A baseline epidemiological survey for malaria and schistosomiasis reveals an alarming burden in primary schools despite ongoing control in Chikwawa District, southern Malawi.

Our study rationale was to establish contemporary epidemiological data on malaria and schistosomiasis among school-going children in Chikwawa District before future environmental changes associated with the Shire Valley Transformation Programme occurred. Our cross-sectional surveys tested 1134 children from 21 government-owned primary schools (approximately 50 children per school); rapid diagnostic tests for malaria (Humasis Pf/PAN) and intestinal schistosomiasis (urine-Circulating Cathodic Antigen) were used, with urine reagents strips and egg-filtration with microscopy for urogenital schistosomiasis. All infected children were treated with an appropriate dose of Lonart® (for malaria) and/or Cesol® (for schistosomiasis). Across 21 schools the overall prevalence was 9.7% (95% CI: 8.8-10.6%) for malaria, 1.9% (95% CI: 1.4-2.3%) for intestinal schistosomiasis, and 35.0% (95% CI: 33.6-36.5%) for egg-patent urogenital schistosomiasis. The prevalence of co-infection of malaria with urogenital schistosomiasis was 5.5% (95% CI: 4.8-6.2%). In a third of the schools, the prevalence of malaria and urogenital schistosomiasis was above national averages of 10.5% and 40-50%, respectively, with two schools having maxima of 36.8% and 84.5%, respectively. Set against a background of ongoing control, our study has revealed an alarming burden of malaria and schistosomiasis in southern Malawi. These findings call for an immediate mitigating response that significantly bolsters current control interventions to better safeguard children's future health.

'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.

A chronological discourse analysis of ancillary care provision in guidance documents for research conduct in the global south.

INTRODUCTION: Numerous guidelines and policies for ethical research practice have evolved over time, how this translates to global health practice in resource-constrained settings is unclear. The purpose of this paper is to describe how the concept of ancillary care has evolved over time and how it is included in the ethics guidelines and policy documents that guide the conduct of research in the global south with both an international focus and providing a specific example of Malawi, where the first author lives and works, as a case study. METHODS: Discourse analysis was conducted on 34 international ethics guidelines and policy documents. Documents were purposively selected if they contained a set of key terms that reflect the concept of ancillary care. Following a process of inductive discourse analysis, five key interrelated text phrases relating to ancillary care were extracted from the documents. The evolution of these phrases over time was explored as they represented the development of the concept of ancillary care as a component of ethical health research guidance and practice. RESULTS: We found key interrelated phrases that represent discourses regarding the evolution of ancillary care including participant protection; provide care as appropriate; supererogation; patient needs prevail over science; and ancillary care as an obligation. Arguments for the provision of ancillary care were characterised by safeguarding the safety, health rights and well-being of study participants. However, despite the evolution of discourse around ethical obligations to provide ancillary care, this is rarely made explicit within guidance documents, leaving interpretive space for differential application in practice. CONCLUSION: While there have been major changes to the ethics guidance that reflect significant evolution in the ethical conduct of research, the specific vocabulary or language used to explain the ethics of researchers' ancillary care obligations to the health needs of their research participants, lacks clarity and consistency. As a result, the concept of ancillary care continues to be under-represented in local ethical guidelines and regulations, with no clear directives for country-level research ethics committees to apply in regulating ancillary care responsibilities.

"An increase in COVID-19 patients would be overwhelming": A qualitative description of healthcare workers' experiences during the first wave of COVID-19 (March 2020 to October 2020) at Malawi's largest referral hospital.

