Protocols

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A two-phase study to investigate novel biomarkers of egg consumption and social marketing effectiveness of egg hubs Malawian infants
(Kamuzu University of Health Sciences, 2020-06-22) Manary, Mark; Maleta, Kenneth
Type of Study: :A controlled feeding study with infants and randomized controlled effectiveness trial to evaluate the impact of social marketing on egg consumption among vulnerable Malawian infants. Problem to be studied: A reliable and convenient way to measure the quantity of egg consumed by an individual. Current dietary assessment methods rely on self-report food intake such as food frequency questionnaires, 24-hr dietary recall, or diet diaries, and the prevalence of misreporting with these tools is estimated at 30-88%. Because there is no reliable way to detect egg consumption, the impact of a social marketing campaign on egg consumption among children in central Malawi in the vicinity of small-scale egg producers is not known. Objective: Identify a novel set of dietary biomarkers that will measure egg consumption, that would be free from participant recall bias, and serve to quantify intake. Utilize novel egg consumption biomarkers to measure egg consumption among infants in communities with social marketing campaigns have been implemented. Methodology:: Phase 1: A total of 25 subjects, children (9-24 months) will consume 2 distinct daily intake dosages of eggs with the daily intake increased every 5 days. Urine samples will be collected 3 times during each 5-day period and blood spots will be collected during a washout period and at the end of the each 5-day period. Urine samples will undergo metabolite detection via ultraperformance liquid chromatography tandem mass spectrometry in positive and negative ion mode. Peaks will be quantified using area-under-the-curve summation and each metabolite will be quantified in terms of its median-scaled relative abundance for the metabolite across the entire data set. A repeated measures 2-way ANOVA will be used to compare egg metabolite abundances over time in an individual baseline level. The result of phase 1 will be that the amount of egg consumed will be able to be measured accurately with a urine test. Phase 2: Among eight different “egg hubs”, a cluster of 10 egg farmers, 4 egg hubs will be randomized to receive social marketing and 4 will not receive social marketing. At the onset of the study before social marketing is implemented, and once a month for 8 months, there will be 1 monitoring day per month in the vicinity of each of the 8 different egg hubs. All will be welcomed, especially mothers of children 6-24 months, during this monitoring day, the research staff will provide community education about good complementary feeding practices. Among the children between 6-24 months, up to 25 will recruited to provide some basic demographic and health information, anthropometric measurements, and to give a urine specimen. Urine samples will undergo detection of the novel biomarker from phase 1 to determine egg consumption. Consumption between intervention and control sites will be compared to detect differences in egg consumption at each time point during the intervention. Expected finding: Egg metabolites that serve as exposure markers, and with varied abundance over time from urine. Novel egg biomarkers will provide a non-bias assessment of the effectiveness of social marketing campaign on egg consumption among vulnerable Malawian children. Dissemination of the results: A report of all results will be submitted to the supporting institutions (The College of Medicine – University of Malawi, Washington University School of Medicine) as well as to COMREC and the participating patients that wish to receive the results. The results will further be submitted to a peer-reviewed journal for publication
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Prevalence of upper gastrointestinal lesions in patients presenting with dyspepsia at Kamuzu Central Hospital in Lilongwe, Malawi
(Kamuzu University of Health Sciences, 2020-07-09) Gausi, Phalles; Fyson, Rashid; Chipewa, Pascal
The proposed research project is a quantitative retrospective cohort study where we intend to explore the prevalence of upper gastrointestinal lesions [UGL] in adult patients with dyspepsia undergoing endoscopy at Kamuzu Central Hospital in Lilongwe, Malawi. The evaluation of UGL in a medically resource limited area can be challenging. The lack of medical personnel, including those trained in gastrointestinal endoscopy and inadequate endoscopy facilities limit appropriate evaluation for patients with UGL. The specific objectives of the study are ;toare; to determine the proportion of patients with UGL among dyspeptic patients at KCH , establish the association between the presence of UGL and socio-demographic factors e.g. gender, residence, alcohol intake and tobacco smoking ,and finally to determine the association between HIV serostatus and presence of UGL. Gastrointestinal endoscopy is expensive, time consuming and has complications. Prioritization of patients referred for endoscopy is key to provision of the service to those who really need endoscopy. We, therefore, hope our study will help hospitals in Malawi to develop criteria for endoscopy recommendation among dyspepsia patients. The study will be conducted at Kamuzu Central Hospital in Lilongwe city for a period of six weeks. It will involve analyzing electronic secondary data collected and stored in the endoscopy unit of the surgery department. The inclusion criteria will be all the patients aged 18 years and above that presented with dyspepsia and underwent endoscopy at KCH endoscopy unit between January 2014 to December 2019. Sample size will not be calculated as we will analyze all the data of the patients who presented for endoscopy between January 2014 to December 2019 and consecutive sampling technique will be used. Dissemination of research finding will be through presentation at the College of Medicine fourth year research final report presentation at Blantyre campus. A copy of the report will also be submitted to COMREC, the head of surgical department at KCH and the College of Medicine library. We will submit our work to the Malawi Medical Journal for publication.
