Clinical trial · Interventional
STOP HCC: Mailed HCV Treatment Outreach Program for HCC Prevention for Elevated LFTs
STOP-HCC Evidence-Based Hepatocellular Cancer Prevention Through Treatment of Hepatitis C Virus Infection
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study will not be conducted as a RCT due to limited project timeline.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis C | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mailed Outreach | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- 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.
- type
- ACTIVE_COMPARATOR
- label
- Mailed Outreach
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 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
References
Publications (0)
Data not yet available