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NCT Number: NCT07784647

A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Abuja, Abuja, Federal Capital Territory, Nigeria

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • RemediumOne
  • The George Institute
  • The George Institute for Global Health, Australia
  • The University of New South Wales
  • University of Abuja
  • University of Kelaniya

Registry information

Official study title

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

Acronym: ACTION

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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