A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV

Not Applicable

Completed

• Conditions: Hepatitis B
• Interventions: Behavioral: PNMI

• Registration Number: NCT02421666
• Lead Sponsor: Temple University

Brief Summary

Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial.

Detailed Description

Asian Americans have the highest incidence, mortality and prevalence rates of hepatocellular carcinoma (HCC) among all U.S. racial and ethnic groups. Inadequate chronic hepatitis B (CHB) monitoring and care are also likely to contribute to poorer outcomes and increased healthcare costs. The goal of this study is to investigate the efficacy of a Patient Navigator-led mobile phone text Messaging Intervention (PNMI) in improving hepatitis B follow-up care management for Asian Americans with chronic hepatitis B infection through a randomized controlled trial. The primary outcome of the study is Asian CHB patient adherence (measured as "having seen a doctor for CHB monitoring") to hepatitis B (HBV) monitoring guidelines at 6-month and 12-month assessments post-intervention.

Patient partners and stakeholders were engaged in all study stages. The findings of this study provided unique and promising opportunities for broadly disseminating and implementing the evidence-based intervention in the real-world practice, thus further preventing chronic liver diseases and reducing health disparities among high-risk underserved populations.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-04-10
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-21
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Results First Submitted: 2020-07-23
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-05
• Last Update Submitted: 2020-10-05
• Results First Posted: 2020-10-08
• Last Update Posted: 2020-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 532

Inclusion Criteria

1. self-identified Chinese, Korean and Vietnamese ethnicity
2. age 18 and above
3. accessible by telephone with text message feature
4. presence in the same geographic study area for a period of one year
5. not enrolled in any chronic HBV adherence management intervention
6. medically diagnosed chronic HBV infection with positive for hepatitis B surface antigen (HBsAg) for more than six months, and
7. Never or non compliant with HBV monitoring guidelines.

Exclusion Criteria

Patients were excluded from the study for the following conditions:

1. diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
2. concurrent hepatitis C infection, and
3. concurrent HIV infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
behavioral PNMI	PNMI	eligible patients received patient navigator led plus mobile phone text messaging intervention(PNMI) or standard care.

Primary Outcome Measures

Name	Time	Method
Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection	6-month and 12-month follow up	The primary outcome is adherence to recommended clinical care for the monitoring of chronic HBV infection, specifically: 1) whether they visited doctors for their CHB, and 2) whether they received a blood test every 6 months such as alanine transaminase (ALT). All primary outcome measures were assessed at both the 6-month and 12-month follow-up surveys.