Improving care pathways for children with severe illness through implementation of the ASPIRE mHealth primary ETAT package in Malawi.

Providing emergency care in low resource settings relies on delivery by lower cadres of health workers (LCHW). We describe the development, implementation and mixed methods evaluation of a mobile health (mHealth) triage algorithm based on the WHO Emergency, Triage, Assessment, and Treatment (ETAT) for primary-level care. We conducted an observational study design of implementation research. Key stakeholders were engaged throughout implementation. Clinicians and LCHW at eight primary health centres in Blantyre district were trained to use an mHealth algorithm for triage. An mHealth patient surveillance system monitored patients from presentation through referral to tertiary and final outcome. A total of 209,174 children were recorded by ETAT between April 2017 and September 2018, and 155,931 had both recorded mHealth and clinician triage outcome data. Concordance between mHealth triage by lower cadres of HCW and clinician assessment was 81·6% (95% CI [81·4, 81·8]) over all outcomes (kappa: 0·535 (95% CI [0·530, 0·539]). Concordance for mHealth emergency triage was 0.31 with kappa 0.42. The most common mHealth recorded emergency sign was breathing difficulty (74·1% 95% CI [70·1, 77·9]) and priority sign was raised temperature (76·2% (95% CI [75·9, 76·6]). A total of 1,644 referrals out of 3,004 (54·7%) successfully reached the tertiary site. Both providers and carers expressed high levels of satisfaction with the mHealth ETAT pathway. An mHealth triage algorithm can be used by LCHWs with moderate concordance with clinician triage. Implementation of ETAT through an mHealth algorithm documented successful referrals from primary to tertiary, but half of referred patients did not reach the tertiary site. Potential harms of such systems, such as cases requiring referral being missed during triage, require further evaluation. The ASPIRE mHealth primary ETAT approach can be used to prioritise acute illness and support future resource planning within both district and national health system.

Enhanced or hindered research benefits? A realist review of community engagement and participatory research practices for non-communicable disease prevention in low- and middle-income countries.

INTRODUCTION: Community engagement and participatory research are widely used and considered important for ethical health research and interventions. Based on calls to unpack their complexity and observed biases in their favour, we conducted a realist review with a focus on non-communicable disease prevention. The aim was to generate an understanding of how and why engagement or participatory practices enhance or hinder the benefits of non-communicable disease research and interventions in low- and middle-income countries. METHODS: We retroductively formulated theories based on existing literature and realist interviews. After initial searches, preliminary theories and a search strategy were developed. We searched three databases and screened records with a focus on theoretical and empirical relevance. Insights about contexts, strategies, mechanisms and outcomes were extracted and synthesised into six theories. Five realist interviews were conducted to complement literature-based theorising. The final synthesis included 17 quality-appraised articles describing 15 studies. RESULTS: We developed six theories explaining how community engagement or participatory research practices either enhance or hinder the benefits of non-communicable disease research or interventions. Benefit-enhancing mechanisms include community members' agency being realised, a shared understanding of the benefits of health promotion, communities feeling empowered, and community members feeling solidarity and unity. Benefit-hindering mechanisms include community members' agency remaining unrealised and participation being driven by financial motives or reputational expectations. CONCLUSION: Our review challenges assumptions about community engagement and participatory research being solely beneficial in the context of non-communicable disease prevention in low- and middle-income countries. We present both helpful and harmful pathways through which health and research outcomes are affected. Our practical recommendations relate to maximising benefits and minimising harm by addressing institutional inflexibility and researcher capabilities, managing expectations on research, promoting solidarity in solving public health challenges and sharing decision-making power.

"Why take the patient back home?": Exploring the lived experiences of caregivers of COVID-19-infected individuals in Blantyre, Malawi.

