Research & Ethics Committee

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Enhancing pathways from agriculture-to-nutrition: a study of women’s empowerment in nutrition, nutrition outcomes, and, strategies for optimising nutrition among beneficiaries of a feeding trial in rural Malawi
(Kamuzu University of Health Sciences, 3-12-21) Kalumikiza, Zione
The proposed study is a cross-survey that determines associations between Women’s empowerment and maternal nutrition outcomes in a rural Malawian community. Problem: The nature, strength, and direction of associations between women’s empowerment and nutrition outcomes seems to vary widely and is ambiguous. No local research has assessed comprehensively associations between women’s empowerment and maternal nutrition or attempted to measure women’s empowerment in the realm of nutrition. Using a measure closely related to nutrition, the proposed study will provide data on the status of women’s empowerment and propose actions to facilitate nutrition empowerment and outcomes. This study, therefore, will not only add to the body of knowledge in the relevant fields, but will generate evidence with policy and programmatic implications. Objectives: Broadly, the study seeks to determine the status of nutritional empowerment among women of reproductive age in a rural Malawian community using a novel index, the Women’s Empowerment in Nutrition Index (WENI) and to assess its associations with nutrition outcomes. Specific study objectives are; (i) to determine the to etermine associations between the WENI and the Body Mass Index (BMI), Mid Upper Arm Circumference, and, dietary diversity of women in the study area; (iii) to assess the effect of provision of a staple food (maize flour) on dietary diversity, and intakes of energy, protein, iron and folate; and, (iv) to assess changes in dietary quality (diversity) among the WRA 2 years after participation in a feeding trial. Methodology: The study combines a cross sectional survey designed to collect and measure status of women’s empowerment in nutrition and its associations with maternal nutrition outcomes, and, secondary analysis of data from an intervention study, the “Alleviating Hidden Hunger with Agronomy (AHHA)” conducted within the Geo Nutrition project (reference: P.05/18/2393). The analysis of the AHHA data will measure changes in diversity and intakes of energy, protein, iron, and folate following receipt of a staple food (maize flour). The changes in diversity over time will also be assessed to see to what extent benefits, if any, are sustained over time. For the WENI survey, face-to-face interviews will be conducted with women who participated in the AHHA study (n=180), guided by a semi-structured interviewer administered questionnaire. Microsoft Excel, IBM SPSS Statistics version 25, will be used in the data entry and analyses phase respectively. In addition to general descriptive statistics, Fischer’s LSD test and the Dunnett’s test will be used to assess changes in nutrient intakes. To test for associations between women’s empowerment in nutrition and nutrition outcomes, chi-square analyses will be used. Multivariate logistic regression will be employed to identify specific empowerment domains closely related to nutrition outcomes.
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Continuity of Essential Health Services (CES) study - Exploring effect of COVID-19 on demand for maternal, newborn and child health services in selected districts in Malawi by William Stones
(Kamuzu University of Health Sciences, 4-06-21) Stones, William
Type of Study This is a Qualitative study in selected geographical areas including key informant interviews (KIIs), focus group discussions (FDGs) and in-depth interviews with specific target groups (e.g. women living with HIV/AIDS). The scope will include data collection, data quality monitoring, transcription/translation, data analysis and reports on study results. BACKGROUND RATIONALE Malawi registered its first Covid-19 cases in March 2020. A Presidential Taskforce on Covid -19 was immediately set up and Covid-19 prevention measures were put in place and these included: Closing down of schools, social distancing, wearing of masks, self- quarantine for all who tested COVID positive and all in-coming travelers, public gatherings were initially limited to 100 people and this was suspended due to injunctions. While government public health and social measures have likely forestalled some COVID-19 spread, they also have deleterious indirect social, economic and health impacts. While attention is understandably focused on the direct impact of the COVID-19 pandemic, it is essential to see the health crisis from a broader perspective. In Malawi, health systems are already fragile and people often live in extremely precarious conditions. The coronavirus pandemic risks further reducing vulnerable people’s already limited access to healthcare, as resources – both human and financial – get diverted from regular healthcare to the COVID-19 response. OBJECTIVES The overall study objective is: • To investigate the effect of COVID-19 pandemic on people’s willingness and ability to access essential MNCH services, their experiences of care and the perspectives of staff on MNCH services’ readiness to provide essential care during the pandemic. Specific study objectives are to: 1. Comprehend how COVID-19 has affected pregnant and breastfeeding women’s access to maternal and newborn health services. 2. Comprehend how COVID-19 has affected access to child health services for the under-fives. 3. Comprehend any specific challenges faced by vulnerable groups during COVID-19 with regard to access to MNCH services. METHODS The methodology will include focus group discussions (FGDs) and key informant interviews (KIIs), followed by in-depth interviews (IDIs) to capture respondents of vulnerable groups. The data will be collected from Mchinji and Blantyre Districts (indicative locations to be confirmed following consultation) and the study population will include adult pregnant/breastfeeding women, parents/caretakers of children under five years of age, adolescents (15 to 19 years of age, 7 companions/partners of pregnant/breastfeeding women and pregnant/breastfeeding adolescents, community-based health workers, health workers and facility based managers. DATA MANAGEMENT AND ANALYSIS All audio and handwritten data collected from the FGDs and interviews will be stored securely. Electronic notes, transcripts and translations will be stored electronically and protected by a password. Only members of the research team will have access to these documents. As soon as the audio-recordings have been transcribed and verified, they will be destroyed by erasing the voice recordings. Framework analysis will be used for cross-sectional analysis of data from FGDs, IDIs and KIIs. The focus will be on understanding the demand and supply-side barriers to seeking routine and emergency health care services, the extent to which the pandemic has impacted people’s willingness and ability to access MNCH services and how service readiness and provision has changed as a result of COVID- 19 and its effects. A combination of deductive and inductive themes will be included. POSSIBLE CONSTRAINTS COVID-19 situation might require adaptation of study methods using more or only virtual methods for interviews and FDGs; virtual FDGs might be not ideal given that moderators should be physically present to be able to catch the dynamics in the groups and to be able to guide and facilitate appropriately. However, the research teams will only do virtual FDGs in case there is no alternative. RESULTS PRESENTATION Key findings will be presented during a webinar with a UN, participating districts and MoH audience. All data collected, analytical memos and framework analysis files will be de-identified and shared with UNICEF alongside draft reports. The report will also be shared with COMREC. IMPLICATIONS OF THIS STUDY We anticipate that findings from this study will highlight the impact of Covid-19 on people’s willingness and ability to access essential MNCH services, their experiences of care and the perspectives of staff on MNCH services’ readiness to provide essential care during the pandemic. 1. Background In Malawi, since March 2020 when the first COVID-19 cases were reported, a Presidential Taskforce on Covid -19 was set up with a mixed membership of Public Health Experts, technocrats and members of the Cabinet. Covid-19 prevention measures were put in place and these included: Closing down of schools, social distancing, wearing of masks, self- quarantine for all who tested COVID positive and all in-coming travelers, public gatherings were initially limited to 100 people and this was suspended due to injunctions. In addition, number of passengers in public vehicles were also limited to 2 people per seat only. Between September and December, 2020, the number of COVID-19 cases reduced which may have fuelled non-adherence to COVID prevention measures. Since January, 2021, Malawi has been hit hard by the second wave of COVID-19 which has caused a sharp rise in the numbers of cases and increase in COVID-19 related deaths. The country has been declared a State of Disaster. The Vice President of Malawi has since led the team to develop new guidelines on COVID response and management. Further restrictions have been made to public gatherings now at 50 people only, the wearing of masks has become mandatory in all public places including markets, shops etc. Restrictions have also been made to trading hours in bars and markets. Since the second wave of COVID-19, more people have tested and hospitalized leading to an overburdened health care system. Government has embarked on efforts to increase the number of health care staff, increase treatment centres and lobby for resources (equipment and supplies) especially oxygen cylinders and accessories and COVID-19 testing kits which are in limited supply. While government public health and social measures have likely forestalled some COVID-19 spread, they also have deleterious indirect social, economic and health impacts. Given relatively limited health care capacity, particularly for critical care, a “bend the curve” paradigm may be less salient in the region and governments need to balance the threat of COVID-19-specific mortality with the potential secondary impacts of mitigation measures, which may also result in excess mortality. The West Africa Ebola epidemic (2014-16) is instructive as it demonstrated that indirect mortality can exceed the direct mortality of the health emergency. Scenario-based modelling of excess maternal and child mortality due to reduced coverage of essential health and nutrition services suggests that the indirect impact of COVID-19 mitigation measures could result in an increase of 9·8% to 44·7% in under-5 child deaths per month, and an 8·3% to 38·6% increase in maternal deaths per month, across 118 countries1. COVID-19 projections estimate that 15 million additional unintended pregnancies could occur over one year if COVID-related service disruptions affected 10% of women in need of sexual and reproductive health (SRH) services in low- and middle-income countries2. Anecdotal evidence from Kenya, Malawi and Mozambique indicates an increase in adolescent pregnancies since the closure of schools due to COVID-19. Within schools, Malawian adolescents have some access to reproductive health information and counselling, presence of mother-groups to support girls in need of services, peer to peer support. The impact of COVID-19 on the availability and quality of MNCH services and social-economic disruption on access to these services requires investigation. The Pulse survey by WHO in 105 responding countries on continuity of essential health services during the COVID-19 pandemic showed disruptions of essential health services reported by nearly all countries, and more so in lower- 1 Timothy Roberton, DrPH. Emily D Carter, PhD. Victoria B Chou, PhD. Angela R Stegmuller, BS. Bianca D Jackson, MSPH. Yvonne Tam, MHS. et al. Early estimates of the indirect effects of the COVID-19 pandemic on maternal and child mortality in low-income and middle-income countries: a modelling study. The Lancet Articles; Volume 8, ISSUE 7, E901-E908, July 01, 2020 2 Riley T, Sully E, Ahmed Z, Biddlecom A. Estimates of the Potential Impact of the COVID-19 Pandemic on Sexual and Reproductive Health In Low- and Middle-Income Countries. Int Perspect Sex Reprod Health. 