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HypertensionHTN-URBANNCT06893198

Conquering Hypertension in Urban Vietnam

A study testing Storytelling intervention, Home BP monitoring and Expanded community health worker services in people with Hypertension, run by University of Massachusetts, Worcester at 1 site in Vietnam.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Storytelling intervention, Home BP monitoring and Expanded community health worker services
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
1 siteVietnam
Study dates
1 Nov 2025to 28 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Health Strategy and Policy Institute

    Hanoi, Vietnam, 10000

Other trials in Vietnam

About this study

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

Read the 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.

Conditions
Hypertension
Being tested
Storytelling intervention, Home BP monitoring, Expanded community health worker services, "Learn More" module only
Keywords
storytelling intervention, home blood pressure monitoring, community health workers, Urban hypertension, Vietnam, HTN-URBAN intervention
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Storytelling interventionBehavioural

    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.

  • Home BP monitoringBehavioural

    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.

  • Expanded community health worker servicesBehavioural

    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.

  • "Learn More" module onlyBehavioural

    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.

Study groups in NCT06893198
Study groupRoleWhat they receive
Comparison GroupActive comparatorPatients in the comparison group will receive the "Learn More" module only.
Receives: Behavioral: "Learn More" module only
Intervention GroupExperimentalPatients 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.
Receives: Behavioral: Storytelling intervention; Behavioral: Home BP monitoring; Behavioral: Expanded community health worker services

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Systolic blood pressure level

    Changes in systolic blood pressure levels

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

  2. 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.

    Measured: at 3, 6, and 12 month follow-up visits

  3. 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.

    Measured: at baseline, 3, 6, and 12 month follow-up visits

  4. 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.

    Measured: at 3, 6, and 12 month follow-up visits

Secondary outcomes (7)

  1. Diastolic blood pressure level

    Changes in diastolic blood pressure levels

    Measured: From baseline to 3, 6 and 12 months

  2. Hypertension control

    Changes in the proportion of patients with hypertension control.

    Measured: From 3 to 6 and12 months follow up visits

  3. Self-efficacy

    Changes in patients medication adherence self-efficacy, which will be measured using the Medication Adherence Self-efficacy Scale (MASES) instrument.

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

  4. Hypertension (HTN) medication adherance

    Changes in adherence to anti-HTN medications, which will be measured using a standardized data collection form.

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

  5. Risk of cardiovascular disease (CVD)

    Changes in CVD risk factors (tobacco use, alcohol consumption, salt intake and physical activities), which will be measured using WHO STEPs questionnaires

    Measured: From baseline to follow-up at 12 months

  6. Patient quality of life

    Changes in patient's quality of life, which will be measured using the SF-12 survey.

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

  7. Cost

    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.

    Measured: at 12 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2025
  2. Study start1 Nov 2025
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized controlled trial.
Masking
Single blind
Who is masked
Participant
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06893198
Sponsor's protocol ID
H00001666
Other IDs
R61HL172269
Acronym
HTN-URBAN
Status last verified
Oct 2026
First submitted
18 Mar 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data that will be collected for this study can be obtained by contacting the study PI.

Publications

  • 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.

    PubMed 33246495

  • 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.

    PubMed 30596749

  • 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.

    PubMed 26762128

  • 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.

    PubMed 31324368

  • 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.

    PubMed 39045484

Questions about this trial

What is this clinical trial studying?

A study testing Storytelling intervention, Home BP monitoring and Expanded community health worker services in people with Hypertension, run by University of Massachusetts, Worcester at 1 site in Vietnam.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic blood pressure level (time frame: From baseline to 3, 6 and 12 month follow up visits). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06893198, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.

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Conquering Hypertension in Urban Vietnam (NCT06893198) | AzTrials