Improving implementation of innovations in treatment for cardiovascular disease in low- and middle-income countries: the IMPLEMENT-CVD Study

Background:

Cardiovascular disease (CVD) is the leading cause of death worldwide. CVD causes almost 18 million deaths each year, 10 million of which are caused by high blood pressure, or hypertension (blood pressure > 140/90 mm Hg). Four out of five CVD deaths occur in low-and middle-income countries (LMICs), and half of these are among people under 70-years of age.

The high number of CVD deaths in LMICs can be largely explained by gaps in treatment. Low drug availability, high costs of treatment and treatment complexity are among the leading barriers to hypertension and CVD treatment use in LMICs, and that the poorest are the most affected by these barriers.

Fixed-dose combination (FDC) therapies for treatment of hypertension (2-3 blood pressure lowering medications combined into one pill) or secondary prevention of CVD (2 blood pressure-lowering medications, a statin, with or without aspirin) are an innovation in drug treatment that offer a safe and effective solution for addressing known barriers to treatment such as treatment complexity and cost. FDCs for hypertension were added to the WHO Essential Medicines List in 2019 and evidence is building for the addition of FDCs for secondary prevention of CVD.

Aim and Objectives:

The overall aim of this research is to understand and address the factors affecting implementation of fixed-dose combination therapy for primary and secondary prevention of CVD in LMICs, focusing on the case of Kenya. Implementation here is defined as "active and planned efforts to mainstream an innovation within an organisation or system".

Drawing on implementation frameworks and theories developed in the UK, my objectives are:

1. To identify the health system factors and the interactions between them affecting implementation of FDCs for hypertension and CVD in Kenya. 2. To design evidence-based implementation strategies for FDCs for hypertension and CVD. 3. To assess the feasibility of these implementation strategies.

4. To adapt implementation research frameworks and theories developed in the UK to addressing these questions in a LMIC context and to share insight and tools for their adaptation to this purpose. 5. To evaluate the effectiveness and cost-effectiveness of the implementation strategy.

6. To adapt and apply the study tools to the development and evaluation of implementation strategies in other contexts with high CVD burden and low use of treatment.

7. To engage key stakeholders throughout the research process to ensure the relevance of the research for the Kenyan context and its impact more globally. Methods:

This programme of research will include 5 work packages. WP 1-3 will take place in Years 1-4 and WP 4 and 5 in years 5-7.

WP 1 will use document review, secondary data analysis and qualitative interviews to identify factors affecting implementation of FDCs in Kenya, using the NASSS implementation framework developed in the UK.

WP2 will use findings from WP1 and the best available evidence to co-create an implementation strategy with key stakeholders, including components at all levels of the health system, and to develop at Theory of Change;

WP3 will evaluate the strategy: i) the feasibility of health service level components will be evaluated using a pilot intervention at 2 health facilities in Trans Nzoia and Busia counties in Kenya; ii) the feasibility of policy components will be evaluated using stakeholder analysis. WP4 will evaluate the effectiveness and cost-effectiveness of the implementation strategy.

WP5 will apply the adapted frameworks and data collection tools used in this research to other LMIC where CVD burden is high and implementation of FDCs is low. Impact:

This research stands to have a significant impact on CVD policy in LMICs and implementation research approaches. I will engage stakeholders throughout the research process to ensure this impact is achieved.