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

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT03413696

Collaborator

(none)

150

Enrollment

Location

27.7

Actual Duration (Months)

5.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual 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 :

Sep 8, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Not referred for HCV therapy
Referred for HCV therapy,did not show up
Referred,attended HCV therapy evaluation

Outcome Measures

Primary Outcome Measures

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

Hepatitis C knowledge (using the modified Treolar's scale) [Baseline before HCV treatment consideration]

Other Outcome Measures

Determinants of inadequate health literacy and HCV knowledge [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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