Research & Ethics Committee

Permanent URI for this community

https://rscarchive.kuhes.ac.mw/handle/20.500.12988/202

Browse

Now showing 1 - 20 of 528

Restricted
Acceptability of covid-19 vaccine and its associated factors among the elderly aged 65 and above in Machinga district
(Kamuzu University of Health Sciences, 2022-02-02) Mbukwa, Kettie
This is a cross-sectional study aimed at exploring the acceptability of COVID 19 vaccine and its associated factors among elderly aged 65 years above in Machinga and it will employ qualitative methods. For its thematic analysis, the study will use a Health Belief Model to analyze the factors that influence the acceptance of COVID 19 vaccine among elderly and which beliefs should be targeted in communication campaigns to cause positive health behaviors. Problem: COVID 19 remain a crucial global pandemic and leading cause of high morbidity and mortality rate among higher risk population. With the development of multiple effective vaccines, reducing the global morbidity and mortality of COVID-19 will depend on the distribution and acceptance of COVID-19 vaccination, while studies generally indicate a low uptake of COVID 19 vaccine among various population, Vaccine hesitancy and refusal are global concerns. According to World Health Organization (WHO) it has been identified as one of the top 10 threats to global health in 2019. Available data for Machinga District by July 2021 it shows that only 3637 received COVID 19 vaccine and only 408 elderly 65 years and above received the vaccine, since the roll out however the vaccine acceptance among elderly is still low. The correct and comprehensive beliefs of the target groups regarding the benefits and barriers of the vaccination must be raised. Various effective social strategies must be adopted to trigger the intention of COVID-19 vaccination. Objectives. – The main objective is to explore the acceptability of Covid 19 vaccine among elderly (aged 65 years above) in Machinga district. Specifically, the study seeks to assess the perceptions, attitude towards Covid 19 vaccine, to assess contextual factors that facilitate and impede the acceptance of Covid 19 vaccine, to assess the health system factors that influence the acceptance of Covid 19 vaccine. Methodology. - A qualitative study design will be used to explore the acceptability of COVID19 vaccine and its associated factors among the elderly people of 65 years above in Machinga District. Study population will include the elderly 65 years and above, residing in both urban and rural communities, both male and female. The sample size will be 36 and the study participants will be purposively selected. The study will collect data in participants own setting using in depth interviews (IDIs) and Key informant Interviews (KII). Collected data will be stored securely in computer data base that have a pass word and only limited access to key study team will be provided. Data analysis will be done using deductive and inductive thematic content analysis. Informed consent will be obtained from each and every study participant before enrollment in the study. Confidentially will be ensured throughout the study and thereafter. Ethical approval will be sought from the College of Medicine Research and Ethics Committee (COMREC). Expected findings. –The study anticipates to identify the factors that act as barriers as well as factors that act as facilitators to the uptake of COVID -19 vaccine among the elderly at individual, social as well as health system levels. Dissemination of Expected findings: Research results will be disseminated in writing and presentations as feedback made to the District Health Management Team (DHMT) for Machinga and to COMREC. Recommendations will be made to various level of decision makers, DHOs office and key implementing partner on improvements that need to be made to optimize uptake of COVID 19 vaccine.
Restricted
Acceptability of new Orange Fleshed Sweet Potato varieties among children and caregivers in Nsanje, Malawi, version 1.0
(Kamuzu University of Health Sciences, 2022-08-04) Manda, Robert
Type of Study: A cross-sectional study will be conducted in Nsanje among children and their caregivers to determine their sensory acceptability and consumer preference for new orange fleshed sweet potato (OFSP) varieties bred in Malawi. Problem Statement: OFSP are some of the bio-fortified crops bred in Malawi. However, bio-fortification results into different visual phenotypes and taste changes than pre-existing varieties of the crops. Due to these changes, sensory attributes are also affected and acceptability of these newly introduced varieties is a challenge. Main Objective: To assess consumer preference and sensory acceptability of new biofortified orange fleshed sweet potato varieties bred in Malawi by International Potato Centre (CIP) among children aged 12-59 months and their caregivers in Nsanje Malawi. Specific Objectives: i) To assess sensory acceptability of new OFSP varieties among children aged 12-59 months. ii) To determine consumer preference for new OFSP varieties among caregivers of children aged 12-59 months. iii) To assess sensory acceptability of new OFSP varieties among caregivers of children aged 12–59 months. Methodology: New OFSP varieties that will be assessed in this study are Anaakwanire, Kaphulira, Mathuthu, Royal Choice, Mthetsanjala and Msungabanja. These varieties will be assessed against local sweet potato varieties grown in Malawi. Plate waste and hedonic Likert scale sensory techniques will be used to assess acceptability of the sweet potatoes among children aged 12-59 years. Paired preference test and preference ranking sensory procedures will be used to assess consumer preference for the sweet potatoes among caregivers of children aged 12–59 months. Pearson correlation co-efficient will be used to measure likeness, preference and levels of satisfaction of the sweet potatoes among children and caregivers. Expected results: The study expects to find acceptability of new OFSP among children and caregivers to reduce Vitamin A Deficiency which is a public health concern in Malawi and drivers of consumers preference for new OFSP varieties. Dissemination: The findings will be disseminated through conference presentation to KUHEs-COM, CIP, UNICEF, DNHA, The Hunger Project, Nsanje District Council, others nutritional stakeholders and journal publication for utilization. For academic purpose, a copy of the dissertation will be sent to Kamuzu University of Health Sciences, COMREC and KUHES libraries for reference.