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Environmental Surveillance of Pathogens
(Kamuzu University of Health Sciences, 2020-10-08) Feasey, Nick
Type of Study Environmental Surveillance, unrelated to clinical cases or carriers. This protocol is therefore submitted as a waiver request. Broad Objective To develop spatial, field sampling and laboratory testing methods to identify environmental reservoirs of S. Typhi, Rotavirus, Enterovirus and SARS-CoV-2 as well as other key bacteria and viruses and use these findings to inform targeted intervention strategies through spatial modelling 1.4 Specific Objectives 1. Optimize strategy for detecting pathogens from food (fruit and vegetables available at the market), water and the environment in the laboratory 2. Optimize field sampling and sample concentration methods to support laboratory identification of pathogens 3. Use spatial modelling based on available data such as the physical geography or population density of Blantyre to develop our sampling strategy 1.5 Methods Optimize strategy for detecting pathogens from food, water and the environment in the laboratory will include: 1)concentration of field samples respecting staff safety and without rendering the pathogen of interest undetectable, 2)avoiding out-competition by other microorganisms (i.e. S. Typhi being outcompeted by E. coli), 3) quantitating the pathogens of interest and 4) multiplexing detection methods to make them cost effective. 2. Optimize field sampling and sample concentration methods to support laboratory identification of pathogens will include: 1)“Grabbing” enough sample that the pathogen of interest is present in and thus detected in the laboratory, 2) maintaining staff safety, 3) protecting equipment deployed overnight, and 4) developing methods that are cost effective. 3 Use spatial modelling based on available data such as the physical geography or population density of Blantyre to develop our sampling strategy will 1) enables a field sampling team to capture samples that the pathogen of interest is present in and 2) determine if this is economically feasible to roll-out at the level of field sampling necessary to reliably detect it. 1.6 Expected findings We aim to develop transferrable and translatable methods for the isolation or detection of pathogens from environmental sources, including S. Typhi, Rotavirus, enterovirus and SARS-CoV-2. This will be used to identify both reservoirs and transmission pathways. This information will be used to create a predictive model for where to locate high pathogen burden areas in an urban African context and this model can be validated and used in a variety of settings to support both future intervention studies. 1.7 Dissemination of study findings The study findings will be proactively disseminated through national and international scientific meetings, to key public health bodies in Malawi and through peerreviewed publications. Specifically, we will disseminate findings to COMREC, CoM and the Blantyre DHO. Any significant research findings will be shared to the Malawi government’s Ministry of Health who are already collaborating on on-going Typhoid and rotavirus vaccine surveillance studies and to support the national effort with regard to the COVID-19 pandemic.
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Exploring Knowledge, Attitude and Practices of the Malawian rural communities towards antimicrobial use and resistance prevention
(Kamuzu University of Health Sciences, 2020-10-16) Ndawala, Maria
Type of study: Descriptive quantitative study using interview guide Problem statement: There is much that is not known about the level of knowledge of the communities on proper antibiotic use, how bacteria become resistant to antibiotics, how human behavior as well as antibacterial usage at home influences anti-bacterial resistance and how resistant microbes’ spreads. A lot of people take antibiotics without prescriptions from the hospital prescribers and choose to stop the medications whenever they feel a relief from the symptoms. Research Aim: The aim of this project is to assess the knowledge, attitude and practices of rural communities towards anti –bacterial use and resistance prevention. The objectives of this study are;  To describe the understanding of the concept anti-microbial resistance by the rural community.  To assess if clients are given information on how to take the antibiotics when they have been prescribed.  To investigate the community’s adherence to taking the prescribed antimicrobial agents.  To determine the community’s common sources of antimicrobials.  To assess availability of anti bacterial resistance campaign in the community Methodology: The study will be conducted in Mangochi in the villages of T/A Namkumba. A sample population of 350 participants will be recruited based on whether the participant took antibiotics in the past six months. Data will be entered using CSPRO and will be analyzed using SPSS version 20. Thereafter the data will be presented and disseminated through presentation in different forums as well as through publishing. Expected findings and dissemination of results This study will reveal the gap in the knowledge that the Namkumba community has in terms of antibiotic use and resistance prevention. In addition, it will also reveal their attitude and the current practices of this community as far as antimicrobial use is concerned. This proposal will end up into a thesis as a fulfillment of the Masters degree in antimicrobial stewardship. Results of this study will be presented at the District level, National level, coordinated by Ministry of Health, and at the College of Medicine Research Dissemination Conference as well as lodged with the COMREC. Finally, the paper will be prepared and submitted to peer review journals for publication. Possible Constraints Interviewing people at the facility during their visit might be a challenge since some might be rushing to their business places and some might not be willing to participate because they are not feeling well. In addition, meeting participants at their homes might be a challenge since some of the people are business oriented and spend most of their time at their business places. Therefore, for those that I will not be able to administer the interview guide on the same day, i would firstly contact them at the health facility and get the contact details so that can easily book an appointment with them for the interview guide on another day.
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Calcium aspirin preeclampsia early prevention and response (CASPER)
(Kamuzu University of Health Sciences, 2020-10-16) Ngwira, Memory Moque
Globally, preeclampsia/ eclampsia remains the third leading cause of maternal mortality. In developing countries, the burden of preeclampsia/eclampsia is worsened by lack of preventive interventions which have been identified to be sophisticated, expensive but effective in early detection of its risk. As a result, there is still more gaps in what could be feasibly work for developing countries. Currently Malawi has not been spared out to this high incidence of preeclampsia/ eclampsia which has highly affected perinatal outcomes and contributed more to an increase in maternal mortality ratio. Despite WHO recommending administration of low dose aspirin or calcium as a preventive measure, literature has not been found regarding its use in the Malawian hospital set up. Problem: There are still some gaps in knowledge as what could be the barrier to early pregnancy this intervention and also the feasibility and effectiveness of low dose aspirin given together with calcium in preventing preeclampsia/ eclampsia in Malawian setting. The barrier to early pregnancy intervention in preventing risk of preeclampsia especially use of calcium and aspirin in Malawi not yet known. Main objectives: To assess the barriers to early pregnancy intervention and the effectiveness of low dose of aspirin and calcium in preventing risk of preeclampsia especially use of calcium and aspirin in Blantyre, Malawi. Specific objectives: Specifically, the ,the study aims at exploring barriers to early pregnancy intervention in preventing preeclampsia/eclampsia among health workers, patients and policy makers in Blantyre, Malawi, assessing knowledge and of health workers and policy on preeclampsia, preventive measures especially use of calcium and low dose aspirin at QECH, Blantyre will assess health worker/ policy makers barriers to providing early pregnancy intervention to prevent preeclampsia/eclampsia to high risk pregnant women especially; the use of calcium and low dose aspirin at QECH , Blantyre Malawi. It will also investigate patient’s barriers to accessing early pregnancy intervention to prevent preeclampsia/eclampsia among women who had suffered from preeclampsia/ eclampsia at QECH Blantyre, Malawi. The study will further investigate the knowledge and perception of patients towards preeclampsia/ eclampsia and also assess the knowledge of health workers and policy makers on the use of calcium and low dose aspirin as a preventive measure of preeclampsia/eclampsia at QECH, Blantyre. Not only that, Phase two will mainly focus on assessing the effectiveness of early low dose of aspirin and calcium in preventing pre-eclampsia and eclampsia in Blantyre, Malawi and identifying challenges of early use of low dose aspirin and calcium in high risk pregnant women in Blantyre, Malawi. Methodology: Design: We will conduct descriptive cross sectional study using qualitative analysis and double blinded randomized controlled clinical trial using quantitative analysis. The study will be split in two phases, phase 1 will be conducted at Queen Elizabeth Central Hospital(QECH) and phase 2 will be conducted at four urban health centers in Blantyre as well as Queen Elizabeth Central Hospital(QECH) as a referral center. Data collection: Qualitative data will be collected using IDIs and SSQ while quantitative data will be collected using questionnaire. Data analysis: Thematic content analysis will be used to analyze and interpret the qualitative data and quantitative data descriptive and inferential statistics will be analyzed using Stata software. Ethical consideration: Approval from the, College of Medicine Research and Ethics committee, Blantyre District Health Office (DHO), QECH and Pharmacy and Poisons Board of Malawi will be sought and reciprocal approval from Western Sydney University. Informed consent will be sought from all study participants. Confidentiality and privacy will be maintained throughout the study. Only investigators of the project and independent project officer (involved in data collection) and statistician will have access to the data. Expected findings: We expect to obtain a different in outcome in the incidence of preeclampsia and eclampsia in Blantyre district. We also expect variations in knowledge of preeclampsia across the interviewed group. We also expect to identify what challenges that may arise in using aspirin and calcium as a preventive measure. Dissemination of findings: A report will be written and submitted to Western Sydney University in the form of a PhD thesis. Presentations at college conferences at Western Sydney, Australia, College of Medicine research disseminations and COMREC in Malawi and at the International Society for the Study of Hypertension in Pregnancy (ISSHP) in 2020, 2021 and 2022 will be planned. Results will be published in peer reviewed journals. In addition the findings will also be shared with BTDHO as well QECH.