Background  COVID-19 is currently a global health threat. Healthcare workers are on the front-line of the COVID-19 outbreak response and therefore at heightened risk of infection. There is a dearth of evidence from Sub-Saharan Africa about healthcare worker experiences in managing COVID-19.  We have reported on healthcare worker responses, experiences, and perspectives on epidemic response strategies at Queen Elizabeth Central Hospital, Malawi's largest referral hospital.   Methods  We conducted 39 face-to-face in-depth interviews with a purposively selected sample of healthcare workers during the first wave of COVID-19 in Malawi (March 2020 to October 2020). The study included healthcare workers who provided direct and indirect patient care.   Results  During the early phase of the first wave (March to May 2020), healthcare workers expressed concerns with inadequate working space, unconducive infrastructure, delayed and rushed training on the management of COVID-19, and lack of incentives. Additionally, the hospital had staff shortages and limited essential resources such as piped oxygen and personal protective equipment. This increased healthcare worker fears of contracting COVID-19 and they were less willing to volunteer at COVID-19 isolation units. Resource constraints and limited preparedness compromised the care pathway particularly with increased numbers of COVID-19 patients. By the peak of the first wave (June to August 2020) many of these issues had been resolved. The hospital provided refresher training courses, personal protective equipment became available, incentives were offered to healthcare workers working in COVID-19 units and piped oxygen was installed. Staff morale was boosted, and more staff were willing to work at the COVID-19 isolation centres.   Conclusion  Experiences of healthcare workers during the first wave of COVID-19 are critical for improving care in future COVID-19 waves. Response strategies in resource-constrained areas should prioritise timely training of staff, creation of adequate isolation areas, provision of adequate medical supplies and strengthening leadership.

"At first, I was very afraid"-a qualitative description of participants' views and experiences in the first Human Infection Study in Malawi.

Background: Human infection studies (HIS) involve deliberately infecting healthy volunteers with a pathogen in a controlled environment to understand infection and support the development of effective vaccines or treatments. HIS research is expanding to many low and middle-income settings to accelerate vaccine development. Given the implementation of the first HIS research to establish the experimental human pneumococcal carriage model's feasibility, we sought to understand the participant's opinions and experiences. Methods: We used a qualitative, descriptive approach to understand participants perceptions and experiences on HIS participation. Sixteen healthy adult participants were invited to participate in in-depth exit interviews to discuss their experiences, motivations and concerns. Results: Our findings showed that the likelihood of participation in HIS research rests on three essential conditions: motivation to participate, compensation and advocacy. The motivation and decision to participate was based on reasons including altruism, patriotism, monetary and material incentives, and while compensation was deemed appropriate, concerns about unanticipated research-related risks were raised. Participant advocate groups were recommended for increasing awareness and educating others in the broader community about HIS research. Conclusions: Participants' experiences of HIS in Malawi provide the basis of what can be acceptable in HIS research in lower-income countries and areas where study procedures could be adjusted.

A pneumococcal controlled human infection model in Malawi: Transfer of an established pneumococcal carriage model from Liverpool, UK to Blantyre, Malawi - A feasibility study.

Streptococcus pneumoniae is the leading cause of morbidity and mortality due to community acquired pneumonia, bacterial meningitis and bacteraemia worldwide. Pneumococcal conjugate vaccines protect against invasive disease, but are expensive to manufacture, limited in serotype coverage, associated with serotype replacement and demonstrate reduced effectiveness against mucosal colonisation.  As asymptomatic colonisation of the human nasopharynx is a prerequisite for pneumococcal disease, this is proposed as a marker for novel vaccine efficacy. Our team established a safe and reproducible pneumococcal controlled human infection model at Liverpool School of Tropical Medicine (LSTM). This has been used to test vaccine induced protection against nasopharyngeal carriage for ten years in over 1000 participants. We will transfer established standardised operating procedures from LSTM to Malawi and test in up to 36 healthy participants. Primary endpoint: detection of the inoculated pneumococci by classical culture from nasal wash recovered from the participants after pneumococcal challenge. Secondary endpoints: confirmation of robust clinical and laboratory methods for sample capture and processing. Tertiary endpoints: participant acceptability of study and methods. We will test three doses of pneumococcal inoculation (20,000, 80,000 and 160,000 colony forming units [CFUs] per naris) using a parsimonious study design intended to reduce unnecessary exposure to participants. We hypothesise that 80,000 CFUs will induce nasal colonisation in approximately half of participants per established LSTM practice. The aims of the feasibility study are: 1) Establish Streptococcus pneumoniae experimental human pneumococcal carriage in Malawi; 2) Confirm optimal nasopharyngeal pneumococcal challenge dose; 3) Confirm safety and measure potential symptoms; 4) Confirm sampling protocols and laboratory assays; 5) Assess feasibility and acceptability of consent and study procedures. Confirmation of pneumococcal controlled human infection model feasibility in Malawi will enable us to target pneumococcal vaccine candidates for an at-risk population who stand the most to gain from new and improved vaccine strategies.

