Conquering Hypertension in Urban Vietnam (HTN-URBAN)

January 26, 2026 updated by: Hoa Nguyen, University of Massachusetts, Worcester
The HTN-URBAN project aims to improve hypertension (HTN) control for adults in a large northern Vietnamese city via a cluster-randomized trial design.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

A Cluster-randomized, Type II Hybrid effectiveness implementation Trial will take place in 14 urban communities in 7 urban districts in Hai Phong city in northern Vietnam.

Community Eligibility Criteria: (1) located in urban Hai Phong city; (2) distance between 2 communities will be at least 10 Km; (3) no other research studies/ health programs currently being implemented; and (4) key community and clinical leaders are willing to participate in the study.

Recruitment

Residents from participating sites will be invited to attend the community screening events run by local community health center (CHC) staff and Community Health Workers (CHWs). Those meeting our pre-defined eligibility criteria will be invited to their CHCs to learn more about the study. Patients with elevated blood pressure (BP) will be invited for re-measurement over the next two weeks (at least 1 week apart). After the second BP measurement, patients with elevated BP will be invited to participate in the study.

Randomization

Fourteen communities in urban Hai Phong (700 patients with uncontrolled hypertension - HTN) will be randomly assigned either to an intervention (7 communities- 50 patients per community) or comparison group (7 communities- 50 patients per community) by a computer procedure. Patients with uncontrolled HTN will be assigned to intervention versus comparison status based on the communities in which they reside.

Intervention group: The intervention group will receive 3 components including digital Storytelling delivered via Computerized Intervention Authoring System (CIAS), home blood pressure self-monitoring and expanded CHW services (frequent contacts, visits and consultations).

Comparison group: Patients in the comparison group will receive only "Learn More" module - didactic material without HTN related stories via CIAS.

Patients in both groups will be followed up at 3, 6 and 12 months.

Study Type

Interventional

Enrollment (Estimated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Vietnam
      • Hanoi, Vietnam, Vietnam, 10000
        • Health Strategy and Policy Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged ≥18 years old;
  • Presence of uncontrolled HTN (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) according to JNC-8;
  • Willing to provide informed consent.

Exclusion Criteria:

  • Participation in another study on hypertension;
  • Pregnant;
  • Advanced cognitive impairment;
  • Previous exposure to storytelling modules;
  • Participant family member;
  • Participant in intervention development.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Comparison Group
Patients in the comparison group will receive the "Learn More" module only.
Behavioral: "Learn More" module only
A supplementary "Learn More" module of didactic material (3 minutes) provides strategies for better patient-physician communication, which will be delivered via Computerized Intervention Authoring System (CIAS) at baseline and at 3, 6, and 9 months after enrollment.
Experimental: Intervention Group

Patients in the intervention group will receive HTN-URBAN intervention, which includes three integrated components:

(1) Storytelling intervention, (2) Home BP monitoring, (3) Expanded community health worker services.
Behavioral: Storytelling intervention
The storytelling intervention consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voice. Based on preferences that emerged during the researchers' formative work with the partnering rural communities, the storytelling intervention will be delivered via Computerized Intervention Authoring System (CIAS) on a biweekly basis. A supplementary "Learn More" module of didactic material (3 minutes) provides strategies for better patient-physician communication and is coordinated with the specific patient stories will be provided via CIAS as well.
Behavioral: Home BP monitoring
Patients with hypertension will be provided blood pressure monitors and guided to self-measure their blood pressure and to record their blood pressure daily at home.
Behavioral: Expanded community health worker services
A training program will be implemented for community health workers for the intervention arm regarding hypertension management at the community level so that they can assist patients better managing their blood pressure at home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure level
Time Frame: From baseline to 3, 6 and 12 month follow up visits
Changes in systolic blood pressure levels
From baseline to 3, 6 and 12 month follow up visits
Acceptability, Appropriateness, Feasibility
Time Frame: at 3, 6, and 12 month follow-up visits
Information will be collected via semi-structured interviews among patients, Community health workers, community leaders, and local clinicians and nurses mentioned previously and patient interviews and post-story viewing surveys.
at 3, 6, and 12 month follow-up visits
Adoption
Time Frame: at baseline, 3, 6, and 12 month follow-up visits
Data for participant recruitment and retention will include the number of patients approached for recruitment, reasons for ineligibility of patients not enrolled or refusing to participate, and completion rates for follow-up visits.
at baseline, 3, 6, and 12 month follow-up visits
Fidelity
Time Frame: at 3, 6, and 12 month follow-up visits
Information will be collected via periodic random observations of blood pressure measurement and patient interviews by study investigators and the project manager who will document and check intervention deliverables using a standardized checklist.
at 3, 6, and 12 month follow-up visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diastolic blood pressure level
Time Frame: From baseline to 3, 6 and 12 months
Changes in diastolic blood pressure levels
From baseline to 3, 6 and 12 months
Hypertension control
Time Frame: From 3 to 6 and12 months follow up visits
Changes in the proportion of patients with hypertension control.
From 3 to 6 and12 months follow up visits
Self-efficacy
Time Frame: From baseline to follow-up at 3, 6, and 12 months
Changes in patients medication adherence self-efficacy, which will be measured using the Medication Adherence Self-efficacy Scale (MASES) instrument.
From baseline to follow-up at 3, 6, and 12 months
Hypertension (HTN) medication adherance
Time Frame: From baseline to 3, 6, and 12 month follow-up visits
Changes in adherence to anti-HTN medications, which will be measured using a standardized data collection form.
From baseline to 3, 6, and 12 month follow-up visits
Risk of cardiovascular disease (CVD)
Time Frame: From baseline to follow-up at 12 months
Changes in CVD risk factors (tobacco use, alcohol consumption, salt intake and physical activities), which will be measured using WHO STEPs questionnaires
From baseline to follow-up at 12 months
Patient quality of life
Time Frame: From baseline to 3, 6 and 12 month follow up visits
Changes in patient's quality of life, which will be measured using the SF-12 survey.
From baseline to 3, 6 and 12 month follow up visits
Cost
Time Frame: at 12 month follow up

Program costs and patient-related costs will be collected.

Program costs include intervention development and its implementation at the district and community levels: personnel, equipment, medical devices, training materials and supplies, transportation, administration, and other operational expenses.

Patient-related costs include medications, time lost from work, Community Health Center visits, and consultation fees and patient utilities will be collected using a survey administered at the final visit.
at 12 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Health Strategy and Policy Institute

Investigators

  • Principal Investigator: Hoa Nguyen, MD, MS, PhD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2025

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H00001666
  • R61HL172269 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data that will be collected for this study can be obtained by contacting the study PI.

IPD Sharing Time Frame

The final dataset will be available from January 2030 to December 2039.

IPD Sharing Access Criteria

The data and associated documentation will be available to qualified academic investigators for non-commercial research under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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