Restricted
Acceptability of Self injected contraception (DMPA-SC) among adolescent girls and young women in Lilongwe district
(Kamuzu University of Health Sciences, 2021-09-15) Chipeta, Taonga
Study Type This study will employ a cross sectional mixed methods approach to collect data. Quantitative data will be collected from secondary sources (family planning registers) while interviews will be used to collect qualitative data. The problem to be studied Approximately 1 in every 2 women (49.85) in Malawi uses an injectable contraceptive (Depo- Provera) and is required to travel to a health facility every 3 months to get their next dose [1]. This is according to the 2015 – 16 Malawi Demographic and Health survey (DHS). In the same DHS, distance to a facility was one of the reported problems in accessing health care by 56% of the women aged 15-49 interviewed. Subcutaneous depot medroxyprogesterone acetate or DMPA-SC, a lower dose of Depo-Provera emerged in 2011 as a new option that could increase access to contraception, especially at the community level in low-income countries as women would be able to inject themselves in the home without visiting the health facility [3]. While Malawi reached a milestone and rolled out DMPA-SC in facilities across the country, published literature is unclear on the extent to which women are self-injecting at home or in the presence of a provider. This study builds upon randomized control studies that have been done by Burke et al to explore the practices around self-injected DMPA-SC in a real world setting as Malawi is scaling up distribution in the public sector. Objectives The main objective of this study is to assess the acceptability of self –injection of DMPA SC among adolescent girls and young women. The specific objectives of the study are to assess the attitudes and perceptions of adolescent girls and young women towards self-injected contraceptive, to explore the interest for self-injection of DMPA-SC and to get the perceived self-efficacy in using self-injected DMPA-SC. The study will also establish a profile of current users of DMPA-SC and the proportion of those self-injecting to help guide implementation. Methodology The study is a cross sectional study that will use both qualitative and quantitative means of data collection. Two facilities, one from a rural area (Ngoni Health Centre) and one from an urban area (Area 25 Health Centre) have been identified as the study sites for this research. The study will use the theoretical framework of acceptability according to Sekhon – 2017 where the 7 components of the theoretical framework will be used. These are Affective attitude, Perceived effectiveness, Burden, Ethicality, Coherence, Self-efficacy and opportunity cost. The study will collect data from family planning registers to establish a profile of current users of DMPASC while qualitative data which responds to the theoretical framework will be collected from service providers and clients sampled through a client exit recruitment process. The quantitative data will be managed and analyzed in Stata while the Qualitative data will be analyzed following the themes aligned with Sekhon’s theoretical framework. The qualitative data will managed in Nvivo. Appendix 8.6 provides details of the theoretical framework to be used. Expected findings and dissemination It is expected that most users of DMPA SC chose to be injected by the provider and are women under the age of 24. Insights into the reasons for Clients opting to be injected by the provider despite undergoing counselling will show a need to build client competency in using DMPASC to ensure more client self-inject compared to provider administration. The study findings will help provide a baseline for identifying an implementation gap before scaling up. The findings will be presented before the College of Medicine Research Ethics Board, Lilongwe District Health Office and the Research dissemination conference.
Restricted
Acceptability, feasibility and economic studies in the context of the Improve & improve - 2 trials (MPROVE-ACCEPT)
(Kamuzu University of Health Sciences, 2020-01-28) Manda-Taylor, Lucinda
Title: Acceptability, feasibility, cost and incremental cost-effectiveness of IPTp with dihydroartemisininpiperaquine with or without azithromycin to prevent malaria, sexually transmitted and reproductive tract infections in HIV-uninfected pregnant women (IMPROVE) and HIV-infected women receiving daily CTX (IMPROVE-2 Kenya and Malawi only) in Kenya, Malawi and Tanzania. Short Title: Acceptability, feasibility and economic studies in the context of the IMPROVE & IMPROVE- 2 trials Type of study: Qualitative study employing in-depth interviews and focus group discussions to understand acceptability of IPTp+DP or or without AZ with HIV-uninfected women and HIV-infected women receiving CTX. Problem: Malaria in pregnancy can have devastating consequences for the mother and foetus. Pregnant women are often infected with malaria without showing any outward signs or symptoms which, if left undetected and untreated, can cause anaemia and interfere with the development of the foetus leading to loss of the pregnancy, or premature birth and low birth weight, which in turn increases the risk of early infant death. The World Health Organisation (WHO) therefore recommends a preventive strategy called ‘intermittent preventive treatment in pregnancy’ (IPTp) in which mothers receive a single dose of 3 tablets of medication called sulphadoxine-pyrimethamine (SP) at each scheduled antenatal visit starting in the 2nd and 3rd trimester. However, the effectiveness of this strategy is being compromised due to high levels of resistance to SP in the malaria parasite population in many parts of sub-Saharan Africa. The IMPROVE trials aim to evaluate alternative drugs for the prevention of malaria in both HIV-uninfected (IMPROVE-1) and HIV-infected (IMPROVE-2) pregnant women. The trials will compare the safety, tolerance and beneficial effects of IPTp with DP alone, or combined with azithromycin, to the current strategy with sulphadoxine- pyrimethamine in reducing pregnancy loss, low birthweight, preterm birth and small-for-gestational- age babies, and early infant deaths. In parallel to the trials, we will conduct a series of studies to explore the feasibility, acceptability, cost and cost effectiveness of these two interventions in comparison to the current strategy. Aims and objectives This multi-centre study will enrol about 2,300 pregnant women in Kenya, Tanzania and Malawi and compare the acceptability, feasibility and ‘costs vs benefits’ of IPTp with DP alone, or combined with azithromycin, to the current strategy with sulphadoxine- pyrimethamine. Methods in Brief This is a mixed methods study using a range of quantitative and qualitative techniques. Acceptability among health providers and pregnant women to the two interventions will be assessed by interviewing pregnant women and health providers participating in the trial sites in Kenya, Malawi and Tanzania. In Malawi, only the qualitative techniques to understand acceptability of the interventions will be assessed. Feasibility of implementation will be assessed by delivering the interventions through the routine health system in adjacent sites to the trial in