A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol

NCT07784647 | Completed

• 3 other identifiers: TGI_UK_PO_P01780NIHR207002 (41379)8021062
• Study Type: observational
• Target: 1,444
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Hypertension; Health Services Accessibility

Keywords

service availability and readiness assessment; hypertension; health services accessibility; blood pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• factors associated with poor control of hypertension

  Baseline (this cross-sectional survey includes a single study visit)

Other Outcomes (5)

• Availability of infrastructure and human and other resources for hypertension care

  Baseline (data is collected during a single study visit in this facility cross-sectional survey)

• Experiences of hypertension care

  Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)

• Perceptions of hypertension care

  Baseline (data is collected during a single study visit in the qualitative interviews and focus group discussions)

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• University of Abuja: collaborator
• The University of New South Wales: collaborator
• RemediumOne: collaborator
• University of Kelaniya: collaborator
• The George Institute: collaborator
• The George Institute for Global Health, Australia: collaborator

Study Sites (2)

University of Abuja

Abuja, Federal Capital Territory, Nigeria

Location

RemediumOne

Colombo, Sri Lanka

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 25, 2026
• Study Start: April 1, 2026
• Primary Completion: July 21, 2026
• Study Completion: August 7, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1); SR (1)