HypertensionACTIONNCT07784647
A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol
An observational study of Hypertension and Health Services Accessibility, run by Imperial College London at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Health Services Accessibility
- How many people
- 1,444 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2026to 7 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
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.
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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Health Services Accessibility
- Keywords
- service availability and readiness assessment, hypertension, health services accessibility, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
prevalence of hypertension control
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.
Measured: Baseline (this cross-sectional survey includes a single study visit)
Secondary outcomes (1)
factors associated with poor control of hypertension
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.
Measured: Baseline (this cross-sectional survey includes a single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 Apr 2026
- Primary completion21 Jul 2026
- Study completion7 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Abuja, RemediumOne (Pvt) Ltd., University of Kelaniya, The George Institute, The George Institute for Global Health, Australia, The University of New South Wales
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784647
- Sponsor's protocol ID
- TGI_UK_PO_P01780
- Other IDs
- NIHR207002 (41379), 8021062
- Acronym
- ACTION
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Low-Cost, Scalable Treatment Strategy for Improving Hypertension Control in Low and Middle-Income Settings: Formative Phase (Aim 1)
- ClinicalTrials.gov ID
- NCT07784647
- Acronym / sponsor ID
- ACTION / TGI_UK_PO_P01780
- Conditions
- Hypertension, Health Services Accessibility
- Keywords
- service availability and readiness assessment, hypertension, health services accessibility, blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,444 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- University of Abuja, RemediumOne (Pvt) Ltd., University of Kelaniya, The George Institute, The George Institute for Global Health, Australia, The University of New South Wales
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 7 Aug 2026 (actual)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
factors associated with poor control of hypertension
Time frame: Baseline (this cross-sectional survey includes a single study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Health Services Accessibility, run by Imperial College London at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria, Sri Lanka. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
prevalence of hypertension control (time frame: Baseline (this cross-sectional survey includes a single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2026.