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A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07784647
Acronym
ACTION
Enrollment
1444
Registered
2026-08-25
Start date
2026-04-01
Completion date
2026-08-07
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Services Accessibility, Hypertension

Keywords

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

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.

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.

Interventions

None listed

Sponsors

Imperial College London
Lead SponsorOTHER
University of Abuja
CollaboratorOTHER
RemediumOne
CollaboratorUNKNOWN
University of Kelaniya
CollaboratorOTHER
The George Institute
CollaboratorOTHER
The George Institute for Global Health, Australia
CollaboratorOTHER
The University of New South Wales
CollaboratorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
prevalence of hypertension controlBaseline (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.

Secondary

MeasureTime frameDescription
factors associated with poor control of hypertensionBaseline (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.

Countries

Nigeria, Sri Lanka

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026