Kenya (only) over a period of 10 months, followed by an evaluation to assess the effectiveness of the health system to deliver the interventions and potential operational hurdles for scale up. Uptake and adherence among pregnant women attending antenatal clinics will be assessed by interviewing women as they leave a health facility and again followed-up at home. Health providers will be interviewed to explore their perceptions and experiences with the new regimens to assess scalability. Collection of cost data will be nested within the feasibility study and the trials and combined with feasibility and data from the trial and use modelling to estimate the incremental costs, benefits and cost-effectiveness of the two interventions compared to IPTp-SP in HIV negative or compared to cotrimoxazole only in HIV positive women. Expected findings: Evidence from qualitative studies in Malawi will provide clarity and useful information on issues around acceptability lity of the delivery and administration of the intervientions so that health care providers and policy makers can make evidence-based decisions on the opportunities and challenges that must be considered when planning for change. Dissemination: Results from this research activity will be disseminated at the CoM Research Dissemination Conference and to specific interest groups, both in meetings / workshops and through conferences, nationally and internationally; and through journal article[s]. Final publications will be shared with COMREC
Restricted
Access to early bubble Continuous positive airway pressure in Neonatal Intensive Care Unit at Kamuzu Central Hospital
(Kamuzu University of Health Sciences, 2021-02-05) Kamanga, Emmanuel; Sichinga, Tuntufye; Mbwana, Zainab
Objective: The main aim of this study is to evaluate accessibility of bubble Continuous Positive Airway Pressure by preterm infants in Neonatal Intensive Care Unit at a large referral hospital of central region. Methods: Study design: The study is going to be a quantitative cross-section study. We will use secondary data recorded in daily running of the neonatal unit from January through December 2019. Methodology: The study will be conducted at Kamuzu Central Hospital, in the Neonatal Intensive Care Unit. The ward is commonly known as Ethel Mutharika Nursery Wing. Participants will include all preterm births born between 28 and 36 weeks of gestation. Neonatal Intensive Care Unit admits about 400 preterm infants requiring Continuous Positive Airway Pressure therapy annually. Research Problem: Prematurity accounts for over a half of neonatal mortality in Malawi and mainly due to RDS respiratory distress syndrome. Low-cost bubble bCPAP is being implemented in hospitals to treat respiratory distress syndromeRDS.. There is limited data on the accessibility of the therapy and the rolled out low-cost bubble Continuous Positive Airway Pressure bCPAP Pumani devices. This study will evaluate the accessibility of early Continuous Positive Airway Pressure CPAP intervention on the preterm infants. Methodology: The study will be conducted at Kamuzu Central Hospital, in the Neonatal Intensive Care Unit. The ward is commonly known as Ethel Mutharika Nursery Wing. Participants will include all preterm births born between 28 and 36 weeks of gestation. Neonatal Intensive Care Unit NICU admits about 400 preterm infants requiring Continuous Positive Airway Pressure CPAP therapy annually. Expected outcomes: The study will provides up-to-date information on the need and utilization of low-cost Continuous Positive Airway Pressure CPAP devices rolled out in NICU Neonatal Intensive Care Unit at Kamuzu Central Hospital.
Restricted
Accessibility of physiotherapy services post-hospital discharge after stroke in Blantyre, Malawi: The patient’ perspectives
(Kamuzu University of Health Sciences, 2021-12-16) Gondwe, Hellen
Stroke is the fourth leading cause of mortality and acquired disability in Malawi(1).Despite challenges faced by people with disability, studies shows that physiotherapy treatment improves the functional status of patients with stroke by minimising impairments hence increasing their quality of life (2). However, anecdotal evidence shows that most Malawian patients with stroke do not attend physiotherapy services after acute hospital discharge and the underlying reasons for such a trend are not empirically established. Therefore, this study aims at exploring the perspectives of people with stroke with regards to accessing and utilising physiotherapy services post-hospital discharge at Queen Elizabeth Central Hospital Blantyre Malawi. Type of the study This research will be a cross-sectional qualitative study Problem Statement The principal investigator has observed that there is an increase in the number of patients diagnosed with a stroke at Queen Elizabeth Central Hospital and these patients do not return for physiotherapy services after being discharged from the hospital after acute medical care. There is no documented evidence to show why patients with stroke do not attend physiotherapy treatment despite given an appointment date. This study aims at exploring the perspectives of people with stroke with regards to accessing and utilising physiotherapy services post-hospital discharge in Blantyre, Malawi. Objectives  To explore the patient's perspectives and experiences with accessing physiotherapy services post-hospital discharge.  To ascertain the patient's understanding of the benefits of utilising physiotherapy services post-hospital discharge.  To investigate challenges faced by patients with stroke on accessing and utilising physiotherapy services post-hospital discharge.  To obtain possible solutions from the patients with stroke for the challenges they face on accessing and utilising physiotherapy services post-hospital discharge. Methodology Study place The study will be conducted in patient’s homes residing in Blantyre within 70km of the discharging hospital Queen Elizabeth Central Hospital. Study population Discharged patients with stroke from Queen Elizabeth Central Hospital between 6 weeks to 12 months during the time of study Study period Three months from December 2021 to February 2022 Sample size In qualitative research, 15 interviews are recommended to reach saturation (19,20) Data collection In-depth interviews using a semi-structured questionnaire will be used to collect data from purposively recruited participants according to the inclusion criteria. Data Management The recorded interviews will be transcribed verbatim for analysis. All identifiable information for the individual participant will be removed and replaced by study code and saved in a password computer. The anonymised data will be analysed using a thematic content approach using both deductive and inductive methods. Expected Findings Financial challenges, lack of mobility aids and inadequate information as being some of the reasons for not accessing and utilising physiotherapy services. Dissemination A copy of the manuscript resulting from this study will be shared with COMREC Committee. The results will also be presented and submitted to the School of Therapeutic Sciences at The University of the Witwatersrand. Oral presentation to the QECH Research Committee and Physiotherapy department respectively.
