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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03413696
• Other study ID #: 20170991
• Secondary ID: 170218
• Status: Completed
• Start date: September 8, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2021
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• HIV/AIDS

Locations

Country	Name	City	State
United States	Owen Clinic - University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Determinants of inadequate health literacy and HCV knowledge	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.	Baseline before HCV treatment consideration
Other	Predictors of patient willingness to HCV treatment	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.	Baseline before HCV treatment consideration
Primary	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.	Baseline before HCV treatment consideration
Secondary	Hepatitis C knowledge (using the modified Treolar's scale)		Baseline before HCV treatment consideration