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An Investigation into the distribution and environmental niches of pathogenic Salmonellae in Blantyre
(Kamuzu University of Health Sciences, 2020-10-16) Feasey, Nicholas
Type of Study: Observational cohort study of all cases of Typhoid Fever presenting to Queen’s Hospital The problem: Invasive Salmonellae are amongst the most important bloodstream pathogens in Africa. There have previously been two confirmed epidemics of Nontyphoidal Salmonella (NTS) bloodstream infection in Malawi and Multidrug Resistant Typhoid Fever became prominent from 2011, thus invasive Salmonella disease (iSD) remains the most important cause of bacterial bloodstream infection in the city. Our data demonstrate that Typhoid is not evenly distributed across Blantyre and that there are specific risk factors, including age (most common aged 5-15), use of river water for cooking and cleaning and one’s social networks, for example attendance at child day care. Following the identification of these risk factors by statistical association in a case-control study, the next step is to confirm the environmental niches of these pathogens by microbiological surveillance in order to inform public health policy and reduce transmission. Objectives and Methodology: We propose to undertake an observational cohort study of all cases of Typhoid Fever presenting to Queen’s Hospital from patients within Blantyre. Having previously conducted a case control study that has identified risk factors for Typhoid, we plan to extend this classical outbreak investigation by looking for the causative pathogen in the community as requested by the district health officer, by undertaking a detailed microbiological survey of the households and the broader environment of cases to identify environmental niches of Salmonellae. Lastly, we plan to describe the geographical distribution of Typhoid within Blantyre to continue our surveillance of hotspots within the city and to use Whole Genome Sequence data from isolates of Salmonella Typhi to model the transmission of the pathogen in Blantyre. Expected outcomes and dissemination: We will describe “hotspots” of iSD in Blantyre, observing both Typhoid and NTS as there are important differences between households affected by NTS compared to those affected by S. Typhi, particularly that NTS may show a higher rate of carriage of Salmonella in the stool of household animals. Lastly, we hope to produce a model of Typhoid transmission in Blantyre. More detailed information about risk factors and environmental niches of S. Typhi and NTS will help to inform public health strategy to control Salmonella infections in Blantyre. Indeed, this study was specifically requested by the District Health Officer of Blantyre when I presented the results of the case control study (then Medson Machaya). This information will be distributed to the College of Medicine, COMREC, the Malawi Ministry of Health and submitted for peer-reviewed publication.
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Evaluating the state of market systems for antimicrobials in Malawi
(Kamuzu University of Health Sciences, 2020-11-11) Masoamphambe, Effie
Type of Study: This study will employ an exploratory qualitative research approach. In-depth interviews and focus group discussions will be done with key informants to generate knowledge and insight for the current processes within the supply chain and market for antimicrobials in Malawi. The product of the study will be network maps that will be used to illustrate the current pathways for antimicrobials from the suppliers to the markets. The problem: Limiting factors within the supply chain cause an imbalance and consequently affects the overall capacity for delivering health care services. This problem is particularly graver for antimicrobials as failure to sustain supply of antimicrobials counters the very efforts of promoting prudent use of antimicrobials as stipulated in the Malawi Antimicrobial Resistance Action Plan. Although studies have reported the role of studying antimicrobial supply chain on ensuring sustainable and timely supply of quality antimicrobials, there is inadequate literature with information regarding the current supply chain system of antimicrobials in Malawi. Study Objectives: A. Broad Objective To describe the supply chain and market system for antimicrobial agents in Malawi. B. Specific Objectives 1. To map routes of antimicrobials from suppliers to markets in Malawi 2. To identify key players and their roles in the antimicrobial supply chain in Malawi 3. To describe the relationships between the antibiotic market system actors, regulators and stakeholders 4. To describe the most commonly purchased antibiotics within the antimicrobial market in Malawi. Methodology: To achieve the objectives of this study, an exploratory qualitative study will be done. Data will be collected using key informant interviews, in-depth interviews and focus group discussions. The study design will allow for non-probabilistic sampling methods which will be convenience sampling and eventually snowball sampling. The data will be systematically organized using NVivo and analyzed through thematic analyses. Expected findings: This study is expected to map out the processes within the antimicrobial supply chain and describe the roles and relationships between supply chain actors in Malawi. Dissemination of Results: The findings from this study will be disseminated through writing and oral presentations. A thesis will be submitted at the Malawi College of Medicine, Pathology department, COMREC, Malawi-Liverpool Wellcome Trust Clinical Research Programme and CoM library. The results will also be presented at the CoM Research Dissemination conference and published in peer reviewed journals.