Restricted
Aclinicaly oriented Microbial resistance surveillance network
(2022-06-22) Lissauer, Samatha
EXECUTIVE SUMMARY Type of study: Descriptive prospective surveillance Problem to be studied: Antimicrobial resistance (AMR) is a major threat to human health with estimates of 10 million AMR deaths per year by 2050. However, these estimates are based on limited data, largely from high-income settings. There is an urgent need to generate better data on the clinical impact on AMR, especially from resource-limited settings. Currently many AMS surveillance systems are passive, pathogen focused, using information from medical laboratories only. As such, we are missing critical information such as impact and cost of drug resistant infection (DRI) at the patient level and patient-level risk factors. This information is crucial in making local and global decisions about treatment and policies. The ACORN2 project is implementation of a clinically orientated antimicrobial resistance surveillance programme of hospitalized patients with suspected acute bacterial infections across 15 sites in 9 countries, of which QECH will be the only site in Malawi. Objectives Primary objective: Implement clinical antimicrobial resistance (AMR) surveillance of hospitalised patients between 0 to 17 years with suspected acute bacterial infections Secondary Objectives  To characterise drug-resistant infections (DRI) by clinical syndrome, place of acquisition (CAI, HAI, HCAI), patient group (adult, paediatric, and neonatal), and location (site, country, region)  To determine the attributable mortality for extended spectrum beta-lactamase producing Escherichia coli, methicillin resistant Staphylococcus aureus bloodstream infection and Enterococci.  To determine the major indications for prescribing parenteral antibiotics by patient group (adult, paediatric, neonatal), timing of prescription (day of admission versus >2 days after admission), and location (site, country, region)  To determine the major empiric antibiotics used by clinical syndrome, place of acquisition (CAI, HAI, HCAI), patient group (adult, paediatric, and neonatal), and location (site, country, region)  To explore clinician knowledge, attitudes, and practice towards AMR surveillance Methodology Setting: Queen Elizabeth Central Hospital Population to be studied: Hospitalised patients aged 0t0 to 17 years at QECH, Blantyre with suspected or confirmed bacterial infection with a focus on paediatric in-patients. 06-Jun-2022 8 ACORN2,Version 12.0, 9 November 20215th May 2022 Number of Participants: 2500 patients for the surveillance data and 30 clinicians for KAP survey. Duration: 24 months of recruitment with follow up at 28 days post enrollment. There will be 6 month follow up for a subgroup of patients with gram positive invasive infection (Staphylococcus Aureus, Escherichia coli and Enterococci)). Expected Findings and Dissemination As forin ACORN1, 88% and 75% of enrolled patients had a blood culture taken for Cambodia and Laos respectively. Of those, approximately 5% of blood cultures will yieldyielded a target organism (pilot: 4.9% for Cambodia and 7.4% for Laos), therefore it is expected that the surveillance across all ACORN 2 sites will yield 37,500 patient episodes, 30,000 blood culture results, and 1,500 target pathogen blood culture isolates with AST data (1). The In Malawi, the study findings will be shared weekly with the paediatric department as part of an existing dashboard, and with the Antimicrobial Resistance Committee at Queen Elizabeth Central Hospital to which the chairperson for the committee has agreed. A final report including any published papers will be submitted to the 7CollegeCollege of Medicine Research Ethics CommitteeSecretariat ,Committee Secretariat, the Kamuzu University of Health Sciences Library and other international conferences.
Restricted
The Active Prevention and Treatment of Maternal Sepsis
(Kamuzu University of Health Sciences, 2022-07-13) Gadama, Luis
Hybrid implementation/effectiveness trial. Multi-country, parallel cluster randomised trial with baseline phase. Setting 32 healthcare facilities in Malawi will participate, as part of a multi-country study The problem Maternal infections and sepsis are reported to cause 11% of direct maternal deaths (1), and recently the WHO GLOSS (Global maternal Sepsis) study, although based on small numbers, Formatted: Font: Bold 13-Jul-2022 x APT-Sepsis Protocol Version 1.0 Date, 13 April 20222.0 Date, 06 June 2022 Formatted: Left suggests maternal infection may contribute to over half of all intra-hospital maternal deaths (2), with by far the greatest burden borne by women in Low- and Middle-Income Countries (LMICs). There is an urgent need to identify ways to combat this problem which are implementable at scale, and are clinically effective, cost effective and sustainable. This study which will be conducted in Malawi aims at assessing the effectiveness of implementing APTSepsis bundle which is the quality of care for mothers, and adherence to WHO evidence-based practices in infection prevention and management. APT- Sepsis is a carefully developed programme designed specifically to be used in countries and facilities where there are limited resources available; Malawi and Uganda are the countries identified to participate in this study. It APT-Sepsis aims to change health care workers’ behaviours to ensure mothers get the best care possible to better prevent and manage infections. Broad Objective The broad objective of this study is to examine if the APT-Sepsis programme is effective at reducing infection related maternal mortality and severe maternal morbidity, at any time prior to discharge infrom health care facilities in Malawi and Uganda. Specific Objectives The specific objectives are, to evaluate if the APT-Sepsis programme is effective at reducing secondary clinical outcomes of sStillbirth, early neonatal death, maternal mortality, maternal near miss; to explore differential or subgroup effects of the APT-Sepsis programme; to understand the implementation of the APT-Sepsis programme in Malawi, to facilitate interpretation of trial outcomes and development of a longer-term implementation strategy; and finally to determine if the APT-Sepsis programme is cost effective. Methods The study is a multi-country, parallel cluster randomised trial with a baseline control phase. There is an integrated implementation evaluation and health economic evaluation. The overall trial will include 630 clusters in Malawi and Uganda, each of which is a health facility. This protocol specifies the activities to be conducted in Malawi. During the first six months each cluster will continue with their current practices and data will be collected to establish weekly rates of maternal infection and mortality. After the baseline period, the clusters will be randomly allocated in a 1:1 ratio to the APT-Sepsis programme or current practice with passive guideline dissemination, using a minimisation algorithm. The intervention seeks to change the behaviours of health care providers to improve adherence to WHO guidelines and best practice in infection prevention and management, and detection and management of maternal sepsis. Expected Findings
Restricted
Adapting and implementing group-based postpartum/well-child care at clinics in Blantyre District, Malawi
(Kamuzu University of Health Sciences, 2021-07-29) Gresh, Ashley
Type of Research Study: A mixed methods study. The Problem: Postpartum care, defined in this study from the time of birth through the first year, sets the stage for long-term health and well-being for both the mother and her child; further it is a critical time to reduce maternal and infant morbidity and mortality. The World Health Organization (WHO) recommends that every mother and baby should have at least four postpartum visits within the first six weeks of giving birth. The first year after childbirth is a period of not only physical recovery but is an important time to identify and manage health and social challenges including psychosocial adaptations and transitions to a parental role, that make women and children vulnerable for poor health outcomes. Globally there is no standardized package of care for the first year postpartum. Further, there are low rates of postpartum care attendance, revealing women’s unmet needs during this critical period in their life course. Sub-Saharan Africa, including Malawi, has some of the highest rates of maternal and infant mortality (MMR 439 maternal deaths per 100,000 live births and 42 infant deaths per 1,000 live births) globally. High rates of maternal and infant morbidity and mortality and preventable illness and disease necessitate transformation in the delivery of postpartum and wellchild care in this critical time in the maternal/infant life course. There is a need to develop through innovative strategies a postpartum/well-child care model that is sensitive to maternal-infant dyads in low resource contexts where rates of maternal and infant morbidity and mortality are high. Objectives: Main objective: The purpose of this study is to adapt, implement, and evaluate the feasibility and acceptability of an integrated postpartum and well-child care group-based healthcare model, called CenteringParenting, in Blantyre District, Malawi. Specific Objective 1: Explore Malawian women’s expectations for culturally appropriate postpartum and well-child clinic care. Specific Objective 2: Co-design with Malawian women, midwives and community volunteers an adapted prototype of group postpartum/well-child care. Specific Objective 3: Examine the acceptability of group postpartum/well-child care with Malawian women, midwives, and community volunteers at clinics in Blantyre District, Malawi. Specific Objective 4: Examine the feasibility of group postpartum/well-child care with Malawian women, midwives, and community volunteers at clinics in Blantyre District, Malawi.Methodology: The proposed mixed methods study will use the five-steps of design thinking approach to adapt CenteringParenting: 1) empathize (interviews); 2) define (data analysis); 3) ideate (incubator sessions); 4) prototype (data analysis); and 5) test. This will be done through a rapid ethnographic assessment through interviews and incubator sessions with women, health surveillance workers, community volunteers and providers to create the group postpartum/well-child care prototype. The prototype will then be tested to determine feasibility and acceptability in the Malawian context through interviews, focus groups and surveys. Expected findings: We expect to co-create a prototype for group-based health care for the first year of postpartum and well-child care that will be acceptable and feasible. The findings will inform the next step in future research to determine the effectiveness of the CenteringParenting program model in Malawi. Dissemination of results: Results will be disseminated to the global research community through international journal publications and presentations at international and national research conferences. We also plan to present results at the COMREC conference, an excellent venue that is attended by policy-makers and researchers in Malawi.
Restricted
The African Covid-19 critical care outcomes study (ACCCOS)
(Kamuzu University of Health Sciences, 2020-10-08) Kachitsa, Clement Precious
TYPE OF STUDY Multi-centre prospective observational cohort study. PROBLEM The infectious disease COVID-19, caused by coronavirus SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), has been declared a pandemic and an international healthcare emergency by the World Health Organization (WHO). It has spread across the globe, overwhelming healthcare systems by causing high rates of critical illness. Mortality from COVID-19 exceeds 4%, with older people with comorbidities being extremely vulnerable. It is expected that between 50-80% of the world’s population may contract SARS-CoV-2 over the next two years. In Africa there is a limited workforce and there are limited intensive care facilities and critical care resources across to provide sufficient care. It is important therefore to establish what resources, comorbidities and interventions are potentially associated with either mortality or survival in patients with COVID-19 who are referred for critical care in Africa. Rapid dissemination of these findings may help mitigate mortality from COVID-19 in critical care patients in Africa. These points provide the rationale for the African COVID-19 Critical Care Outcomes Study (ACCCOS). STUDY OBJECTIVES The main objectives of this study are to identify critical care resources associated with survival, identify patient comorbidities and other risk factors associated with in-hospital mortality and to identify in hospital interventions associated with in-hospital survival in patients with suspected or known COVID-19 in Africa. METHODS An African multi-centre retrospective and prospective observational cohort study of adult (≥18 years) patients referred to critical care or high-care units with suspected or known COVID-19 infection. Patient follow up will be for a maximum of 30 days in-hospital. The intention is to provide a representative sample of the mortality and the risk factors associated with mortality in adult patients with suspected or known COVID-19 referred for critical care in Africa. This study will run between Aprils to December 2020. EXPECTED FINDINGS AND DISSEMINATION We expect the outcomes to be potentially worse in Africa, because firstly, there is a limited workforce, and secondly there are limited intensive care facilities and critical care resources across Africa to provide sufficient care. A report of the research findings will be submitted to the College of Medicine Research and Ethics Committee, the College of Medicine Library, the Health Sciences research committee, the University research and publication committee, the Lancet Commission and the Ministry of Health.
