by TriHealth Inc. at 1 site in United States.
Trial summary
The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Educational Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 26 Aug 2019
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Study population includes Faculty Medical Center obstetrics and postpartum patients enrolled in the HOPE program who are 18 years old or older.
- The study will include patients with and without a Hepatitis C diagnosis.
- Patients will be recruited at their routine office visits and/or during any admissions to the hospital.
Who cannot join
- Patients who do not speak and understand English.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.
Read the detailed description
The study will compare the effectiveness of providing HCV education by providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.
- Conditions
- Hepatitis C
- Being tested
- Educational Intervention
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Patients will be randomized to a group that receives the pamphlets only and a group that receives the pamphlets and has an expert educator review that pamphlets with them and answer questions.
| Study group | Role | What they receive |
|---|---|---|
| Pamphlets plus Review with Expert Educator | Other | Educational Intervention includes Pamphlets plus Review with Expert Educator Receives: Other: Educational Intervention |
| Pamphlets only | Other | Educational Intervention includes Pamphlets only Receives: Other: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Questions Scored Correct on the Hepatitis C Knowledge Survey
Number of questions scored correct on the Hepatitis C knowledge survey
Measured: 2-8 weeks after study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start30 Oct 2017
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Marcotte, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320889
- Sponsor's protocol ID
- 17-057
- Status last verified
- Aug 2019
- First submitted
- 2 Oct 2017
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Education for Pregnant Women With Opiate Dependence - Phase 2
- ClinicalTrials.gov ID
- NCT03320889
- Acronym / sponsor ID
- 17-057
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 25 Oct 2017 (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 goal of this study is to assess patients' attitudes and knowledge of Hepatitis C, analyze the variables that may influence patients' knowledge, and educate patients on Hepatitis C.
Detailed description
The study will compare the effectiveness of providing HCV education by providing a pamphlet and expert education compared to providing a pamphlet only. The information gained in completing this study will help the medical community improve patient education on the disease and specifically understand how the medical community can best serve pregnant patients with opiate dependence burdened by Hepatitis C.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group 1: Educational Intervention includes Pamphlets plus Review with Expert Educator Group 2: Educational Intervention includes Pamphlets only
| Arm | Type | Receives |
|---|---|---|
| Pamphlets plus Review with Expert Educator | Other | Other: Educational InterventionEducational Intervention includes Pamphlets plus Review with Expert Educator |
| Pamphlets only | Other | Other: Educational InterventionEducational Intervention includes Pamphlets only |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Study population includes Faculty Medical Center obstetrics and postpartum patients enrolled in the HOPE program who are 18 years old or older.
- The study will include patients with and without a Hepatitis C diagnosis.
- Patients will be recruited at their routine office visits and/or during any admissions to the hospital.
Key exclusion criteria (1 listed)
- Patients who do not speak and understand English.
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 |
|---|---|---|
| Educational InterventionPatients will be randomized to a group that receives the pamphlets only and a group that receives the pamphlets and has an expert educator review that pamphlets with them and answer questions. | Other | Pamphlets only, Pamphlets plus Review with Expert Educator |
Primary outcome
Number of Questions Scored Correct on the Hepatitis C Knowledge Survey
Time frame: 2-8 weeks after study intervention
Number of questions scored correct on the Hepatitis C knowledge survey
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 28 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Michael Marcotte, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Hepatitis C, run by TriHealth Inc. 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 28 Aug 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?
Number of Questions Scored Correct on the Hepatitis C Knowledge Survey (time frame: 2-8 weeks after study intervention). 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 28 Aug 2019.