Acceptability of fixed-dose combination treatments for hypertension in Kenya: a qualitative study using the Theoretical Framework of Acceptability.

medrxiv(2024)

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摘要
Background Fixed-dose combinations (FDCs) – 2-3 anti-hypertensive medications in a single pill - have the potential to improve hypertension treatment and outcomes. Yet, they are not widely implemented. Factors undermining implementation remain unknown, particularly in sub–Saharan Africa, where hypertension is a major cause of disease burden and is poorly treated. Methods We used in-depth semi-structured interviews to explore the acceptability of FDCs among patients, caregivers, and healthcare workers. We interviewed a total of 58 participants across four purposively selected health facilities in one county in Kenya. Data were analyzed using abductive thematic analysis approach, and emergent themes categorized according to the Theoretical Framework of Acceptability. Results Overall, FDCs are potentially acceptable to all participant groups. Acceptability is supported by a perception of FDCs as a means of reducing treatment burden (for patients and healthcare workers) and improving treatment adherence, and patients’ deferral to and trust in health workers. Acceptability among health workers may be undermined by variable levels of FDC coherence, concerns among health workers about FDCs as an “inflexible” treatment that does not allow dose titration or identifying causes of side effects, and concerns about consistent availability and affordability of FDCs in Kenya. Conclusion FDCs are a potentially acceptable treatment approach for hypertension in Kenya. Efforts to improve acceptability and thus implementation of FDCs in Kenya should consider improving understanding of treatment and strengthening the capacity of all health worker cadres to appropriately prescribe, inform about, and support adherence to FDCs. These efforts must align with work to address upstream health system factors such as poor availability and affordability. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement We acknowledge UKRI for funding this research study through the UKRI Future Research Leader Fellowship grant awarded to Dr Adrianna Murphy by the UK Research and Innovation fund, grant number MR/T042508/1. The funding sources had no role in the study design, writing of the report and in the decision to submit the manuscript for publication. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Not Applicable The details of the IRB/oversight body that provided approval or exemption for the research described are given below: This study was approved by Kenya Medical Research Institute’s scientific and ethics review unit (SERU) (Approval NO: KEMRI/RES/7/3/1), National Commission of Science and Technology (NACOSTI) (Approval NO: NACOSTI/P/22/21524) and London School of Hygiene and Tropical Medicine Research Ethics Committee (28062). Permissions were also granted by the county government and each facility before commencement of the study. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Not Applicable I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Not Applicable I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Not Applicable The dataset used during this study is available from the authors upon reasonable request and permission from the KEMRI Wellcome Trust Research and Governance Committee.
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