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STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03706742
Recruitment Status : Active, not recruiting
First Posted : October 16, 2018
Last Update Posted : March 17, 2021
Information provided by (Responsible Party):
Amit Singal, University of Texas Southwestern Medical Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hepatitis C HepatoCellular Carcinoma Behavioral: Mailed outreach Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Screening
Official Title: STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection
Actual Study Start Date : September 10, 2018
Actual Primary Completion Date : August 18, 2019
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Usual Care
Patients randomized to Group 1 will receive visit-based HCV screening, as offered by clinic providers as part of usual care. Providers must identify at-risk patients who are eligible for HCV screening, understand the benefits of screening in this population, and enter orders for HCV Ab testing. If the HCV antibody is abnormal, providers must order appropriate follow-up tests including HCV viral load to confirm HCV infection. Once HCV is confirmed, providers must refer the patients for fibrosis assessment and treatment evaluation. These efforts are augmented by an established best practice alert and health maintenance reminders.
Active Comparator: Mailed outreach
Patients randomized to Group 2 will receive low literacy, written materials about HCV screening among baby-boomers in English and Spanish. The invitation will include patient-centered educational materials that discuss the risk of HCV in baby boomers and the benefits and risks of HCV screening. The invitation will include a phone number to schedule the HCV antibody blood test. Written materials will be developed and validated in Spanish using the Spanish Language Translation Resource. Once a potential subject is identified and randomized in Group 2, an outreach invitation will be mailed out. Shortly after the letter, a bilingual patient navigator will place a follow-up call to this potential subject. These follow-up calls will occur in the 2nd - 4th week after mailing invitations; up to three attempts in total will be made to reach the patient to facilitate HCC screening completion.
Behavioral: Mailed outreach
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 Outcome Measures :
  1. Hepatitis C Screening [ Time Frame: 3 months ]
    Proportion with HCV Ab within 3 months of randomization

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   53 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03706742

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United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Amit Singal, Principal Investigator, University of Texas Southwestern Medical Center Identifier: NCT03706742    
Other Study ID Numbers: STU 072015-022
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site