Is it ethical to prevent secondary use of stored biological samples and data derived from consenting research participants? The case of Malawi

BackgroundThis paper discusses the contentious issue of reuse of stored biological samples and data obtained from research participants in past clinical research to answer future ethical and scientifically valid research questions. Many countries have regulations and guidelines that guide the use and exportation of stored biological samples and data. However, there are variations in regulations and guidelines governing the reuse of stored biological samples and data in Sub-Saharan Africa including Malawi.DiscussionThe current research ethics regulations and guidelines in Malawi do not allow indefinite storage and reuse of biological samples and data for future unspecified research. This comes even though the country has managed to answer pertinent research questions using stored biological samples and data. We acknowledge the limited technical expertise and equipment unavailable in Malawi that necessitates exportation of biological samples and data and the genuine concern raised by the regulatory authorities about the possible exploitation of biological samples and data by researchers. We also acknowledge that Malawi does not have bio-banks for storing biological samples and data for future research purposes. This creates room for possible exploitation of biological samples and data collected from research participants in primary research projects in Malawi. However, research ethics committees require completion and approval of material transfer agreements and data transfer agreements for biological samples and data collected for research purposes respectively and this requirement may partly address the concern raised by the regulatory authorities. Our concern though is that there is no such requirement for biological samples and data collected from patients for clinical or diagnostic purposes.SummaryIn conclusion, we propose developing a medical data and material transfer agreement for biological samples and data collected from patients for clinical or diagnostic purposes in both public and private health facilities that may end up in research centers outside Malawi. We also propose revision of the current research ethics regulations and guidelines in Malawi in order to allow secondary use of biological samples and data collected from primary research projects as a way of maximizing the use of collected samples and data. Finally, we call for consultation of all stakeholders within the Malawi research community when regulatory authorities are developing policies that govern research in Malawi

Early Antiretroviral Therapy Initiation and Mortality Among Infants Diagnosed With HIV in the First 12 Weeks of Life: Experiences From Kinshasa, DR Congo and Blantyre, Malawi

AB Background: Based on clinical trial results, the WHO recommends infant HIV testing at age 4-6 weeks and immediate antiretroviral therapy (ART) initiation in all HIV-infected infants. Little is known about the outcomes of HIV infected infants diagnosed with HIV in the first weeks of life in resource-limited settings. We assessed ART initiation and mortality in the first year of life among infants diagnosed with HIV by 12 weeks of age. Methods: Cohort of HIV-infected infants in Kinshasa and Blantyre diagnosed before 12 weeks to estimate 12-month cumulative incidences of ART initiation and mortality, accounting for competing risks. Multivariate models were used to estimate associations between infant characteristics and timing of ART initiation. Results: 121 infants were diagnosed at a median age of 7 weeks (interquartile range 6-8). The cumulative incidence of ART initiation was 46% (95% CI: 36%, 55%) at 6 months and 70% (95% CI: 60%, 78%) at 12 months. Only age at HIV diagnosis was associated with ART initiation by age 6 months, with a subdistribution hazard ratio of 0.70 (95% CI: 0.52, 0.91) for each week increase in age at DNA PCR test. The 12-month cumulative incidence of mortality was 20% (95% CI: 13%, 28%). Conclusions: Despite early diagnosis of HIV, ART initiation was slow and mortality remained high, underscoring the complexity in translating clinical trial findings and WHO guidance into real-life practice. Novel and creative health system interventions will be required to ensure that all HIV infected infants achieve optimal treatment outcomes under routine care settings

Implementing early infant diagnosis of HIV infection at the primary care level: experiences and challenges in Malawi

Malawi’s national guidelines recommend that infants exposed to the human immunodeficiency virus (HIV) be tested at 6 weeks of age. Rollout of services for early infant diagnosis has been limited and has resulted in the initiation of antiretroviral therapy (ART) in very few infants

Validity of US norms for the Bayley Scales of Infant Development-III in Malawian children

Most psychometric tests originate from Europe and North America and have not been validated in other populations. We assessed the validity of United States (US)-based norms for the Bayley Scales of Infant and Toddler Development-III (BSID-III), a neurodevelopmental tool developed for and commonly used in the US, in Malawian children

Preparedness for and impact of COVID-19 on primary health care delivery in urban and rural Malawi : a mixed methods study

Objective Across Africa, the impact of COVID-19 continues to be acutely felt. This includes Malawi, where a key component of health service delivery to mitigate against COVID-19 are the primary healthcare facilities, strategically placed throughout districts to offer primary and maternal healthcare. These facilities have limited infrastructure and capacity but are the most accessible and play a crucial role in responding to the COVID-19 pandemic. This study assessed health facility preparedness for COVID-19 and the impact of the pandemic on health service delivery and frontline workers. Setting Primary and maternal healthcare in Blantyre District, Malawi. Participants We conducted regular visits to 31 healthcare facilities and a series of telephone-based qualitative interviews with frontline workers (n=81 with 38 participants) between August 2020 and May 2021. Results Despite significant financial and infrastructural constraints, health centres continued to remain open. The majority of frontline health workers received training and access to preventative COVID-19 materials. Nevertheless, we found disruptions to key services and a reduction in clients attending facilities. Key barriers to implementing COVID-19 prevention measures included periodic shortages of resources (soap, hand sanitiser, water, masks and staff). Frontline workers reported challenges in managing physical distancing and in handling suspected COVID-19 cases. We found discrepancies between reported behaviour and practice, particularly with consistent use of masks, despite being provided. Frontline workers felt COVID-19 had negatively impacted their lives. They experienced fatigue and stress due to heavy workloads, stigma in the community and worries about becoming infected with and transmitting COVID-19. Conclusion Resource (human and material) inadequacy shaped the health facility capacity for support and response to COVID-19, and frontline workers may require psychosocial support to manage the impacts of the COVID-19 pandemic

How useful are malaria risk maps at the country level? Perceptions of decision-makers in Kenya, Malawi and the Democratic Republic of Congo

BackgroundDeclining malaria prevalence and pressure on external funding have increased the need for efficiency in malaria control in sub-Saharan Africa (SSA). Modelled Plasmodium falciparum parasite rate (PfPR) maps are increasingly becoming available and provide information on the epidemiological situation of countries. However, how these maps are understood or used for national malaria planning is rarely explored. In this study, the practices and perceptions of national decision-makers on the utility of malaria risk maps, showing prevalence of parasitaemia or incidence of illness, was investigated.MethodsA document review of recent National Malaria Strategic Plans was combined with 64 in-depth interviews with stakeholders in Kenya, Malawi and the Democratic Republic of Congo (DRC). The document review focused on the type of epidemiological maps included and their use in prioritising and targeting interventions. Interviews (14 Kenya, 17 Malawi, 27 DRC, 6 global level) explored drivers of stakeholder perceptions of the utility, value and limitations of malaria risk maps.ResultsThree different types of maps were used to show malaria epidemiological strata: malaria prevalence using a PfPR modelled map (Kenya); malaria incidence using routine health system data (Malawi); and malaria prevalence using data from the most recent Demographic and Health Survey (DRC). In Kenya the map was used to target preventative interventions, including long-lasting insecticide-treated nets (LLINs) and intermittent preventive treatment in pregnancy (IPTp), whilst in Malawi and DRC the maps were used to target in-door residual spraying (IRS) and LLINs distributions in schools. Maps were also used for operational planning, supply quantification, financial justification and advocacy. Findings from the interviews suggested that decision-makers lacked trust in the modelled PfPR maps when based on only a few empirical data points (Malawi and DRC).ConclusionsMaps were generally used to identify areas with high prevalence in order to implement specific interventions. Despite the availability of national level modelled PfPR maps in all three countries, they were only used in one country. Perceived utility of malaria risk maps was associated with the epidemiological structure of the country and use was driven by perceived need, understanding (quality and relevance), ownership and trust in the data used to develop the maps

Nutritional status at admission of children with cancer in Malawi

Background. Malnutrition at diagnosis is found in 10-50% of children with cancer in industrialized countries. In developing countries a large proportion of the normal paediatric population is undernourished and children with cancer often present late with advanced disease. Therefore it would be expected that many children with cancer are malnourished at admission. Malnutrition is associated with more severe chemotherapy toxicity and infectious complications. Methods. All new paediatric oncology patients admitted in the Queen Elizabeth Central Hospital, Blantyre, Malawi between 1, January 2007 and 1, January 2008 were included. We documented age, clinical diagnosis, HIV status, weight, height, mid-upper-arm-circumference (MUAC) and triceps skinfold (TSF), and calculated arm muscle area (AMA). Nutritional data were compared with the 1978 NCHS growth curves. Results. 01 128 children, 70 (55.1% had an AMA for age <5th percentile and 76 (59.3%) had a TSF and MUAC below the 5th percentile, both parameters indicating acute malnutrition. Fifty seven patient (44.5%) had a height for age <-2 SD (indicative of stunting), and 22 patients (17.2%) had a weight for height (WFH) <-2 SD. Conclusion. Arm anthropometry shows that more than half of Malawian children with cancer are severely acutely malnourished at diagnosis. WFH, in children with large tumour masses, is less sensitive than arm anthropometry in detecting acute malnulation. Forty-five percent of paediatric oncology patients in Malawi are stunted, making interpretation of weight for age (WFA) very difficul

"It means you are grounded" - caregivers' perspectives on the rehabilitation of children with neurodisability in Malawi

