Hepatitis CNCT03413696
Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients
An observational study of Hepatitis C and Hepatitis C, Chronic, run by University of California, San Diego at 1 site in United States.
Trial summary
A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Hepatitis C, Chronic, HIV/AIDS
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2017to 31 Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients living with HIV, coinfected with HCV, who are receiving care at the UCSD Owen Clinic at the time of data collection
Who may be able to join
- Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
- Regardless of ethnic background
- English or Spanish speaking
- With active HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody
Who cannot join
- Neurocognitive impairment precluding participation
- Physical illness precluding participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Owen Clinic - University of California, San Diego
San Diego, California, 92103-8186
About this study
Official title: Effects of Health Literacy and Hepatitis C Knowledge on Hepatitis C Treatment Willingness in HIV-coinfected Patients, According to Hepatitis C Treatment Referral Status
A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.
Read the detailed description
The main purpose of this research study is to investigate the prevalence of inadequate health literacy and hepatitis C knowledge and their determinants among people living with HIV/AIDS co-infected with hepatitis C. The observation will determine if health literacy and/or hepatitis C knowledge are predictors of patient willingness and intention to be treated for HCV in the overall cohort and stratified according to study groups as noted above.
- Conditions
- Hepatitis C, Hepatitis C, Chronic, HIV/AIDS
- Keywords
- HIV, Health literacy, Hepatitis C, Hepatitis C knowledge, HIV knowledge, Hepatitis C treatment
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Not referred for HCV therapy | Not described | |
| Referred for HCV therapy,did not show up | Not described | |
| Referred,attended HCV therapy evaluation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate health literacy (s-TOFHLA inventory)
The primary outcome will measure the point prevalence of inadequate health literacy among persons with HIV/AIDS with active hepatitis C infection.
Measured: Baseline before HCV treatment consideration
Secondary outcomes (1)
Hepatitis C knowledge (using the modified Treolar's scale)
Measured: Baseline before HCV treatment consideration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start8 Sep 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 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.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward Cachay, MD, MAS, University of California, San Diego
- Investigators
- Edward Cachay, MD, MAS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413696
- Sponsor's protocol ID
- 20170991
- Other IDs
- 170218
- Status last verified
- Sep 2021
- First submitted
- 22 Jan 2018
- Last updated
- 5 Sep 2021
- 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Health Literacy and Hepatitis C Knowledge on Hepatitis C Treatment Willingness in HIV-coinfected Patients, According to Hepatitis C Treatment Referral Status
- ClinicalTrials.gov ID
- NCT03413696
- Acronym / sponsor ID
- 20170991
- Conditions
- Hepatitis C, Hepatitis C, Chronic, HIV/AIDS
- Keywords
- HIV, Health literacy, Hepatitis C, Hepatitis C knowledge, HIV knowledge, Hepatitis C treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 8 Sep 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 29 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.
A clinical observational study for patients with HIV co-infected with hepatitis C that investigates the levels of their health literacy, hepatitis C and HIV knowledge. Participants will complete a one-time assessment of these studied domains and categorized in three groups defined by their hepatitis C treatment referral status: not-referred, referred-attended, referred and no-show.
Detailed description
The main purpose of this research study is to investigate the prevalence of inadequate health literacy and hepatitis C knowledge and their determinants among people living with HIV/AIDS co-infected with hepatitis C. The observation will determine if health literacy and/or hepatitis C knowledge are predictors of patient willingness and intention to be treated for HCV in the overall cohort and stratified according to study groups as noted above.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Not referred for HCV therapy | – | – |
| Referred for HCV therapy,did not show up | – | – |
| Referred,attended HCV therapy evaluation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients living with HIV, coinfected with HCV, who are receiving care at the UCSD Owen Clinic at the time of data collection
Key inclusion criteria (4 listed)
- Any adult (≥ 18 years) HIV-infected patient attending the UCSD Owen Clinic
- Regardless of ethnic background
- English or Spanish speaking
- With active HCV infection defined as having a detectable HCV viral load with or without a positive HCV antibody
Key exclusion criteria (2 listed)
- Neurocognitive impairment precluding participation
- Physical illness precluding participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inadequate health literacy (s-TOFHLA inventory)
Time frame: Baseline before HCV treatment consideration
The primary outcome will measure the point prevalence of inadequate health literacy among persons with HIV/AIDS with active hepatitis C infection.
1 secondary outcome
Hepatitis C knowledge (using the modified Treolar's scale)
Time frame: Baseline before HCV treatment consideration
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 5 Sep 2021.
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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.
Edward Cachay, MD, MAS principal investigator
University of California, San Diego
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 and Hepatitis C, Chronic, run by University of California, San Diego 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 4 inclusion and 2 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 5 Sep 2021. 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?
Inadequate health literacy (s-TOFHLA inventory) (time frame: Baseline before HCV treatment consideration). 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 5 Sep 2021.