STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention

• ClinicalTrials.gov Identifier: NCT03706742
• Recruitment Status: Active, not recruiting
• First Posted: October 16, 2018
• Last Update Posted: March 17, 2021
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Amit Singal, University of Texas Southwestern Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Hepatitis C; HepatoCellular Carcinoma	Behavioral: Mailed outreach	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 27000 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
• Actual Primary Completion Date: August 18, 2019
• Estimated Study Completion Date: March 31, 2021

Arms and Interventions

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).

Outcome Measures

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
4. Cost: Cost-per patient screened [ Time Frame: 3 months ]
   The primary measure of costs will be the cost per Ab completion.
5. Cost: Cost per-HCV diagnosis [ Time Frame: 12 months ]
   The primary measure of costs will be the cost per-patient diagnosed with HCV.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Texas

Parkland Hospital

Dallas, Texas, United States, 75235

Sponsors and Collaborators

University of Texas Southwestern Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. 2020 Dec 17;Publish Ahead of Print. doi: 10.14309/ajg.0000000000001085. [Epub ahead of print]

• Responsible Party: Amit Singal, Principal Investigator, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT03706742
• Other Study ID Numbers: STU 072015-022
• First Posted: October 16, 2018
• Last Update Posted: March 17, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hepatitis C; Carcinoma, Hepatocellular; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; RNA Virus Infections; Flaviviridae Infections; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site