2020;46:73–6 income than higher-income countries. The majority of service disruptions were partial defined as a change of 5–50% in service provision or use. All services were affected, including essential services for communicable diseases, non-communicable diseases, mental health, reproductive, maternal, newborn, child and adolescent health, and nutrition services. Emergency services were the least disrupted, although 16 countries reported disruptions across all emergency services. The most severely affected service delivery platforms were mobile services, often suspended by government, and campaigns, for example as used for malaria prevention or immunization. The causes of the disruptions were a mix of demand and supply factors. On the demand side, 76% of countries reported reductions in outpatient care attendance. Other factors, such as lockdowns hindering access and financial difficulties during lockdown were also mentioned. On the supply side, the most commonly reported factor was cancellation of elective services (66%). Other factors mentioned included staff redeployment to provide COVID-19 relief, unavailability of services owing to closures of health facilities or health services, and supply-chain difficulties. 2. RATIONALE While attention is understandably focused on the direct impact of the COVID-19 pandemic, it is essential to see the health crisis from a broader perspective. In Malawi, health systems are already fragile and people often live in extremely precarious conditions. The coronavirus pandemic risks further reducing vulnerable people’s already limited access to healthcare, as resources – both human and financial – get diverted from regular healthcare to the COVID-19 response. During 2020, Malawi experienced that health services were downsized or closed to limit the risk of transmission. Shortage of staff was accelerated as frontline healthcare workers fell sick or died in places where there were already too few to provide essential services. Keeping essential health services available and accessible is vital to prevent losing even more lives, whether from malaria, measles, malnutrition or complicated pregnancies. This study study on Continuity of Essential Health Services (CES) aims at contributing to fill the knowledge gap on the demand and supply-side factors exploring barriers to seeking routine and emergency MNCH services. The immediate target groups include pregnant women, women of reproductive age with newborns and children under five years of age including breast-feeding women and adolescent women. In addition, health personnel, both clinical and management, as well as relevant community members will be included in the study. There is a need to understand the extent to which the pandemic has impacted people’s willingness and ability to access (i.e. availability, accessibility, affordability and acceptability) essential MNCH services and experiences of care during the pandemic. Furthermore, this study will also explore the supply side of health service delivery including the perception of health programme managers and health staff on resiliency of the health system and their view on why people are or are not coming in for care and the impact that the pandemic has on quality and the continuation of routine services delivery. The study will have a specific focus on vulnerable populations groups of women of reproductive age, including those living with HIV/AIDS and adolescents, as well as children under five. 3. Objectives of the study The overall study objective is:  To investigate the effect of COVID-19 pandemic on people’s willingness and ability to access essential MNCH services, their experiences of care and the perspectives of staff on MNCH services’ readiness to provide essential care during the pandemic. Specific study objectives are to: 1. Comprehend how COVID-19 has affected pregnant and breastfeeding women’s access to maternal and newborn health services.2. Comprehend how COVID-19 has affected access to child health services for the under-fives. 3. Comprehend any specific challenges faced by vulnerable groups during COVID-19 with regard to access to MNCH services. Specific research questions: The two main research questions are: (A) What is the influence of demand side factors (intention action/gap drivers, reaching care, and receiving care); (B) what is the influence of supply side factors (providing care). These are further elaborated as below. A. Maternal, newborn and child health: Demand side factors Intention action/gap drivers a. Did the target groups of primary interest (as defined above) during COVID-19 pandemic use essential MNCH services (essential as defined in the national packages of care and provided by skilled personnel) to the same extent (frequency, based on needs/demands) as during non-COVID times? b. What were the main factors / reasons that affected the use of essential MNCH services by the primary target groups during COVID-19 pandemic? What was different to non-COVID times in regard to the topics below? Reaching essential MNCH services a. To what extent and how were the primary target groups able to reach to a health facility / seek essential MNCH services during COVID-19 pandemic compared to non-COVID times? b. What were the main factors/reasons that stopped or made it difficult for the primary target groups to reach essential MNCH care during COVID-19 pandemic compared to non-COVID times? Receiving essential MNCH services when the health facility is reached c. To what extent and why were essential MNCH services not available to the primary target groups when reached? d. What kind of changes were observed or experienced by the primary target groups with regard to the quality of MNCH services provided during COVID-19 pandemic compared to non-COVID times? B. Maternal, newborn and child health: Supply side factors Providing adequate care to the primary target groups according to demand and needs a. To what extent did essential MNCH services become disrupted and/or unavailable during COVD-19? How was the readiness of essential MNCH - to serve the primary target population as needed - affected? b. Which MNCH services were most affected and why? Lessons learned- demand and supply-side The study teams will elaborate based on above raised questions on what were the main lessons learned from the COVID-19 pandemic in regard to demand for, access to and readiness of MNCH services. In addition, the interviews will include a question on what the lessons learned were 11  Health services  Health care providers  Health care users  Community-based health service delivery  Referral pathways/linkages between community systems and health systems, and other. 4.3 Target groups of the study The target groups will include specifically: (1) Adult pregnant/breastfeeding women (20 to 49 years) (2) Adolescent pregnant/breastfeeding women (15-19 years) (3) Pregnant/breastfeeding women (15 – 49 years) living with HIV/AIDS (4) Parents/caretakers of children under five years of age including adolescent mothers and fathers (5) Facility based health care workers and health facility managers (6) Community health workers/volunteers and other community-based health agents such as peer mother supporters etc. (7) Sub-national health care managers (district/subcounty, region/county/province) 4. STUDY DESIGN This is a Qualitative study in selected geographical areas including key informant interviews (KIIs), focus group discussions (FDGs) and in-depth interviews with specific target groups (e.g. women living with HIV/AIDS). The scope will include data collection, data quality monitoring, transcription/translation, data analysis and reports on study results. Conceptual Framework The “Governance and Capacity to Manage Resilience of Health Systems” conceptual framework postulates that health systems have three levels of resilience: absorptive capacity, adaptivecapacity and transformative capacity3. This framework is considered relevant as it arose from African experience of the Ebola outbreaks, that presented certain similar challenges to health systems. The absorptive capacity relates to the capacity of a health system to continue to deliver the same level (quantity, quality and equity) of basic healthcare services and protection to populations despite the shock (in this instance the Covid-19 pandemic) using the same level of resources and capacities. Adaptive capacity is the capacity of the health system actors (such as health workers) to deliver the same level of healthcare services with fewer and/ or different resources, which requires making organisational adaptations. Finally, the transformative capacity describes the ability of health system actors to transform the functions and structure of the health system to respond to a changing environment such as adaptations to Covid-19 guidelines and provision of Covid-19 care without compromising other services.
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Explore the occurrence and predictors of depression and anxiety amongst adults (60 years and above) utilizing secondary data collected by the Malawi Longitudinal Study on Family and Health in the three selected districts of Malawi i.e. Rumphi, Mchinji and Balaka
(Kamuzu University of Health Sciencies, 4-08-21) Khosa, Justice
This is a cross-sectional quantitative study design aimed at exploring the occurrence and predictors of depression and anxiety amongst older adults 60 years and above in Malawi (Rumphi, Mchinji and Balaka districts) utilizing secondary data collected by the Malawi Longitudinal Study on families and Health. Problem Statement Life expectancy trajectory in Malawi shows a steady increase which indicates that the country might have an aging population at some point in the years to come. Few studies have explored some of the factors that affect quality of life in different special groups including the elderly. Study Objectives The main aim of this study is to determine the occurrence and predictors of depression and anxiety amongst people aged 60 years and above (the elderly) inMalawi. Specifically; (i) To investigate the prevalence of depression and anxiety amongst people aged 60 and above (the elderly) in Malawi. (ii) To identify the social predictors of depression and anxiety amongst people aged 60 and above in Malawi. (iii) To establish the physiological (physical conditions) predictors of depression and anxiety in people aged 60 and above in Malawi. Methodology The study will utilize data already collected by the MLSFH in the three districts ofMalawi namely Rumphi, Mchinji and Balaka representing all the three regions ofMalawi. This study will include all adults aged 60 years and above in the MLSFH mature adult dataset of 2018. Data will be abstracted fromthe parent study to suit the current need. Consent will be sought fromthe MLSFH team to utilize their data and a waiver from COMREC. Data will be analyzed using Stata (version 14.0) to establish the prevalence and physiological and social predictors of depression and anxiety. Expected results and Dissemination: It is anticipated that this study will help to isolate the magnitude of depression and anxiety and factors that predict the two conditions inMalawi. Results of this studywill be presented to MLSFH team, COMREC and published in peer reviewed medical journal for reference. The study results will also help to isolate some specific factors that affect the quality of life of such special groups, and then design proper programs and interventions aimed at promoting and improving quality of life for such groups.
