NCT02421666

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
532

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

October 8, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

3.4 years

First QC Date

April 10, 2015

Results QC Date

July 23, 2020

Last Update Submit

October 5, 2020

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Change of the Rates of Participants Who Adherent to Recommended Clinical Care for the Monitoring of Chronic HBV Infection

    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.

    6-month and 12-month follow up

Study Arms (2)

behavioral PNMI

EXPERIMENTAL

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

Behavioral: PNMI

control

NO INTERVENTION

eligible chronic HBV patients received standard care

Interventions

PNMIBEHAVIORAL

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.

behavioral PNMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients were excluded from the study for the following conditions:
  • diagnosed with cirrhosis, hepatocellular carcinoma, liver failure and liver cancer
  • concurrent hepatitis C infection, and
  • concurrent HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 36749506DERIVED

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Limitations and Caveats

In this study, we validated only those who reported their follow up visits and blood tests in collaboration with clinical partners; validating for all participants enrolled would be ideal. The results may not represent all Asian American groups.

Results Point of Contact

Title
Dr. Grace X. Ma
Organization
Center for Asian Health, Lewis Katz School of Medicine, Temple University
grace.ma@temple.edu
2157078823

Study Officials

  • Grace X Ma, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 21, 2015

Study Start

September 1, 2014

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

October 8, 2020

Results First Posted

October 8, 2020

Record last verified: 2020-10