Assessing Antimicrobial Use Patterns in Christian Health Association of Malawi (CHAM) Health Facilities: A Cross-Sectional Study Protocol

Abstract

Introduction The threat of antimicrobial resistance (AMR) in Malawi is high with reported mortality of 19,300 annually, the 23rd highest age-standardised mortality. One of the drivers of AMR is misuse of antibiotics, a phenomenon that has not been adequately researched in Malawi. This study aims to investigate antimicrobial use patterns using prescribing, patient and facility indicators Christian Health Association of Malawi (CHAM) health facilities.   Methods This will be a multiple cross-sectional study which will collect data from facility (194), patients (388), and prescriptions (3,104). Data will be collected using KoboToolbox v2021, and exported into Microsoft Excel version 2016 for cleaning and coding. Variables will be categorized according to the antimicrobial use indicators. The study will use STATA Version 14 statistical software for data analysis. Subsequently, facilities will be put in GPS map to show hotspots of irrational antimicrobial use. The study will run from January 2024 to December 2025.   Discussion This study will provide detailed information on frequently used antimicrobials, the cost of antimicrobials relative to medicine budget, the intensity of exposure to antimicrobials, the availability of antimicrobials, patients’ understanding of antimicrobials use, and availability of important documents for antimicrobial use. Secondarily, the study will unravel the prevalence of irrational antimicrobial use, the main factors contributing to it, and location where irrational use is most prevalent. These findings will inform the national antimicrobial stewardship action plan, aiming to safeguard the available antimicrobials.   Ethics and Dissemination The protocol has been approved by Malawi’s College of Medicine Research Ethics Committee (COMREC) [Protocol # P.04/24-0651]. Participation in the study will be voluntary, and consent and assent will be sought during data collection. Data will be handled confidentially, with findings disseminated in conferences, to key AMR focused stakeholders, and finally through manuscript publication in a peer reviewed journal.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

The author(s) received no specific funding for this work.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

INSTITUTIONS OF AFFILIATION: The study is affiliated to three institutions and these are (1) Christian Health Association of Malawi (CHAM), (2) Malawi-Liverpool Wellcome Programme (MLW), and (3) Kamuzu University of Health Sciences (KUHES; formerly University of Malawi, College of Medicine). ETHICS COMMITTEE/IRB: The study received ethical approval from College of Medicine Research Ethics Committee (COMREC). The ethics approval number is P.04/24-0651.

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.

Yes

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).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

This data from KoboToolbox v2021.2.4 will be downloaded to Microsoft Excel Version 2016, cleaned and coded. The data will be stored on a password-protected computer, and access will be restricted to only study team, and relevant authority under full authorization of the PI. The data will not be connected to patients as numbers and letters will be used to identify participants. Data will be archived for any future research and participants will assent and consent to the future use of data for research purposes.

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