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Phenotypic and genotypic characterization of invasive bacterial isolates collected through MLW diagnostic activities from 1996 – 2030
(Kamuzu University of Health Sciences, 2020-11-24) Cornick, Jennifer
This protocol is a minimally updated version of Protocol P.08/14/1614 which expired on 15/12/2018. Due to increasing rates of drug-resistant infections being observed at Queen Elizabeth Central Hospital in Blantyre, it is important that we resume our phenotypic and genotypic characterization of invasive bacterial isolates collected through Malawi-Liverpool-Wellcome (MLW) Trust diagnostic activities. This audit will allow us to access archived bacterial isolates obtained from routine blood and CSF cultures over a period of more than three decades (1996– 2030). Invasive bacterial infections caused by typhoidal and nontyphoidal Salmonella, Streptococcus pneumoniae, Staphylococcus aureus, Escherichia coli and, Klebsiella amongst others, account for high rates of morbidity and mortality in both Malawian children and adults at Queen Elizabeth Central Hospital (QECH). Treatment of bacteraemia and meningitis caused by these bacterial species is made difficult because of increased levels of multiple antibiotic resistant strains. Bacterial surveillance at QECH and MLW in Blantyre began in 1996 and has thus far provided a rich collection of strains that allows phenotypic and genotypic investigations with a historical perspective, data which is used by the Ministry of Health to support its surveillance programmes. Whole genome sequencing has given us novel insights into the epidemiology and mechanisms of antibiotic resistance (AMR) of diverse bacteria that are regionally relevant. For example, WGS gave deep insights into the genetic diversity of S. pneumoniae strains in the era before the introduction of the pneumococcal conjugate vaccine in Malawi, which has been invaluable to support vaccine implementation and to the study of vaccine effectiveness. We have been able to describe increasing antimicrobial resistance rates over the last twenty years amongst key enteric pathogens, with some now locally impossible to treat using first line antibiotics. This audit aims to expand on these achievements by investigating the phenotype and genotype of all the major invasive bacterial isolates at QECH over time. From past experience with stored, frozen samples, it is anticipated that >95% of isolates will be recoverable and the impact on the validity of results obtained would therefore be very limited. Specifically, the audit aims to characterize the type and nature of isolates causing severe bacterial disease in Malawi making use of advanced genotyping and phenotyping techniques, some of which are not yet possible in Malawi. The audit has five main objectives: 1. To perform antimicrobial susceptibility testing to assess AMR rates over time; 2. To perform genotypic characterisation to identify genetic markers of AMR and virulence over time; 3. To employ whole genome sequencing to detect epidemic outbreaks; 4. To perform phenotypic characterization of bacterial isolates to identify the biological mechanisms driving AMR and virulence and to evaluate the efficacy of novel antimicrobials; 5. To build upon existing or develop novel bioinformatic pipelines to analyse bacterial genomic data. The findings will be disseminated among collaborating partners and manuscripts will be prepared for publication in international peer-reviewed journals. A copy of any published paper(s) of the research findings will also be submitted to the College of Medicine Research and Ethics Committee (COMREC), the College of Medicine Research Dissemination Conference, College of Medicine Library, the National Health Sciences Research Committee and the University Research and Publication Committee (URPC) (the latter two through the COMREC Secretariat). As with all our work, with collaborators at the Wellcome Trust Sanger Institute, sequencing will be undertaken free of charge. The number of isolates that can be sequenced each year will be dictated by the Wellcome Trust Sanger Institute sequencing budget. In addition to this, we will actively pursue research funding from national and international funders to prospectively address the objectives outlined in the proposal. At this moment in time, it is however impossible to predict how many samples we will process in total. COMREC overhead costs will therefore be retrospectively calculated based on the number of bacterial isolates
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A retrospective study on the burden of carbapenem resistance among urinary tract enterobacteriaceae isolates in Lilongwe
(Kamuzu University of Health Sciences, 2021-01-19) Chipingu, Chifundo
Type of Study-This is a retrospective cross-section study looking at the burden of Carbapenem resistance in Enterobacteriaceae isolated from the urinary tract of residents in Lilongwe district, central Malawi. Problem-Antimicrobial Resistance is a global challenge and Malawi being part of the global family faces similar challenges and threat to treatment of common ailments. Urinary tract infections are common in Malawi though detailed information on the extent of the burden is lacking due to poor documentation and reporting of cases, a common finding within Africa. Further to this, documentation of antimicrobial resistant patterns has been a challenge therefore calling for an effort in understanding the burden to address context and focus on root causes specific to Malawi and neighboring countries. Carbapenems have been used as last resort for treatment of Carbapenem-producing - Enterebacteriaceae. Development of resistance to this line of drugs presents a major threat for treatment of infection caused by these organisms. Globally, 44% Carbapenem resistance on gram negatives (Righi et al., 2017) has been recorded and this study will look at burden specific to Malawi. Objectives-This study will aim primarily to establish Carbapenems antimicrobial resistance burden among residents of Lilongwe, Malawi with urinary tract infection. The study will describe the burden of Enterobacteriaceae species resistance to Carbapenems from laboratory data. It will also aim to examine the relationship between the burden of UTl, demographics and clinical outcomes patients residing in Lilongwe with UTI Methodology-Retrospective urine culture and sensitivity results data for a period of six months from Partners in Hope (PIH) and National Microbiology reference laboratories will be used for this analysis. Demographic data and culture isolates data will be captured on paper based data collection forms with each sample given a unique identifier in place of patient names, electronic data in excel will also be maintained. Details of Carbapenem used will recorded for each and every isolate. Paper records and password protected electronic file will be maintained with limited access to study investigators. Expected findings and Dissemination- We estimate that the overall prevalence of Carbapenem resistance for gram negative organisms will be 44% over a period of 3 months Results for this study will be shared with Kamuzu University of Health sciences, Ministry of Health, COMREC and scientific community during conference through abstracts and presentations to inform nation for appropriate interventions.
