The role of healthcare providers and caregivers in monitoring critically ill children: a qualitative study in a tertiary hospital, southern Malawi.

BACKGROUND: Critically ill children require close monitoring to facilitate timely interventions throughout their hospitalisation. In low- and middle-income countries with a high disease burden, scarce paediatric critical care resources complicates effective monitoring. This study describes the monitoring practices for critically ill children in a paediatric high-dependency unit (HDU) in Malawi and examines factors affecting this vital process. METHODS: A formative qualitative study based on 21 in-depth interviews of healthcare providers (n = 12) and caregivers of critically ill children (n = 9) in the HDU along with structured observations of the monitoring process. Interviews were transcribed and translated for thematic content analysis. RESULTS: The monitoring of critically ill children admitted to the HDU was intermittent, using devices and through clinical observations. Healthcare providers prioritised the most critically ill children for more frequent monitoring. The ward layout, power outages, lack of human resources and limited familiarity with available monitoring devices, affected monitoring. Caregivers, who were present throughout admission, were involved informally in monitoring and flagging possible deterioration of their child to the healthcare staff. CONCLUSION: Barriers to the monitoring of critically ill children in the HDU were related to ward layout and infrastructure, availability of accurate monitoring devices and limited human resources. Potential interventions include training healthcare providers to prioritise the most critically ill children, allocate and effectively employ available devices, and supporting caregivers to play a more formal role in escalation.

Assessing the implementation fidelity, feasibility, and sustainability of community-based house improvement for malaria control in southern Malawi: a mixed-methods study.

BACKGROUND: Despite significant success in the fight against malaria over the past two decades, malaria control programmes rely on only two insecticidal methods: indoor residual spraying and insecticidal-treated nets. House improvement (HI) can complement these interventions by reducing human-mosquito contact, thereby reinforcing the gains in disease reduction. This study assessed the implementation fidelity, which is the assessment of how closely an intervention aligns with its intended design, feasibility, and sustainability of community-led HI in southern Malawi. METHODS: The study, conducted in 22 villages (2730 households), employed a mixed-methods approach. Implementation fidelity was assessed using a modified framework, with longitudinal surveys collecting data on HI coverage indicators. Quantitative analysis, employing descriptive statistics, evaluated the adherence to HI implementation. Qualitative data came from in-depth interviews, key informant interviews, and focus groups involving project beneficiaries and implementers. Qualitative data were analysed using content analysis guided by the implementation fidelity model to explore facilitators, challenges, and factors affecting intervention feasibility. RESULTS: The results show that HI was implemented as planned. There was good adherence to the intended community-led HI design; however, the adherence could have been higher but gradually declined over time. In terms of intervention implementation, 74% of houses had attempted to have eaves closed in 2016-17 and 2017-18, compared to 70% in 2018-19. In 2016-17, 42% of houses had all four sides of the eaves closed, compared to 33% in 2018-19. Approximately 72% of houses were screened with gauze wire in 2016-17, compared to 57% in 2018-19. High costs, supply shortages, labour demands, volunteers' poor living conditions and adverse weather were reported to hinder the ideal HI implementation. Overall, the community described community-led HI as feasible and could be sustained by addressing these socioeconomic and contextual challenges. CONCLUSION: Our study found that although HI was initially implemented as planned, its fidelity declined over time. Using trained volunteers facilitated the fidelity and feasibility of implementing the intervention. A combination of rigorous community education, consistent training, information, education and communication, and intervention modifications may be necessary to address the challenges and enhance the intervention's fidelity, feasibility, and sustainability.

Fourth Controlled Human Infection Model (CHIM) meeting - CHIMs in endemic countries, May 22-23, 2023.

Earlier meetings laid the foundations for Controlled Human Infection Models (CHIMs), also known as human challenge studies and human infection studies, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on CHIM studies being conducted in endemic countries. Over the last ten years we have seen a vast expansion of the number of countries in Africa performing CHIM studies, as well as a growing number of different challenge organisms being used. Community and public engagement with assiduous ethical and regulatory oversight has been central to successful introductions and should be continued, in more community-led or community-driven models. Valuable initiatives for regulation of CHIMs have been undertaken but further capacity building remains essential.