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Assessment of prescription patterns and cost analysis of oncology drugs used in the Paediatric Unit of Queen Elizabeth Central Hospital, Malawi
(Kamuzu University of Health Sciencies, 6-09-21) Kilowe, Carlos Edwin
Background: Cancer is one of the global leading causes of childhood morbidity and mortality. High childhood cancer mortality rates in developing countries have been linked to irrational chemotherapy prescribing patterns. Irrational prescribing leads to ineffective treatment, occurrence of adverse events, prolonged hospitalization and increased economic burden to patients and their community. Children are more vulnerable to effects of irrational prescribing owing to their underdeveloped pharmacokinetic and pharmacodynamic profiles. Therefore, it is important to follow principles of rational prescribing as well as study prescribing patterns in order to ascertain how drugs are being used. Despite the need for periodical assessment of prescribing patterns and cost analysis, Malawi has a paucity of data on prescribing patterns and cost analysis of pediatric anticancer drugs. Objectives The objective of this study is to assess prescribing patterns and costs analysis of anticancer drugs used in paediatric cancer patients at Queen Elizabeth Central Hospital in Blantyre, Malawi. Methodology A retrospective cohort study will be conducted in pediatric oncology unit at Queen Elizabeth central hospital (QECH). The study will review and abstract data from patients’ files of children aged 0-18 diagnosed with cancer between January 2017 and December 2020. Rationality of prescribing patterns will be assessed using WHO rational prescribing indicators. The WHO indicators include: average number of drugs per encounter, percentage generic prescribing and drugs prescribed from national formulary. Quantity of drugs dispensed from the patient files will be used to compute cost of the drugs using current market prices obtained from Central 21-Aug-9 Version 6 xii Medical Stores catalogue and private wholesale supplier. Descriptive data analysis will be conducted where continuous variables will be summarized as mean and standard deviation. Frequencies and proportions will be computed for categorical variables. Regression analysis will be carried out to summarize possible relationships between anticancer prescribing patterns and predictor variables such as patient’s demographic data, cancer type and stage, and type of medications used. The level of significance will be set at 0.05. Expected findings The study is expected to shed light on rational chemotherapy prescribing patterns and cost of chemotherapy prescription in Malawi. Rational chemotherapy use improves childhood cancer clinical outcomes, reduces occurrence of adverse reactions, and optimizes health expenditure on chemotherapy drugs. Dissemination The findings of this study will be shared with University of Nairobi, Kamuzu university of Health sciences and Queen Elizabeth central hospital. The findings will also be published in peer reviewed journal.
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Long-term outcomes of severe childhood malnutrition study
(Kamuzu University of Health Sciencies, 7-07-21) Kirolos, Amir
Type of research study This study is a cross-sectional follow-up of an existing cohort of adolescents/young adults who suffered from severe malnutrition as children. The problem Childhood malnutrition is widespread in Malawi and has health impacts which are often life long 1. Severe wasting in childhood is particularly deadly 2, and the ‘double burden of malnutrition’ (undernutrition of nutritionally rich foods and oversupply of foods with low nutritional value) is being increasingly recognised as a major health problem globally 3. Current malnutrition treatment programmes have a major focus on preventing acute mortality. While the acute risk of death in early childhood is well described, there is a need for further research on the medium- and long-term outcomes of survivors to understand the long-term disease burden and tailor treatment interventions 4. Children exposed to severe malnutrition may be at higher risk of adult noncommunicable diseases due to impaired organ development, altered body composition, rapid catchup growth through high calorie feeding and exposure to an obesogenic environment. Severe childhood malnutrition is also associated with developmental delay 5, and early insults to the developing brain from malnutrition may impair cognitive potential in later life 6. Mental health and behavioural problems may be also be more common in survivors due to damage to the developing brain, environmental factors and adverse life events 7. However, mental health and behavioural outcomes in severe malnutrition have been poorly researched thus far. Objectives Our main objective is to investigate factors that influence the medium- and long-term health outcomes of children with severe childhood malnutrition. We aim: 1. To quantify the long-term survival after discharge from treatment for severe childhood malnutrition in comparison to controls 2. To measure long-term growth and body composition following severe childhood malnutrition 3. To measure the prevalence of early markers of chronic cardiovascular or metabolic disease in those previously treated for severe childhood malnutrition in comparison to controls 4. To measure the effect of severe childhood malnutrition on cognition, behaviour and mental health 5. To explore predictors of favourable or adverse long-term health outcomes
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Cultural adaptation of an evidence-based psychosocial screening tool for adolescents living with HIV/AIDS in adolescents’ antiretroviral therapy program in Zomba, Malawi
(Kamuzu University of Health Sciencies, 7-07-21) Kip, Esther C.
Executive Summary D. Title of the study: Cultural adaptation of an evidence-based psychosocial screening tool for adolescents living with HIV/AIDS in adolescents’ antiretroviral therapy program in Malawi Problem Statement: In Malawi, a study on depression among adolescents living with HIV (ALHIV) revealed a prevalence rate of 18.9%3. Despite the high prevalence and impact of depression on ALHIV health outcomes, lack of awareness and stigma around mental health services leave ALHIV with depression undetected and there are few culturally, sensitive, standardized, and validated instruments available for depression screening in the African region1,6. The Home, Education, Activities, Drugs, Sexuality, Suicide/Depression (HEADSS) psychosocial screening tool, is an efficacious evidence-based intervention (EBI)8-10 to improve identification of psychosocial issues, such as depression screening and risky behavior. This tool was recommended for use in the adolescent antiretroviral therapy (ART) program called Teen Club (TC) in Malawi in an attempt to identify the above-mentioned challenges. However, its introduction has had poor uptake. Our previous formative study on “Implementation barriers of the HEADSS screening tool in Teen Club Program in two districts in Malawi” found that HEADSS was too long, time consuming and not culturally appropriate to the Malawi setting and some of the suggestions included modification of this tool in order to be culturally acceptable for use in Malawi. Therefore, this current study builds upon our previous findings. Main objective of the study: The long-term goal of this study is to culturally adapt the HEADSS psychosocial screening tool based on our formative work, identify the barriers and facilitators to implementing the modified HEADSS, and identify implementation strategies to address identified barriers to improve the mental health outcomes among ALHIV in Malawi. Specific Objectives are to: 1) Review prior formative study findings and conduct systematic modifications process of the existing HEADSS psychosocial screening tool. 2) Identify the barriers and facilitators to the implementation of the adapted HEADSS among the HCPs in Teen Club program and ALHIV in order to understand the usability and acceptability of the adapted HEADSS screening tool. 3) Based on the findings in objective 2, identify implementation strategies to address the identified barriers to improve the mental health outcomes among ALHIV in Malawi. Methodology: This will be a cross-sectional descriptive qualitative study design and it will take place in Zomba district (Zomba Central Hospital and 1 health center). A purposive sampling approach will be used to select the participants. In-depth interviews (IDIs) using a semi-structured questionnaire will be conducted with key informants (KIs) and health care providers (HCPs) then FGDs with adolescents living with HIV (ALHIV) between 12 and 18 years old. The sample will comprise of 1 clinical psychologist, 1 psychosocial counsellor, 1 Adolescent Coordinators from the NGOs, 1 District Nursing Officer as key informants and 4 HCPs from the Health center and 2 from Zomba Central Hospital Teen Club Program (Lighthouse). A similar proportion of male and female ALHIV will be included in the FGDs from each site, totalling to 20 ALHIV in the 2 sites. An estimated total of 30 research participants will be included in this study. Potential constraints: Not many ALHIV might feel comfortable to speak up, however, our formative study showed that the ALHIV were open and expressed themselves without any problem. The training will be provided to the Research Assistant prior to commencement of data collection, and this will deliver specialized communication skills to enable ALHIV to feel free and speak out on their experiences. Support will be provided to those ALHIV who need to be referred to specialized mental health services and the research team will be trained to ensure that a correct support and referral system is in place before the start of data collection. Some participants may also experience discomfort to respond to the questions, however, they will be informed during the consenting process that they have the right to refuse to answer any question that makes them uncomfortable and to stop the interview at any time. In addition, while the research is aiming to reach an equal number of females and males, it may not be possible be get a gender balanced participation. However, we will communicate these limitations clearly during feedback, recommendation and dissemination activities. Additionally, due to the Covid pandemic, it might be a challenge to get the number of ALHIV on the appointed date as there is limited number of staff and ALHIV assigned for each day. We might even have to do face-to face interviews instead of FGDs depending on how the situation will be during
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“Factors associated with antiretroviral therapy defaulting among HIV positive youth in Mzimba south, Malawi”. by Isaac Paul Kasalu
(Kamuzu University of Health Sciences, 8-10-21) Kasalu, Isaac Paul
Thetype of research study:The researcher proposes to conduct a case control studyto identify factors associated withAnti-retroviraltherapy(ART)defaulting among the Human ImmunodeficiencyVirus (HIV)positiveyouthsaccessing HIV carein MzimbaSouth Districtof Malawi. The problem:There is evidence thatART defaulting is highest amongHIV positiveyouth in Malawi. Studies conducted in someparts ofMalawiindicatethatbetween 11 and 30 per 100HIV positiveyouthsdefault ART. ART defaulting has been associated with development ofdrug resistance in individuals enrolled onART. This could lead to increased morbidity and mortality of HIV positive clients due toresurgence ofopportunistic infections. In addition,an ARTresistant strain of HIVcan be transmitted from one patient taking ARVs to anotherthrough unprotected sexual intercourse.Evidencesuggeststhat physical, psychological,socialeconomic,demographic and health facilityfactors can contribute to ART defaulting.Nevertheless,there is scarcity of reportedevidence regarding specific factorsthat contribute to ART defaulting among the youth in Mzimba.Thisstudy therefore,aims atassessingfactorsinfluencingARTdefaulting in HIV positive youth enrolled onARTinMzimba. Objectives:The main objective of this study is to determine factors contributing to defaulting amongHIV positive youth enrolled on antiretroviral therapy in Mzimba South District.Specific objectives are:to determine prevalence of ART defaulting among the youth living with HIV in Mzimba South district;to assess patient (physical, psychological) related factors influencing ART defaulting among the youth in Mzimba South;to assess availability of communitysocial support initiativesfor youth on ART program;to identify healthfacilityinitiativesfor youths accessing HIV care in Mzimba Southand to identify risk factors for ART defaulting among the youth accessing HIV carein Mzimba South District. Methodology:Thisstudy will utilizeaquantitative,case control design.A sample population of 411HIV positive youth(137cases and274controls) attendingan HIV careclinic will be recruited. BothART defaulters and non-defaulterswill beenrolledinthis studyusing stratified random sampling technique.Data will be collected using astructured questionnaire.Datawill be analyzed using the Statistical Package for Social Scientists (SPSS)version 20.0.Chi-squareandbinary logistic regression will be carried out to establish relationship between ART defaulting and the independent variables. Expected findings anddissemination:It is expected thatthis study will identify specific factors that contribute to defaulting of treatment among the youth livingwith HIVandAIDSin Mzimba South.Findingsfrom this studywill be disseminated to the health facility management and care providers in respective facilities where the study will be conducted.Furthermore, resultswill be shared to the District ExecutiveCommittee (DEC)for M’mbelwa council, Kamuzu College of Nursing,College of medicine research and ethics committee (COMREC)and other research seminars. The manuscripts shall also be prepared for publication.
