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Completed

NCT Number: NCT03706742

STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

Aim 1: The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among baby-boomers (i.e. persons born between 1945-1965): inreach with electronic medical record alerts and provider education vs. combination of inreach and provider education plus mailed outreach and patient navigation.

Aim 2: The investigators will evaluate patient navigation strategies to promote follow-up testing and treatment evaluation among non-baby boomer Parkland patients (i.e. born before 1945 or after 1965) who are either: a) HCV antibody positive but have not completed follow-up viral load testing or b) HCV viral load positive and who have not completed in-clinic treatment evaluation.

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Key information

Conditions

Hepatitis C Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases Digestive System Diseases Digestive System Neoplasms Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Hepatocellular Carcinoma Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial RNA Virus Infections Virus Diseases

Age range

53 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Hospital

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • born between 1945 and 1965
  • ≥ 1 outpatient visit during 12 months prior to randomization at Parkland
  • no prior HCV screening (prior HCV antibody, viral load, or genotype).
  • any active medical coverage
  • speaks Spanish or English

Exclusion criteria

  • a life expectancy less than one year including end stage CHF, end stage COPD, metastatic cancer, and those who received a palliative care or hospice referral in the past year
  • history of HCC.
  • non-English or Spanish speakers
  • no address or phone number on file

Treatment and study plan

Mailed outreach

Behavioral

The investigators will randomize all baby boomer patients (~12,000 patients) using a centrally maintained computer-generated list. Patients will be randomly assigned to one of two HCV screening strategies including: visit-based screening as part of usual care (Group 1) or mailed screening invitation outreach and centralized patient navigation (Group 2).

Primary outcomes

  1. Hepatitis C Screening

    Time frame: 3 months

    Proportion with HCV Ab within 3 months of randomization

Secondary outcomes

  1. Hepatitis C Screening

    Time frame: 12 months

    Proportion with HCV Ab within 12 months of randomization

  2. Hepatitis C Confirmation

    Time frame: 3 months

    Proportion with HCV Viral Load within 3 months of positive antibody result

  3. Hepatitis C Linkage to care

    Time frame: 6 months

    Proportion with clinic visit within 6 months of positive HCV Viral Load

  4. Cost: Cost-per patient screened

    Time frame: 3 months

    The primary measure of costs will be the cost per Ab completion.

  5. Cost: Cost per-HCV diagnosis

    Time frame: 12 months

    The primary measure of costs will be the cost per-patient diagnosed with HCV.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Oct 16, 2018
Registry last updated
Apr 20, 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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