Maternal mental health research in Malawi: Community and healthcare provider perspectives on acceptability and ethicality.

Maternal mental health (MMH) is recognised as globally significant. The prevalence of depression and factors associated with its onset among perinatal women in Malawi has been previously reported, and the need for further research in this domain is underscored. Yet, there is little published scholarship regarding the acceptability and ethicality of MMH research to women and community representatives. The study reported here sought to address this in Malawi by engaging with communities and healthcare providers in the districts where MMH research was being planned. Qualitative data was collected in Lilongwe and Karonga districts through 20 focus group discussions and 40 in-depth interviews with community representatives and healthcare providers from January through April 2021. All focus groups and interviews were audio recorded, transcribed verbatim (in local languages Chichewa and Tumbuka), translated into English, and examined through thematic content analysis. Participants' accounts suggest that biopsychosocial MMH research could be broadly acceptable within the communities sampled, with acceptability framed in part through prior encounters with biomedical and public health research and care in these regions, alongside broader understandings of the import of MMH. Willingness and consent to participate do not depend on specifically biomedical understandings of MMH, but rather on familiarity with individuals regarded as living with mental ill-health. However, the data further suggest some 'therapeutic misconceptions' about MMH research, with implications for how investigations in this area are presented by researchers when recruiting and working with participants. Further studies are needed to explore whether accounts of the acceptability and ethicality of MMH research shift and change during and following research encounters. Such studies will enhance the production of granular recommendations for further augmenting the ethicality of biomedical and public health research and researchers' responsibilities to participants and communities.

'It is the child with the big head' - Primary healthcare providers' perceptions of paediatric hydrocephalus in Blantyre, Malawi: A qualitative study.

Children in Africa are disproportionately burdened by the neurosurgical condition hydrocephalus. In Blantyre, Malawi, paediatric hydrocephalus represents the majority of surgical procedures performed in the neurosurgical department at Queen Elizabeth Central Hospital. To reduce morbidity and mortality, timely detection followed by referral from surrounding primary health centres is crucial. Aiming to explore perceptions and identify enablers and barriers to detection and referral, we conducted a qualitative study among primary healthcare providers (n = 30) from ten health centres in Blantyre district. Using a semi-structured interview-guide, we audio-recorded and transcribed the interviews before conducting a thematic analysis. One main finding is that there is a potential to improve detection through head circumference measurements, which is the recommended way to detect hydrocephalus early, yet healthcare providers did not carry this out systematically. They described the health passport provided by the Malawian Ministry of Health as an important tool for clinical communication. However, head circumference growth charts are not included. To optimise outcomes for paediatric hydrocephalus we suggest including head circumference growth charts in the health passports. To meet the need for comprehensive management of paediatric hydrocephalus, we recommend more research from the continent, focusing on bridging the gap between primary care and neurosurgery.

Psychosis Recovery Orientation in Malawi by Improving Services and Engagement (PROMISE) protocol.

Malawi has a population of around 20 million people and is one of the world's most economically deprived nations. Severe mental illness (largely comprising psychoses and severe mood disorders) is managed by a very small number of staff in four tertiary facilities, aided by clinical officers and nurses in general hospitals and clinics. Given these constraints, psychosis is largely undetected and untreated, with a median duration of untreated psychosis (DUP) of around six years. Our aim is to work with people with lived experience (PWLE), caregivers, local communities and health leaders to develop acceptable and sustainable psychosis detection and management systems to increase psychosis awareness, reduce DUP, and to improve the health and lives of people with psychosis in Malawi. We will use the UK Medical Research Council guidance for developing and evaluating complex interventions, including qualitative work to explore diverse perspectives around psychosis detection, management, and outcomes, augmented by co-design with PWLE, and underpinned by a Theory of Change. Planned deliverables include a readily usable management blueprint encompassing education and community supports, with an integrated care pathway that includes Primary Health Centre clinics and District Mental Health Teams. PWLE and caregivers will be closely involved throughout to ensure that the interventions are shaped by the communities concerned. The effect of the interventions will be assessed with a quasi-experimental sequential implementation in three regions, in terms of DUP reduction, symptom remission, functional recovery and PWLE / caregiver impact, with quality of life as the primary outcome. As the study team is focused on long-term impact, we recognise the importance of having embedded, robust evaluation of the programme as a whole. We will therefore evaluate implementation processes and outcomes, and cost-effectiveness, to demonstrate the value of this approach to the Ministry of Health, and to encourage longer-term adoption across Malawi.