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Toxicity and safety implications of herbal medicines widely reported and used in Malawi
(Kamuzu University of Health Sciences, 2021-03-04) George, Mary; Nota, Prisca
Herbals Medicines are widely used in developing countries and there has also been an increase in the use in the recent years in developed countries. An estimation of 40-90% of traditional medicine in Africa is plant based. In Malawi, there has also been an increase in the use of medicinal plants. Some of the examples of widely used herbal medicines in Malawi include Moringa oleifera (chamwamba), Hibiscus sabdariffa (chidede), Acacia brevisca, Mango, fig tree (Mkuyu), garlic (adyo) and others. The herbal medicines have also been associated with toxicity and safety issues. Because of this, several studies have been done on many medicinal plants to evaluate their toxicity and safety. However, in Malawi, the increase in demand for traditional medicines has directly resulted to an influx of herbal medicines of unknown efficacy, safety, toxicity and quality into the market, which is also a concern. This act has raised an alarm of fear and concern of contamination as everyone in the country is just practicing with no any supervision and legal responsibilities of the practitioners. Ddespite increase in use of herbal medicines, few studies have been reported concerning the toxicity and safety of plants that are used as medicines. Even though Pharmacy Medicines and Poison Board (PMPB) regulates newly produced drugs in Malawi but the herbal medicines at the moment that is not the case. Although it is known that there are limited studies on toxicity and safety of medicinal plants used in Malawi, the extent of the limitation of the studies is not known. Therefore, this study is aimed at evaluating the toxicity and safety implications of herbal medicines widely used and reported in Malawi. The main objective of this research is to determine the toxicity and safety implications of herbal medicines used in Malawi. This will be a systematic review study that will evaluate the literature to determine the extent to which Medicinal plants used in Malawi have been evaluated for toxicity and safety. The study will be done through the analysis of books, articles, internet articles, surveys and reports on toxicity and safety widely used herbal medicine in Malawi(1). Specific key words related to toxicity and safety of drugs will be used to search for information for the study. The data will then Herbals Medicines are widely used in developing countries and there has also been an increase in the use in the recent years in developed countries. An estimation of 40-90% of traditional medicine in Africa is plant based. In Malawi, there has also been an increase in the use of medicinal plants. Some of the examples of widely used herbal medicines in Malawi include Moringa oleifera (chamwamba), Hibiscus sabdariffa (chidede), Acacia brevisca, Mango, fig tree (Mkuyu), garlic (adyo) and others. The herbal medicines have also been associated with toxicity and safety issues. Because of this, several studies have been done on many medicinal plants to evaluate their toxicity and safety. However, in Malawi, the increase in demand for traditional medicines has directly resulted to an influx of herbal medicines of unknown efficacy, safety, toxicity and quality into the market, which is also a concern. This act has raised an alarm of fear and concern of contamination as everyone in the country is just practicing with no any supervision and legal responsibilities of the practitioners. Ddespite increase in use of herbal medicines, few studies have been reported concerning the toxicity and safety of plants that are used as medicines. Even though Pharmacy Medicines and Poison Board (PMPB) regulates newly produced drugs in Malawi but the herbal medicines at the moment that is not the case. Although it is known that there are limited studies on toxicity and safety of medicinal plants used in Malawi, the extent of the limitation of the studies is not known. Therefore, this study is aimed at evaluating the toxicity and safety implications of herbal medicines widely used and reported in Malawi. The main objective of this research is to determine the toxicity and safety implications of herbal medicines used in Malawi. This will be a systematic review study that will evaluate the literature to determine the extent to which Medicinal plants used in Malawi have been evaluated for toxicity and safety. The study will be done through the analysis of books, articles, internet articles, surveys and reports on toxicity and safety widely used herbal medicine in Malawi(1). Specific key words related to toxicity and safety of drugs will be used to search for information for the study. The data will then
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Chemical and biological properties of cannabis sativa seeds, flowers and leaves found in Malawi
(Kamuzu University of Health Sciences, 2021-03-04) Chirwa, Anthony; Peter, Patrick
Cannabis sativa is an important herbaceous specie originally from Central Asia, where it was used for various purposes such as food, recreation, spiritual things as well as treatment for various diseases. (1). Currently researches are underway investigating the application of Cannabis sativa on various diseases like cancer, diabetes, psychotropic, hallucinogen and malaria (2-4). It has also been and is being used for numerous industrial and commercial applications like paper, building materials, textiles, cosmetics, food products, and as nutritional supplements. (5-7), the above applications are due to chemical and biological composition of Cannabis sativa such as cannabidiol and delta-9-tetrahydrocannabinol. (THC) This research will be laboratory-based type of study as it will involve determination of Cannabinoid levels and antimicrobial activity testing in the laboratory. Therefore, this research will focus on determining chemical and biological properties of Cannabis Sativa. To answer the problem described above this research will use the following specific objectives, to extract chemical constitutes of Cannabis sativa, to determine the antibacterial activity of Cannabis sativa extract and to compare levels of cannabinoids in Malawian Cannabis with that in other countries. Various techniques (methods) have been used to isolate the chemical constituents of Cannabis sativa and some of the most commonly applied techniques include, Gas chromatography, Reverse phase -High Performance Liquid Chromatography and Ultraviolent detector (8-9), but in this research will use thin layer chromatograph. After extraction of Cannabis sativa chemical constituents, it will be used to test anti-bacterial activity. Our expectation is that chemical constituents of Cannabis sativa found in Malawi will be similar to that found in other parts of the world. And that will mean that there’s chance that Malawian Cannabis can also achieve the same biological activities. The findings of this study will be disseminated at college of medicine in a presentation
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Evaluation of pharmaceutical waste and wastewater management in health facilties
(Kamuzu University of Health Sciences, 2021-03-17) Banda, Ella; Zulu, Daisy
Type of study/Place of study: This is a descriptive cross sectional design study, which will involve structured questionnaires, face to face interviews and direct observation by investigators. The study will be conducted in six health facilities in Blantyre. Background and Introduction: Pharmaceutical waste is any waste which contains expired, spilt, unused and contaminated pharmaceutical products like drugs and vaccines. It also includes vials, bottles, IV bags/tubing, oral medications, ointments, creams and other items that are used in handling pharmaceuticals. Pharmaceutical wastewater is defined as water that is not clean because it has already been used in the pharmaceuticals. The management practices of these wastes involve a series of processes from segregation; treatment; storage; transportation and final disposal of the waste through landfills, incineration, sewer, burning in open containers. Pharmaceutical waste and wastewater produced in health facilities pose a risk to health of the public and the environment. However, there is paucity of information on the management and disposal practices by the health facilities in Blantyre. Study Objectives: The main objective of the study is to evaluate the pharmaceutical waste and wastewater management practices in health facilities in Blantyre. The specific objectives are to: i) determine the existing pharmaceutical waste methods and practices used in the selected health facilities, ii) assess the application and compliance of policies and guidelines on pharmaceutical waste and wastewater by health workers, and iii) identify resources used in pharmaceutical waste management. Methodology: The study will be conducted in six health facilities in Blantyre, three in rural health facilities and three in urban health facilities. Health workers in the selected health facilities will be identified by a purposive sampling method and interviewed. The survey will seek to identify the resources used for waste management, health workers’ knowledge of pharmaceutical waste methods and practices and bottlenecks for waste handling in the facilities. Data Management and Dissemination: The quantitative data will be entered into Microsoft excel, this data will be processed into graphs, tables and charts. The research results will be disseminated through oral presentation to the Pharmacy Department College of Medicine and the final project report will be submitted to COMREC, Pharmacy department, College of Medicine library and academic staff. Expected Findings: It is hypothesized that the majority of the selected health facilities will have poor pharmaceutical waste and waste water management practices because of inadequate human resources, finances, inadequate infrastructure like incinerators and lack of knowledge of the personnel on proper handling of these wastes.