The Corona Virus Disease 2019 (COVID-19) pandemic continues to have serious health and socio-economic consequences. In Malawi, COVID-19 cases are managed at home, with hospital admission reserved for severe cases. This study described the lived experiences of caregivers of COVID-19-infected individuals in Blantyre, Malawi. This descriptive qualitative study was conducted from January to June 2021 in Blantyre, Malawi, among caregivers of confirmed SARS-COV-2 cases enrolled in the SARS-CoV-2 study and aimed to explore infections, transmission dynamics, and household impact. We conducted 37 in-depth interviews with caregivers of SARS-COV-2 cases who were purposively sampled. We captured data using telephonic interviews, digitally recorded, transcribed verbatim, managed using NVivo, and analysed it using a thematic approach guided by the theory of caregiving dynamics. Caregivers stated that the economic status of a family largely influenced caregiving roles and abilities because it determined the resources that a household could access or not. Caregivers expressed being committed to their role despite being ill-prepared to manage a COVID-19 patient at home, in addition to fears about the contagious nature of COVID-19. They prioritised their patients' health by ensuring that they were present to offer nutritional and medical treatment. Caregivers highlighted challenges faced in the implementation of preventive measures because of financial limitations and cultural factors. They further expressed fear resulting from the increase in death rates, and the lack of proper information challenged their expectation of having their patients healed. Caregivers stated that they managed their role by sharing responsibilities, getting better at it with time, and getting support from religious institutions and social networks. Caring for confirmed cases of COVID-19 demanded commitment from the caregivers while ensuring that the transmission of the virus was minimised. There is a need to support households in isolation with the right information on how to manage their patients and streamline social support for the ultra-poor.

'Why would they spend all this money and give us these items for free?': Exploring precarity and power in a cleaner cookstove intervention in rural Malawi.

We carried out a qualitative study to gain a deeper understanding of the social context of the Cooking and Pneumonia Study (CAPS) and implications for implementation of clean cooking and similar interventions. Such initiatives are recognised as complex, power-laden processes, which has consequences for outcomes and uptake. However, understanding of how precarious livelihoods and unequal power differentials impact on trials of technology is limited and potentially hampers the achievement of the SDGs including SDG 7, Affordable and Clean Energy. An in-depth exploration of experiences and perceptions of cooking and cookstove use within CAPS was completed using qualitative methods and the participatory methodology Photovoice. Ten CAPS participants from each of five villages participated in Photovoice activities and five village representatives were interviewed. Twelve fieldworkers participated in gender specific focus groups and four were interviewed. A thematic content approach was used for data analysis. The analysis showed that economic and power inequity underpinned the complex social relationships within CAPS impacting on trial participation, perceptions of the cookstoves, and on the potential of the intervention to affect health and other benefits. Power can be understood as relational and productive within the research environment. This is illustrated by an analysis of the role of fieldworkers and community representatives who needed to negotiate resistance to trial compliance decisions, including 'satanic' rumours about cookstoves and blood-taking. Transformative approaches that challenge existing power inequities are needed to maximise the success and beneficence of cookstove and other health promoting interventions, and achievement of the SDGs.

'Guidance should have been there 15 years ago' research stakeholders' perspectives on ancillary care in the global south: a case study of Malawi.

BACKGROUND: Medical researchers in resource-constrained settings must make difficult moral decisions about the provision of ancillary care to participants where additional healthcare needs fall outside the scope of the research and are not provided for by the local healthcare system. We examined research stakeholder perceptions and experiences of ancillary care in biomedical research projects in Malawi. METHODS: We conducted 45 qualitative in-depth interviews with key research stakeholders: researchers, health officials, research ethics committee members, research participants and grants officers from international research funding organisations. Thematic analysis was used to analyse and interpret the findings. FINDINGS: All stakeholders perceived the provision of ancillary care to have potential health benefits to study participants in biomedical research. However, they also had concerns, particularly related to the absence of guidance to support it. Some suggested that consideration for ancillary care provision could be possible on a case-by-case basis but that most of the support from research projects should be directed towards strengthening the public health system, emphasising public good above individual or personal benefits. Some researchers and ethics committee members raised concerns about potential tensions in terms of funding, for example balancing study demands with addressing participants' additional health needs. CONCLUSION: Our findings highlight the complexities and gaps in the guidance around the provision of ancillary care in Malawi and other resource-constrained settings more generally. To promote the provision of ancillary care, we recommend that national and international guidelines for research ethics include specific recommendations for resource-constrained settings and specific types of research.

'Labouring' on the frontlines of global health research: mapping challenges experienced by frontline workers in Africa and Asia.