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Prevalence of asymptomatic SARS-CoV-2 infection among returnees from South Africa at Mwanza Border
(Kamuzu University of Health Sciences, 10-03-22) Kenneth, Owen Ajassie Zacchaeus
SARS-CoV-2 which has spread rapidly throughout the world can present as symptomatic or asymptomatic infection. Literature shows that asymptomatic individuals play a significant role in the ongoing pandemic, but their relative number and effect have been uncertain. In Malawi, there are no reliable estimates of the true burden of imported asymptomatic SARS-CoV-2 cases published. Malawi’s mainland testing algorithm for MoH priotises those with symptoms, thereby maximizing the risk for silent spread by asymptomatic persons. It is thus imperative that testing programs include those without symptoms. Under travel restrictions, Mwanza border, the main border for most returnees from SA (a high risk nation), remained the only border which was open during the partial border lockdown and SARS-CoV-2 testing was conducted in all the returnees irrespective of symptoms. With the information above, a retrospective study will be conducted to estimate the burden of asymptomatic SARS-CoV-2 infection where 350 cases will be employed as participants. Stratified sampling will be used to recruit the participants. The design has both quantitative and qualitative aspects The quantitative aspect will involve reviewing existing case-based records of returnees who presented at Mwanza border The qualitative aspect will involve administering of questionnaires to health-care workers at the border to find out how they managed the cases. No patient names will be mentioned in any of our data collection tools for complete privacy. Data analysis will be done both manually and electronically using SPSS. The aim of the study is to review and provide the available evidence on asymptomatic SARS-CoV-2 infection among returnees from SA at Mwanza Border. In this study we are going assess the prevalence of SARS-CoV-2 infection among the returnees at Mwanza border as our main objective and specific objectives as follows: to assess clinical and demographic characteristics of the returnees with asymptomatic SARS-CoV-2 infection, to develop an understanding on how returnees with SARS-CoV-2 were managed according to the standard management protocol, to compare the proportion of asymptomatic cases to symptomatic cases and to assess the association between demographic characteristics and SARS-CoV-2 status stratified by symptom status. We expect to find a high prevalence of asymptomatic SARS-CoV-2 infection among the returnees as testing was carried out on the returnees regardless of symptom presentation and the returnees were coming from a high risk nation. A report of the findings will be handed in to COMREC, Kuhes library and other relevant institutions. Findings from this study will have potential role to inform policy-makers and stake holders to devise, review and enforce measures and policies to effectively combat the pandemic, will help in laying a foundation for future studies, and the data collected will help us estimate the magnitude of the problem at Mwanza Border so that with our recommendations together, we can somehow help improve the quality of health-care services.
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The effect of pulmonary rehabilitation on cardio-respiratory function of patients with chronic lung diseases identified during chest X-ray screening for pulmonary tuberculosis
(Kamuzu University of Health Sciences, 11-03-22) Gwelama, Precious
Type of Research Study This study will use an Experimental Study-it is a Randomized Controlled Trial (RCT) with 1:1 allocation to assess The Effect of Pulmonary Rehabilitation (PR) on Cardio-Respiratory Function of Patients with Pulmonary Tuberculosis in Blantyre. Problem to be studied The prevalence of Chronic Lung Diseases (CLDs) is high in patients undergoing Tuberculosis (TB) screening mostly due to previous pulmonary infections including pulmonary Tuberculosis (pTB). In order to prevent progressive loss of pulmonary function in these patients, interventions that prevent CLDs need to be employed. The National Tuberculosis Control Program (NTP) in Malawi does not have established guidelines in the management of pTB to prevent CLDs. Previous TB infection usually causes lung damage and post pTB survivors frequently present with persistent respiratory symptoms which clinically present as CLDs. Even though PR has shown to be effective in the management of CLDs by improving respiratory symptoms, physical function and health related quality of life (HRQoL), there is still limited evidence on the effect of PR during TB treatment. Furthermore the few studies performed so far with regard to PR in TB sequelae have confirmed the same positive results as those that are found with PR use in CLDs. Objectives Broad objective To compare the effect of PR (breathing exercises, strengthening and aerobic training PR techniques used in chronic lung diseases) at 6 weeks of treatment with no PR in the management of patients with TB. Specific objectives 1. To compare changes in spirometry Forced Expiratory Volume in one second (FEV1) and Forced Vital Capacity (FVC) values in Litres (L) between participants receiving PR with those not receiving PR. 2. To assess the effect of PR on exercise tolerance in participants receiving PR in comparison to those not receiving PR. 3. To compare respiratory symptoms improvement of pTB between participants receiving PR with participants not receiving PR. Methodology This study will be conducted from 1st March to 31st May 2022 at the physiotherapy clinics based at Queen Elizabeth Central Hospital (QECH), Kamuzu University of Health Sciences (KUHES), and private practitioners in Blantyre. The study participants who will be selected will include a total of 240 participants. These participants will include pTB patients (≥18 years) who have initiated TB treatment with known HIV status from Blantyre District. Data on spirometry, physical function and HRQOL will be collected. Study Participants will then be randomly assigned to receive PR (the intervention) and no PR (control arm) using a sequence pre-generated by a statistician. The PR program will run for 6 weeks with a 90 min–120min supervised session at week one and week three. Continuous data will be analysed using a T test and Analysis of Variance (ANOVA) if normally distributed, and if skewed a Wilcoxon Rank Sum Test will be used. Furthermore, categorical variables will be analysed using a Fisher's exact test. Finally Logistic regression will be done to show differences between the intervention and control group. Expected findings and their dissemination It is expected that at the end of the study there will be evidence of clinically significant improvements in HRQoL, exercise tolerance, respiratory symptoms and lung function in patients receiving PR. These findings will be disseminated at District level, national conferences, the health facilities of the TB patients, College of Medicine Research and Ethics Committee (COMREC), Blantyre District Health Office (DHO), NTP and wider audiences through journal publications such as the Malawi Medical Journal.
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Determinants of timely access to care for prenatal and postnatal services in Malawi by Liness Kataika
(Kamuzu University of Health Sciencies, 11-08-21) Kataika, Liness
EXECUTIVE SUMMARY Type of study This is the cross sectional qualitative study that will utilize secondary data from a study titled “Integrating a neonatal Health care package for Malawi,” 2018-May 2020 Background Problem Timely access to prenatal and postnatal services is a key to maternal health services that can significantly help reduce maternal mortality. However, timely access to maternal and neonatal care services has always been a challenge in Malawi due to several factors. Understanding the factors that hinder timely access to service utilization helps to design appropriate strategies and policies towards improvement of services utilization and thereby reduce maternal mortality. Objective The objective of this study is to determine factors that affect timely access to prenatal and postnatal services in Malawi. Methodology This is the cross sectional qualitative study that will use secondary data from a study titled “Integrating a neonatal Health care package for Malawi”2018-May 2020). Data will be taken from the primary owner and will be analyzed thematically. Measures to ensure confidentiality will be followed throughout the period and there after Ethical approval will be sought from ethics committee COMREC Dissemination of expected find. Study design This is the cross sectional qualitative study that will utilize secondary data from a study titled “Integrating a neonatal Health care package for Malawi”2018-May 2020). The qualitative study was employed to fully gather the information from parents and guardians of neonates who are receiving care using the interventions under observation. Study Place This was a qualitative study conducted in 3 public Health facilities (Mulanje, Chikwawa and one central hospital in Blantyre Urban (Queen Elizabeth Central Hospital) and one private health facility (Mission hospital) Holy family hospital in Phalombe in Malawi from May 2018- May 2020. Study Population, Study Period, Sample Size, Data collection and management The study targeted Health Care workers, Mothers of Neonates, Fathers of Neonates, and Elderly Women or grandmothers in the southern rejoin of Malawi. The study from Nov 2020- June 2021. Participants were sampled purposively using maximum variation. Data will be taken from primary owner and permission already granted. Data will be managed manually Data analysis Data will be analyzed thematically. The extraction of data from primary data will be done guided by the coding guide which has been developed guided by the conceptual framework of the study [32]. Both inductive and deductive approach to the analysis will be employed.
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Rapid assessment to evaluate the defaulter tracing program for under five children immunization services in Rumphi district
(11-11-21) Tembo, Atupele Kapito
EXECUTIVE SUMMARY Type of Study:Amixed methods study where retrospective data will be used and prospective data will be collected as well.Mixed quantitative and qualitative methods will be used.Secondary analysis of Ministry of Health(MOH)routineExpanded Programme on Immunisation (EPI)administrative datawill be conducted. Background:The MOHwith funding fromUNICEF has been implementing acommunity-based defaulter tracing program in Rumphi districtto improveequity and effectiveness of the immunization program.Thedefaulterprogramhas two approaches, one usingmother care group volunteers(MCGs)andthe other one usesreligious institutionsin the communities.It is anticipated that the defaulter program willincreaseproportionof fully immunized children and vaccination coverage in under-five childrenin the district. However,after implementing the program since August 2019,there is need to systematically evaluate theperformanceof the defaulter programin the districtregardingits impactand toinformtheimplementersand policy makerson areas requiring improvementsand strengthening. Main Objective:Evaluatethe performanceand impactof theMOH community-baseddefaulter programfor routine immunization in under-five childrenbeingimplemented byMCGs volunteers and religious institutionsinRumphidistrict. Methods:Wepropose toconductsecondary analysis of MOH routine EPIquantitative administrative data from 2018 to date toestablishthe immunization coverage trendsin the districtbefore and after the defaulter tracing program.We will also conductcross-sectional quantitative and qualitativeevaluation assessments.Theassessmentswill be conductedin4 randomly sampled health facilities, 2 from each of the implementation approaches(MCGs and religious institutions).Based on vaccination coverage performance,2 health facilities(one best EPI performing and one poor EPI performing health facility)will be randomly chosen from the listof facilitiesfor each approach.For the quantitative component, we willconduct exit interviews with child caregivers.We willenrol30 participants using simple randomsampling from each of the 4 selected facilities.For the qualitative component, we will conduct10focus group discussions (FGDs).The FGDs will be conducted as follows: a)Twowill be with child caregivers of under-immunised children attending therandomly sampled2low performing facilities, one from each approach b) Two will be with child caregivers of under-immunised children from communities of the 2low performing facilities, one from each approach c) One will be with MCGs who will be randomly sampled from a list of MCG volunteers d) One will be with religious volunteers who will be randomly sampled from a list of religious groups volunteersand e) Four will be with health workers from each of the 4 sampled health facilities.Each FGD will be comprised of 6-8participants.Wealso propose to conduct 8in-depth interviews (IDIs)with key informantsselectedpurposively.These will includedistrict EPI and community health coordinators,DEHO orAEHOs,health facility EPI focal personsor seniorHSAs. The exit interviews,FGDs and IDIs with key informants will be employed toobtain information ondefaulter program includingknowledge of the program,it’sstructure and systems, best practices,lessonslearnt, implementation strengths, challenges and recommendations.All qualitative interviews will be digitally-recorded and transcribed verbatim, coded and thematic analysis will beconducted.Quantitative data will be analysed using statistical software packages. Expectedfindings and dissemination: Weexpect thisevaluationtoprovide information on vaccinationcoveragetrends before and after the defaulter tracing program for immunization in Rumphi district to assess impact. In addition, the evaluation will document andprovide information on the currentimplementationstructuresand systems, best practices,lessons learnt, strengths and challenges of the defaulter tracing program. Theinformationwillguide implementers and policy makerson the areas requiringstrengthening andimprovementforthe program.It is planned that the findingswill be shared with College of Medicine Research and Ethics Committee, MOHand presented at college, national and/or international research dissemination conferences and will be publishedin peer-reviewed journals.
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Strategies for linking HIV exposed infants to HIV care services at South Lunzu health centre by Rhoda Salome Kunje
(Kamuzu University of Health Sciences, 12-05-21) Kunje, Rhoda Salome
Background: HIV exposed infant care in Malawi is integrated with maternal ART follow-up to improve retention. Malawi National HIV Testing and Counselling (HTC) guide lines for HIV –exposed infants recommend a DNA PCR test done at 6 weeks, followed by 2 confirmatory rapid tests at 12 and 24 months to determine the HIV status of HIV exposed infants. Infants also receive 6 weeks of Nevirapine(NVP) starting at birth and early infant HIV DNA polymerase chain Reaction(PCR) diagnosis using dried blood spots after 6 weeks of age are done, Infants are clinically followed up until determination of final HIV infection status(1). Despite efforts to improve retention, lost to follow-up remains a challenge in the care of HIV exposed infants. Astudy done by Wingston F. Ng’ambi and others in Lilongwe Malawi showed that overall 48% of HIV-exposed infants were declared lost to follow-up due to a number of reasons (2). Available data at South Lunzu health facility in Blantyre Malawi, demonstrates that from 2018 to 2020, there has been increased numbers of children who have defaulted from HIV care services especially at 12 months and 24 months after being initiated in care.In 2018, out of the 213 HIV exposed infants that were enrolled at 2 months,96.6% were retained in care and 2.4% was the default rate.At 12 months 190 infants were enrolled in care and 70.4% was the retaintion rate and 9.6% was the default rate.At 24 months 176 infants were enrolled and there was 57.4% retaintion rate and 42.6% default rate.In 2019, 175 HIV exposed infants were enrolled and retention rate was at 97.6% and default rate was at 2.4%. At 12 months 162 HIV exposed infants were enrolled, 81.8% was the retention rate and 18.2% was the default rate. At 24 months, 146 infants were enrolled and retention rate was 61.1% and 38.4% was the default rate. This trend of defaulting from HIV care continued for the year 2020 especially as the children grew older. For this study, the researcher expects to find that there are no strategies or interventions at the health facility that are put in place to link back the HIV exposed infants who are lost to follow up for HIV health care services despite the increased default rates. PROBLEM STATEMENT Early Infant Diagnosis (EID) of HIV infection at the primary care level in Malawi is challenging. Many children are indeed tested for HIV and some are found to be HIV infected while others are HIV uninfected in the HIV diagnosis and treatment program and they are lost to follow-up at various stages. In Malawi’s option B+, loss to follow-up remains a great challenge in the care of HIV exposed infants, and although the Malawi government recommends HIV exposed infants receive Early Infant Diagnosis(EID) at under-five Paediatric clinics, most of these children are never enrolled. In 2014, less than 20% of HIV-exposed infants received early infant diagnosis test in the first 2 months of life, and only 30% of the HIV infected children were on antiretroviral therapy (13). Those children who are lost to follow are at higher risk of infection and opportunities to enter them into care are rare, consequently these children do not come back, if they come at all, its until they develop serious AIDS- defining illnesses, leading to death. OBJECTIVES: The aim of the study is to explore strategies for linking HIV- exposed infants who are lost to follow-up back into HIV care services at South Lunzu Health Centre in Blantyre,Malawi.Specifically, the study seeks to determine the proportion of HIV-exposed babies who tested positive to HIV and were lost to follow-up in relation to HIV care services,to describe the views of Health Care workers on effectiveness of the interventions currently in place for linking HIV exposed infants to HIV care services and to establish the remedies suggested by postpartum/breastfeeding mothers who are infected with HIV on minimizing lost to follow up cases amongst HIV positive infants at South Lunzu Health Centre. METHODOLOGY The research is a cross-sectional study using mixed methods (quantitative and qualitative) where data will be collected at the same time or approximately the same time period. Questionnaires and Focus Group Discussions will be used to collect the data at the same time period. The population of interest for this study will include ;HIV positive mothers who have exposed their infants to HIV but are lost to follow-up to HIV services and care, HIV exposed infants, and the health Care Workers at South Lunzu health facility (Nurse midwives, Health Surveillance Assistants, Clinicians, Expert clients).The sample size for the quantintative method will be 384 and participants will be randomly sampled from health records at the facility.The sample size for the qualitative method will be approximately 30, and participants will be purposefully selected.Data collection for the qualitative method will be done right at the health facility in quiet and private rooms through focus group discussions(FGDs).Abstrction sheet will be used to abstract data from health records. Data collected from participants will be securely stored in a computer data base that has a password and limited access will be provided to the study team. Data analysis will be done using deductive thematic content analysis. Informed consent will be obtained from each participant before being enrolled in the study. Confidentiality throughout study participation and therafter will be ensured. Ethical approval will be sought from College of Medicine and Ethics Committee(COMREC). DISSEMINATION OF EXPECTED FINDINGS The results of this study shall be disseminated in writing and presentations as feedback will be made to the: College of Medicine Research Ethics Committee(COMREC), investigators and study team, College of Medicine library, The University Research and Publication Committee(URPC)through the COMREC secretariat, All health workers at South Lunzu Health Centre, District Health Management Team (DHMT)for Blantyre including the Blantyre District PMTCT/EID Technical Working Group and to the wider scientific community through the COM Research and Dissemination Conference and preparation of a manuscript for submission to a peer-review journal.