Restricted
African Surgical Outcomes Study in Paediatric patients (ASOS-Paeds)
(Kamuzu University of Health Sciences, 2022-06-15) Mulwafu, Wakisa
TYPE OF STUDY Multi-centre prospective observational cohort study. PROBLEM Access to safe surgery is a basic human right. This is highlighted by the work of the Lancet Commission on Global Surgery.There is a burden of surgical disease in the paediatric surgical population with a large need. In Africa, children comprise a significant proportion of the population with approximately 50% of the population being ≤19 years old. Limited Limited data from Africa suggests the risk factors for, incidence and outcomes associated with paediatric surgical complications differ from HICs. The African Surgical Outcomes Study (ASOS) has described surgical outcomes in adult patients in Africa. There is a need to determine the burden of the complications in paediatric surgical patients in Africa, and the risk factors for and the type of complications experienced. STUDY OBJECTIVES The main objective of this study is to confirm the incidence of in-hospital postoperative complications up to 30 days post-surgery in paediatric surgical patients aged < 18 years in Africa. In paediatric surgical patients < 18 years in Africa: 1. To determine the in-hospital postoperative complications including mortality up to 30 days post-surgery, 2. To evaluate the incidence of intraoperative critical incidents, 3. To assess the association between pre-operative, intra-operative and facility factors with postoperative complications including death. METHODS An African multi-centre prospective observational cohort study of All consecutive paediatric patients aged < 18 years admitted to participating hospitals undergoing elective and non-elective surgery . The primary outcome measure is in-hospital postoperative complications. Obstetric surgery will be excluded. The primary outcome measure is in-hospital postoperative complications censored at 30 days post operatively. This study is expected to start in March 2022. EXPECTED FINDINGS AND DISSEMINATION We expect the outcomes to be potentially worse in Africa, because firstly, there is a limited workforce, and secondly there are limited intensive care facilities and critical care resources across Africa to provide sufficient care. A report of the research findings will be submitted to the College of Medicine Research and Ethics Committee, the College of Medicine Library, the Health Sciences research committee, the University research and publication committee, the Lancet Commission and the Ministry of Health 2. Summary Short title ASOS-Paeds Methodology A prospective international, multi-centre, African observational study Research sites Hospitals undertaking paediatric surgery in participating African Objective To confirm the incidence of in-hospital postoperative complications up to 30 days post-surgery in paediatric surgical patients aged < 18 years in Africa. Number of 7000 patients Inclusion All consecutive paediatric patients aged < 18 years admitted to criteria participating hospitals undergoing elective and non-elective surgery Exclusion Obstetric surgery
Restricted
Analysis of beta-carotene from Malawians grown carrots for pharmaceuticals and food colourings
(Kamuzu University of Health Sciences, 2021-03-04) Fundi, Beatrice; Milanzi, Alinafe
Type of study/Place of study: The research design is an experimental method and will be conducted at the Pharmacy laboratories. Background and Introduction: Carrot is one of the important root vegetables. It has a long history of use by Malawians, traditionally being used in salad. However, carrot has medicinal properties, particularly as antioxidant and anticancer due to presence of carotenoids most commonly β-carotene. The use of β-carotene from carrots in food and pharmaceutical products increase intake of micronutrients which are essential for body processes. In Malawi up to date no research has been conducted to analyze β-carotene from the Malawian grown carrots for pharmaceuticals and food colorings. Study Objectives: The main aim of this work is to investigate the physicochemical properties of β-carotene from Malawian grown carrots for application in food and pharmaceutical products. The specific objectives of this study include; to establish the β-carotene levels from carrots grown under different ecological zones, to determine the stability of β-carotene extracted from carrots obtained from different sources and to determine the solubility of β- carotene in oil-water (o/w) interfacial solvent system. Methodology: Carrots will be collected from the garden at Bvumbwe and Sangano in Thyolo and Ntcheu districts respectively. This is because these districts have different climatic conditions and soil type which might affect levels of β-carotene. Carrots will be randomly collected and kept at room temperature and the analysis will be done at COM Pharmacy laboratory. The carrot roots will be grinded or crushed and the extract where the β-carotene will be produced is extracted using suitable solvents. Solvents will be used for the extraction and the extracts will be tested for the presence and concentration of β-carotene using a standard method outlined in methodology. Data Management and Dissemination: All the data collected will be presented and recorded in Microsoft Excel 2016and statistical analysis will be done using Epi info. It is expected that the results will positive. The results of this study will be disseminated to the following bodies COMREC, Pharmacy department, Undergraduate research project coordinators and COM library
Restricted
An analysis of enteric pathogens among HIV infected individuals with and without diarrhea at Queen Elizabeth Central Hospital
(Kamuzu University of Health Sciences, 2022-08-17) Nyirenda, James
Eastern and Southern Africa bears the blunt of the Human Immunodeficiency Virus (HIV) and Acquired Immunodeficiency Virus Syndrome (AIDS) pandemic having about 54% of world’s HIV/AIDS infected individuals coming from this region. Diarrhea is one of the most common complications of HIV with 80% of all HIV/AIDS infected individuals developing this condition. There is an association between CD4+ T cell count and presence of opportunistic infections. Management of diarrhea in developing countries including Malawi depends on empirical administration of drugs, mostly antibiotics. This is often times due to lack of proper diagnostic capability to determine full profile of enteric pathogens that are likely to contribute to diarrhea for particular patients. Objective: To identify and determine entero-pathogens which are likely contributors of diarrhea among HIV infected individuals in Malawi. Specific Objectives:  Determine the profile of enteric pathogens across HIV infected individual with and without diarrhea.  To identify pathogens detected in diarrheagenic amounts among HIV infected individuals with and without diarrhea. To determine if the antibiotic prescribing pattern among clinicians covers enteropathogens detected using TaqMan array card.  To determine if there is an association between CD4 T cell count and type of pathogens detected in HIV positive individuals with and without diarrhea. Methods: This study will be nested in a phase 2A clinical Trial investigating the safety and efficacy of Clofazimine for treatment of Cryptosporidiosis among HIV+ adults. Two arms of study participants will be used to answer our questions; 22 HIV infected individuals with diarrhea and 10 infected individuals without diarrhea. TaqMan array based polymerase chain reaction (PCR) was used to detect multiple enteric pathogens from stool samples in the main study. In this study threshold cycle (Ct) values and pathogens detected from each group will be analyzed and used to determine the mostly likely pathogen contributing or causing diarrhea. In addition CD4 T cell values and profile of identified entero-pathogens will be analyzed to determine if level of an individual’s immunity plays a role in profile of enteric pathogens among HIV infected individuals. Furthermore, antibiotics that were administered to manage diarrhea will be analyzed to determine whether it necessary for treating the type of pathogens detected. Study Place: Data analysis and investigations will be conducted at the College of Medicine Department of Pathology and college of medicine Library. Expected outcome: We expect to identify enteric pathogens that are more likely than others to contribute to diarrhea among HIV infected individuals. We will identify pathogens and make profile of pathogens in relation to CD4 T cell values. This data will be essential for policy formulation for management of diarrhea in HIV infected adults since treatment is mostly empirical in developing countries such as Malawi due to poor diagnostic capacity.
