Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan

January 29, 2026 updated by: Zainab Samad, Aga Khan University

A Multi-component Intervention for Controlling Hypertension in the Adult Rural Population of Pakistan: a Protocol for a Hybrid Type III Implementation-effectiveness Cluster Randomized Controlled Trial

This is a research about cardiovascular disease risk reduction: a comprehensive package for the reduction of risk in Sindh, Pakistan. The research is being conducted by the Aga Khan University and is funded by the National Institute of Health and Care Research UK.

Hypertension is a major public health concern globally. It is a significant risk for cardiovascular disease (CVD) and premature death. In Pakistan, the prevalence of hypertension, including those on medication, is high. However, there are also high rates of undertreatment and underdiagnosis of hypertension in Pakistan. Addressing the prevention and control of CVD requires a multi-faceted approach that targets diverse populations across different settings. In some populations, we have interventions that have been proven effective but have not been implemented for example in rural communities. In Pakistan, prior community-based trial regarding multi-component hypertension intervention has proven to be effective in reducing blood pressure. However, the findings of this work have not translated to change in practice on the ground suggesting the need for implementation research to examine the best ways to implement this intervention in the real world. Hence, in this study researchers aim to assess the impact of this evidence-based intervention when implemented at scale in rural communities.

Participants will be asked to participate in a research study designed to improve their blood pressure control. This study enrols participants aged 35 years and above. As part of this study, they will undergo:

  • blood pressure measurements at regular intervals by lady health workers
  • home health education sessions conducted by lady health workers
  • participants may be referred to a nearby health facility/qualified medical practitioners for management of high blood pressure
  • baseline survey at the start of the study having questions about participants' medical history, risk factors for cardiovascular disease and high blood pressure and bodily measurements including weight, height and waist circumference
  • follow-up surveys every 6 months for 2 years. The survey questions will comprise of medical history, risk factors for cardiovascular disease and high blood pressure; and bodily measurements including weight, height and waist circumference
  • blood and urine samples for testing at baseline survey and during endline survey

POSSIBLE RISKS OR DISCOMFORT

There are no risks involved as a result of participants' participation in this study except for their time. Since they will be followed up for 2 years, any new information developed during the study that may affect their willingness to continue participation will be communicated to them. Participants may feel a little discomfort at the site of the needle prick when drawing a blood sample.

POSSIBLE BENEFITS

Participants will be able to know about their risk of high blood pressure and cardiovascular disease. They'll be referred to a qualified medical practitioner for the management of your high blood pressure. Also, the results of their blood and urine tests will be shared with participants that will help them know about their health.

The main contact for this research study is the principal investigator Dr Zainab Samad (02134864660).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3476

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥35 years
  2. Residents of the selected clusters

  3. Have hypertension defined as either:

    • Persistently elevated BP (Systolic blood pressure [SBP] SBP ≥140 mm Hg or diastolic blood pressure [DBP] DBP ≥90 mm Hg) from each set of the last two of the three readings from two separate days, where BP measurements on the same day were measured at least 1 minute apart OR
    • Diagnosed previously by a physician as hypertensive and/or on antihypertensive medications.

Exclusion Criteria:

  1. Pregnant women and persons with advanced illness (e.g., those receiving dialysis or with liver failure), cancer
  2. Unable to travel to the clinic
  3. Unwilling/unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Multicomponent hypertension intervention
The multicomponent hypertension intervention arm (control arm) will receive the proven multicomponent hypertension intervention (MCHI) comprising four components.
Behavioral: Multicomponent hypertension intervention

The multicomponent hypertension intervention has four components as follows:

