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

• ClinicalTrials.gov Identifier: NCT03413696
• Recruitment Status: Completed
• First Posted: January 29, 2018
• Last Update Posted: September 5, 2021
• Sponsor: University of California, San Diego
• Information provided by (Responsible Party): Edward Cachay, MD, MAS, University of California, San Diego

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
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: September 8, 2017
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Groups and Cohorts

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: Edward Cachay, MD, MAS; University of California, San Diego

More Information

• Responsible Party: Edward Cachay, MD, MAS, Associate Professor of Clinical Medicine, University of California, San Diego
• ClinicalTrials.gov Identifier: NCT03413696
• Other Study ID Numbers: 20170991; 170218 ( Other Identifier: UCSD Human Research Protections Program )
• First Posted: January 29, 2018
• Last Update Posted: September 5, 2021
• Last Verified: September 2021

• 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:

Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Blood-Borne Infections; Communicable Diseases; Flaviviridae Infections; Hepatitis, Chronic