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CompletedNCT07784647ACTIONUpdated Sep 11, 2026

A Combination Triple Pill Implementation Strategy for Blood Pressure cONtrol

An observational study in Hypertension and Health Services Accessibility, sponsored by Imperial College London. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Imperial College London · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,444
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Hypertension
  • Health Services Accessibility

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Keywords

  • service availability and readiness assessment
  • hypertension
  • health services accessibility
  • blood pressure
03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 1,444 is above the median of 350 across 1,163 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Eligibility 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
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,444 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: 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.

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

Other outcomes

  1. 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.

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

  2. Experiences of hypertension care

    Experiences of hypertension care will be explored through qualitative data collected during focus group discussions and in-depth interviews.

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

  3. Perceptions of hypertension care

    Perceptions of hypertension care will be explored through qualitative data collected during focus group discussions and in-depth interviews.

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

  4. 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.

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

  5. 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.

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

07

Study locations

2 sites
  • University of Abuja
    Abuja, Federal Capital Territory, Nigeria
  • RemediumOne
    Colombo, Sri Lanka
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07784647
Collaborators
University of Abuja, RemediumOne, University of Kelaniya, The George Institute, The George Institute for Global Health, Australia, The University of New South Wales
Responsible party
Sponsor
First posted
Aug 25, 2026
Start date
Apr 1, 2026
Primary completion
Jul 21, 2026
Completion
Aug 7, 2026
Last update
Sep 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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