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Effects of Health Literacy and HCV Knowledge on HCV Treatment Willingness in HIV-coinfected Patients

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ClinicalTrials.gov Identifier: NCT03413696
Recruitment Status : Enrolling by invitation
First Posted : January 29, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Cachay, MD, MAS, University of California, San Diego

Brief 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 referral status: not-referred, referred-attended, referred and no-show.

Condition or disease
Hepatitis C Hepatitis C, Chronic HIV/AIDS

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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Not referred for HCV therapy
Referred for HCV therapy,did not show up
Referred,attended HCV therapy evaluation



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Hepatitis C knowledge (using the modified Treolar's scale) [ Time Frame: Baseline before HCV treatment consideration ]

Other Outcome Measures:
  1. Determinants of inadequate health literacy and HCV knowledge [ Time Frame: Baseline before HCV treatment consideration ]
    To ascertain determinants of inadequate health literacy and HCV knowledge among PLWH coinfected with HCV in the overall study group and stratified according to group membership: (1) not referred for HCV therapy, (2) those referred but no show, and (3) those referred and attended HCV therapy.

  2. Predictors of patient willingness to HCV treatment [ Time Frame: Baseline before HCV treatment consideration ]
    To ascertain predictors of patient willingness and intention to be treated for HCV with particular attention to the independent effect of health literacy and HCV knowledge in the overall cohort and stratified according to study groups as noted above.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients living with HIV, coinfected with HCV, who are receiving care at the UCSD Owen Clinic at the time of data collection
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Neurocognitive impairment precluding participation
  • Physical illness precluding participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413696


Locations
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United States, California
Owen Clinic - University of California, San Diego
San Diego, California, United States, 92103-8186
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Edward Cachay, MD, MAS University of California, San Diego

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Responsible Party: Edward Cachay, MD, MAS, Associate Professor of Clinical Medicine, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03413696     History of Changes
Other Study ID Numbers: 20170991
170218 ( Other Identifier: UCSD Human Research Protections Program )
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Edward Cachay, MD, MAS, University of California, San Diego:
HIV
Health literacy
Hepatitis C
Hepatitis C knowledge
HIV knowledge
Hepatitis C treatment

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic