AFM1 Secretion and Efficacy of Novasil Clay in Kenyan Dairy Cows

The occurrence of aflatoxin M1 (AFM1) in milk has been widely reported in Kenya, with levels freqently exceeding national and international thresholds. Exposure to aflatoxin increases the risk of hepatic cancers and can also have other negative health impacts in children such as growth impairment and immunosuppression. Anti-mycotoxin agents (AMAs) included in contaminated feeds can greatly reduce the amount of AFM1 released in milk. A 45-day trial was designed to assess secretion of AFM1 in milk from individual cows fed commercial Kenyan dairy feed, as well as the efficacy of Novasil™ Plus in reducing the levels. A four-by-four Latin square cross-over design was used for the experiment. Four cows were fed on naturally contaminated with AFB1 feed, with levels ranging from 19 to 47 µg/kg, and either no binder or inclusion of binder at the rate of 0.6 or 1.2%. Milk samples were collected each day and analyzed for AFM1. The results showed that AFM1 levels in the milk varied between the cows, even when fed similar levels of contaminated feed. On average, inclusion of 0.6% binder into the diet resulted in 34% decline in milk AFM1 levels, while 1.2% binder dose resulted in a decline of 45%. Significant reduction in AFM1 secretion was observed in all experimental units (

Ethical considerations in Controlled Human Malaria Infection studies in low resource settings: Experiences and perceptions of study participants in a malaria Challenge study in Kenya [version 2; referees: 2 approved]

Background: The range and amount of volunteer infection studies, known as Controlled Human Infection Model (CHMI) studies, in Low-Middle Income Countries (LMICs) is increasing with rapid technological advancement, world-class laboratory facilities and increasing capacity development initiatives. However, the ethical issues these studies present in LMICs have not been empirically studied. We present findings of a descriptive social science study nested within a malaria volunteer infection study, on-going at the time of writing, at the KEMRI-Wellcome Trust Research Programme (KWTRP) on the Kenyan Coast. Methods: The study included non-participant observations, five group discussions with more than half of the CHMI study participants, two in-depth interviews with study team members, and an exit questionnaire administered to the participants. Results: Participants understood the key elements of the study, including that they would be deliberately infected with malaria parasites and may get malaria as a result, there would be regular blood draws, and they would spend up to 24 days in a residence facility away from their homes. The greatest motivation for participation was the monetary compensation of 20 USD per overnight stay given as a lump-sum at the end of their residency stay. Also appreciated were the health screening tests prior to enrolment and the positive relations with the study team. Concerns raised included the amount and regularity of blood draws experienced, and concerns that this type of research may feed into on-going rumours about research generally. Conclusion: With the increasing range and number of CHMI studies being conducted in LMICs, current ethical guidance are inadequate. This study highlights some of the ethical issues that could emerge in these settings, emphasizing the heavy responsibility placed on research review and regulatory systems, researchers and funders, as well as the importance of carefully tailored community engagement and consent processes

Ethical Considerations for Movement Mapping to Identify Disease Transmission Hotspots.

Traditional public health methods for detecting infectious disease transmission, such as contact tracing and molecular epidemiology, are time-consuming and costly. Information and communication technologies, such as global positioning systems, smartphones, and mobile phones, offer opportunities for novel approaches to identifying transmission hotspots. However, mapping the movements of potentially infected persons comes with ethical challenges. During an interdisciplinary meeting of researchers, ethicists, data security specialists, information and communication technology experts, epidemiologists, microbiologists, and others, we arrived at suggestions to mitigate the ethical concerns of movement mapping. These suggestions include a template Data Protection Impact Assessment that follows European Union General Data Protection Regulations

'The Words Will Pass with the Blowing Wind': Staff and Parent Views of the Deferred Consent Process, with Prior Assent, Used in an Emergency Fluids Trial in Two African Hospitals

