Browsing by Author "Mwale S"

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Challenges that may impact achieving and maintaining accreditation in clinical laboratories in Zambia during the COVID-19 pandemic.
(2021) Daka V; Mubanga M; Mukanga B; Mfune RL; Chileshe M; Machiko A; Mudenda S; Chikwanda E; Mudenda T; Simusika P; Mwale S; Musalula S; Ndola Teaching Hospital, Ndola, Zambia.; Mary Begg Health Services, Ndola, Zambia.; University of Zambia, School of Veterinary Medicine, Lusaka, Zambia.; Public Health Department, School of Medicine, Copperbelt University, Ndola, Zambia.; University of Zambia, School of Health Sciences, Lusaka, Zambia.; Tropical Diseases Research Centre, Ndola, Zambia.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Engagement of ethics and regulatory authorities on human infection studies: Proceedings of an engagement workshop in Zambia.
(2021) Kunda-Ng'andu EM; Simuyandi M; Kapulu M; Chirwa-Chobe M; Mwanyungwi-Chinganya H; Mwale S; Chilengi R; Sharma A; Nuffield Department of Medicine, Centre for Tropical Medicine and Global Health, University of Oxford, Oxford, UK.; Research Department, The centre for Infectious Disease Research in Zambia, Lusaka, Zambia, 10101, Zambia.; Biosciences, KEMRI-Wellcome trust research Programme, Kilifi, Kenya.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
Human infection studies (HIS) have generally been used as a tool in the pathway for vaccine development in high income settings. Over the last decade, this model has been implemented in LMICs with the aim of accelerating development of next generation vaccines that would perform better in these settings. However, in most LMICs, the ethics and regulatory framework for the conduct of these studies are not in place. In Zambia, these studies are yet to be conducted and thus we conducted a stakeholder engagement workshop in October 2019. We engaged with bioethicists, regulatory authority officials, and scientists from within Zambia and other African countries to anticipate and address foreseeable ethical and regulatory issues when conducting HIS in Zambia for the first time. The workshop largely focused on sensitizing the stakeholders on the benefits of these studies with the following main points for consideration on the implementation of these studies in Zambia: need for in-country legal framework and guidelines; need for adequate informed consent based on comprehensive understanding of the concept of HIS and study requirements; and requirements for heightened vigilance to assure participant safety including good ethical and clinical practice with regulatory, ethical, data safety, and community oversight. Additionally, the workshop emphasized the need for rigorous health screening prior to enrolment; suitable infrastructure for containment; and personnel to provide appropriate treatment including emergency resuscitation and evacuation if indicated. Specific recommendations included compensation for burden of participation; access to care and provision for study related injury (e.g. no-fault insurance); and withdrawal and exit procedures to preserve individual and community safety. Finally, the meeting concluded that researchers should actively engage key gate keepers including civic leaders such as parliamentarians, universities, researchers, potential participants and laypersons to avoid circulation of misinformation.
HIV treatment and monitoring patterns in routine practice: a multi-country retrospective chart review of patient care.
(2018) Musa BM; Ibekwe E; Mwale S; Eurien D; Oldenburg C; Chung G; Heller RF; People's Open Access Education Initiative, Manchester, M30 9ED, UK.; Johnson & Johnson, New Brunswick, NJ, 08901, USA.; Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, M15 6GX, UK.; Department of Medicine, Aminu Kano Teaching Hospital, Bayero University Kano, Kano, Nigeria.; Department of Ophthalmology, University of California, San Francisco, San Francisco, CA, 94143, USA.; Centre for Infectious Disease Research in Zambia, Lusaka, 10101, Zambia.; The Francis I. Proctor Foundation for Research in Ophthalmology, University of California, San Francisco, San Francisco, CA, 94143, USA.; Advanced Field Epidemiology Training Program , Kampala, Uganda.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)