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

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: Recruiting
• Conditions: Hypertension; Health Services Accessibility

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: Observational
• Enrollment (Estimated): 1357

Contacts and Locations

Study Locations

• Nigeria
  • Federal Capital Territory
    • Abuja, Federal Capital Territory, Nigeria
      • Recruiting
      • University of Abuja
      • Contact: Ikechukwu Orji; Phone Number: +234 8065913813; Email: drtony2013@gmail.com
• Sri Lanka
  • Colombo, Sri Lanka
    • Recruiting
    • RemediumOne
    • Contact: Saumiyah Ajanthan; Phone Number: +94768269923; Email: saumiyahajanthan@remediumone.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

Outcome Measure	Measure Description	Time Frame
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.	Baseline (this cross-sectional survey includes a single study visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (this cross-sectional survey includes a single study visit)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Availability of infrastructure and human and other resources for hypertension care	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	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	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	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	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

• Sponsor: Imperial College London
• Collaborators: 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

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: August 6, 2026
• First Submitted That Met QC Criteria: August 20, 2026
• First Posted (Actual): August 25, 2026

Study Record Updates

• Last Update Posted (Actual): August 31, 2026
• Last Update Submitted That Met QC Criteria: August 26, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; blood pressure; health services accessibility; service availability and readiness assessment
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID 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