CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 382 enrolled
Drug / intervention
VPN +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04082338
NCT04082338N/ACompleted

Long-Term Adherence To Monitoring/Treatment In Underserved Asian Americans With Chronic HBV

Temple University·interventional·Posted Sep 9, 2019·Updated Jun 22, 2023

In Brief

A clinical study evaluating VPN and TM for Hepatitis B, Chronic. Completed, enrolled 382 participants across 2 sites.

Detailed Summary

About 75% of liver cancers are attributed to chronic hepatitis B (CHB). An estimated 2.2 million individuals in the U.S. have CHB. Although Asian Americans make up 6% of total U.S. population, they account for over 58% of Americans with CHB. Prevalence rates of CHB range from 8% to 13% in Asian Americans vs 1% in Non-Hispanic whites (NHW). Asian Americans are 8-13 times more likely to develop liver cancer with 60% higher death rate than NHW. Regular monitoring of CHB is vital in preventing HCC. Research indicates that regular monitoring (e.g., every six months doctor visit; blood tests) combined with antiviral treatment when appropriate, is critical to reduce the risk of liver disease (including HCC). Unfortunately, treatment effectiveness diminishes if CHB patients do not adhere to long-term monitoring and treatment guidelines. Adherence among Asian Americans with CHB is low. Poor healthcare access and significant cultural barriers prevent long-term adherence to monitoring and optimal treatment, placing Asian Americans at disproportionately high risk for HCC and increased healthcare costs. Building on previous studies, the investigators will use a virtual patient navigation (VPN) toolkit system (a web/mobile application) to help CHB patients improving their liver disease management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 9, 2019
Enrollment StartApr 1, 2019
Primary CompletionMar 31, 2022
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 6.8 years ago

Interventions

VPNbehavioral

The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application). The system includes education modules on HBV management, CHB patient success stories and virtual patient navigation clinical support for overcoming barriers. In addition to the VPN, each participant will receive 5 text messages; one message once a week for 5 weeks on HBV management for every 6 months in the 18-month study period.

TMbehavioral

Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.