NCT06893198

Brief Summary

The HTN-URBAN project aims to improve hypertension (HTN) control for adults in a large northern Vietnamese city via a cluster-randomized trial design.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
35mo left

Started Nov 2025

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress15%
Nov 2025Feb 2029

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2029

Last Updated

January 27, 2026

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

March 18, 2025

Last Update Submit

January 26, 2026

Conditions

Hypertension

Keywords

storytelling interventionhome blood pressure monitoringcommunity health workersUrban hypertensionVietnamHTN-URBAN intervention

Outcome Measures

Primary Outcomes (4)

  • Systolic blood pressure level

    Changes in systolic blood pressure levels

    From baseline to 3, 6 and 12 month follow up visits

  • Acceptability, Appropriateness, Feasibility

    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

    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

    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 Outcomes (7)

  • Diastolic blood pressure level

    From baseline to 3, 6 and 12 months

  • Hypertension control

    From 3 to 6 and12 months follow up visits

  • Self-efficacy

    From baseline to follow-up at 3, 6, and 12 months

  • Hypertension (HTN) medication adherance

    From baseline to 3, 6, and 12 month follow-up visits

  • Risk of cardiovascular disease (CVD)

    From baseline to follow-up at 12 months

  • +2 more secondary outcomes

Study Arms (2)

Comparison Group

ACTIVE COMPARATOR

Patients in the comparison group will receive the "Learn More" module only.

Behavioral: "Learn More" module only

Intervention Group

EXPERIMENTAL

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 interventionBehavioral: Home BP monitoringBehavioral: Expanded community health worker services

Interventions

Expanded community health worker servicesBEHAVIORAL

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.

Intervention Group
Storytelling interventionBEHAVIORAL

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.

Intervention Group
Home BP monitoringBEHAVIORAL

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.

Intervention Group
"Learn More" module onlyBEHAVIORAL

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.

Comparison Group

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Strategy and Policy Institute

Hanoi, Vietnam, 10000, Vietnam

Location

Related Publications (5)

  • Ha DA, Tran OT, Nguyen HL, Chiriboga G, Goldberg RJ, Phan VH, Nguyen CT, Nguyen GH, Pham HV, Nguyen TT, Le TT, Allison JJ. Conquering hypertension in Vietnam-solutions at grassroots level: study protocol of a cluster randomized controlled trial. Trials. 2020 Nov 27;21(1):985. doi: 10.1186/s13063-020-04917-8.

    PMID: 33246495BACKGROUND

  • Nguyen HL, Ha DA, Goldberg RJ, Kiefe CI, Chiriboga G, Ly HN, Nguyen CK, Phan NT, Vu NC, Nguyen QP, Allison JJ. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam- 12 month follow up results: A cluster randomized controlled feasibility trial. PLoS One. 2018 Dec 31;13(12):e0209912. doi: 10.1371/journal.pone.0209912. eCollection 2018.

    PMID: 30596749BACKGROUND

  • Allison JJ, Nguyen HL, Ha DA, Chiriboga G, Ly HN, Tran HT, Phan NT, Vu NC, Kim M, Goldberg RJ. Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial. Trials. 2016 Jan 14;17:26. doi: 10.1186/s13063-015-1147-6.

    PMID: 26762128BACKGROUND

  • Ha DA, Tran OM, Nguyen HL, Nguyen HT, Dao AM, Nguyen HV, Vu NC, Chiriboga G, Goldberg RJ, Houston TK, Allison JJ. Stakeholder Engagement in Late-Stage Translation Phase 4 Research for Noncommunicable Diseases in Low- and Middle-Income Countries: What Works and Why-The Vietnam Experience (UMMS-Vietnam Team). Glob Heart. 2019 Jun;14(2):143-147. doi: 10.1016/j.gheart.2019.05.003.

    PMID: 31324368BACKGROUND

  • Nguyen HL, Ha DA, Tran OT, Phan VH, Nguyen CT, Nguyen GH, Nguyen TT, Le TT, Goldberg RJ, Wang B, Tang ET, Chiriboga G, Budhwani H, Allison JJ. Conquering hypertension in Vietnam: 12- month follow up results from a cluster-randomised controlled trial. Lancet Reg Health West Pac. 2024 Jul 1;48:101123. doi: 10.1016/j.lanwpc.2024.101123. eCollection 2024 Jul.

    PMID: 39045484BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Hoa Nguyen, MD, MS, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Last Updated

January 27, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The final dataset will be available from January 2030 to December 2039.
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.

Locations

VN(1)