A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol (ACTION)

August 26, 2026 updated by: Imperial College London

A Low-Cost, Scalable Treatment Strategy for Improving Hypertension Control in Low and Middle-Income Settings: Formative Phase (Aim 1)

This study includes a survey of primary healthcare facilities in Nigeria and Sri Lanka. It will aim to assess the availability and readiness of hypertension care in primary healthcare facilities, and feasibility to conduct a future randomised controlled trial.

This study also includes a survey of patients with high blood pressure who will be recruited from primary care in Sri Lanka and Nigeria. Its aim is to understand the characteristics of patients with hypertension, hypertension management and control, including use of pharmacological interventions and lifestyle management. Patients will have their blood pressure, height and weight measured. They will also be asked about their age, sex/gender, socio-economic status, medical history, and health behaviours and lifestyle.

Additionally, this study includes focus group discussions and in-depth interviews with adults with high blood pressure and their carers; healthcare providers (community health workers, nurses, and doctors or physicians); clinic administrators; and policymakers. The discussions and interviews will aim to explore experiences, practices, and views on hypertension care and the new treatment strategies. Topics will cover experiences of current high blood pressure care; service availability, accessibility, and affordability; healthcare staff training and how well they follow medical guidelines for helping patients with high blood pressure; what works well and what are the problems with helping patients with high blood pressure; experiences of patients who need help with their high blood pressure; and how well new ways of helping people with high blood pressure are received.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This is a cross-sectional mixed-methods observational study including facility assessments (SARA), patient surveys, and qualitative interviews.

The cross-sectional survey of primary healthcare facilities in Nigeria and Sri Lanka will include a structured facility survey using an adapted version of World Health Organization (WHO)'s Service Availability and Readiness Assessment tool. The focus will be to capture the contemporary availability of infrastructure and human and other resources (diagnostics, medicines etc.) for hypertension care.

This study will include a patient cross-sectional survey and will recruit patients with high blood pressure from primary care facilities in Nigeria and Sri Lanka. After obtaining written informed consent, participants will be asked to share their medical records for review and respond to questions posed by the research staff. Data will be collected using a structured interviewer administered questionnaire informed by the STEPS instrument on various parameters including age, sex, height, weight, socio-economic status, medical history (current and past blood pressure, medications), and health behaviours and lifestyle interventions (smoking, alcohol consumption, diet including consumption of salt and use of salt substitutes, and physical activity). Blood pressure will be measured on the day of enrolment.

Focus group discussions and in-depth interviews with adults with hypertension and their carers; healthcare providers; clinic administrators; and policymakers will also be conducted in Sri Lanka and Nigeria as part of this study. Topics will cover experiences of current hypertension care; service availability, accessibility, and affordability; provider training and adherence to guidelines; barriers and facilitators to hypertension treatment and control; patient journey of people seeking hypertension care; and appropriateness and acceptability of the new treatment strategies in primary care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1357

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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Facility Survey (SARA):

This survey will be conducted in family medicine clinics within primary care facilities where most patients with hypertension are managed.

Patient Cross-Sectional Survey:

Adults with hypertension attending primary healthcare facilities screened as part of Facility Survey (SARA) in Nigeria and Sri Lanka.

Group Discussions and In-Depth Interviews:

Participants will include adults with hypertension and their carers; healthcare providers (community health workers, nurses, and doctors or physicians); clinic administrators; and policymakers.

Description

SARA Facility Survey Inclusion Criteria:

- primary care facility must be located in the Federal Capital Territory in Nigeria, and in the Gampaha District in Sri Lanka

Patient Cross-Sectional Survey Inclusion Criteria:

  • adult (age ≥18 years)
  • hypertensive (defined as prior documented diagnosis of hypertension, or current use of BP-lowering drugs for hypertension, or SBP ≥140 mmHg, and/or DBP ≥90 mmHg measured on two separate occasions)

Patient Cross-Sectional Survey Exclusion Criteria:

  • receiving BP-lowering drugs for conditions other than hypertension (e.g., benign prostate hyperplasia, migraine, etc)
  • normotensive

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cross-Sectional Facility Survey (SARA)
Service Availability and Readiness Assessment of primary care facilities in Sri Lanka and Nigeria
Cross-Sectional Patient Survey
Cross-sectional survey of adult patients with hypertension recruited from primary care facilities screened as part of Cross-Sectional Patient Survey
Qualitative Focus Groups Discussions and In-Depth Interviews
Focus group discussions and in-depth interviews with patients and healthcare providers/policymakers will explore experiences and perceptions of hypertension care, including acceptability of current and proposed management strategies.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
prevalence of hypertension control
Time Frame: Baseline (this cross-sectional survey includes a single study visit)
Hypertension is defined as prior documented diagnosis of hypertension, or current use of Blood Pressure (BP) lowering drugs for hypertension, or Systolic Blood Pressure (SBP) ≥140 mmHg, and/or Diastolic Blood Pressure (DBP) ≥90 mmHg measured on two separate occasions. Hypertension control is defined as achieving SBP < 140 mmHg and DBP < 90 mmHg with BP-lowering medications. The prevalence will be estimated separately for Nigeria and Sri Lanka.
Baseline (this cross-sectional survey includes a single study visit)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
factors associated with poor control of hypertension
Time Frame: Baseline (this cross-sectional survey includes a single study visit)
Multilevel logistic regression with clustering by primary healthcare centre (random intercept) will be used. Covariate selection will be guided by a conceptual framework; core adjustments will include age, sex, treatment status, and comorbidity.
Baseline (this cross-sectional survey includes a single study visit)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Availability of infrastructure and human and other resources for hypertension care
Time Frame: Baseline (data is collected during a single study visit in this facility cross-sectional survey)
A structured facility survey will be administered using and an adapted version of WHO's Service Availability and Readiness Assessment tool. Descriptive statistics will be used to summarise facility characteristics.
Baseline (data is collected during a single study visit in this facility cross-sectional survey)
Experiences of hypertension care
Time Frame: Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)
Experiences of hypertension care will be explored through qualitative data collected during focus group discussions and in-depth interviews.
Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)
Perceptions of hypertension care
Time Frame: Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)
Perceptions of hypertension care will be explored through qualitative data collected during focus group discussions and in-depth interviews.
Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)
Appropriateness of new hypertension treatment strategies
Time Frame: Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)
Participants' perceptions of the appropriateness of new treatment strategies for hypertension management in primary care will be explored through focus group discussions and in-depth interviews.
Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)
Acceptability of new hypertension treatment strategies
Time Frame: Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)
Participants' perceptions of the acceptability of new treatment strategies for hypertension management in primary care will be explored through focus group discussions and in-depth interviews.
Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Kelaniya
The University of New South Wales
The George Institute
The George Institute for Global Health, Australia
University of Abuja
RemediumOne

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TGI_UK_PO_P01780
  • NIHR207002 (41379) (Other Grant/Funding Number: NIHR)
  • 8021062 (Other Identifier: Imperial College Research Ethics Committee (ICREC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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