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Assessing the association of COVI-19 with under-five children malnutrition in Namphungo and Chambe rural Health Centers of Mulanje District by Carolyn Kang’ombe
(Kamuzu University of Health Sciencies, 13-07-21) Kang'ombe, Carolyn
XECUTIVE SUMMARY Background: Malnutrition contributes significantly to child morbidity and mortality. While the COVID-19 pandemic will increase mortality due to the virus, it is also likely to increase mortality indirectly. The economic, food, and health systems disruptions resulting from the COVID-19 pandemic are expected to continue to exacerbate all forms of malnutrition. In this study, we generate information about the burden of Covid-19 towards under-5 child nutrition resulting from the potential disruption of health systems, economic system and decreased access to food. Objectives: The broad objective of the study is to assess the association of covid-19 with underfive child malnutrition in rural health centers of Mulanje District.. To achieve the broad objective, the study will achieve the three specific objectives outlined; 1. To conduct a comparative description of accumulated cases of malnutrition in under-five children cases admitted on Outpatient Therapeutic Program and Supplementary Feeding Program during and before onset on COVID-19 pandemic. 2 To assess the food situation and income security in households of malnourished under five children during and before onset of COVID-19 pandemic. 3 To compare the health services delivery in under five clinics before and during the COVID-19 pandemic in the rural areas of Mulanje. Methods: The study will be conducted at Namphungo and Chambe Health centers. A mixed method design will be used where cross-sectional qualitative and quantitative study design will be employed. For quantitative data, secondary data will be used to address the first objective. Health center under-five clinic registration will be used to extract data. Participants will be care givers to the admitted under five children under Out-patient Therapeutic Program and Supplementary Feeding Program (n=71) that will be randomly sampled from the secondary data in the respective health centers registry. Qualitative data will be collected through in-depth interview with care takers (n=10) that have under-five children on out-patient therapeutic program and supplementary feeding program on food situation analysis. Key informants (n=4) at the respective health centers will be interviewed to understand the working modalities that were applied as COVID-19 response measure. Expected results and dissemination: This study expects to enlighten any association and impact on food production and access, provision of health services and changes in practices and behavior due to the COVID-19 and its contribution towards exacerbation of malnutrition among under five children in the communities. The results will assist in informing policy and advocacy which may 13-Jul-2021 Version 3, revised 22nd June,2021 2 | P a g e lead to the refinement and improvement of maternal and child nutrition preparedness in emergencies. The findings will be disseminated to COMREC, college of medicine school of public health and family medicine, Department of Nutrition, HIV and AIDS (DNHA), Mulanje District Health Office, Mulanje Agriculture Office as well as research dissemination conferences. Results will help to advocate for under-five nutrition measures that will assist in coping with the COVID- 19 pandemic and hence reducing under-five malnutrition.
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Prevalence and Factors Associated With Puerperal Sepsis among Postnatal Women at Queen Elizabeth Central Hospital, Blantyre by Priscabell Ndasauka Kalumbi
(Kamuzu University of Health Sciencies, 15-07-21) Kalumbi, Ndasauka
Executive Summary Study Type: An analytical cross-sectional study of hospital records. The problem: Globally 6 million women developed puerperal sepsis and around 77,000 mothers died from it in 2017(Atlaw et al,2017). Puerperal sepsis is the fifth common cause of maternal mortality worldwide. In Malawi a confidential inquiry into maternal deaths indicated that puerperal sepsis is the leading cause of maternal death (MOH, 2019) and it contributes to 9.3 % of all maternal deaths in the country. Anecdotal statistics from Queen Elizabeth Central Hospital(QECH) in 2019 showed there are 12.2 % puerperal sepsis cases out of 30 % caesarean section deliveries performed (QECH, HMIS ,2019). Despite its great impact on maternal mortality and morbidity, there is not enough literature on the prevalence and associated factors of puerperal sepsis among postnatal mothers in Malawi. With this backdrop, the aim of this study is to estimate prevalence and associated factors of puerperal sepsis among postnatal mothers at Queen Elizabeth Central Hospital - a tertiary referral hospital in Malawi. Objectives Main Objective To determine prevalence and associated factors of puerperal sepsis among postnatal mothers at Queen Elizabeth Central Hospital. Specific Objectives 1. To describe the demographic and clinical characteristics of women with puerperal sepsis during the postpartum period at Queen Elizabeth Central Hospital. 2. To determine factors associated with puerperal sepsis in postpartum women at Queen Elizabeth Central Hospital. 3. To assess relationship between puerperal risk factors and poor maternal outcomes at Queen Elizabeth Central Hospital. Methodology This study will deploy an analytical cross-sectional design with a non-predetermined sample size of postnatal women records in Chatinkha postnatal ward. Purposive total sampling technique will be used to select the study participants into the study. Data will be extracted from files of patients admitted from January 2020 to June 2020 and analysed using SPSS version 20. The data will be presented in form of percentages, frequencies through tables, graphs and charts. Logistic regression will be used to establish relationship between maternal factors and poor outcomes. Possible Constraints The major constraint in the study is missing data from the use of medical records. Multiple imputation will be done where data is missing. Expected Findings This will study will describe the burden of puerperal sepsis in postpartum women in QECH and Identify factors associated with it. The generated data will help health care providers and policy makers to develop interventions that focus on the primary causes of sepsis and prioritise the factors that will be associated with Sepsis. . It will also enable policy-makers and managers to consider integrating puerperal sepsis education with emphasis on factors that have shown to have poor maternal outcomes. Expected findings and dissemination: The results will be presented in tables showing summary statistics and odds ratios. A final master’s dissertation will be written and presented to the post graduate committee at the Kamuzu College of Nursing. The final dissertation will be shared with the Kamuzu College of Nursing library and The College of Medicine Research and Ethics Committee. Results from this research will be published in an open access peer reviewed journal and presented at research dissemination conferences. Background information and introduction Introduction Puerperal Sepsis has been defined by the World Health Organization as the infection of the genital tract occurring at any time between the onset of labour, rupture of membranes and the 42nd day postpartum. The Puerperal sepsis presents commonly with fever (oral temperature of 38.5 degrees Celsius or higher on any given occasion) and other symptoms such as pelvic pain, abnormal vaginal discharge, abnormal smell/foul odour discharge or delay in uterine involution (less than 2cm/day) during the first eight days (WHO, 2015). Puerperal sepsis accounts for a substantial contribution to the Maternal Mortality Rate (MMR). Global estimates suggest that direct (obstetric) infections are the third most common cause of maternal mortality, representing about 10.7% of deaths, a majority of which occur in Low- and Middle-Income Countries (LMIC) (WHO, 2020). The toll is higher in LMICs compared to high income countries (HICs) (Say et.al., 2014). In sub-Saharan Africa, maternal sepsis is one of the leading causes of over 70% of maternal deaths, others include: haemorrhage, hypertension disorders, unsafe abortion, and obstructed labour (Dillen et.al., 2010). Maternal sepsis, specifically, contributes 10.3% of all cause maternal deaths in SSA (Bonnet et.al., 2018). The Global Burden of Diseases Study reported a 30 % prevalence of maternal sepsis (James et al., 2018). A WHO maternal sepsis cohort study conducted in 713 health facilities found that 70.4 out of 1000 live births reported to health facilities with an infection (puerperal sepsis) (Group, 2020). Recent estimates suggest that in sub–Saharan Africa (SSA) the burden is highest compared to other regions with sepsis accounting for up to 45% (Rudd et.al., 2020). However, reliable estimates of the incidence and mortality of maternal sepsis in sub-Saharan Africa are incomplete (Otu et.al., 2020). In Malawi, a confidential inquiry showed that puerperal sepsis is the leading cause of maternal mortality accounting for 9.3 % of maternal deaths (MOH, 2019). Nevertheless, there is no programmatic interventions focused on prevention of puerperal sepsis. Malawi participated in the WHO-led Global Maternal Sepsis Study (GLOSS) and Awareness Campaign umbrella of the “Global Maternal and Neonatal Sepsis Initiative” the aims of which were to assess the burden of maternal sepsis, validate the identification criteria and raise awareness of maternal sepsis among health care workers. However, there is no evidence of Malawi’s implementation of this study following the campaign (GLOSS, 2017). According to Brizuela et.al., (2020), evaluation of countries that implemented the campaign shows improvements in service provision, reduced overall risk of mortality and morbidity from maternal sepsis in high-income as well as in low-income countries. The Malawi Emergency Obstetric and New-born Care Needs Assessment results showed that puerperal sepsis contributes to 18.9% of direct maternal deaths (MOH,2015). Nevertheless, there is paucity of evidence with regards to the epidemiology (when, where, who, what and why) of sepsis in maternal mortality and morbidity burden. As in many developing countries many cases of puerperal infections can go undiagnosed and underreported (Panelope et al., 2013). Hospital-based anecdotal evidence suggests that puerperal sepsis potentially carries the biggest morbidity burden at Queen Elizabeth Central Hospital, a tertiary hospital in southern Malawi. According to 2019 hospital records, there were over 2911 caesarean section deliveries performed at Queen Elizabeth Central Hospital (QECH), comprising 38 % of the total deliveries; 12.2% of these deliveries developed puerperal sepsis within 42 days of post-delivery (QECH HMIS, 2019). Given that puerperal sepsis significantly contributes to preventable maternal morbidity and mortality, combating sepsis is an integral part of realizing the Sustainable Development Goals (SDGs) targets 3.1 and 3.2 relating to maternal wellbeing, as well as target 3.3 on infectious diseases (WHO, 2020). Indirectly, sepsis is relevant to other targets in SDG 3 such as 3.8 on quality of care for all, and its prevention and management is inherently linked with vaccination, efforts to combat antimicrobial resistance (UN, 2020). For Malawi to achieve this lofty goal, reduction of maternal mortality rate must set targets that need urgent achievement. Consequently, identifying potential contributors or determinants to maternal mortality would assist in having focused interventions that respond to the specific causes of the problem. Sepsis is an ever-changing problem. The patterns of sepsis have been shown to differ in time. One of the factors related to the changes in patterns has been the increasing antimicrobial resistance. While several attempts have made to quantify the burden of sepsis by estimating the prevalence, not many have studied the factors associated with it at the individual level in Malawi. Hence the need for this study to bring evidence for developing of policies and guidelines to address the problem. Background Puerperal sepsis is a preventable postpartum complication, and has the potential to quickly progress to septic shock, which can eventually result into death (GLOSS, 2017). The global incidence of puerperal sepsis is 4.4 per 100 live births (Taskin et. al., 2016) and case fatality as high as 30-50 % has been reported in Low- and Middle-Income Countries (UNFPA, 2012). Regional disparities in the prevalence of puerperal sepsis exist. According