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Biological and physicochemical characteristics of nanocellulose from sugarcane molasses
(Kamuzu University of Health Sciences, 2021-03-17) Tembo, Sandra; Lingson, Pilirani
Type of study/Place of study: The research design is an experimental method and will be conducted at the Pharmacy laboratories. Background and Introduction: Cellulose is the most abundant polymer on earth and is regarded as a very important raw material for several purposes. Potential applications include barrier films, antimicrobial films, biomedical implants, pharmaceuticals and drug delivery. By extracting cellulose at the nanoscale, the majority of the defects associated with the hierarchical structure of cellulose can be minimized, and a new cellulose based ‘‘building block’’ is available for the next generation of cellulose based composites. Therefore, this experimental study focusing on determining the suitability of nanocellulose extracted from sugarcane molasses as excipients in manufacturing pharmaceutical products. Study Objectives: The aim of the study is to investigate the biological and physicochemical characteristics of nanocellulose from sugarcane molasses. The specific objectives are three-fold: i) to determine the cytotoxicity of nanocellulose sugarcane molasses, ii) to assess the physical characteristics of nanocellulose from sugarcane molasses, iii) to evaluate chemical properties of nanocellulose of sugarcane molasses. Methodology: Sugarcane molasses will be collected from Nchalo Sugar Mill, followed by cellulose extraction by acid hydrolysis to obtain nanocellulose. The generated nanocellulose will be subjected to various biological and physicochemical standard assays in order to elucidate their suitability as excipients in pharmaceutical products. Data Management and Dissemination: The results will be presented to the College of Medicine (COM) staff and the pharmacy department and copies will be made available to the undergraduate research coordinators, College of Medicine Research and Ethics Committee (COMREC) and College of Medicine library. It is expected that the findings from this study will provide useful information for use of nanocellulose extracted from sugarcane molasses can be suitable excipients in manufacturing pharmaceutical products
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Chemical and biological properties of cannabis sativa seeds, flowers and leaves found in Malawi
(Kamuzu University of Health Sciences, 2021-03-21) Chirwa, Anthony; Peter, Patrick
Cannabis sativa is an important herbaceous specie originally from Central Asia, where it was used for various purposes such as food, recreation, spiritual things as well as treatment for various diseases. (1). Currently researches are underway investigating the application of Cannabis sativa on various diseases like cancer, diabetes, psychotropic, hallucinogen and malaria (2-4). It has also been and is being used for numerous industrial and commercial applications like paper, building materials, textiles, cosmetics, food products, and as nutritional supplements. (5-7), the above applications are due to chemical and biological composition of Cannabis sativa such as cannabidiol and delta-9-tetrahydrocannabinol. (THC) This research will be laboratory-based type of study as it will involve determination of Cannabinoid levels and antimicrobial activity testing in the laboratory. Therefore, this research will focus on determining chemical and biological properties of Cannabis Sativa. To answer the problem described above this research will use the following specific objectives, to extract chemical constitutes of Cannabis sativa, to determine the antibacterial activity of Cannabis sativa extract and to compare levels of cannabinoids in Malawian Cannabis with that in other countries. Various techniques (methods) have been used to isolate the chemical constituents of Cannabis sativa and some of the most commonly applied techniques include, Gas chromatography, Reverse phase -High Performance Liquid Chromatography and Ultraviolent detector (8-9), but in this research will use thin layer chromatograph. After extraction of Cannabis sativa chemical constituents, it will be used to test anti-bacterial activity. Our expectation is that chemical constituents of Cannabis sativa found in Malawi will be similar to that found in other parts of the world. And that will mean that there’s chance that Malawian Cannabis can also achieve the same biological activities. The findings of this study will be disseminated at college of medicine in a presentation.
