HypertensionNCT06726057
Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan
A study testing Imlementation strategies in conjunction with multicomponent hypertension intervention and Multicomponent hypertension intervention in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Imlementation strategies in conjunction with multicomponent hypertension intervention and Multicomponent hypertension intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,459 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2024to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥35 years
- Residents of the selected clusters
- 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.
Who cannot join
- Pregnant women and persons with advanced illness (e.g., those receiving dialysis or with liver failure), cancer
- Unable to travel to the clinic
- Unwilling/unable to provide consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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 2.5 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 2.5 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).
- Conditions
- Hypertension
- Being tested
- Imlementation strategies in conjunction with multicomponent hypertension intervention, Multicomponent hypertension intervention
- Keywords
- multicomponent hypertension intervention, rural PAkistan, primary care setting, basic health unit, lady health workers, community health workers, hypertension in rural adult population, health education, blood pressure monitoring by community health workers, referrals, hypertension management, implementation trial, hybrid type III trial, implementation effectiveness trial, cluster randomized controlled trial, trial on hypertension, CFIR, ERIC, consolidated framework for implementation research, expert recommendations for implementation change
- Medical subject headings
- Hypertension, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imlementation strategies in conjunction with multicomponent hypertension interventionBehavioural
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.
Multicomponent hypertension interventionBehavioural
The multicomponent hypertension intervention has four components as follows:
- Training of community health workers (CHWs) in conducting health education sessions regarding hypertension, its risk factors, prevention, and health-seeking
- Blood pressure (BP) monitoring and referral of hypertensive individuals by CHWs to general practitioners in primary care facilities
- Training of general practitioners in primary care settings in BP monitoring and management of hypertension
- Hypertension care coordination in primary care facilities for the care of referred patients.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent hypertension intervention | Active comparator | The multicomponent hypertension intervention arm (control arm) will receive the proven multicomponent hypertension intervention (MCHI) comprising four components. Receives: Behavioral: Multicomponent hypertension intervention |
| Implementation strategies in conjunction with multicomponent hypertension intervention | Experimental | Implementation strategies in conjunction with multicomponent hypertension intervention arm (Intervention arm) will receive implementation strategies in conjunction with multi-component hypertension intervention (MCHI) Receives: Behavioral: Imlementation strategies in conjunction with multicomponent hypertension intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BP-lowering medications per participant
Primary outcome will be the change in BP-lowering medications per participant from baseline to end line
Measured: From enrollment to the end of Intervention at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Dec 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hybrid type III implementation-effectiveness cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 3,459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of York
- Responsible party
- Principal investigator, Zainab Samad, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726057
- Sponsor's protocol ID
- 2023-9084-26739
- Status last verified
- Aug 2026
- First submitted
- 29 Oct 2024
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Naeem I, Almas A, Sheikh A, Hewitt C, Khwaja H, Afaq S, Bukhari S, Soofi S, S Virani S, Hanif S, Hashmi S, Walker S, Bhutta ZA, Siddiqi K, Samad Z. Multicomponent intervention for controlling hypertension in the adult rural population of Pakistan: a protocol for a hybrid type III implementation-effectiveness cluster randomised controlled trial. BMJ Open. 2025 Jun 27;15(6):e100365. doi: 10.1136/bmjopen-2025-100365.
PubMed 40578881
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06726057
- Acronym / sponsor ID
- 2023-9084-26739
- Conditions
- Hypertension
- Keywords
- multicomponent hypertension intervention, rural PAkistan, primary care setting, basic health unit, lady health workers, community health workers, hypertension in rural adult population, health education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,459 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University of York
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 2.5 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 2.5 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hybrid type III implementation-effectiveness cluster randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Multicomponent hypertension intervention | Active comparator | Behavioral: Multicomponent hypertension interventionThe multicomponent hypertension intervention arm (control arm) will receive the proven multicomponent hypertension intervention (MCHI) comprising four components. |
| Implementation strategies in conjunction with multicomponent hypertension intervention | Experimental | Behavioral: Imlementation strategies in conjunction with multicomponent hypertension interventionImplementation strategies in conjunction with multicomponent hypertension intervention arm (Intervention arm) will receive implementation strategies in conjunction with multi-component hypertension intervention (MCHI) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥35 years
- Residents of the selected clusters
- Have hypertension defined as either:
Key exclusion criteria (3 listed)
- Pregnant women and persons with advanced illness (e.g., those receiving dialysis or with liver failure), cancer
- Unable to travel to the clinic
- Unwilling/unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imlementation strategies in conjunction with multicomponent hypertension interventionIn 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. | Behavioural | Implementation strategies in conjunction with multicomponent hypertension intervention |
| Multicomponent hypertension interventionThe 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. | Behavioural | Multicomponent hypertension intervention |
Primary outcome
Change in BP-lowering medications per participant
Time frame: From enrollment to the end of Intervention at 24 months
Primary outcome will be the change in BP-lowering medications per participant from baseline to end line
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Background: PubMed 40578881Naeem I, Almas A, Sheikh A, Hewitt C, Khwaja H, Afaq S, Bukhari S, Soofi S, S Virani S, Hanif S, Hashmi S, Walker S, Bhutta ZA, Siddiqi K, Samad Z. Multicomponent intervention for controlling hypertension in the adult rural population of Pakistan: a protocol for a hybrid type III implementation-effectiveness cluster randomised controlled trial. BMJ Open. 2025 Jun 27;15(6):e100365. doi: 10.1136/bmjopen-2025-100365.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imlementation strategies in conjunction with multicomponent hypertension intervention and Multicomponent hypertension intervention in people with Hypertension, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BP-lowering medications per participant (time frame: From enrollment to the end of Intervention at 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06726057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.