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Factors affecting retention in care of patients initiated on antiretroviral treatment at Umodzi Art Clinic, Blantyre
(Kamuzu University of Health Sciences, 16-03-22) Kaunda, Esther Shalom
Type of research study: The study is a cross-sectional analytical that will use mixed methods. Problem to be studied: The United Nations Programme on HIV/AIDS (UNAIDS) 95–95-95 target states that 95% of people living with HIV should know their status, 95% of people living with HIV who know their status should be on treatment, and 95% of people on treatment should be virally suppressed by 2025. Malawi strives to ensure that by the year 2030, she achieves this 95-95-95 target. However, only 69% of all people living with HIV were virally suppressed in Malawi in the year 2018, plus, available data at Umodzi clinic indicate that not all people that are initiated on ART are retained in care after 12 months which puts the 3rd 95 at a far to reach place. Broad Objective The study will investigate factors affecting retention in care of clients initiated on antiretroviral treatment at Umodzi ART clinic, Blantyre. Specifically, the study will: 1. Describe the social, economic and demographic profiles of both retainers and nonretainers, 2. Describe the factors affecting retention in care of patients on antiretroviral treatment, 3. Determine ways through which clients can be retained in care from their own perspective. Methodology: Study population will include all clients that were initiated on ART from January, 2017 to December, 2021 but did not retain in care. The sample size will be 172 and we will systematically enrol participants into the study. A checklist will be used to collect data from the files and an interviewer administered questionnaire will be used to have a deeper insight on the reasons for non-retention and ways that could help in improving retention of clients into care from their perspective. 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 Stata software for quantitative data, and deductive analysis for the qualitative part. Informed consent will be obtained from each and every study participant before enrolment in the study and confidentiality will be ensured throughout the study period. Permission to undertake the study will be sought from QECH and ethical approval will be sought from the College of Medicine Research and Ethics Committee (COMREC). Expected findings and their dissemination: We expect to describe the profile of those that retain and that do not retain in care, find factors that lead to no-retention and find ways that will improve retention among those initiated on ART. These expected results will be disseminated in writing and presentations as feedback made to Umodzi clinic, QECH and the District Health Management Team (DHMT) for Blantyre. Recommendations will be made to various levels of decision making including, Umodzi clinic, QECH, BDHO, MOH and other key implementing partners on improvements that need to be made to ensure that clients are retained in care in ART clinics.
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Chatinkha Nursery ultraviolet-C (UV-C) light box use study for disinfection of small medical equipment and devices
(Malawi Liverpool Welcome Trust, 16-03-22) Ginsburg, Amy Sarah
Type of research study Observational and feasibility, usability and acceptability study Problem statement Multi-use, high-touch, shared medical equipment and devices such as thermometers, oxygen saturation probes, stethoscopes, are difficult to clean and provide potential sources of contamination and transmission of antimicrobial-resistant pathogens in healthcare settings. Ultraviolet-C (UV-C) light disinfection has been identified as an effective strategy to potentially decrease hospital-acquired, multidrug-resistant epidemiologically important pathogens. UV-C light box technologies are currently being developed to disinfect masks, gloves, small devices such as mobile phones, tablets, and medical equipment such as stethoscopes. Assessing the feasibility, usability and acceptability of UV-C light boxes for disinfection of multi-use medical equipment and devices in Chatinkha Nursery has the potential to decrease pathogen contamination and enhance infection prevention and control (IPC) measures and warrants further exploration and evaluation. Broad objective To assess the effectiveness of pilot the use of candidate UV-C light boxes for disinfection of frequently used medical equipment and devices for IPC in Chatinkha Nursery. Specific objectives 1. To identify the most frequently touched medical devices in Chatinkha Nursery. 2. To measure the effectiveness of candidate UV-C light boxes to disinfect 2-3 most frequently used small medical equipment/devices used in Chatinkha Nursery. identified by the observations. 3. To determine the feasibility of using , usability, and acceptability of candidate UV-C light boxes for disinfecting multi-use, high-touch, shared medical equipment and devices among health care workers in Chatinkha Nursery. Methodology The study will use observational, quantitative, and qualitative methods including observations, laboratory-based quantitative microbiology protocols, and in-depth interviews with health care workers (HCW) in Chatinkha Nursery and QECH administrators. Expected findings Multi-use, high-touch, shared medical equipment and devices will be identified and it is anticipated that the candidate UV-C light boxes will be effective, feasible, usable, and acceptable for disinfecting multi-use, high-touch, shared medical equipment and devices in Chatinkha Nursery, as a means of IPC interventions. Dissemination Upon completion of our analyses, we will share the data and our findings with Chatinkha Nursery staff, QECH hospital management, KUHES, COMREC and other relevant stakeholders. We will also consider presenting the findings at national and international conferences and in peer-reviewed scientific journals.
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Impact of the coronavirus disease (COVID-19) pandemic on routine childhood immunization in Mwanza-Malawi, version 1.0
(Kamuzu University of Health Sciences, 16-03-22) Kuchanje, Tamandani R. Reuben
The type of research study: Before and after study design using routine immunization data collected in all Mwanza health facilities. - The problem COVID-19 pandemic has created a number of global challenges which includes access to the general health care. Routine child immunization maybe part of the components affected by the COVID-19 pandemic as several studies done in different countries have shown reduction in vaccine coverage before and after or during COVID-19. The impact of COVID-19 in low income settings may be far more than what has been shown in studies conducted in other settings. Immunization has played a major role in reducing child mortality world-wide. Reduction in coverage may thus affect the fight in reducing global child mortality. Understanding the impact of COVID-19 on immunization may therefore help in putting up targeted intervention to improve immunization amidst the COVID-19 pandemic. - The broad objective To compare the vaccine coverage before and during (COVID-19) pandemic on routine childhood immunization among under-five children in Mwanza district - Specific objective 1. To equate coverage of three specific vaccines (DPT, PCV and Measles vaccine) received by under-five children between pre and post Covid-19 at Mwanza health facility 2. To balance vaccine coverage between male and female under-five children who got their immunization services from Mwanza health facilities between pre-pandemic period (January to December 2019) and during pandemic period (January to December 2021) 3. To assimilate vaccine coverage among under-five children who got their vaccines timely according to vaccine schedule based on age between pre-pandemic period (January to December 2019) and during pandemic period (January to December 2021) - Methodology A before and after study design will be used for this study. All the children who received vaccine before covid-19 and those who received vaccine during covid-19 will be included into the study until the sample size is reached, using routinely collected medical data dated 1st April to 31st July, 2019 and 1st April to 31st July, 2020.. This study will collect demographic data of children, Children vaccination data before Covid-19, and Children vaccination data during Covid-19 pandemic. Our Primary outcomes will be the percentage difference in the proportion of vaccinated and the secondary outcome is Vaccine preventable outbreak. Distributions of age, and sex will be compared between the 2019 pre-COVID-19 period and 2020 COVID-19 period. Trend analysis will be done to see the progress of vaccination. The percentage differences of routine vaccine doses administered during the pre-pandemic period (April to July 2019) and during the period of COVID-19 (April to July 2020) will be calculated and compared. The percentage difference of routine vaccine doses administered at each health facility before and during COVID-19 will be calculated and compared. The percentage difference of routine vaccine doses administered based on age eligibility will be calculated and compared. The difference-indifference (DID) analyses will be done to take care of any normal trends due to changes in the size of the population and vaccine acceptance. And Pearson Chi-square test will be used for statistical significance test. Complete vaccination coverage for all mentioned routinely-recommended vaccines at each milestone age (6, 10, 14, weeks, 9 months and 12-15 months) in a period will be calculated by dividing the number of children who received all routine vaccine doses before a milestone age by the number of eligible children who reached that milestone age during the period. Complete vaccination coverage by month from April to July 2019 and April to July 2020 will be estimated. - Expected findings and their dissemination. The study anticipates finding reduced vaccine coverage. Findings will prompt the Government of Malawi and stakeholders to introduce or roll out adequate communication strategies in order to reduce concerns about vaccinations and to redress the decline in vaccination coverage that will occur during the covid-19 pandemic period. At the same time, it will inform ministry for the need for immunization catch up campaign.
