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NCT Number: NCT03413696

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

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.

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Key information

Conditions

Hepatitis C Acquired Immunodeficiency Syndrome Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Genital Diseases HIV Infections HIV/AIDS Hepatitis Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Owen Clinic - University of California, San Diego

San Diego, California, 92103-8186, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Hepatitis C knowledge (using the modified Treolar's scale)

    Time frame: Baseline before HCV treatment consideration

Other outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2018
Registry last updated
Sep 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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