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The toxicity and safety evaluation of Jenda herbal product(s) used for the management of covid-19 patients
(Kamuzu University of Health Sciences, 2021-06-21) Chikowe, Ibrahim
Type of study: This will be a retrospective case study and prospective laboratory in-vitro study evaluating the toxicity of Jenda herbal product in patients. Problem: In Malawi, several herbal practitioners have claimed the effectiveness of their herbal products against symptoms associated with COVID-19 disease. Despite the lack of data on quality control, safety and efficacy of the products, many people have confidence in the traditional interventions offered to them. Some of the herbal practitioners have challenged scientists to test their products for efficacy and safety. This comes on the wheels of the fact that unlike the many plants in the Chinese medicines, Malawian medicinal plants lack documented efficacy, toxicity and safety data against the practitioners’ claims, which prevents them from being taken directly into clinical testing despite their long term use. Yet, calls have been made to assess the efficacy of the herbal products in a clinical setting in Malawi (Mzungu, 2020).This study seeks to fill the gap on one of the products being produced by one of the herbal practitioners, who has also challenged the scientists to evaluate his product for toxicity and efficacy. However, based on the principle of ‘primum non nocere’ (‘first, not do harm’) (Pierantozzi, 2013), the study firstly assesses the toxicity of the herbal product before looking at the efficacy. Aim: The study evaluates the toxicity and safety of Jenda herbal product that is widely being used for the management of COVID-19 patients in Malawi. Study objectives: The objectives of the study include screening phytochemicals of the herbal product, assessing acute and sub-acute toxicity of the herbal preparation in patients and evaluating the toxicity and safety of the herbal product Hypothesis: Jenda herbal product is a safe herbal product that can be used in the management of Covid -19 like symptoms and signs. Method This will be a mixed methods study involving qualitative (laboratory and survey) and quantitative (laboratory and survey) methods. The aqueous Jenda herbal product will be qualit at ively screened for phytochemical constituents such as flavonoids, phenols, alkaloids and others. Quant it at ive Antioxidant activity will be done using the free radical scavenging capacity of 2,2-Diphenyl-1-Picrylhydrazil radical (DPPH) method. Gas Column Chromatography will be used to fingerprint non-volatile compounds. Acute toxicity studies will be done using brine shrimp. All the tests will be done using various published and standardized methods. Qualitative and quantitative The case study data collection will involve 40 volunteers (either male or female) that used Jenda herbal product to manage Covid-19 like symptoms from 23 July 2020 to 07 Mar 2021using key informant interviews. Participants will be requested to respond to a questionnaire and submit urine samples for biochemical analysis after informed consent. Quantitative data will be analyzed descriptively using STATA software while qualitative data will be analysed using thematic analysis coupled with N-VIVO software. Expected findings: The study expects to find no acute or sub-acute toxicity results both in human subjects and brine shrimp model. Dissemination: Findings from this study will be sent to CoMREC and College of Medicine library. Publications will also be made in peer reviewed journals.
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Determining the normal Urea, Creatinine and Electrolytes Indices for young Malawian adults
(Kamuzu University of Health Sciences, 2021-07-15) Mapila Mutsai, Oliver, Bakali
1.1.Type of Research This will be a cross-sectional descriptive study aimed at establishing the normal Urea, Creatinine and electrolytes indices for young Malawian adults in Mangochi. 1.2.The problem to be studied Most of the medical decisions that are made by the clinicians are arrived at based on the laboratory results. Reference indices or reference intervals act as the guiding tools for the clinicians to make accurate interpretation of the laboratory findings. However, reference values currently being used in most laboratories in African countries including Malawi are adopted from the literature or the reagent inserts accompanying the reagent manuals. These indices are derived from far more distant populations and may not actually be applicable and relevant to Malawian population due to inherit variations such as age, gender, ethnicity and environment including altitude and geo-chemicals among others. 1.3. Objectives The main objective of this study is to establish normal Urea, Creatinine and electrolytes reference indices for young Malawian adults in Mangochi. A total of 50 samples will be collected from the Voluntary, non-remunerated blood donors at Mangochi District Hospital who will meet the inclusion criteria. The samples will be analyzed at the College of Medicine biochemistry laboratory and reference intervals will be established using Epi info data management system. 1.4. Expected findings and dissemination We expect the reference intervals of the Malawian population, Mangochi in particular to be different from other reference intervals provided by machine inserts or those in the literature. The results will be presented to the College faculty and a copy of the results will be submittedto the COMREC and to the COM library. We are also planning to publish the results for public access.
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Assessing health workers’ knowledge on blood culture sample management at Kamuzu Central Hospital
(Kamuzu University of Health Sciences, 2021-08-11) Chinguwo, Peter; Bakali, Benson
Sample management is a part of process control, one of the essentials of a quality management system. The laboratory must be proactive in ensuring that the samples it receives meet all the requirements needed to produce accurate test results. Blood culture bottle contains nutrients used by bacteria to grow and this is used to identify organisms in both children and adults. Blood culture is a gold standard methods for identifying organisms in the blood stream. This research broadly aims at assessing health workers’ level of knowledge on blood culture sample management. The Malawian picture on management of blood culture involving nurses, clinicians and laboratory technologists may not vary much with many developing countries, however there is no data available to establish this claim. It is not known how well are the health workers, if at all, equipped with knowledge on management of blood culture. This research has the following objectives; to determine health worker’s knowledge on blood culture sample management, to assess health workers’ attitude towards blood culture sample management and to explore the health worker’s experience with blood culture sample management. Cross sectional research design will be used during the research. The sample size will be 63, and participants will be selected using convenience sampling techniques. We will only allow health workers who participate in blood culture sample management; at clinical or laboratory level. Data is to be collected using a questionnaire and presented in proportions, percentage, graphs, tables and charts. We will seek permission from College of Medicine Research and Ethics Committee (COMREC) and Kamuzu Central Hospital Administrator before conducting the study. This study is expected to help fill the existing gap on data of health workers’ knowledge on blood culture sample management. A full written report of our findings will be presented to COMREC, COM library, KCH and MLS department. Upon approval by the COMREC the findings will be published in Malawi medical journal.
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Clinical assessment of the accuracy and functionality of a low- cost, low-powered intravenous infusion monitor for gravity led Iv set in peadiatric oncology unit at Queen Elizabeth Central Hospital, Blantyre Malawi
(Kamuzu University of Health Sciences, 2021-08-30) Chagaluka, George
Type of study This is Non-randomised Control Trial aimed at assessing the accuracy of gravity led method of intravenous fluid administration between drip monitor vs no drip monitor (current standard of care) in children admitted in paediatric oncology unit. Problem Statement Traditional gravity led IV infusion method requires the nurse or caregivers to manually calculate the required flow rate and monitor the infusion at periodic intervals. Literature shows that gravity-flow IV infusion systems are highly inaccurate and wrong flow rate of administration was established as the most prevalent and significant problem in its use[1][2]. Inaccuracy may result into complications. On the other hand, commercial IV drip monitors remain a burden for Malawi and other low resource settings due to their high cost, complexity to use, high maintenance and training requirements and constant power outages. A team of collaborators from College of Medicine and MUST, are working on building an affordable and effective drip monitor with locally available materials to alleviate this burden. This study aims at assessing the potential of the drip monitor to improve the accuracy of IV fluid and medication administration compared to a traditional way of IV fluids administration. Objective The primary objective of this study is to assess the accuracy and functionality of a low-cost, lowpowered gravity led intravenous drip monitor compared to traditional method in paediatric oncology ward at Queen Elizabeth Centra Hospital, Blantyre.Our secondary objectives are to assess time taken to set up an IV infusion between drip monitor and without drip monitor, to determine factor contributing to error in accuracy and to assess associated adverse events. Methodology The type of research study: A prospective, non-randomized Trial, where eligible participants will be assigned to either drip monitor or no drip monitor group. Study place : The study will take place at paediatric oncology ward at Queen Elizabeth Central Hospital, Blantyre in Southern Malawi Study population: Children admitted at oncology unit prescribed IV fluids and meeting the eligibility criteria. Study period: Approximately 3-4 months of data collection after College of Medicine Research and Ethics Committee (COMREC) approval. One week of pilot data collection will begin at QECH oncology ward following study approval by the COMREC. Following pilot study drip monitor will be implemented at the site. Data Management: The standard data collection tool, Open Data Kit (ODK), will be used to collect data for all enrolled participants. Data will be analysed on STATA version 14.0 and will be presented in form of charts, graphs and tables. Expected findings: We expect to find low accuracy in the tradition method of IV fluid administration (without drip monitor) and that the introduction of a low-cost drip monitor will demonstrate a significant improvement in the accuracy of IV gravity infusion method of administration of fluids. We are also anticipating a reduction in IV infusion associated adverse events to the intervention arm. Dissemination The final copy of the findings will be made available at COMREC, Ministry of Health, and Department of Paediatrics, QECH, where the data will be collected and the final copy will be presented at national and international conferences and published in a peer-reviewed scientific journal.
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Assessing the quality and use of antibiotics and associated clinical outcomes in southern Malawi
(Kamuzu University of Health Sciences, 2021-12-10) Chiumia, Francis
Type of study This study will be a quantitative cohort study which will use both prospective and retrospective approaches. Problem Inappropriate medication and use of poor-quality antibiotic medicines have the potential to cause poor outcomes such as occurrence of adverse drug reactions, treatment failure and antimicrobial resistance. Substandard and falsified medicines is a global problem which disproportionally affects LMICs such as Malawi but its clinical impact has been poorly assessed and documented. Moreover, it has been known that high disease incidence is associated with a high prevalence of substandard and falsified (SF) medicines, suggesting that the risk of SF antibiotics is high in Malawi as antibiotics are one of the most prescribed class of medicines in low-middle income countries (LMICs). In addition, the appropriateness of the use antibiotics and clinical outcomes is still not investigated. Objectives The goal or purpose of this study is to assess the quality and use of antibiotic medicines and the associated clinical outcomes in southern Malawi. The specific objectives are to: 1. To assess the availability of antibiotics in public and private health sectors 2. To determine the prevalence of substandard and falsified antibiotics in public and private health sectors 3. To assess the storage factors that affect quality of antibiotics 4. To evaluate appropriateness of the use of antibiotics Methodology We will focus on a list of 15 selected antibiotics (sample size of 553) that are prescribed to treat common infections according to the Malawi standard treatment guidelines and the essential medicine list and recruit a sample size of 398 in-patients who are exposed to these antibiotics. Firstly, we will collect data from stock cards on the availability of our selected antibiotics in government, CHAM and private sector using a form. We will also collect data from clinical records such as patient files to assess the appropriateness of the use of these antibiotic medicines according to local and international guidelines. A global trigger tool will be used to detect any occurrence of adverse drug events or failure of treatment and the patient outcomes will be assessed for each patient. Medicine quality analysis will be done for the batches of the antibiotic medicines administered to the study participants. This will involve inspection of visual defects, labelling and registration status of the medicine, followed up by dissolution tests and chemical analysis for the presence and quantity of the active ingredients according to official pharmacopeial specifications. The analytical assays will apply different techniques such as thin layer chromatography, high performance liquid chromatography and ultra-violet visible spectrophotometry and titration. Furthermore, storage conditions will be longitudinally recorded for these antibiotic conditions to determine the effect of storage on the quality of the antibiotic formulations. Data will be entered in Microsoft excel and analyzed in SPSS or STATA. We will use descriptive statistics to describe the baseline characteristics of our variables and apply analytical statistics to determine associations among quality of antibiotic medicines, factors that influence the quality of medicines, appropriateness of antibiotic use and the patient outcomes. These results will be presented in appropriate tables, graphs and charts. Expected finding and their dissemination By the end of this study, we expect to describe the prevalence of SF antibiotic medicines and establish the pattern for the use of antibiotics and characteristics of associated outcomes such as any adverse drug reactions including failure of treatment. The study will be done in a period of three years and the results will finally be disseminated to College of Medicine Research and Ethics Committee (COMREC), local and international stakeholders in the medical or pharmaceutical field and the academia through conference presentations and scientific publications in peer reviewed journals.
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Utilization of ultrasound at a district hospital setting in Malawi: A case of Mangochi District Hospital
(Kamuzu University of Health Sciences, 2022-02-02) Charles, Hassan
The study will be a prospective descriptive cross-sectional study on the utilization of ultrasound at Mangochi District Hospital in patients. Problem Statement: There is growing evidence on the impact of ultrasound use on patient management in low income resource setting district hospitals like Malawi and ultrasonography is being used in district hospitals in Malawi including Mangochi, however there is no baseline data the extent of its utilization looking at the scan indications, the scan request forms and the report as these forms contains data that can help assess the utility and finally the impact of the scan on patient care. Objectives Broad Objective: 1. To assess the utilization of ultrasound at Mangochi District Hospital Specific objectives: 1. To assess the indications for ultrasound use at Mangochi District Hospital 2. To assess the comprehensiveness of ultrasound request forms and reports at Mangochi District Hospital. 3. To determine the impact of ultrasound scan results on patient management at Mangochi District Hospital. Methodology: This is a quantitative descriptive study. The study will use a checklist as a tool to assess the comprehensiveness of ultrasound request and reporting forms looking for presence of clinical and non-clinical information and a clear indication for the scan, including differential diagnosis as well as relevant findings and comments. Finally, we are going to assess the impact of the ultrasound the management, all this is going to be done by the study investigator. Data analysis: will use descriptive analysis (mean, chi-square). Ethical Consideration: Authorization from the district research committee and ethical clearance will be sort from COMREC. Expected outcome: At the end of the study we are going to have: the baseline data of the extent at which ultrasonography is being used at the district looking at the indications, its impact on patient care and the comprehensiveness of both scan requests and reports. Dissemination: The research findings will be disseminated at the local dissemination College of Medicine (COMREC) as well as published in a research journal.