Loss to Hospital Follow-Up in Pediatric Cerebral Malaria Survivors: A Case-Control Study.

Children surviving central nervous system (CNS) infections are at high risk of neurological, behavioral, and cognitive sequalae. Early identification, characterization, and treatment of these sequelae may improve child and family health. In Africa, it is unclear if there are demographic or clinical factors that increase the risk of post-hospital loss to follow-up in children with CNS infections. If these factors exist, targeted educational efforts to increase rates of post-hospital retention could be focused on families at highest risk. We performed a case-control study of Malawian children with cerebral malaria, a locally common CNS infection, previously admitted to a specialized research unit in Blantyre, Malawi. Routine survivor post-hospital follow-up was scheduled for 1 month, 6 months, and 12 months. We compared demographic and clinical characteristics between 84 children who missed one or more of these post-hospital visits with 120 children who attended all visits. There were no statistically significant differences in demographic or clinical characteristics between children whose families returned for all follow-up visits and those who did not. Specifically, when comparing these groups, we found no differences in age (P = 00.646), sex (P = 0.789), duration of hospitalization (P = 0.903), distance from home to hospital (P = 0.355), type or severity of neurological sequelae (P = 0.837), guardian literacy (P = 0.057), or number of discharge medications (P = 0.464). No factors assessed in this study were associated with higher risk of loss to follow-up in Malawian child survivors of CNS infections. During hospitalization, educational efforts to increase post-hospital retention should focus on all families.

Community Participation in Habitat Management and Larviciding for the Control of Malaria Vectors in Southern Malawi.

Larval source management (LSM) could reduce malaria transmission when executed alongside core vector control strategies. Involving communities in LSM could increase intervention coverage, reduce operational costs, and promote sustainability via community buy-in. We assessed the effectiveness of community-led LSM to reduce anopheline larval densities in 26 villages along the perimeter of Majete Wildlife Reserve in southern Malawi. The communities formed LSM committees which coordinated LSM activities in their villages following specialized training. Effectiveness of larviciding by LSM committees was assessed via pre- and post-spray larval sampling. The effect of community-led LSM on anopheline larval densities in intervention villages was assessed via comparisons with densities in non-LSM villages over a period of 14 months. Surveys involving 502 respondents were undertaken in intervention villages to explore community motivation and participation, and factors influencing these outcomes. Larviciding by LSM committees reduced anopheline larval densities in post-spray sampling compared with pre-spray sampling (P < 0.0001). No differences were observed between anopheline larval densities during pre-spray sampling in LSM villages and those in non-LSM villages (P = 0.282). Knowledge about vector biology and control, and someone's role in LSM motivated community participation in the vector control program. Despite reducing anopheline larval densities in LSM villages, the impact of the community-led LSM could not be detected in our study setting because of low mosquito densities after scale-up of core malaria control interventions. Still, the contributions of the intervention in increasing a community's knowledge of malaria, its risk factors, and its control methods highlight potential benefits of the approach.

The menstrual cycle and football: The experiences of African women football players.

