Studying the practicality and acceptability of a community intervention to manage high blood pressure in rural Kenya and The Gambia

Plain English Summary

Background and study aims
High blood pressure (known medically as hypertension) is a major cause of death worldwide, causing over 10.8 million deaths each year. In sub-Saharan Africa (SSA), high blood pressure is very common and often leads to serious health problems like heart failure, stroke, and kidney disease. In rural areas of SSA, many people do not know they have high blood pressure, or they do not receive the treatment they need. This study aims to find better ways for the diagnosis and management of high blood pressure in these regions.

This study wants to find out whether trained community health workers can help identify people with high blood pressure in rural areas of Kenya and The Gambia by checking their blood pressure and sending those with high blood pressure to a health facility. At the health facility, healthcare providers will do more checks, and if needed, give them a simple treatment of one pill that contains two medicines for treating high blood pressure (Fixed Dose Combination). These medicines are called ‘Amlodipine’ and ‘Perindopril’. Research has shown they are safe and effective, and they are approved and licensed for sale and use in Kenya and The Gambia. They have been chosen because research evidence shows that most patients need two medicines to control their blood pressure and that Amlodipine works well in treating blood pressure for patients of black African origin. The study will examine if this way of identifying and managing high blood pressure is practical and acceptable to both healthcare providers and patients. The study will also assess any challenges faced in using this way of delivering high blood pressure services and how it can be made to work in the long term.

Who can participate?
The study will take place in two rural sites: Kilifi South and Kilifi North in Kenya and Kiang West in The Gambia, and plans to include 500 participants, with 250 from each country. Participants will be chosen randomly from the local population in Kilifi North and South, areas that are covered by the Kilifi Demographic Health Surveillance System and Kiang West in the Gambia, and they will be between 30 to 80 years old.

What does the study involve?
This study will involve three main parts. First, Community Health Promoters (CHPs) in Kilifi, Kenya or Village Health Workers (VHWs) in Kiang West, in The Gambia will visit people’s homes to check their blood pressure using a simple machine. If someone has high blood pressure, they will be sent to a health facility for more tests to see if they are at risk for heart disease or if their organs (such as the heart, kidneys, or eyes) have been affected. People who have high blood pressure will be advised on lifestyle changes by the healthcare provider (nurse/clinical officer), and if they are at high risk for heart disease or their organs are affected, the healthcare provider at the health facility will provide a fixed-dose combination (FDC)- (a single pill that combines two medicines) to lower their blood pressure. After that, community healthcare providers will continue to visit participants at their homes to check their blood pressure and make sure they are taking their medication regularly. If someone’s blood pressure is still high, they will be asked to go back to the health facility for further help. The frequency of home visits for those patients put on the FDC pill (one pill with two high blood pressure drugs) will vary depending on whether participants’ blood pressures are well-controlled or not.

In addition to this process to identify and treat people with high blood pressure, members of the study team will also talk to participants and healthcare providers to understand their experiences with it. They want to know if this way of managing high blood pressure is easy to use and acceptable for everyone involved, and what challenges they may face. This will help us learn how to improve this approach in the future. They will also observe some community healthcare workers and healthcare providers at the health facilities to see if they are doing everything they are supposed to do correctly. This will help us understand whether their training was effective, and whether the tasks are practical or if they are too difficult or complex to do.

What are the possible benefits and risks of participating?
For healthcare providers, being part of the study might mean seeing more patients than usual, especially during the first month when blood pressure screenings are happening. The study will schedule activities on the same day as the regular blood pressure (hypertension) clinic. While there are no direct personal benefits for healthcare providers, their participation will help improve our understanding of how to manage high blood pressure in the community and shape future health policies.

For community participants, the main risk during the study is a brief discomfort when their blood pressure is checked using a cuff that squeezes their upper arm, but this will only last a few seconds. The study visits and activities in the community will take about 15 minutes and will be done at their homes, so they do not need to travel and it shouldn’t disrupt their daily routine. If someone is found to have high blood pressure, they will need to go to a healthcare facility for further tests, which might take more time and they will need to cover their own travel costs.

Fixed dose combinations are included in the guidelines for the management of high blood pressure. There is already a strong evidence base for their effectiveness and potential to reduce treatment burden. The specific product proposed is already authorised for marketing in Kenya and it will be used exactly as licensed in the proposed feasibility study. The study will meet the costs of the tests offered at the primary healthcare facility and drugs for the patients who are put on FDC (one pill with two medications for hypertension treatment). The drugs used in this study are already available in the Kenyan market. One year’s worth of the medication will be to study participants and are working with Kilifi County Health Department and KEMSA to facilitate procurement for the longer term.

For the part of the study that talks to participants about their experiences, they will be asked to come to a convenient location and their travel costs will be covered. Patient/caregiver participants will be reimbursed for travel costs incurred and Kshs 500 r for out-of-pocket expenses for any interviews or focus group discussions conducted at the health facility. These talks will also be scheduled at times that suit them. During these conversations, participants can choose not to answer any questions they find uncomfortable. If participants need medication to manage their high blood pressure, there may be some side effects, which a healthcare provider will explain to them in detail. The main benefit for patients is finding out if they have high blood pressure and getting help to manage it early.

When does the study start and how long is it expected to run for?
August 2024 to December 2025. The study will start once ethical approval is obtained and run until December 2025. The overall study duration for the participants receiving the intervention will be 6 months.

Who is funding the study?
National Institute for Health and Care Research (NIHR), UK

Who is the main contact?
Prof Pablo Perel, pablo.perel@lshtm.ac.uk
Dr Anthony Etyang, AEtyang@kemri-wellcome.org

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Gambia
• Kenya

Study participating centres

Sponsor information

London School of Hygiene & Tropical Medicine
University/education

Keppel Street
London
WC1E 7HT
England
United Kingdom

Phone	+44 (0)20 7636 8636
Email	rgio@lshtm.ac.uk
Website	https://www.lshtm.ac.uk
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Government

Results and Publications

Editorial Notes

09/04/2025: The following changes were made:
1. The recruitment start date was changed from 01/04/2025 to 01/05/2025.
2. The recruitment end date was changed from 30/04/2025 to 30/06/2025.
3. A new study contact was added.
06/02/2025: Study's existence confirmed by the Gambia Government/Medical Research Council Joint Ethics Committee.