{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T12:32:27Z","timestamp":1777984347114,"version":"3.51.4"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.24040.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:00:00Z","timestamp":1775692800000}},{"DOI":"10.12688\/wellcomeopenres.24040.2","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:00:00Z","timestamp":1775692800000}},{"DOI":"10.12688\/wellcomeopenres.24040.3","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:00:00Z","timestamp":1775692800000}}],"reference-count":24,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T00:00:00Z","timestamp":1775692800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"NIHR Global Professorship","award":["NIHR301627"],"award-info":[{"award-number":["NIHR301627"]}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>Background Healthcare associated infections (HAIs) are infections that patients acquire while receiving treatment and are not present during admission. The prevalence of HAIs is typically higher (15%) in low-and middle-income countries than that in high-income countries (7%). HAIs present a significant burden on patients, families, and health systems as they contribute to longer hospital stays, increased healthcare costs, and antimicrobial resistance. HAIs can be prevented or reduced by implementing infection prevention and control (IPC) measures. However, IPC measures are often poorly implemented due to resource shortages, lack of training, and other systemic challenges. The goals of this formative study were twofold: 1. to carry out a situational analysis of IPC practices for HAI control in three hospitals in Southern Malawi, highlighting specific bottlenecks and enablers of IPC practices; and 2. to co-design tailored implementation strategies based on insights from situational analysis using participatory approaches with key IPC stakeholders to support more consistent and effective IPC implementation at the study sites. Methods The study will be conducted in three health facilities in Malawi representing different healthcare levels: Queen Elizabeth Central Hospital, Zomba Central Hospital, and Chikwawa District Hospital. For situational analysis, six data collection tools will be used: a desk review of IPC policies and guidelines, the World Health Organization IPC Assessment Framework, participant and non-participant structured observations, interviews, and focus group discussions. The participatory component involves a three-day co-design workshop. Participants in both study components will include healthcare workers, support staff, policymakers, patients, and patient caregivers (guardians). Descriptive statistics will be used to analyse the quantitative data. A thematic framework analysis using NVivo 12 will be done on the qualitative data. The findings will be disseminated through workshops, academic publications, and stakeholder meetings. Conclusion Multifaceted IPC implementation strategies tailored to the context of each hospital will be designed.<\/ns3:p>","DOI":"10.12688\/wellcomeopenres.24040.4","type":"journal-article","created":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T11:49:06Z","timestamp":1775735346000},"page":"223","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Designing implementation strategies for improving infection prevention and control in acute healthcare facilities in Malawi: A formative study protocol"],"prefix":"10.12688","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-8766-8669","authenticated-orcid":false,"given":"Dorica","family":"Ng'ambi","sequence":"first","affiliation":[{"name":"Infection Biology - BDRI Blantyre Southern Region Malawi-Liverpool-Wellcome Trust Clinical Research Programme"},{"name":"Clinical Sciences Liverpool England Liverpool School of Tropical Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tara","family":"Tancred","sequence":"additional","affiliation":[{"name":"Clinical Sciences Liverpool England Liverpool School of Tropical Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4041-1405","authenticated-orcid":false,"given":"Nicholas","family":"Feasey","sequence":"additional","affiliation":[{"name":"Infection Biology - BDRI Blantyre Southern Region Malawi-Liverpool-Wellcome Trust Clinical Research Programme"},{"name":"Clinical Sciences Liverpool England Liverpool School of Tropical Medicine"},{"name":"The School of Medicine St Andrews Scotland University of St Andrews Faculty of Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wilned Zoto","family":"Hara","sequence":"additional","affiliation":[{"name":"Quality Improvement Unit Blantyre Southern Region Queen Elizabeth Central Hospital"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Owen","family":"Musopole","sequence":"additional","affiliation":[{"name":"Quality Management Directorate Lilongwe Central Region Government of Malawi Ministry of Health"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomasena","family":"O'Byrne","sequence":"additional","affiliation":[{"name":"Infection Biology - BDRI Blantyre Southern Region Malawi-Liverpool-Wellcome Trust Clinical Research Programme"},{"name":"Clinical Sciences Liverpool England Liverpool School of Tropical Medicine"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2026,4,9]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1186\/s13756-016-0149-9","article-title":"Core Components for Effective Infection Prevention and Control Programmes: New WHO Evidence-Based Recommendations.","volume":"6","author":"J Storr","year":"2017","journal-title":"Antimicrob Resist Infect Control."},{"key":"ref2","doi-asserted-by":"publisher","first-page":"228-241","DOI":"10.1016\/S0140-6736(10)61458-4","article-title":"Burden of Endemic Health-Care-Associated Infection in Developing Countries: Systematic Review and Meta-Analysis.","volume":"377","author":"B Allegranzi","year":"2011","journal-title":"Lancet."},{"key":"ref3","doi-asserted-by":"publisher","first-page":"845-856","DOI":"10.1016\/S1473-3099(21)00809-4","article-title":"The First WHO Global Survey on Infection Prevention and Control in Health-Care Facilities.","volume":"22","author":"S Tomczyk","year":"2022","journal-title":"Lancet Infect Dis."},{"key":"ref4","doi-asserted-by":"publisher","first-page":"e1178-e1180","DOI":"10.1016\/S2214-109X(17)30427-8","article-title":"Global Infection Prevention and Control Priorities 2018\u201322: A Call for Action.","volume":"5","author":"B Allegranzi","year":"2017","journal-title":"Lancet Glob 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v4\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v4\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v4\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T11:49:07Z","timestamp":1775735347000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4,9]]},"references-count":24,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.24040.4","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/wellcomeopenres.24040.3","asserted-by":"subject"},{"id-type":"doi","id":"10.12688\/wellcomeopenres.24040.2","asserted-by":"subject"},{"id-type":"doi","id":"10.12688\/wellcomeopenres.24040.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.28812.r152969","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.28812.r152967","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4,9]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v4#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.28214.r144787, Nehad J Ahmed, Prince Sattam Bin Abdulaziz University, Al Kharj, 18 Mar 2026, version 3, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v3#referee-response-144787","order":0,"name":"referee-response-144787","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.28214.r145013, Eva Cappelli, Universita degli Studi di Verona, Verona, Veneto, 23 Jan 2026, version 3, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v3#referee-response-145013","order":1,"name":"referee-response-145013","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Dorica Ng'ambi<\/b>; \n<i>Posted: 27 Feb 2026<\/i>; This is a timely and ambitious study addressing a critical gap in the implementation of Infection Prevention and Control practices in resource-constrained healthcare settings. The following comments aim to strengthen the clarity and methodological rigour of an otherwise strong protocol. Thank you.  \n<b>Comment 1. <\/b>The methods are generally well described and reflect a robust and well-integrated mixed-methods design. The use of multiple data sources (IPCAF, observations, interviews, FGDs, and a participatory workshop) represents a major strength of the protocol. However, some elements would benefit from further clarification to fully support replication. In particular, the protocol does not explicitly state the implementation science framework guiding the identification and interpretation of barriers and enablers, which may limit analytical transparency and comparability across studies (e.g. Consolidated Framework for Implementation Research, Theoretical Domains Framework, Capability\u2013Opportunity\u2013Motivation\u2013Behaviour). \n<b>Response 1. <\/b>Thank you for this comment. We are using the Exploration, Preparation, Implementation and Sustainment (EPIS) framework and have described how this has been used in this phase of the study.  \n<b>Comment 2.<\/b> In addition, the process by which findings from the situational analysis will be translated into specific and prioritised implementation strategies during the participatory workshop could be described in more detail (e.g. criteria for prioritisation, decision-making or consensus processes). \n<b>Response 2. <\/b>We agree and have added more detail here. Specifically, we have indicated that, \u201c\n<i>. In participatory workshops, findings from the situational analysis will be presented for initial reflection and discussion. The most pressing problems that will emerge from these discussion will be revisited in smaller groups. There, root cause analysis will be carried out using problem trees to identify the major causes and contributing factors to these larger problems. Participants will then rank the root causes to address using a problem prioritisation matrix, which will be based on feasibility, affordability and impact. Following this exercise, participants will reflect against the root causes that will be deemed to be the most feasible, affordable and impactful to address, and from these, a group brainstorming activity will be carried out in which possible activities to address these root causes could be undertaken. These, too, will be prioritised on the basis of feasibility, affordability and impact. Overlapping activities will be synthesised into wider implementation strategies that could accomplish them, leading to the creation of the implementation strategies.\u201d<\/i>  \n<b>Comment 3.<\/b> Given the well-documented staff shortages in the study context, further clarification on how the proposed implementation strategies will account for existing workload constraints and long-term sustainability would also be valuable. \n<b>Response 3.<\/b> Thank you for this observation. As participatory research will be used to establish the implementation strategies, the well-known staff shortages were taken into consideration by stakeholders, particularly as they reflected around \u201cfeasibility\u201d aspects of activities. As such, stakeholders proposed ways in which the proposed implementation strategies could be incorporated into routine work in the facilities, and how newly established responsibilities may fit within existing roles and supervisory structures in the facilities.  \n<b>Comment 4.<\/b> Finally, although observation methods are clearly outlined, the manuscript could more explicitly address how potential observer effects (e.g. Hawthorne effect) will be mitigated. Addressing these points would strengthen methodological clarity, feasibility, and reproducibility. \n<b>Response 4.<\/b> Thank you for this observation, we have addressed the Hawthorne effect under data collection.  \n<b>Comment 5.<\/b> As this is a study protocol, datasets are not yet available; however, data management and anonymisation procedures are clearly described and represent a strength. Greater clarity would nonetheless be beneficial regarding future data accessibility and reuse, for example by specifying which datasets (e.g. aggregated IPCAF scores or de-identified observation summaries) will be shared, in what formats, and under what access conditions. Brief clarification on how qualitative data excerpts will be curated to protect confidentiality would further strengthen transparency and alignment with open science practices. \n<b>Response 5. <\/b>Thank you for this suggestion. We have clarified and added the anticipated data sharing approach.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v4#referee-comment-6449","order":2,"name":"referee-comment-6449","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.28214.r145012, Jennifer JP Collins, University of the West of Scotland, Paisley, Scotland, 16 Feb 2026, version 3, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v3#referee-response-145012","order":3,"name":"referee-response-145012","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Dorica Ng'ambi<\/b>; \n<i>Posted: 27 Feb 2026<\/i>; Thank you for the opportunity to review this pertinent research, which I believe will bring a clear added value to the existing scientific literature on infection, prevention and control implementation  \n<b>Comment 1.&nbsp;<\/b>It would be useful to more clearly state in the introduction when discussing facility level vs national as this is not explicit to the reader at present. It may also be helpful to stress the difference between the minimum requirements and the core components when introducing these. \n<b>Response 1.<\/b> Thank you for this comment, this has been addressed in the introduction  \n<b>Comment 2.&nbsp;<\/b>It is recommended to include relevant WASH documents within the desk review, as several pertinent guidance on this overlap and include components on Infection, prevention and control at the facility level (such as the WASHFIT guideline). This is particularly important as the study includes considerations for the hospital environment. \n<b>Response 2.<\/b> Thank you for your observation. This has been included under the desk\/document review section. It was an oversight, as already in Malawi the IPC guidelines includes the WASH component. &nbsp; \n<b>Comment 3.&nbsp;<\/b>The methods mention using IPCAF in surgical and medical departments. As this is a facility wide tool it is not clear what is meant by this, and how this would be conducted. It is important to clarify why these departments alone are mentioned (in relation to the IPCAF). It would also help to understand if this suggests a need for tool adaption if only being used in departments, given the questions and indicators focus on the facility level. This should be addressed to ensure scientific rigor. \n<b>Response 3.<\/b> Thank you for noting this mistake, it has been corrected the IPCAF survey will be conducted for the facility not in the previously mentioned departments.  \n<b>Comment 4.&nbsp;<\/b>It would be important to consider measures to mitigate observer bias within the observation of IPC practices, or the consideration for this within the data analysis. These should be included within the methodology and\/or data analysis section. \n<b>Response 4.<\/b> Thank you for this comment. This has been addressed under data collection  \n<b>Comment 5.&nbsp;<\/b>The inclusion of cleaners within the study is pertinent and should bring an important under reported perspective to the study. \n<b>Response 5.<\/b> Thank you.  \n<b>Comment 6.&nbsp;<\/b>As the research focuses on implementation it would be useful to draw on frameworks from Implementation Science and to structure the components within these. \n<b>Response 6.<\/b> Thank you for this comment. We have included the Exploration, Preparation, Implementation and Sustainment framework as its overall phased approach aligns very well with our study design. This formative phase aligns with the \u201cexploration\u201d and \u201cpreparation\u201d phases of EPIS, and much of the qualitative enquiry we will carry out maps to better understanding \u201cinner\u201d and \u201couter\u201d contextual factors. We have made this more clear in the manuscript.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/10-223\/v4#referee-comment-6450","order":4,"name":"referee-comment-6450","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This study is funded and supported by NIHR Global Professorship (NIHR301627). The funders had no role in study design, preparation of the manuscript and decision to publish. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":5,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}