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STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

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ClinicalTrials.gov Identifier: NCT03706742
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : February 28, 2019
Sponsor:
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 : 12000 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : June 2020

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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03706742


Contacts
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Contact: Patrice Perryman, MPH 214-648-3803 patrice.perryman@utsouthwestern.edu
Contact: Katharine McCallister 214-648-3219 katharine.mccallister@utsouthwestern.edu

Locations
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United States, Texas
Parkland Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Amit Singal, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center

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Responsible Party: Amit Singal, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03706742     History of Changes
Other Study ID Numbers: STU 072015-022
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
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
Hepatitis C
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site