Purpose: Rates of childhood disability are estimated to be high in African settings; however, services to provide information and support are limited. This study aims to explore perspectives and experiences of caregivers of children with disabilities (CWD) from acquired brain injury to inform the development of training packages for health-workers (HW) in hospital settings. Methods: The study was conducted in a tertiary hospital using qualitative methods. Fourteen in-depth interviews (IDIs) were conducted with parents/carers (PC), and 10 IDIs and 4 focus-group discussions (FGDs) with HW. Data were audio-recorded, transcribed, translated and analysed using thematic approaches. Results: HWs and PCs held varying perspectives on aetiology and prognosis for CWD. HWs raised concerns about impact on families, risks of neglect and abuse. Barriers to care and support included prioritisation of acute illness, lack of HW knowledge and confidence, stigma, poor communication, focus on physical disability, and poor availability of services. Among ideas for improvement, good communication and counselling was seen as a priority but not often achieved. Conclusion: A range of family, health service and wider contextual factors affect care for CWD. Training for HW should emphasise disability rights, access to services, a range of disabilities and specific training on counselling. IMPLICATIONS FOR REHABILITATION: To create good training programmes for workers who manage children with neurodisability, workers’ views on their training needs, as well parents’ views of what feel they need to know most, must be taken into account. The need for training regarding communication skills is a priority for health-workers (HW), who manage children with neurodisability in Malawi and confidence in this area is likely to be vital in providing support for these families. Disability rights and inclusion should be imperative in any training programme for managing children with neurodisability in hospital settings. Even in low-resource settings such as Malawi, it is vital that the links between hospital management and the limited resources in the community are updated and maintained

‘We just dilute sugar and give’ health workers’ reports of management of paediatric hypoglycaemia in a referral hospital in Malawi

Background: Acutely sick children in resource-constrained settings who present with hypoglycaemia have poor outcomes. Studies have questioned the current hypoglycaemia treatment cut-off level of 2.5 mmol/l. Improved knowledge about health workers’ attitudes towards and management of hypoglycaemia is needed to understand the potential effects of a raised cut-off level. Objective: This research explored health workers’ perceptions about managing acutely ill children with hypoglycaemia in a Malawian referral hospital. A secondary objective was to explore health workers’ opinions about a potential increase in the hypoglycaemia cut-off level. Methods: We used a qualitative design with semi-structured individual interviews performed with health workers in the Paediatric Accident and Emergency Unit at Queen Elizabeth Central Hospital, Malawi, in October 2016. Data were analysed using latent content analysis. Ethical approval was obtained from the University of Malawi, College of Medicine Research and Ethics Committee P.01/16/1852. Results: Four themes were formed that described the responses. The first, ‘Critical and difficult cases need easy treatment’, showed that health workers perceived hypoglycaemia as a severe condition that was easily manageable. The second, ‘Health system issues’, revealed challenges relating to staffing and resource availability. The third, ‘From parental reluctance to demand’, described a change in parents’ attitudes regarding intravenous treatments. The fourth, ‘Positive about the change but need more information’, exposed health workers’ concerns about potential risks of a raised cut-off level for hypoglycaemia treatment, as well as benefits for the patients. Conclusions: Health workers perceived hypoglycaemia as a severe condition that is easy to manage when the required equipment and supplies are available. Due to the common lack of test equipment and dextrose supplies, health workers have adopted alternative strategies to diagnose and manage hypoglycaemia. A change to the hypoglycaemia treatment cut-off level raised concerns about potential risks, but was also thought to be of benefit for some patients

Feeding practices and association of fasting and low or hypo glycaemia in severe paediatric illnesses in Malawi : a mixed method study

BACKGROUND: The presence of low or hypo glycaemia in children upon admission to hospital in low income countries is a marker for poor outcome. Fasting during illness may contribute to low blood glucose and caretakers' feeding practices during childhood illnesses may thus play a role in the development of low or hypo glycaemia. This study aims to describe the caretaker's feeding practices and association of fasting with low or hypo glycaemia in sick children in Malawi. METHODS: A mixed method approach was used combining quantitative cross-sectional data for children aged 0-17 years admitted to Queen Elizabeth Central Hospital (QECH), a tertiary hospital in Malawi, with qualitative focus group discussions conducted with caretakers of young children who were previously referred to QECH from the five health centres around QECH. Logistic regression was used to analyse the quantitative data and thematic content analysis was conducted for qualitative data analysis. RESULTS: Data for 5131 children who were admitted through the hospital's Paediatric Accident and Emergency Department (A&amp;E) were analysed whereof 2.1% presented with hypoglycaemia (&lt; 2.5 mmol/l) and 6.6% with low glycaemia (≥2.5mmoll/l - &lt; 5 mmol/l). Fasting for more than eight hours was associated with low glycaemia as well as hypoglycaemia with Adjusted Odds Ratios (AOR) of 2.9 (95% Confidence Interval (CI) of 2.3-3.7) and 4.6, (95% CI 3.0-7.0), respectively. Caretakers demonstrated awareness of the importance of feeding during childhood illness and reported intensified feeding attention to sick children but face feeding challenges when illness becomes severe causing them to seek care at a health facility. CONCLUSION: Results suggests that caretakers understand the importance of feeding during illness and make efforts to intensify feeding a sick child but challenges occur when illness is severe leading to fasting. Fasting among children admitted to hospitals may serve as a marker of severe illness and determine those at risk of low and hypoglycaemia