Drawing on the reflections and discussions from a special session at the 2021 Global Health Bioethics Network summer school, this paper has summarised the key challenges faced by Frontline Workers (FWs) across research sites in Africa and Asia in performing the everyday 'body work' entailed in operationalising global health research. Using a 'body work' lens, we specifically explore and map key challenges that FWs face in Africa and Asia and the physical, social, ethical, emotional, and political labour involved in operationalising global health in these settings. The research encounter links with wider social and economic structures, and spatial dimensions and impacts on the FWs' performance and well-being. Yet, FWs' 'body-work' and the embedded emotions during the research encounter remain hidden and undervalued.

Power and Powerlessness in a Group Based Digital Story Telling Project-An Exploration of Community Perceptions of Health Concerns in Urban Malawi.

Digital Story Telling (DST) is an art-based research method used to explore embodied experience of health and initiate dialogue with under-represented groups on issues affecting them. It involves engaging participants to create and share their stories using photos, drawings, and audio recordings in short videos. Benefits of DST include enhancing co-creation of knowledge, empowering participants to confront dominant narratives and revise inaccurate representations. We report our experiences and reflections of using DST to explore community perceptions of health concerns in urban Malawi. Community leaders were briefed about the project before and after study related activities. Three participatory workshops were organized to train community members in DST, support them to develop videos and discuss their experiences of DST. Twenty-six participants from two high density urban communities consented to be part of the workshops. They were all new to DST. All the 26 participants were invited together to the three workshops and their DSTs were developed in smaller groups (n = 7), based on their geographical location. Although we engaged residents from selected communities to share priority health concerns, all the seven groups presented challenges pertaining to Water, Sanitation and Hygiene (WASH), and their powerlessness to address the complex challenges. The collective focus on WASH showed that DST effectively empowered communities to present priority health concerns. The inability of community members to address the challenges without external assistance or failure to use findings from DST to generate social change however raise questions on the ideals of empowerment and social justice. In addition, lack of financial resources or technical know-how to produce digital stories and unequal power relationships between service providers and community, may affect the use of DST for community activism among socio-economically disadvantaged groups. We conclude that DST empowered participants to articulate genuine health challenges that they felt powerless to address. We question the realization of "empowerment" and social justice of vulnerable participants in cases where structural challenges present obstacles to effectively address social inequalities.

A critical examination of research narratives 'rumours' and passive community resistance in medical research.

Several studies in Africa have reported effects of 'rumours, misconceptions or misinformation' on medical research participation and uptake of health interventions. As such, community engagement has sometimes been used for instrumental purposes to enhance acceptability of research or interventions and prevent 'rumours'. This paper seeks to highlight the value of ongoing engagement with communities to understand research narratives 'rumours' reproduced in medical research. We demonstrate that 'rumours' are a form of divergent communication or local interpretation of medical research that needs critical attention, and we question the ethics of dismissing such divergent communication.This paper draws on experiences from ethnographical research, which aimed to understand community engagement in medical research projects conducted in Malawi. We observed that even though community meetings were held to improve participation, 'rumours' about research influenced decision making. 'Rumours' presented local critiques of medical research, legitimate concerns informed by historical experiences and local conceptualisation of health. Structural inequalities, negative outcomes or absence of visible benefits following research participation informed unmet expectations, discontent with research and consequently passive resistance. The sociocultural context where participating research communities often rely on social networks for information nurtured propagation of these divergent perspectives to inform lay discourse around medical research.We conclude that ongoing engagement, critical self-reflection and attempts to decode deeper meaning of 'rumours' throughout research implementation is necessary, to show respect and address community concerns expressed through 'rumours', enhance informed participation and adoption of future health interventions.

A network of empirical ethics teams embedded in research programmes across multiple sites: opportunities and challenges in contributing to COVID-19 research and responses.

