The HPAfrica protocol : assessment of health behaviour and population-based socioeconomic, hygiene behavioural factors - a standardised repeated cross-sectional study in multiple cohorts in sub-Saharan Africa

The objective of the Health Population Africa (HPAfrica) study is to determine health behaviour and population-based factors, including socioeconomic, ethnographic, hygiene and sanitation factors, at sites of the Severe Typhoid Fever in Africa (SETA) programme. SETA aims to investigate healthcare facility-based fever surveillance in Burkina Faso, the Democratic Republic of the Congo, Ethiopia, Ghana, Madagascar and Nigeria. Meaningful disease burden estimates require adjustment for health behaviour patterns, which are assumed to vary among a study population.; For the minimum sample size of household interviews required, the assumptions of an infinite population, a design effect and age-stratification and sex-stratification are considered. In the absence of a population sampling frame or household list, a spatial approach will be used to generate geographic random points with an Aeronautical Reconnaissance Coverage Geographic Information System tool. Printouts of Google Earth Pro satellite imagery visualise these points. Data of interest will be assessed in different seasons by applying population-weighted stratified sampling. An Android-based application and a web service will be developed for electronic data capturing and synchronisation with the database server in real time. Sampling weights will be computed to adjust for possible differences in selection probabilities. Descriptive data analyses will be performed in order to assess baseline information of each study population and age-stratified and sex-stratified health behaviour. This will allow adjusting disease burden estimates. In addition, multivariate analyses will be applied to look into associations between health behaviour, population-based factors and the disease burden as determined in the SETA study.; Ethic approvals for this protocol were obtained by the Institutional Review Board of the International Vaccine Institute (No. 2016-0003) and by all collaborating institutions of participating countries. It is anticipated to disseminate findings from this study through publication on a peer-reviewed journal

The HPAfrica protocol: Assessment of health behaviour and population-based socioeconomic, hygiene behavioural factors - a standardised repeated cross-sectional study in multiple cohorts in sub-Saharan Africa.

INTRODUCTION: The objective of the Health Population Africa (HPAfrica) study is to determine health behaviour and population-based factors, including socioeconomic, ethnographic, hygiene and sanitation factors, at sites of the Severe Typhoid Fever in Africa (SETA) programme. SETA aims to investigate healthcare facility-based fever surveillance in Burkina Faso, the Democratic Republic of the Congo, Ethiopia, Ghana, Madagascar and Nigeria. Meaningful disease burden estimates require adjustment for health behaviour patterns, which are assumed to vary among a study population. METHODS AND ANALYSIS: For the minimum sample size of household interviews required, the assumptions of an infinite population, a design effect and age-stratification and sex-stratification are considered. In the absence of a population sampling frame or household list, a spatial approach will be used to generate geographic random points with an Aeronautical Reconnaissance Coverage Geographic Information System tool. Printouts of Google Earth Pro satellite imagery visualise these points. Data of interest will be assessed in different seasons by applying population-weighted stratified sampling. An Android-based application and a web service will be developed for electronic data capturing and synchronisation with the database server in real time. Sampling weights will be computed to adjust for possible differences in selection probabilities. Descriptive data analyses will be performed in order to assess baseline information of each study population and age-stratified and sex-stratified health behaviour. This will allow adjusting disease burden estimates. In addition, multivariate analyses will be applied to look into associations between health behaviour, population-based factors and the disease burden as determined in the SETA study. ETHICS AND DISSEMINATION: Ethic approvals for this protocol were obtained by the Institutional Review Board of the International Vaccine Institute (No. 2016-0003) and by all collaborating institutions of participating countries. It is anticipated to disseminate findings from this study through publication on a peer-reviewed journal

The Surveillance for Enteric Fever in Asia Project (SEAP), Severe Typhoid Fever Surveillance in Africa (SETA), Surveillance of Enteric Fever in India (SEFI), and Strategic Typhoid Alliance Across Africa and Asia (STRATAA) Population-based Enteric Fever Studies: A Review of Methodological Similarities and Differences

Building on previous multicountry surveillance studies of typhoid and others salmonelloses such as the Diseases of the Most Impoverished program and the Typhoid Surveillance in Africa Project, several ongoing blood culture surveillance studies are generating important data about incidence, severity, transmission, and clinical features of invasive Salmonella infections in sub-Saharan Africa and South Asia. These studies are also characterizing drug resistance patterns in their respective study sites. Each study answers a different set of research questions and employs slightly different methodologies, and the geographies under surveillance differ in size, population density, physician practices, access to healthcare facilities, and access to microbiologically safe water and improved sanitation. These differences in part reflect the heterogeneity of the epidemiology of invasive salmonellosis globally, and thus enable generation of data that are useful to policymakers in decision-making for the introduction of typhoid conjugate vaccines (TCVs). Moreover, each study is evaluating the large-scale deployment of TCVs, and may ultimately be used to assess post-introduction vaccine impact. The data generated by these studies will also be used to refine global disease burden estimates. It is important to ensure that lessons learned from these studies not only inform vaccination policy, but also are incorporated into sustainable, low-cost, integrated vaccine-preventable disease surveillance systems

The Severe Typhoid Fever in Africa Program: Study Design and Methodology to Assess Disease Severity, Host Immunity, and Carriage Associated With Invasive Salmonellosis

Background. Invasive salmonellosis is a common community-acquired bacteremia in persons residing in sub-Saharan Africa. However, there is a paucity of data on severe typhoid fever and its associated acute and chronic host immune response and carriage. The Severe Typhoid Fever in Africa (SETA) program, a multicountry surveillance study, aimed to address these research gaps and contribute to the control and prevention of invasive salmonellosis. Methods. A prospective healthcare facility-based surveillance with active screening of enteric fever and clinically suspected severe typhoid fever with complications was performed using a standardized protocol across the study sites in Burkina Faso, the Democratic Republic of Congo (DRC), Ethiopia, Ghana, Madagascar, and Nigeria. Defined inclusion criteria were used for screening of eligible patients for enrollment into the study. Enrolled patients with confirmed invasive salmonellosis by blood culture or patients with clinically suspected severe typhoid fever with perforation were eligible for clinical follow-up. Asymptomatic neighborhood controls and immediate household contacts of each case were enrolled as a comparison group to assess the level of Salmonella-specific antibodies and shedding patterns. Healthcare utilization surveys were performed to permit adjustment of incidence estimations. Postmortem questionnaires were conducted in medically underserved areas to assess death attributed to invasive Salmonella infections in selected sites. Results. