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

Completed

• Conditions: Hepatitis C, Chronic; HIV/AIDS; Hepatitis C

• Registration Number: NCT03413696
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-09-08
• Study First Submitted: 2018-01-22
• Study First Submitted QC: 2018-01-22
• Study First Posted: 2018-01-29
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inadequate health literacy (s-TOFHLA inventory)	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

Name	Time	Method
Hepatitis C knowledge (using the modified Treolar's scale)	Baseline before HCV treatment consideration

Trial Locations

Locations (1)

Owen Clinic - University of California, San Diego; 🇺🇸 San Diego, California, United States