STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

HepatoCellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706742
• Other study ID #: STU 072015-022
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12386
• Est. completion date: March 31, 2021
• Est. primary completion date: August 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 53 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis
• Hepatitis C
• HepatoCellular Carcinoma

Intervention

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).

Locations

Country	Name	City	State
United States	Parkland Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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