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

NCT ID: NCT02421666

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 532 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2018-01-31

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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

behavioral PNMI

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

Group Type: EXPERIMENTAL

PNMI

Intervention Type: BEHAVIORAL

Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.

control

eligible chronic HBV patients received standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

PNMI

Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Temple University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Grace X Ma, PhD

Role: PRINCIPAL_INVESTIGATOR

Temple University

References

Ma GX, Zhu L, Tan Y, Zhai S, Ma X, Ogunwobi OO, Yang WJ, Ting T, Kim S, Wang MQ. A Comparative Trial of Improving Care for Underserved Asian Americans Infected with Hepatitis B Virus. Dig Dis Sci. 2023 Jun;68(6):2333-2343. doi: 10.1007/s10620-023-07840-5. Epub 2023 Feb 7.

Reference Type: DERIVED

PMID: 36749506 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PCORI-HBV

Identifier Type: -

Identifier Source: org_study_id