Restricted
Anti-Sexual Harassment Policy
(Kamuzu University of Health Sciences, 2022-06-01) Saidi, Alice Siyenunu
Restricted
Antibiotic prescription audit at QECH and KCH
(Kamuzu University of Health Sciences, 2022-03-10) Unyolo, Takondwa; Mwambene, Grace
There is an increase in antibiotic resistance by bacteria to most of the available antibiotics and it is an issue of great public health concern. Antibiotic resistance is mostly brought about by inappropriate and unnecessary prescribing of antibiotics despite the availability of prescribing guidelines. Antibiotic stewardship involves appropriate selection, dose, route and duration of antibiotic therapy, and has been shown to minimize emergence of resistance. Auditing antibiotic use is essential in monitoring appropriate use within an institution. This cross sectional and retrospective study aims to conduct an audit on antibiotic prescription at QECH and KCH in Malawi to appreciate the extent of antibiotic prescription between these two referral hospitals. The objectives of this study include, assessing if prescription is based on proper diagnosis, evaluating if antibiotic prescriptions are based on prescribed guidelines and identifying the most commonly prescribed antibiotics at QECH and KCH in the medical wards We are going to audit antibiotic prescription at the two referral hospitals in the medical wards using questionnaires. This process will involve prescribers who are authorized to prescribe antibiotics in the medical department of the hospitals and the use of patient files of those prescribed antibiotics. It is expected that they will be minimal adherence to the prescribing guidelines in the Malawi Standard Treatment Guidelines by the prescribers and that most prescription of antibiotics will be done without appropriate diagnosis. The results of this study will be submitted to KUHES library, they will also be presented to the academic staff and students.
Restricted
Apredictive monitoring system for criticaly ill children in Malawi. A mixed methods usability and implentation research
(2022-03-22) Manda Taylor, Lucinda
Type of Research: This study will employ qualitative and quantitative research methods from the social sciences and human-centred design to assess the usability and implementation determinants of a predictive vital sign monitoring system for critically ill children in Queen Elizabeth Central and Zomba Central hospitals in Malawi. The problem: Each year in low-income countries, millions of children die because high-quality healthcare is not provided. Many of these deaths result from poverty-related diseases that are recognized too late. The monitoring of vital signs is essential to detect critical illness promptly. However, the monitoring systems widely and effectively used in high-resource settings are not suitable for lowincome settings because of their high up-front and ongoing costs, and limited adaptation to the socioeconomic background, working conditions and workflows. To address this problem, a consortium of Malawian and European researchers is developing an affordable, durable, and user-friendly monitoring system (IMPALA) for hospitalised children in lowincome countries. The IMPALA system combines innovative sensors, predictive machine learning algorithms, and point-of-care biomarkers within a simple monitoring system that enables health workers to detect and predict critical illness quickly. The implementation and usability research will run prior to and in parallel with clinical research on the IMPALA system. The setting often complicates the implementation and ultimate impact of health interventions: even interventions that may seem simple, such as the mass rollout of malaria rapid diagnostic tests, can fail to deliver the desired effects and have unintended consequences. Usability and implementation research seeks to examine the acceptability, accessibility, feasibility, and appropriateness of interventions in real-life circumstances and the factors (barriers and drivers) that influence their impact. Such research hence enables health interventions such as IMPALA to maximize the desired impact, in this case, improving critical care for children and their health outcomes. The objectives: The study's broad aim is to explore the (healthcare system, social and cultural) context-related factors to be considered in the design and implementation of the IMPALA system to optimise its feasibility, usability and impact on clinical care. The methodology: A mixed-methods approach, combining qualitative and quantitative methods from the social sciences and user-centered design, will be used. The study comprises three stages (pre- IMPALA, IMPALA 2.0 and IMPALA 3.0). During pre-IMPALA, the current context of care for critically ill children in Zomba Central Hospital will be studied. In stage 2.0, alongside clinical research on the IMPALA system 2.0 (described in a separate protocol), the implementation of the monitoring system will be studied. Stage 3.0 focuses on the updated IMPALA system with monitoring based on predictive algorithms. Methods include questionnaire-based surveys, in-depth interview, focus group discussions/co-design sessions, cognitive walkthroughs, heuristic evaluation, analysis of de-identified routine monitoring data and medical records, and ethnographic and structured observations. Data will be collected with healthcare providers, support staff, and the parents/guardians of critically ill children. Expected findings: The study results will be used to adapt the system during its ongoing development and make recommendations to ensure that its implementation has the desired impact on clinical practice and the health outcomes of critically ill children.
