ClinicalTrials.gg
CompletedNCT03413696Updated Sep 5, 2021

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

An observational study in Hepatitis C, Hepatitis C, Chronic and HIV/AIDS, sponsored by University of California, San Diego. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-05.

Primary conditionHepatitis C, ChronicRegistry: Hepatitis CReclassifiedWhy we changed it
Registry
Hepatitis C — the first condition term the registry derived for this study.
ClinicalTrials.gg
Hepatitis C, Chronic
Why
  1. The study's listed conditions name Hepatitis C, Chronic, a narrower term within Hepatitis C.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of California, San Diego · Observational

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Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
150
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 256 studies in Hepatitis C, Chronic with a site in United States — none open to participants now, 3 under way, none of them phase 3. Hepatitis C, Chronic · United States.

Enrollment
14th of 31
150 · median 100
Started
2017
with 14 others
Observational
31 of 256
none open now
Registered
241st of 256
by date

Among the 256 studies in Hepatitis C, Chronic with a site in United States, this one is the 14th largest by enrollment of the 31 observational ones that give a count, is one of 15 that started in 2017, is one of 31 observational ones, and was the 241st registered.

Hepatitis C, Chronic

950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.

Browse Hepatitis C, Chronic studies →

Open to participants now

None of the 256 studies in Hepatitis C, Chronic with a site in United States is open now. The open studies under Hepatitis C, Chronic, anywhere →

Who these studies take

Of the 5 Hepatitis C, Chronic studies recruiting now, 2 set no upper age limit and 2 stop at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 256 studies in Hepatitis C, Chronic with a site in United States as a file.
02

Study 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.

Read the 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.

03

Conditions studied

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

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Keywords

  • HIV
  • Health literacy
  • Hepatitis C
  • Hepatitis C knowledge
  • HIV knowledge
  • Hepatitis C treatment
04

In context

Hepatitis C, Chronic Reclassified

950 studies on the registry are indexed under Hepatitis C, Chronic; 8 are open to participants now.

This study's enrollment of 150 is below the median of 282 across 211 observational studies indexed under Hepatitis C, Chronic.

Browse Hepatitis C, Chronic studies →

Lead sponsor

University of California, San Diego is the lead sponsor of 980 studies on the registry; 195 are open to participants now.

Of its 113 completed or terminated interventional studies of FDA-regulated products, 71 (63%) have results posted.

Compared within Hepatitis C, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hepatitis C. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Any adult (≥ 18 years) -infected patient attending the UCSD Owen Clinic
  • Regardless of ethnic background
  • English or Spanish speaking
  • With active infection defined as having a detectable HCV viral load with or without a positive HCV antibody

Exclusion criteria

Exclusion Criteria:

  • Neurocognitive impairment precluding participation
  • Physical illness precluding participation
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

06

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Not referred for HCV therapy
  • Referred for HCV therapy,did not show up
  • Referred,attended HCV therapy evaluation
07

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline before HCV treatment consideration

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

    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.

    Time frame: Baseline before HCV treatment consideration

  2. 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.

    Time frame: Baseline before HCV treatment consideration

08

Study locations

1 site
  • Owen Clinic - University of California, San Diego
    San Diego, California 92103-8186, United States
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2017 to primary completion in Dec 2019, 27 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2018
First posted
Jan 29, 2018
StartActual
Sep 8, 2017
Primary completionActual
Dec 31, 2019
CompletionActual
Dec 31, 2019
Last update
Sep 5, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03413696
Responsible party
Edward Cachay, MD, MAS (Associate Professor of Clinical Medicine, University of California, San Diego) — Principal investigator
First posted
Jan 29, 2018
Start date
Sep 8, 2017
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Sep 5, 2021

Study contacts

Edward Cachay, MD, MAS
principal investigator · University of California, San Diego

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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