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Impact of the COVID -19 pandemic on morbidity and mortality due to enteric infections in children < 5 years of age in Malawi
(Malawi Liverpool Welcome Trust, 16-03-22) Jere, Khuzwayo
Study type: Observational study Problem: Since April 2020, Malawi has experienced three waves of Sars-Cov-2 rapid transmission and associated deaths. The spread of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has impacted health services globally. Consequent disruption of routine health services is expected to have long-term and far-reaching consequences. Significant reductions in the numbers of inpatients or attendance to primary/community health care clinics for illnesses other than COVID-19 have been described in many settings. Among other reasons, these changes could be due to movement restrictions preventing travel to health care facilities, lack of space at these facilities due to COVID-19, or avoidance of medical institutions due to concerns of exposure. Main objective: This protocol aims to assess the impact of COVID-19 on morbidity and mortality associated with enteric illness in Low -Middle-Income Countries (LMICs). Specific objectives: a. Evaluate the temporal diarrheal trends in relation to national and, where available, local COVID-19 activity, by examining routinely collected data on hospital admissions or attendance to the outpatient department (OPD) and community health clinics with a diagnosis of diarrhea. b. Assess the temporal trends in diarrheal disease severity and mortality among children under 5 years of age in relation to COVID-19 activity, by examining hospitalization data with a diagnosis of diarrheal illness. c. Estimate the impact of disruption to Extended Programme on Immunisation (EPI) on rotavirus diarrheal disease Methodology: Data on the monthly number of diarrheal disease cases, on monthly EPI vaccine and dose-specific administration, and on inpatient diarrheal cases’ associated mortality for children <5 for all 28 districts of Malawi will be obtained from the Ministry of Health’s Health Management Information System (HMIS). Data will be aggregated by the 5 health zones (Northern, Central East, Central West, Southeast, and Southwest regions of Malawi). Exploratory analysis will include data aggregation by urban-rural categories too. Where data gaps exist in the electronic database inspection of the physical records will be done in the districts. Expected Results and Dissemination: A negative impact on seeking care for diarrheal disease and on EPI is expected due to fear of contracting COVID19 at health facilities. Once the data is generated and analyzed for trends, the findings thereof will be shared with the College of Medicine Research Ethics Committee (COMREC), the Ministry of Health (MoH), published in peer reviewed journals and will be disseminated to the general public through the annual College of Medicine Research dissemination conference.
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Reproductive health practices among women with heart disease at Queen Elizabeth Central Hospital, version 3.0
(Kamuzu University of Health Sciences, 16-03-22) Kumwenda, Wanangwa
Type of Study This is a qualitative study that is going to be conducted at an outpatient clinic at Queen Elizabeth Central Hospital. Problem Heart disease is one of the leading causes of Indirect Maternal deaths in developed countries (1). The obstetric transition concept suggests that as a country’s maternal mortality ratio decreases, as has been the case for Malawi, the burden of maternal mortality switches from direct to indirect causes, such as heart disease (2–5). In Malawi, data for heart disease in pregnancy is meagre but likely to be underestimated. However, studies in LMICs have demonstrated heart disease in pregnancy to be associated with increased mortality and morbidity, as the provision of optimal care is challenging in most circumstances (6). The recommended strategies for reducing the burden of heart disease on maternal health include counselling on the possible complications that can arise if they get pregnant, avoiding unintended pregnancies by offering appropriate contraception, optimising health before pregnancy and good antenatal care with a multidisciplinary approach (7,8). These strategies are recommended to be started at the time of diagnosis or as early as menarche for those with congenital heart disease (9). There is need to understand the local reproductive health practices among women with heart disease as the obstetric transition happens. This understanding will help identify the factors to address when promoting the reproductive health of women with heart disease. Objectives The main objective is to understand the factors affecting the reproductive health practices among women with heart disease who attend the Chest Clinic at QECH. Specific Objectives • To identify the factors that influence the desired fertility of women with heart disease • To assess perceptions of effects of heart disease on reproductive health among women with heart disease • To explore perceptions about the effects of pregnancy on heart disease among women with heart disease To compare provisions contained in the international, national, and local normative guidance on the care of pregnant women with heart disease with the actual practice of providing care to this group at QECH Methodology This study will use qualitative methods. It will be done at Queen Elizabeth Central Hospital and will recruit 25 women with heart diseases and 3 medical key informants. In-depth interviews will be used to collect the data, and thematic analysis will be done. Expected Findings This study will provide an understanding of the reproductive health practices among women with heart disease and the factors affecting them. This knowledge will help with areas of focus when planning ways of promoting the reproductive health of women with heart disease
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Using lactate testing to improve maternal sepsis identification: a multi-country test accuracy study: LACTate in mATernal sEpsis
(Kamuzu University of Health Sciences, 16-03-22) Gadama, Luis
Type of study This is a prospective, multi-site, phase III test accuracy study. Problem Maternal infections left untreated may lead to sepsis and consequently death. Maternal sepsis can develop in pregnant women and women who have recently experienced pregnancy and is defined as a life-threatening condition with organ dysfunction resulting from infection during pregnancy, childbirth, post-abortion, or the post-partum period”(1) . Multiple studies have tested the accuracy of blood lactate for the early identification of people likely to experience worsening sepsis in high income adult populations. The evidence suggests that lactate levels are informative, and a tiered recommendation was made of different actions based on the lactate measurement. A raised lactate level (>2 mmol/L) can be used as a triage tool to prompt initiation of urgent treatment and the patients can be identified as more severe (lactate level of >4 mmol/L) prompting more intensive treatment and monitoring. The need for high quality evidence of diagnostic accuracy for this test has been highlighted as a research priority. Currently there is no high-quality test accuracy study of lactate testing for maternal sepsis. After multiple systematic reviews we concluded there is no reliable evidence of test accuracy in the pregnant population. There is need to investigate if a lactate measurement has incremental benefit over conventional maternal vital sign assessment in the diagnosis of sepsis and identification of women at risk of severe morbidity or mortality in low resource settings. This study can help determine the diagnostic and prognostic accuracy of venous lactate measurement in the maternity populations, in low resource settings, which is unknown. Broad objective The broad objective of the Lactate test accuracy study is to determine the diagnostic accuracy of maternal venous lactate measurement in addition to maternal vital sign thresholds, in maternal sepsis in low-resource health facility settings in Malawi, Uganda and Pakistan. Specific objectives The specific objectives are to assess the immediate diagnostic value of lactate testing by comparing the baseline index test with baseline reference standard; to assess short-term predictive value of lactate testing, by comparing the baseline index test with 24-hour reference standard, in those without sepsis at baseline; to explore if baseline venous lactate, in addition to vital sign measurements, improves prediction of severe morbidity and mortality from infection; to explore if the test accuracy of lactate in addition to maternal vital sign monitoring alone varies by the prespecified subgroups of pregnancy status (pregnant or post-delivery / post miscarriage / postabortion) and recruitment country; to explore and examine the effects of adjusting the threshold values for both vital sign and lactate assessment on the sensitivity and specificity of the index tests; and finally to explore and validate the use of an alternative reference standard in which the SOFA score is modified to use maternity specific ranges for creatinine and platelet concentration Methods The study will be conducted in the maternity wards at Queen Elizabeth Central Hospital in Blantyre, Malawi. Women will be recruited to have an additional blood sample taken at two time points during admission; at day 0 and day one for lactate testing. There will be no additional clinical procedures or interventions conducted with eligible women by members of the study team or by hospital staff for other reasons than those of their usual clinical practice. We will estimate diagnostic accuracy to detect sepsis as defined by comparison with the reference standard diagnosis of sepsis, at baseline and at 24 hours. We will compare (a) baseline index test with baseline reference standard to determine immediate diagnostic value, (b) baseline index test with 24-hour reference standard in those without sepsis at baseline to determine short-term predictive value and (c) baseline index test with occurrence of infection related “severe maternal outcome” (near miss or maternal mortality) prior to hospital discharge to determine predictive value for severe morbidity or mortality Expected findings If lactate testing in this population is found to offer incremental benefit over the standard sepsis triggering approach, and is feasible to implement in an integrated approach, then this has the potential to improve maternal sepsis outcomes. Dissemination The study report will be submitted to College of Medicine Research and Ethics committee (COMREC). Research findings will be disseminated via download on relevant websites and will also be shared with both local (QECH, Blantyre DHO, community gatekeepers and participants) and global stakeholders through research dissemination conferences, peer reviewed publications and via participant and public information groups, national and international forums and conferences and. Data will be retained and be supported to produce additional secondary outputs as appropriate.