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STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

Primary Purpose

Hepatitis C, HepatoCellular Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mailed outreach
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C

Eligibility Criteria

53 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Parkland Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care

Mailed outreach

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hepatitis C Screening
Proportion with HCV Ab within 3 months of randomization

Secondary Outcome Measures

Hepatitis C Screening
Proportion with HCV Ab within 12 months of randomization
Hepatitis C Confirmation
Proportion with HCV Viral Load within 3 months of positive antibody result
Hepatitis C Linkage to care
Proportion with clinic visit within 6 months of positive HCV Viral Load
Cost: Cost-per patient screened
The primary measure of costs will be the cost per Ab completion.
Cost: Cost per-HCV diagnosis
The primary measure of costs will be the cost per-patient diagnosed with HCV.

Full Information

First Posted
October 11, 2018
Last Updated
April 16, 2021
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03706742
Brief Title
STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention
Official Title
STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2018 (Actual)
Primary Completion Date
August 18, 2019 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, HepatoCellular Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
12386 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
Mailed outreach
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mailed outreach
Intervention Description
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 Measure Information:
Title
Hepatitis C Screening
Description
Proportion with HCV Ab within 3 months of randomization
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hepatitis C Screening
Description
Proportion with HCV Ab within 12 months of randomization
Time Frame
12 months
Title
Hepatitis C Confirmation
Description
Proportion with HCV Viral Load within 3 months of positive antibody result
Time Frame
3 months
Title
Hepatitis C Linkage to care
Description
Proportion with clinic visit within 6 months of positive HCV Viral Load
Time Frame
6 months
Title
Cost: Cost-per patient screened
Description
The primary measure of costs will be the cost per Ab completion.
Time Frame
3 months
Title
Cost: Cost per-HCV diagnosis
Description
The primary measure of costs will be the cost per-patient diagnosed with HCV.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
53 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33337657
Citation
Desai N, Rich NE, Jain MK, Blackwell JM, Murphy CC, Perryman P, McBryde J, Quirk L, Clark C, Villarreal D, Waljee AK, Gopal P, Singal AG. Randomized Clinical Trial of Inreach With or Without Mailed Outreach to Promote Hepatitis C Screening in a Difficult-to-Reach Patient Population. Am J Gastroenterol. 2021 May 1;116(5):976-983. doi: 10.14309/ajg.0000000000001085.
Results Reference
derived

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STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

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