Objective To document and explore the views and experiences of key stakeholders regarding the consent procedures of an emergency research clinical trial examining immediate fluid resuscitation strategies, and to discuss the implications for similar trials in future. Methods A social science sub-study of the FEAST (Fluid Expansion As Supportive Therapy) trial. Interviews were held with trial team members (n = 30), health workers (n = 15) and parents (n = 51) from two purposively selected hospitals in Soroti, Uganda, and Kilifi, Kenya. Findings Overall, deferred consent with prior assent was seen by staff and parents as having the potential to protect the interests of both patients and researchers, and to avoid delays in starting treatment. An important challenge is that the validity of verbal assent is undermined when inadequate initial information is poorly understood. This concern needs to be balanced against the possibility that full prior consent on admission potentially causes harm through introducing delays. Full prior consent also potentially imposes worries on parents that clinicians are uncertain about how to proceed and that clinicians want to absolve themselves of any responsibility for the child’s outcome (some parents’ interpretation of the need for signed consent). Voluntariness is clearly compromised for both verbal assent and full prior consent in a context of such vulnerability and stress. Further challenges in obtaining verbal assent were: what to do in the absence of the household decision-maker (often the father); and how medical staff handle parents not giving a clear agreement or refusal. Conclusion While the challenges identified are faced in all research in low-income settings, they are magnified for emergency trials by the urgency of decision making and treatment needs. Consent options will need to be tailored to particular studies and settings, and might best be informed by consultation with staff members and community representatives using a deliberative approach

Kenyan health stakeholder views on individual consent, general notification and governance processes for the re-use of hospital inpatient data to support learning on healthcare systems

Abstract Background Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. Methods We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Results Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. Conclusions As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs

AFM1 secretion and efficacy of Novasil™ clay in Kenyan dairy cows

The occurrence of aflatoxin M1 (AFM1) in milk has been widely reported in Kenya, with levels frequently exceeding national and international thresholds. Exposure to aflatoxin increases the risk of hepatic cancers and can also have other negative health impacts in children such as growth impairment and immunosuppression. Anti-mycotoxin agents (AMAs) included in contaminated feeds can greatly reduce the amount of AFM1 released in milk. A 45-day trial was designed to assess secretion of AFM1 in milk from individual cows fed commercial Kenyan dairy feed, as well as the efficacy of Novasil™ Plus in reducing the levels. A four-by-four Latin square cross-over design was used for the experiment. Four cows were fed on naturally contaminated with AFB1 feed, with levels ranging from 19 to 47 µg/kg, and either no binder or inclusion of binder at the rate of 0.6 or 1.2%. Milk samples were collected each day and analyzed for AFM1. The results showed that AFM1 levels in the milk varied between the cows, even when fed similar levels of contaminated feed. On average, inclusion of 0.6% binder into the diet resulted in 34% decline in milk AFM1 levels, while 1.2% binder dose resulted in a decline of 45%. Significant reduction in AFM1 secretion was observed in all experimental units (p < 0.005), though only minimal reduction was recorded in one of the units (Cow 4) compared to the other three. This trial shows novel data on aflatoxin exposure and excretion in Kenyan dairy cows in a field setting where AFB1 level is uncontrolled. We demonstrate significant reduction in AFM1 secretion in milk using AMA, though AFM1 levels were still above the recommended EC standard of 50 ŋg/kg. This study suggests that AMAs alone cannot be relied on to reduce AFM1 in milk to safe levels. Training and good feeding practices are recommended in addition to use of AMAs

Benefits in cash or in kind? A community consultation on types of benefits in health research on the Kenyan Coast.

Providing benefits and payments to participants in health research, either in cash or in kind, is a common but ethically controversial practice. While much literature has concentrated on appropriate levels of benefits or payments, this paper focuses on less well explored ethical issues around the nature of study benefits, drawing on views of community members living close to an international health research centre in Kenya.The consultation, including 90 residents purposively chosen to reflect diversity, used a two-stage deliberative process. Five half-day workshops were each followed by between two and four small group discussions, within a two week period (total 16 groups). During workshops and small groups, facilitators used participatory methods to share information, and promote reflection and debate on ethical issues around types of benefits, including cash, goods, medical and community benefits. Data from workshop and field notes, and voice recordings of small group discussions, were managed using Nvivo 10 and analysed using a Framework Analysis approach.The methods generated in-depth discussion with high levels of engagement. Particularly for the most-poor, under-compensation of time in research carries risks of serious harm. Cash payments may best support compensation of costs experienced; while highly valued, goods and medical benefits may be more appropriate as an 'appreciation' or incentive for participation. Community benefits were seen as important in supporting but not replacing individual-level benefits, and in building trust in researcher-community relations. Cash payments were seen to have higher risks of undue inducement, commercialising relationships and generating family conflicts than other benefits, particularly where payments are high. Researchers should consider and account for burdens families may experience when children are involved in research. Careful context-specific research planning and skilled and consistent communication about study benefits and payments are important, including in mitigating potential negative effects

Summary information for participants.

<p>Summary information for participants.</p

Study Scenarios.

<p>Study Scenarios.</p

Summary information for participants.

<p>Summary information for participants.</p