BACKGROUND: The menstrual cycle is a normal biological process in women and girls. However, it is often the reason why they tend to be excluded from football medicine research. Consequently, our understanding of the menstrual cycle and football performance is still limited, especially in African women football players. AIM: The study aimed to explore African women football players' current and historical menstrual cycle status, menstrual symptoms, lived experiences, and perceptions of the menstrual cycle. METHODS: Women football players at the COSAFA Women's Championship 2020 completed demographic questionnaires and the Moos Menstrual Distress Questionnaire. RESULTS: The main findings were that 90% of the players did not use contraceptives, . Most of the players had access to their preferred choice of sanitary product; however, 36% used alternatives such as old rags during their periods, . The most commonly reported symptoms during menses were abdominal cramps (53%), headache (41%), mood swings (41%) and irritability (47%). Further, players reported irritability (48%), mood swings (52%), and breast tenderness (48%) in the week before their period. CONCLUSION: The low use of contraceptives is likely due to community level socio-cultural factors. While the use of old rags as impromptu sanitary products is likely because they cannot always afford their preferred choice. Menstrual symptoms can affect training and competition; therefore, team support personnel should be aware of the menstrual cycle's implications for African women football players and their effect on athletic performance and well-being. Additionally, team support personnel ought to be mindful of African women football players' socio-economic and religio-cultural contexts and their interaction with biological processes such as the menstrual cycle and contraceptive use.

An implementation research programme to support an intravenous iron intervention for pregnant women with moderate and severe anaemia in Malawi: study protocol.

BACKGROUND: Antenatal iron supplementation is critical to maternal and child health; however, access and adherence to oral iron are inconsistent in many low- and middle-income countries (LMICs). Modern intravenous (IV) iron products have become available in high-income clinical settings and provide an opportunity to deliver high doses of iron in a single-short infusion during pregnancy. However, there is limited knowledge of the drivers and barriers for such an intervention to be effectively delivered and upscaled in LMICs. In this study protocol, we describe the implementation research programme to support an IV iron intervention in Malawi for pregnant women with moderate and severe anaemia. METHODS: The implementation research programme has three phases, each guided by implementation science conceptual frameworks. In Phase 1, we will conduct formative research (context assessment of the health system with key informant interviews) to determine how IV iron can be effectively introduced into routine antenatal care. We will use the findings to co-develop potential strategies with end-users and healthcare providers to improve intervention implementation. In Phase 2, we will disseminate the implementation strategies to support the uptake and delivery of the intervention in the study settings. In Phase 3, the intervention will be implemented, and we will conduct formative evaluation (interviews with end-users, healthcare providers, and analysis of health services data) to investigate the feasibility and acceptability of the intervention and strategies. We will also identify processes and contextual factors that facilitate or impede the delivery and uptake of IV iron. DISCUSSION: In LMICs, modern IV iron products present a novel opportunity to rapidly cure moderate and severe anaemia in pregnancy, thereby improving maternal and child health outcomes. This implementation research programme will provide guidance and recommendations on how best an IV iron intervention for pregnant women with anaemia can be implemented in an LMIC setting like Malawi. We will develop locally relevant and culturally appropriate implementation strategies by engaging with key stakeholders (pregnant women, healthcare providers, and policymakers) and identifying factors likely to facilitate successful implementation. The findings of this research can guide the implementation of an IV iron intervention in Malawi and other LMICs.

Community-based house improvement for malaria control in southern Malawi: Stakeholder perceptions, experiences, and acceptability.