Stakeholder views on the acceptability of human infection studies in Malawi.

BACKGROUND: Human infection studies (HIS) are valuable in vaccine development. Deliberate infection, however, creates challenging questions, particularly in low and middle-income countries (LMICs) where HIS are new and ethical challenges may be heightened. Consultation with stakeholders is needed to support contextually appropriate and acceptable study design. We examined stakeholder perceptions about the acceptability and ethics of HIS in Malawi, to inform decisions about planned pneumococcal challenge research and wider understanding of HIS ethics in LMICs. METHODS: We conducted 6 deliberative focus groups and 15 follow-up interviews with research staff, medical students, and community representatives from rural and urban Blantyre. We also conducted 5 key informant interviews with clinicians, ethics committee members, and district health government officials. RESULTS: Stakeholders perceived HIS research to have potential population health benefits, but they also had concerns, particularly related to the safety of volunteers and negative community reactions. Acceptability depended on a range of conditions related to procedures for voluntary and informed consent, inclusion criteria, medical care or support, compensation, regulation, and robust community engagement. These conditions largely mirror those in existing guidelines for HIS and biomedical research in LMICs. Stakeholder perceptions pointed to potential tensions, for example, balancing equity, safety, and relevance in inclusion criteria. CONCLUSIONS: Our findings suggest HIS research could be acceptable in Malawi, provided certain conditions are in place. Ongoing assessment of participant experiences and stakeholder perceptions will be required to strengthen HIS research during development and roll-out.

Perceived HIV-protective benefits of male circumcision: Risk compensatory behaviour among women in Malawi.

BACKGROUND: Male circumcision (MC) reduces men's risk of contracting HIV by approximately 60% and has the potential to significantly alter HIV epidemics. However, MC does not significantly reduce the risk of HIV transmission to women from a circumcised man. In Malawi, several researchers has examined the acceptability, accessibility and sexual behaviour change after circumcision in men but behaviour change in women following their partner's circumcision remains uncertain. In order to fully realise the protective benefits of MC against HIV, factors related to risky sexual behaviour is imperative as some studies have shown potentials of increased risky behaviour in men following voluntary medical male circumcision (VMMC). This study aimed to explore the perceptions and opinions of female school teachers and health workers on HIV-protective benefits of MC and its impact on risk compensatory behaviour among women in Malawi. METHODS: We conducted a cross-sectional survey of women (N = 68) between May and June 2016 in three districts of southern Malawi. Risk compensatory behaviour was measured by number of sexual partners and use of protection during sex among female teachers and health care workers who are involved with educating people on benefits of VMMC. The bivariable analysis was conducted to test for association between HIV-protective benefits and risk compensatory behaviour. Purposive sampling was used to conduct eight qualitative in-depth interviews with women from the selected districts and the qualitative data was analysed thematically. RESULTS: The mean age of women who participated in the survey was 30 years. Most women (94.1%) correctly indicated that HIV-positive circumcised men can still infect their partner and approximately, 90% of were knowledgeable of risky sexual behaviour for HIV. However, 55.9% perceived MC can lead women to adopt risky sexual behaviour. On the contrary to this finding, qualitative data indicate women's misconceptions regarding their partners' circumcision and HIV-protective benefits. Most women expressed that risky sexual behaviour such as having multiple sexual partners and inconsistent or non-use of condoms can easily be observed among women if they learn of their partners' partial HIV-protective benefits circumcision. CONCLUSION: Exploring women's sexual behaviour change in the right of HIV-protective benefits of MC fills in a research knowledge important to public health. In-depth studies are therefore required to give more evidence that will guide the development of HIV risk-reduction interventions.