Hepatitis CNCT03245931
Hepatitis C Education for Pregnant Women With Opiate Addiction - Phase 1
An observational study of Hepatitis C, run by TriHealth Inc. at 1 site in United States.
Trial summary
The goal of this study is to assess the health literacy level of patients enrolled in the HOPE program, identify any gaps in their 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?
- Qualitative Interview
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2017to 26 Aug 2019
- Phase
- Observational
- 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
Study population: Study population includes obstetrics patients enrolled in the HOPE program who are 18 years old or older.
Who may be able to join
- The study will include patients with and without Hepatitis C diagnosis.
- Patients will be recruited at their routine prenatal and post-partum visits.
- Patients who speak and understand English
Who cannot join
- Patients under the age of the 18 years
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to assess the health literacy level of patients enrolled in the HOPE program, identify any gaps in their 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 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
- Qualitative Interview
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative InterviewOther
Complete 6 open-ended qualitative questions on patients in the HOPE program to assess basic current understanding about Hepatitis C and topics of interest that patients in the HOPE program would like to learn more about.
What is being measured
The primary outcome is the main question the study is designed to answer.
Discovering the gaps in patients' knowledge of Hepatitis C
Through interview, 6 open-ended qualitative questions will be asked of the patients in the HOPE program to assess basic current understanding about Hepatitis C
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start20 Jul 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 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
- NCT03245931
- Sponsor's protocol ID
- 17007
- Status last verified
- Aug 2019
- First submitted
- 21 Jul 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 Addiction - Phase 1
- ClinicalTrials.gov ID
- NCT03245931
- Acronym / sponsor ID
- 17007
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 10 Aug 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 the health literacy level of patients enrolled in the HOPE program, identify any gaps in their 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 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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population includes obstetrics patients enrolled in the HOPE program who are 18 years old or older.
Key inclusion criteria (3 listed)
- The study will include patients with and without Hepatitis C diagnosis.
- Patients will be recruited at their routine prenatal and post-partum visits.
- Patients who speak and understand English
Key exclusion criteria (1 listed)
- Patients under the age of the 18 years
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 |
|---|---|---|
| Qualitative InterviewComplete 6 open-ended qualitative questions on patients in the HOPE program to assess basic current understanding about Hepatitis C and topics of interest that patients in the HOPE program would like to learn more about. | Other | – |
Primary outcome
Discovering the gaps in patients' knowledge of Hepatitis C
Time frame: 2 months
Through interview, 6 open-ended qualitative questions will be asked of the patients in the HOPE program to assess basic current understanding about Hepatitis C
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?
An observational study of 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?
Discovering the gaps in patients' knowledge of Hepatitis C (time frame: 2 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 28 Aug 2019.