Browsing by Author "Mbeye, Nyanyiwe"

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    Efficacy, safety and pharmacokinetic exposure of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in HIV infected Malawian children on antiretroviral treatment
    (Kamuzu University of Health Sciences, 2021-03-17) Mbeye, Nyanyiwe
    Type of research study: A prospective observational study will recruit and follow up two groups of children aged between 6 months and 16 years diagnosed with uncomplicated malaria in Lilongwe district. One group will be HIV infected and on antiretroviral treatment and another one will be HIV uninfected. The problem: There is paucity of consolidated evidence to guide optimisation of the current arsenal of drugs that are used to fight malaria in individuals co-infected with HIV especially in key at-risk subpopulations such as children. Potential drug-drug interactions between antimalarial drugs and antiretroviral therapy (ART) raise concern in the control of malaria in children who are co-infected with HIV. Artemether-lumefantrine (AL) is a commonly used artemisinin-based combination therapy (ACT) in most malaria programmatic settings but there is limited understanding of its efficacy in malaria and HIV co-infected children in light of the potential drug-drug interactions between ACTs and ART. WHO recommends countries to evaluate efficacy of their first-line antimalarial drugs at least once every two years. Since these studies are done in HIV negative children, there is an important need to assess the efficacy of first-line antimalarial drugs in HIV infected children on ART as well. Objective: This study aims to evaluate the efficacy and safety of artemether lumefantrine (AL) for the treatment of uncomplicated P. falciparum malaria in HIV infected and HIV uninfected children in Lilongwe, Malawi. Methodology: A prospective observational study of antimalarial efficacy will be conducted in a total of 71 HIV-malaria coinfected children on ART and 141 HIV uninfected children with confirmed malaria who meet the inclusion criteria. Once enrolled, participants will be given AL for treatment and followed up for 28 days. The follow up will consist of fixed schedule of visits (at Day 1,2,3,7,14,21 and 28) with corresponding clinical and laboratory examinations. The proportion of participants experiencing therapeutic failure during the follow-up period will be used to estimate the efficacy of AL. PCR analysis will be used to distinguish between recrudescence and reinfection. On day 7, post treatment initiation, a blood sample will be collected to quantify lumefantrine concentrations, as a predictor of overall lumefantrine exposure. These concentrations will be correlated with AL treatment efficacy. The design has adapted some procedures of the recommended WHO methods for surveillance of antimalarial drug efficacy. Expected findings and their dissemination: This study is designed to generate the information required to assess whether AL is efficacious in HIV infected children on ART. It is anticipated that the study results will improve the management of malaria in HIV infected children on antiretroviral drugs in areas affected by both HIV and malaria. This study will also provide information on the pharmacokinetics of AL and its efficacy that would contribute to the development of appropriate approaches/options for optimal effectiveness of the treatment. The findings of this study will be published in peer-reviewed journals and shared with all relevant stakeholders.
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    Identifying priorities for guidelines on newborn and child health in Malawi: a protocol for a priority setting exercise, version 1.0
    (2022-08-17) Mbeye, Nyanyiwe
    Type of Research: A cross sectional study design will be applied to set the priority topics related to Poverty Related Diseases in the field of new born and child health for guideline development or adaptation in Malawi. Problem Statement: Despite progress in the health of young children globally, most countries in sub-Saharan Africa (SSA) fall below the average gains and do not meet maternal and child health targets set by Sustainable Development Goal number 3 to ‘ensure healthy lives and promote wellbeing’. Poverty related diseases (PRD) remain amongst the leading causes of death in children under-5 years, including pneumonia, diarrhoea and malaria. Guidelines based on the best available evidence are key to informing care and funding decisions. The guideline development process can be complex and resource-intensive, and there is scope for improvement in the process in sub Saharan Africa (SSA). Objectives: The GELA project is where the impact of research on poverty-related diseases will be maximised through enhancing researchers and decision makers’ capacity to use global research to develop locally relevant Clinical Practice Guidelines (CPGs) for poverty-related diseases (PRDs) in the field of new born and child health. The first step of this project will be a priority setting process. This will ensure that stakeholders shape the project by advising us about the important issues and conditions to be addressed in clinical guidelines. Methods: Mixed methods will be employed following good practice methods for priority setting. These will include stakeholder mapping, and stakeholder engagement and document review to identify an initial long list of potential priority topics, in the pre-prioritisation stage; and an online survey with a broad range of stakeholders followed by a consensus meeting with a guideline steering group to identify the final priority topics in the prioritisation stage. The stakeholders will be asked to rank the proposed topics in order of importance according to pre-specified criteria. Expected findings and their dissemination: The priority setting process will identify top three priority topics. These will be shared with the Steering Committee in the Ministry of Health, the College of Medicine Research and Ethics Committee (COMREC) and the wider team of stakeholders. The topics will further be taken forward to the next steps in the GELA project, i.e. to develop or update guidance on these topics.