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
University of California, San Diego
Information provided by (Responsible Party):
Edward Cachay, MD, MAS, University of California, San Diego
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 CHepatitis C, ChronicHIV/AIDS
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.
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 :
Hepatitis C knowledge (using the modified Treolar's scale) [ Time Frame: Baseline before HCV treatment consideration ]
Other Outcome Measures:
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients living with HIV, coinfected with HCV, who are receiving care at the UCSD Owen Clinic at the time of data collection
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