STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention for Elevated LFTs

Not Applicable

Withdrawn

• Conditions: Hepatitis C; Hepatocellular Carcinoma
• Interventions: Behavioral: Mailed Outreach

• Registration Number: NCT04395118
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The investigators will conduct a randomized controlled trial comparing two strategies to promote HCV screening, follow-up testing, and treatment among Parkland patients who are 18 years or older who have elevated liver functioning test (LFT) results: in reach with electronic medical record alerts and provider education vs. combination of in reach and provider education plus mailed outreach and patient navigation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02
• Study Start: 2020-08-15
• Primary Completion: 2021-06-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• ages 18 or older
• elevated liver functioning tests (AST or ALT >35 that are separated by at least one month)
• ≥ 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 any history of 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 in English and Spanish. The invitation will include patient-centered educational materials that discuss the risk of HCV in patients with elevated LFTs and the benefits and risks of HCV screening. The invitation will include a phone number to schedule the HCV antibody test. 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 call to this potential subject. Patients will also receive centralized patient navigation to facilitate screening completion and appropriate test follow-up. He/she will help patients schedule HCV antibody testing and will assume responsibility for tracking results. Patients referred to the Hepatitis C clinic for treatment evaluation will receive reminder calls from trained and credentialed study staff 5-7 business days for scheduled appointments.

Primary Outcome Measures

Name	Time	Method
Hepatitis C Screening	6 months	Proportion with HCV Ab or HCV VL within 6 months of randomization

Secondary Outcome Measures

Name	Time	Method
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 Per Patient Screened	3 months	The primary measure of costs will be the cost per Ab completion.
Cost Per HCV Diagnosis	12 months	The primary measure of costs will be the cost per-patient diagnosed with HCV.

Trial Locations

Locations (1)

Parkland Hospital; 🇺🇸 Dallas, Texas, United States