House improvement (HI) refers to the full screening or closing of openings such as windows, doors, and eaves, as well as the installation of ceilings, to reduce mosquito-human contact indoors. HI is a viable supplementary intervention that reduces malaria transmission further than the existing strategies alone. In Malawi, HI has not been widely implemented and evaluated for malaria control. Concerns about lack of local evidence, durability in different epidemiological and cultural settings, and the cost of large-scale implementation are among the reasons the strategy is not utilised in many low-income countries. This study assessed community perceptions, experiences, and acceptability of community-led HI in Chikwawa district, southern Malawi. This was a qualitative study where separate focus group discussions were conducted with members from the general community (n = 3); health animators (n = 3); and HI committee members (n = 3). In-depth interviews were conducted with community members (n = 20), and key-informant interviews were conducted with health surveillance assistants and chiefs (n = 23). All interviews were transcribed and coded before performing a thematic content analysis to identify the main themes. Coded data were analysed using Nvivo 12 Plus software. Study participants had a thorough understanding of HI. Participants expressed satisfaction with HI, and they reported enabling factors to HI acceptability, such as the reduction in malaria cases in their villages and the safety and effectiveness of HI use. Participants also reported barriers to effective HI implementation, such as the unavailability and inaccessibility of some HI materials, as well as excessive heat and darkness in HI houses compared to non-HI houses. Participants indicated that they were willing to sustain the intervention but expressed the need for strategies to address barriers to ensure the effectiveness of HI. Our results showed the high knowledge and acceptability of HI by participants in the study area. Intensive and continued health education and community engagement on the significance of HI could help overcome the barriers and improve the acceptability and sustainability of the intervention.

Perceptions and experiences of intravenous iron treatment for anaemia in pregnancy in Malawi: a formative qualitative study.

Background: The study objective was to explore opinions, identify experiences, and describe perspectives on the acceptability of intravenous (IV) iron to treat anaemia in pregnancy and identify potential barriers and facilitators of introducing IV iron in the Malawian healthcare system. Methods: We conducted 15 in-depth interviews and two focus group discussions with pregnant women, and seven in-depth interviews with health workers at a community-based health centre in Blantyre and a tertiary hospital in Zomba. Results: Most women who used IV iron treatment during the second trimester of pregnancy reported feeling better and stronger after receiving the intervention. Women perceived that IV iron treatment worked faster than oral iron tablets and increased their haemoglobin count. However, cultural beliefs that IV iron treatment will cause miscarriage and the perception that study procedures involved Satanism and vampirism practices were barriers to acceptability. Health workers found IV iron treatment easy to administer because it is a single-dose treatment, simultaneously reducing the burden for pregnant women taking daily oral iron tablets. However, health workers expressed concerns about the costs and the need to train health workers before the large-scale implementation and integration of IV iron treatment into Malawi's routine care. Conclusions: Despite the perceived concerns and challenges experienced in participating in the first IV iron infusion trial in Malawi, participants' reflections suggest that IV iron infusion is acceptable for treating iron-deficiency anaemia in pregnancy. Participant advocate groups can offer a peer-to-peer education approach to sensitize and engage community members on the benefits of treatment and dispel concerns when the country contemplates integrating IV iron infusion for treating anaemia in pregnancy in Malawi.

A feasibility study of controlled human infection with Streptococcus pneumoniae in Malawi.

BACKGROUND: Persistent carriage of pneumococcal vaccine serotypes has occurred after introduction of PCV13 vaccination in Africa but the mechanisms are unclear. We tested the feasibility of using a human pneumococcal challenge model in Malawi to understand immune correlates of protection against carriage and to trial alternative vaccine candidates. We aimed to identify a dose of Streptococcus pneumoniae serotype 6B sufficient to establish nasopharyngeal carriage in 40% of those nasally inoculated and evaluate nasal mucosal immunity before and after experimental inoculation. METHODS: Healthy student volunteers were recruited and inoculated with saline, 20,000 CFU/naris or 80,000 CFU/naris of Streptococcus pneumoniae serotype 6B Post inoculation carriage was determined by nasal sampling for bacterial culture and lytA PCR. Immunological responses were measured in serum and nasal mucosal biopsies before and after bacterial inoculation. FINDINGS: Twenty-four subjects completed the feasibility protocol with minimal side effects. pneumococcal carriage was established in 0/6, 3/9 and 4/9 subjects in the saline, 20,000 CFU/naris and 80,000 CFU/naris groups, respectively. Incidental (natural) serotype carriage was common (7/24 participants carried non-6B strains, 29.2%. Experimentally induced type 6B pneumococcal carriage was associated with pro-inflammatory nasal mucosal responses prior to inoculation and altered mucosal recruitment of immune cells post bacterial challenge. There was no association with serum anti-capsular antibody. INTERPRETATION: The serotype 6B experimental human pneumococcal carriage model is feasible in Malawi and can now be used to determine the immunological correlates of protection against carriage and vaccine efficacy in this population. FUNDING: None.

