STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

Not Applicable

Completed

• Conditions: Hepatitis C; HepatoCellular Carcinoma
• Interventions: Behavioral: Mailed outreach

• Registration Number: NCT03706742
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-10
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-16
• Primary Completion: 2019-08-18
• Study Completion: 2021-03-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12386

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mailed outreach	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Parkland Hospital; 🇺🇸 Dallas, Texas, United States