Restricted
Assessing an association between utilization of focused antenatal care services and low birthweight at Zomba Central Hospital in Zomba District, Malawi
(2022-02-09) Nyambalo, Lawrence
The prevalence of low birthweight in Malawi stands at 12.1% and is relatively higher compared to other countries in the sub-Saharan region (1). Reproductive health policies and promotion of adequate maternal health initiatives were put in place to encourage adequate antenatal care utilization in Malawi as one way of reducing low birth weight. Antenatal care (ANC) is the care provided by skilled health-care professionals to pregnant women and adolescent girls in order to ensure the best health conditions for both mother and baby during pregnancy (2).The traditional antenatal model of care was initially introduced by the WHO and was later replaced by focused antenatal care (FANC) in 2002.The focused antenatal care had four mean visits which antenatal mothers were advised to comply. The focused antenatal care was instituted in an attempt to overcome the challenges posed by the traditional antenatal model of care such as classifying pregnant women into high risk or low risk group based on pre-identified criteria, and the possibility of the low risk group developing complications at delivery (3).Recently, WHO has extended recommendations for more comprehensive coverage of antenatal interventions with up to eight contacts for additional components of care (4) , but in Malawi and many Africa countries in the sub-Saharan region, the challenge remains to achieve the earlier standard of four ANC visits. Globally, during the period 2007–2014, only 64% of pregnant women attended the WHO-recommended minimum four contacts for ANC, suggesting that much more work needs to be done to address ANC utilization and quality (2).In Malawi, the national coverage of first trimester of the WHOrecommended minimum four contacts for ANC is at 12%.The study therefore aims to establish an association that exist between number of antenatal contacts and low birthweight at Zomba to improve early child development and reduce neonatal deaths in Zomba District, Malawi.
Restricted
Assessing Antibiotics Prescribing Practices in Dentistry
(Kamuzu University of Health Sciences, 2022-03-10) Bonongwe, John; Bandawe, Rhoda
This is retrospective cross-sectional study. The study is trying to explore the antibiotic prescribing pattern among dental therapists or dentists. We are trying to investigate the practices which might lead to expansion of the antimicrobial resistance and how to curb it. Worldwide, there is a general outcry of antimicrobial resistance spreading at a fast rate. This calls for surveillance systems and organization of data which can aid to halt the resistance spread. Unregulated use and empiric antimicrobial prescriptions among others are contributing to this impediment of treating infections. Aim and Objectives: The main aim is to investigate the antibiotic prescribing patterns among dental specialties. The specific objectives will include to describe the most common antibiotic regimen prescribed by dentists, to identify clinical and nonclinical indications in which antibiotics are prescribed in dentistry and to describe the factors influencing the Antibiotic prescription patterns among dental practitioners. Methodology: This is a cross section study, and we aim at using a structured questionnaire to interview the participants. We aim at collecting data from the written prescriptions from the participants. Specifically, we are targeting to get data related to antimicrobials prescribed for oral infection problems. Both private and public hospitals within Blantyre will be reached. Data analysis will be done at Kamuzu University of Health Sciences (KUHeS). And since it is cross section semi-quantitative research, we aim to use qualitative methods such as thematic data analysis as well as quantitative methods with application of software such as Minitab and SPSS. Expected Findings and Dissemination: Once the data is generated and analyzed, the findings will be shared with various stakeholders such as ministry of health and COMREC through pharmacy department. We desire to publish the findings in a peer-reviewed journal.
Restricted
Assessing architectural design factors of maternity ward that influence quality of health care and patient outcomes at Queen Elizabeth Central Hospital in Blantyre, Malawi
(Kamuzu University of Health Sciences, 2020-11-11) Harnish, Christopher
This study seeks to describe and assess the architectural design factors of delivery suites that influence the maternal birth experience and peripartum health outcomes at Queen Elizabeth Central Hospital in Blantyre, Malawi. The factors of quality of care and patient outcomes which will be assessed are: maternal privacy; peripartum maternal mental health; paternal and guardian involvement and spatial efficiency at Queen Elizabeth Central Hospital. This information will inform evidence-based maternity ward architectural guidelines to improve quality of health care, patient outcomes and patient satisfaction. Assessing architectural design factors of maternity ward that influence quality of health care and patient outcomes at Queen Elizabeth Central Hospital in Blantyre, Malawi. These findings may lead to improvements in architectural designs of maternity wards in health facilities in Malawi; health worker flow and efficiency; patient outcomes; and satisfaction for themselves and their families.
Restricted
Assessing breastfeeding and complimentary feeding practices during COVID-19.
(Kamuzu University of Health Sciences, 21-08-11) Phuka, John
Study type: Mixed methods cross-sectional study Problem: The corona virus disease (COVID-19) has had severe consequences on the social aspects of human interaction. Particularly, measures aimed at deterring the spread of disease such as social distancing and wearing of masks have likely hindered infant and young child feeding and care practices including breast feeding, child and mother interaction as well as family or community participatory support. Breast feeding is essential for children’s optimal physical and cognitive growth, especially in settings highly burdened with malnutrition. Monitoring of breastfeeding and complementary feeding practices during the pandemic is critical to ensure that women can continue to breastfeed their children safely and mitigate the risks of malnutrition. However, care practices of infants and children in the context of pandemic have not been well studied. Therefore, this study aims to pilot our modified questionnaire on breastfeeding knowledge and practices as well as obtain essential data on infant and young child feeding practices Methodology: The study will recruit 415 participants from Nkhata Bay and Lilongwe. Enumeration areas will be randomly selected from each district, thereafter households with children aged 0-24 months will be identified through community leaders and health surveillance officers. Data will be collected from mothers or care givers of children through a structured questionnaire and focus group discussions. Expected results and dissemination: Study outcomes may inform national nutrition programming, the global maternal nutrition reports and other key advocacy reports on exclusive breast feeding and complementary feeding practices during the pandemic. The findings of this research will be presented to United National Children’s Emergency Fund (UNICEF), DNHA, Ministry of Health and relevant stakeholders. A completed final report of the study will be submitted to UNICEF, DNHA, COMREC and MoH.