Improving competencies and skills across clinical contexts of care: a qualitative study on Malawian nurses' experiences in an institutional health and training programme.

AIM: To explore what competencies and skills Malawian nurses gained after participating in an institutional health and training programme in Norway and how they viewed these competencies applicable upon return to Malawi. Furthermore, to examine facilitators and challenges experienced on the exchange programme and opportunities and obstacles to make the competencies usable in own local hospital context. DESIGN: Qualitative study with an explorative design. METHODS: Fourteen interviews and one focus group discussion were conducted at Queen Elizabeth Central Hospital, Blantyre, Malawi, from August to September 2018. RESULTS: Competencies gained in Norway included clinical skills, teamwork, coordination and strengthened professionalism. The main finding was that the exchange programme was a transformative experience. Upon return to Malawi, the competencies gained on the exchange were helpful. However, the return was characterized by mixed emotions due to the considerable difference between the two clinical settings.

Developing Biopsychosocial Research on Maternal Mental Health in Malawi: Community Perspectives and Concerns.

Interest in maternal mental health research is growing around the world. Maternal mental health research studies in Malawi have, for instance, sought to determine and establish the incidence and prevalence of depression and anxiety in pregnant people and the factors that contribute to experiences of these states. This article reports stakeholder perspectives on potential community concerns with biopsychosocial mental health research (which might include collecting blood samples) in Malawi. These perspectives were generated through a town hall event that featured five focus group discussions with various participants. In this article, we reflect on key themes from these discussions, demonstrating the endurance of long-standing concerns and practices around autonomy, consent, and the drawing of blood. We conclude by arguing that, while maternal mental health research conducted in Malawi could benefit Malawian women and children, consultation with community stakeholders is necessary to inform whether and how such research should be conducted.

The effect of community-driven larval source management and house improvement on malaria transmission when added to the standard malaria control strategies in Malawi: a cluster-randomized controlled trial.

BACKGROUND: Current standard interventions are not universally sufficient for malaria elimination. The effects of community-based house improvement (HI) and larval source management (LSM) as supplementary interventions to the Malawi National Malaria Control Programme (NMCP) interventions were assessed in the context of an intensive community engagement programme. METHODS: The study was a two-by-two factorial, cluster-randomized controlled trial in Malawi. Village clusters were randomly assigned to four arms: a control arm; HI; LSM; and HI + LSM. Malawi NMCP interventions and community engagement were used in all arms. Household-level, cross-sectional surveys were conducted on a rolling, 2-monthly basis to measure parasitological and entomological outcomes over 3 years, beginning with one baseline year. The primary outcome was the entomological inoculation rate (EIR). Secondary outcomes included mosquito density, Plasmodium falciparum prevalence, and haemoglobin levels. All outcomes were assessed based on intention to treat, and comparisons between trial arms were conducted at both cluster and household level. RESULTS: Eighteen clusters derived from 53 villages with 4558 households and 20,013 people were randomly assigned to the four trial arms. The mean nightly EIR fell from 0.010 infectious bites per person (95% CI 0.006-0.015) in the baseline year to 0.001 (0.000, 0.003) in the last year of the trial. Over the full trial period, the EIR did not differ between the four trial arms (p = 0.33). Similar results were observed for the other outcomes: mosquito density and P. falciparum prevalence decreased over 3 years of sampling, while haemoglobin levels increased; and there were minimal differences between the trial arms during the trial period. CONCLUSIONS: In the context of high insecticide-treated bed net use, neither community-based HI, LSM, nor HI + LSM contributed to further reductions in malaria transmission or prevalence beyond the reductions observed over two years across all four trial arms. This was the first trial, as far as the authors are aware, to test the potential complementary impact of LSM and/or HI beyond levels achieved by standard interventions. The unexpectedly low EIR values following intervention implementation indicated a promising reduction in malaria transmission for the area, but also limited the usefulness of this outcome for measuring differences in malaria transmission among the trial arms. Trial registration PACTR, PACTR201604001501493, Registered 3 March 2016, https://pactr.samrc.ac.za/ .

