CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled
Drug / intervention
Test-and-treat EHR-CHW intervention +1 moreother
Likely dose
Not stated in record
Key inclusion· 5
  • Self-identifies as Chinese American
  • Age 21 years and older
  • Confirmed H. pylori infection by at least one approved diagnostic method (C-urea breath test, histology, rapid urease test, bacterial culture, fecal stool antigen test, or other clinically approved test)
  • Plans to remain in region for 12 months
Key exclusion· 4
  • Advanced chronic disease that would prevent completion of follow-up or attendance at visits
  • Allergy to any study drugs
  • Pregnant or breastfeeding
  • Took antibiotics or bismuth salts within 2 weeks before study

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

Search/NCT03340454
NCT03340454N/ACompleted

Patient-Centered Cancer Prevention In Chinese Americans

NYU Langone Health·interventional·Posted Nov 13, 2017·Updated Jul 3, 2024

In Brief

A clinical study evaluating Test-and-treat EHR-CHW intervention and Usual care of EHR-only intervention for H. Pylori Infection. Completed, enrolled 135 participants across 1 site.

Detailed Summary

This study will assess the efficacy, adoption, and impact of an integrated intervention to improve adherence to recommended stomach cancer prevention guidelines (H. pylori test-and-treat) for at-risk Chinese Americans in NYC. The integrated multifaceted theory-based intervention involves: 1) a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies; and 2) a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability. Using a 2-arm randomized controlled trial (RCT) design, \> 144 Chinese American patients across NYC safety net hospital endoscopy clinics and primary health centers will participate.

Study Details

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

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedNov 13, 2017
Enrollment StartAug 15, 2018
Primary CompletionJun 15, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.6 years ago

Interventions

Test-and-treat EHR-CHW interventionother

a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies

Usual care of EHR-only interventionother

a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.