Covid-19 continues to teach the global community important lessons about preparedness for research and effective action to respond to emerging health threats. We share the COVID-19 experiences of a pre-existing cross-site ethics network-the Global Health Bioethics Network-which brings together researchers and practitioners from Africa, Europe, and Southeast Asia. We describe the network and its members and activities, and the work-related opportunities and challenges we faced over a one-year period during the pandemic. We highlight the value of having strong and long-term empirical ethics networks embedded across diverse research institutions to be able to: 1) identify and share relevant ethics challenges and research questions and ways of 'doing research'; 2) work with key stakeholders to identify appropriate ways to contribute to the emerging health issue response - e.g., through ethics oversight, community engagement, and advisory roles at different levels; and 3) learn from each other and from diverse contexts to advocate for positive change at multiple levels. It is our view that being embedded and long term offers opportunities in terms of deep institutional and contextual knowledge, existing relationships and access to a wide range of stakeholders. Being networked offers opportunities to draw upon a wide range of expertise and perspectives, and to bring together internal and external insights (i.e.drawing on different positionalities). Long term funding means that the people and resources are in place and ready to respond in a timely way. However, many tensions and challenges remain, including difficulties in negotiating power and politics in the roles that researchers and research institutions can and should play in an emergency, and the position of empirical ethics within research programmes. We discuss some of these tensions and challenges and consider the implications for our own and similar networks in future.

Engaging communities in non-communicable disease research and interventions in low- and middle-income countries: a realist review protocol.

INTRODUCTION: Engaging communities and intended beneficiaries at various stages of health research is a recommended practice. The contribution of community engagement to non-communicable disease research in low- and middle-income countries has not yet been extensively studied or synthesised. This protocol describes the steps towards generating an understanding of community engagement in the context of non-communicable disease research, prevention and health promotion using a realist review approach. A realist lens enables a rich explanatory approach to causation while capturing complexity, and an openness to multiple outcomes, including unintended consequences. The review will thus develop an understanding of community engagement without assuming that such practices result in more ethical research or effective interventions. METHODS AND ANALYSIS: We propose a realist approach aiming to examine how, why, under what circumstances and for whom community engagement works or does not work. The iterative review steps include clarifying the review scope; searching for evidence; appraising studies and extracting data; synthesising evidence and drawing conclusions; and disseminating, implementing and evaluating the findings. Principles of meta-narrative review (pragmatism, pluralism, historicity, contestation, reflexivity and peer review) are employed to ensure practicable and contextualised review outputs. The proposed review will draw on theoretical and empirical literature beyond specific diseases or settings, but with a focus on informing non-communicable disease research and interventions in low- and middle-income countries. The synthesis of existing literature will be complemented by qualitative realist interviews and stakeholder consultation. Through drawing on multiple types of evidence and input from both experts and intended beneficiaries, the review will provide critical and pragmatic insights for research and community engagement in low- and middle-income countries. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the University of the Witwatersrand. Dissemination will include traditional academic channels, institutional communications, social media and discussions with a wide range of stakeholders.

The Lived Experience Of Participants in an African RandomiseD trial (LEOPARD): protocol for an in-depth qualitative study within a multisite randomised controlled trial for HIV-associated cryptococcal meningitis.

INTRODUCTION: Individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable. This is especially true in low-income settings. The decision to enrol may be influenced by existing inequalities, poor healthcare infrastructure and fear of death. Where patients are confused or unconscious the responsibility for this decision falls to relatives. This qualitative study is nested in the ongoing AMBIsome Therapy Induction OptimisatioN (AMBITION) Trial. AMBITION is recruiting participants from five countries in sub-Saharan Africa and is trialling a novel treatment approach for HIV-associated cryptococcal meningitis, an infection known to affect brain function. We aim to learn from the experiences of participants, relatives and researchers involved in AMBITION. METHODS AND ANALYSIS: We will collect data through in-depth interviews with trial participants and the next of kin of participants who were confused at enrolment and therefore provided surrogate consent. Data will be collected in Gaborone, Botswana; Kampala, Uganda and Harare, Zimbabwe. Interviews will follow a narrative approach including participatory drawing of participation timelines. This will be supplemented by direct observation of the research process at each of the three recruiting hospitals. Interviews will also take place with researchers from the African and European institutions that form the partnership through which the trial is administered. Interviews will be transcribed verbatim, translated (if necessary) and organised thematically for narrative analysis. ETHICS AND DISSEMINATION: This study has been approved by the Health Research Development Committee, Gaborone (Reference: HPDME:13/18/1); Makerere School of Health Sciences Institutional Review Board, Kampala (Reference: 2019-061); University of Zimbabwe Joint Research Ethics Committee, Harare (Reference: 219/19), and the London School of Hygiene and Tropical Medicine (Reference: 17957). Study findings will be shared with research participants from the sites, key stakeholders at each research institution and ministries of health to help inform the development and implementation of future trials. The findings of this study will be published in journals and presented at academic meetings. TRIAL REGISTRATION: Registered at www.clinicaltrials.gov:NCT04296292.

Participant compensation in global health research: a case study.

BACKGROUND: Compensation for research participants can be provided for reasons including reimbursement of costs; compensation for time lost, discomfort or inconvenience; or expression of appreciation for participation. This compensation involves numerous ethical complexities, at times entailing competing risks. In the context of transnational research, often incorporating contexts of economic inequality, power differentials and post-colonialism, these issues extend into wider questions of ethical research conduct. METHODS: We describe experiences of conducting a community-based study of air pollution in southern Malawi incorporating ethnographic, participatory and air quality monitoring elements. Decisions surrounding participant compensation evolved in response to changing circumstances in the field. RESULTS: Attention to careful researcher-participant relationships and responsiveness to community perspectives allowed dynamic, contextualised decision-making around participant compensation. Despite widely cited risks, including but not restricted to undue influence of monetary compensation on participation, we learned that failure to adequately recognise and compensate participants has its own risks, notably the possibility of 'ethics dumping'. CONCLUSIONS: We recommend active engagement with research participants and communities with integration of contextual insights throughout, including participant compensation, as for all elements of research conduct. Equitable research relationships encompass four central values: fairness, care, honesty and respect.

Structural coercion in the context of community engagement in global health research conducted in a low resource setting in Africa.

BACKGROUND: While community engagement is increasingly promoted in global health research to improve ethical research practice, it can sometimes coerce participation and thereby compromise ethical research. This paper seeks to discuss some of the ethical issues arising from community engagement in a low resource setting. METHODS: A qualitative study design focusing on the engagement activities of three biomedical research projects as ethnographic case studies was used to gain in-depth understanding of community engagement as experienced by multiple stakeholders in Malawi. Data was collected through participant observation, 43 In-depth interviews and 17 focus group discussions with community leaders, research staff, community members and research participants. Thematic analysis was used to analyse and interpret the findings. RESULTS: The results showed that structural coercion arose due to an interplay of factors pertaining to social-economic context, study design and power relations among research stakeholders. The involvement of community leaders, government stakeholders, and power inequalities among research stakeholders affected some participants' ability to make autonomous decisions about research participation. These results have been presented under the themes of perception of research as development, research participants' motivation to access individual benefits, the power of vernacular translations to influence research participation, and coercive power of leaders. CONCLUSION: The study identified ethical issues in community engagement practices pertaining to structural coercion. We conclude that community engagement alone did not address underlying structural inequalities to ensure adequate protection of communities. These results raise important questions on how to balance between engaging communities to improve research participation and ensure that informed consent is voluntarily given.

Complexities and dilemmas in community consultation on the design of a research project logo in Malawi.

BACKGROUND: Community engagement on research design is widely highlighted as an important approach for ethical research. This article reports the experience of consulting with communities on the logo used for an influenza study in Malawi. The logo was designed for use on badges worn by study researchers, participant information sheets and other project documents, and could affect perceptions of the study and consequent engagement in the research. METHODS: Four focus group discussions were conducted with populations targeted by the influenza study: pregnant women, people with HIV, mothers and community members. The focus groups incorporated a participatory matrix exercise focusing on key themes emerging from the discussions such as: attractiveness, comprehension, acceptability and suggestions for improvement. Findings from the focus groups were analyzed according to these key themes. RESULTS: The consultation highlighted important benefits of discussion with communities on research design, including providing new perspectives and helping to avoid harm. For example, people living with HIV felt that one of the possible logos could increase stigma within communities. The experience also indicated potential challenges of consultation. In particular, there were contrasting perspectives among the groups, such that the consultation did not provide a clear answer about which logo should be selected. CONCLUSIONS: Our experience adds to current evidence on community engagement by reporting on an area where there is less discussion of community consultation for design of a study logo. The consultation exercise reaffirmed the value of community engagement, but also the difficulty of relying on a brief consultation for decision-making in research design. Further ethical guidance is required on how to negotiate contradictory views during consultations.

"Not just dogs, but rabid dogs": tensions and conflicts amongst research volunteers in Malawi.

Building trust between researchers and communities involved in research is one goal of community engagement. This paper examines the implications of community engagement for trust within communities, including trust among community volunteers who assist with research and between these volunteers and other community members. We describe the experiences of two groups of community volunteers recruited as part of an HIV and TB intervention trial in Malawi: cluster representatives, recruited both to act as key informants for TB suspects and mortality reporting and to identify and report community concerns, and community counsellors, recruited to provide semi-supervised HIV self-testing. We examine tensions experienced due to playing multiple roles, and the implications of volunteer responsibilities for short- and long-term community relationships. Data was collected through a workshop, in-depth interviews and focus group discussions with volunteers and community members. While the volunteer system initially enhanced trust among volunteers and with the community, relationships deteriorated when cluster representatives assumed an additional supervisory role part-way through the trial. Combined with challenging recruitment targets and unequal power relations between volunteers, this new role damaged trust, with implications for volunteer well-being and social relationships. These experiences suggest researchers should consider potential social implications when designing community engagement systems.

Using theories of change to design monitoring and evaluation of community engagement in research: experiences from a research institute in Malawi.

Background: Evaluation of community and public engagement in research is important to deepen understanding of how engagement works and to enhance its effectiveness. Theories of change have been recommended for evaluating community engagement, for their ability to make explicit intended outcomes and understandings of how engagement activities contribute to these outcomes. However, there are few documented examples of using theories of change for evaluation of engagement. This article reports experience of using theories of change to develop a framework for evaluating community engagement in research at a clinical research organisation in Malawi. We describe the steps used to develop theories of change, and the way theories of change were used to design data collection plans. Based on our experience, we reflect on the advantages and challenges of the theory of change approach. Methods: The theories of change and evaluation framework were developed through a series of workshops and meetings between engagement practitioners, monitoring and evaluation staff, and researchers. We first identified goals for engagement, then used 'so that' chains to clarify pathways and intermediate outcomes between engagement activities and goals. Further meetings were held to refine initial theories of change, identify priority information needs, and define feasible evaluation methods. Results: The theory of change approach had several benefits. In particular, it helped to construct an evaluation framework focused on relevant outcomes and not just activities. The process of reflecting on intended goals and pathways also helped staff to review the design of engagement activities. Challenges included practical considerations around time to consider evaluation plans among practitioners (a challenge for evaluation more generally regardless of method), and more fundamental difficulties related to identifying feasible and agreed outcomes. Conclusions: These experiences from Malawi provide lessons for other research organisations considering use of theories of change to support evaluation of community engagement.

'We are the eyes and ears of researchers and community': Understanding the role of community advisory groups in representing researchers and communities in Malawi.

Community engagement to protect and empower participating individuals and communities is an ethical requirement in research. There is however limited evidence on effectiveness or relevance of some of the approaches used to improve ethical practice. We conducted a study to understand the rationale, relevance and benefits of community engagement in health research. This paper draws from this wider study and focuses on factors that shaped Community Advisory Group (CAG) members' selection processes and functions in Malawi. A qualitative research design was used; two participatory workshops were conducted with CAG members to understand their roles in research. Workshop findings were triangulated with insights from ethnographic field notes, key informant interviews with stakeholders, focus group discussions with community members and document reviews. Data were coded manually and thematic content analysis was used to identify main issues. Results have shown that democratic selection of CAG members presented challenges in both urban and rural settings. We also noted that CAG members perceived their role as a form of employment which potentially led to ineffective representation of community interests. We conclude that democratic voting is not enough to ensure effective representation of community's interests of ethical relevance. CAG members' abilities to understand research ethics, identify potential harms to community and communicate feedback to researchers is critical to optimise engagement of lay community and avoid tokenistic engagement.