"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.

Adoption of evidence-based global policies at the national level: intermittent preventive treatment for malaria in pregnancy and first trimester treatment in Kenya, Malawi, Mali and The Gambia.

In 2012, the World Health Organization (WHO) updated its policy on intermittent preventive treatment in pregnancy with sulphadoxine-pyrimethamine (IPTp-SP). A global recommendation to revise the WHO policy on the treatment of malaria in the first trimester is under review. We conducted a retrospective study of the national policy adoption process for revised IPTp-SP dosing in four sub-Saharan African countries. Alongside this retrospective study, we conducted a prospective policy adoption study of treatment of first trimester malaria with artemisinin combination therapies (ACTs). A document review informed development and interpretation of stakeholder interviews. An analytical framework was used to analyse data exploring stakeholder perceptions of the policies from 47 in-depth interviews with a purposively selected range of national level stakeholders. National policy adoption processes were categorized into four stages: (1) identify policy need; (2) review the evidence; (3) consult stakeholders and (4) endorse and draft policy. Actors at each stage were identified with the roles of evidence generation; technical advice; consultative and statutory endorsement. Adoption of the revised IPTp-SP policy was perceived to be based on strong evidence, support from WHO, consensus from stakeholders; and followed these stages. Poor tolerability of quinine was highlighted as a strong reason for a potential change in treatment policy. However, the evidence on safety of ACTs in the first trimester was considered weak. For some, trust in WHO was such that the anticipated announcement on the change in policy would allay these fears. For others, local evidence would first need to be generated to support a change in treatment policy. A national policy change from quinine to ACTs for the treatment of first trimester malaria will be less straightforward than experienced with increasing the IPTp dosing regimen despite following the same policy processes. Strong leadership will be needed for consultation and consensus building at national level.

A qualitative study exploring stakeholder perspectives on the use of biological samples for future unspecified research in Malawi.

BACKGROUND: There is growing interest in the collection, storage and reuse of biological samples for future research. Storage and future use of biological samples raise ethical concerns and questions about approaches that safeguard the interests of participants. The situation is further complicated in Africa where there is a general lack of governing ethical frameworks that could guide the research community on appropriate approaches for sample storage and use. Furthermore, there is limited empirical data to guide development of such frameworks. A qualitative study to address this gap was conducted with key stakeholders in Malawi to understand their experiences and perspectives regarding storage and usage of samples for future research. METHODS: This study conducted 13 in-depth interviews with ethics committee members, regulators and researchers, and five focus group discussions with community representatives and clinical trial participants in Malawi. Interviews and focus group discussions were audio-recorded, transcribed verbatim, and thematically analysed. RESULTS: On the current regulatory guidelines that governs the collection, storage and reuse of samples in Malawi, participants highlighted their different understanding of it, with some indicating that it prohibited the reuse and sharing of samples, while others believed it permitted. Views on the informed consent model used in Malawi, some stakeholders expressed that the current model limited options for sample contributors regarding future use. Researchers supported storing samples for future use in order to maximize their value and reduce research costs. However, they expressed concern over the exportation of samples highlighting that it could lead to misuse and would not support the development of research capacity within Malawi. They recommended use of broad consent or tiered consent and establishment of biobanks to address these concerns. CONCLUSIONS: Study findings highlighted the need for a review of the current regulatory guideline and the development of infrastructure to support the use of stored biological samples for future use among the research community in Malawi. At the moment, there are ethical and practical concerns arising from the collection, storage and secondary use of biological samples make it hard to reconcile scientific progress and the protection of participants.