  1. Training of community health workers (CHWs) in conducting health education sessions regarding hypertension, its risk factors, prevention, and health-seeking
  2. Blood pressure (BP) monitoring and referral of hypertensive individuals by CHWs to general practitioners in primary care facilities
  3. Training of general practitioners in primary care settings in BP monitoring and management of hypertension
  4. Hypertension care coordination in primary care facilities for the care of referred patients.
Experimental: Implementation strategies in conjunction with multicomponent hypertension intervention
Implementation strategies in conjunction with multicomponent hypertension intervention arm (Intervention arm) will receive implementation strategies in conjunction with multi-component hypertension intervention (MCHI)
Behavioral: Imlementation strategies in conjunction with multicomponent hypertension intervention
In this study, the researchers will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) programme in Pakistan. Implementation strategies will be devised through an engagement process and will involve the use of implementation frameworks including the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators to the implementation of MCHI& Expert Recommendations for Implementation Change (ERIC) to identify a set of implementation strategies addressing each barrier. Input for the development of strategies will be sought from the community, public health sector managers, general practitioners and community health workers. The implementation strategies will be used to randomise study clusters while MCHI will be implemented in both intervention and control arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BP-lowering medications per participant
Time Frame: From enrollment to the end of Intervention at 24 months
After estimating the proportional change in the number between the baseline and the 24-month follow-up, the mean difference between both the study arms will be estimated. A mean difference of 0.1 would be considered clinically significant.
From enrollment to the end of Intervention at 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implementation outcomes [as per RE-AIM framework domain of Adoption ]
Time Frame: From enrollment to the first 12 months of Intervention
The proportion of LHWs from 30 study clusters conducting HHE sessions, monitoring blood pressure and doing referrals of hypertensive patients to health facilities during the first 12 months Data source: HHE and referral checklists by LHWs, Baseline/follow-up survey
From enrollment to the first 12 months of Intervention
Implementation outcomes [as per RE-AIM framework domain of Adoption ]
Time Frame: From enrollment to the first 12 months of Intervention
The proportion of GPs from 30 study clusters screening and providing hypertension management to hypertensive patients at BHU/RHC referred by LHW during the first 12 months Data source: GP checklists, Baseline/follow-up surveys
From enrollment to the first 12 months of Intervention
Implementation outcomes [as per RE-AIM framework domain of Implementation]
Time Frame: From enrollment to the end of Intervention at 24 months
The mean number of the planned home visits/participant over 24 months (a maximum of sixteen visits, one every 3 months, are planned per participant) by LHW for HHE and BP monitoring Data source: LHWs' HHE and referral checklists, Baseline/follow-up surveys
From enrollment to the end of Intervention at 24 months
Implementation outcomes [as per RE-AIM framework domain of Implementation]
Time Frame: From enrollment to the end of Intervention at 24 months
The mean number of healthcare contacts with GPs at the Basic Health Unit per participant over 24 months among those identified as having uncontrolled BP (SBP≥140 mm Hg and/or DBP≥90 mm Hg) by LHW at one or more than one occasion during the trial Data source: GP checklists, Baseline/follow-up surveys
From enrollment to the end of Intervention at 24 months
Implementation outcomes [as per RE-AIM framework domain of Maintenance]
Time Frame: From enrollment to the end of Intervention at 24 months

The proportion of participants receiving visits by LHWs for HHE and BP monitoring at 6, 12, and 24 months.

Data source: LHWs' HHE & referral checklists, Baseline/follow-up surveys
From enrollment to the end of Intervention at 24 months
Implementation outcomes [as per RE-AIM framework domain of Maintenance]
Time Frame: From enrollment to the end of Intervention at 24 months

The proportion of participants that received advice and/or treatment from the GPs at the Basic Health Unit after being identified as having uncontrolled BP (SBP≥140 mm Hg and/or DBP≥90 mm Hg) by LHW at 6, 12, and 24 months.

Data source: GP checklists, Baseline/follow-up surveys
From enrollment to the end of Intervention at 24 months
Effectiveness outcomes
Time Frame: From enrollment to the end of Intervention at 24 months
Health-related quality of life i.e., EQ-5D-5L range, 0 to 100, with higher scores indicating better health.
From enrollment to the end of Intervention at 24 months
Effectiveness outcomes
Time Frame: From enrollment to the end of Intervention at 24 months
The proportion of participants with blood-pressure control (SBP 140 mmHg and DBP 90 mmHg)
From enrollment to the end of Intervention at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

University of York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 10, 2024

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-9084-26739

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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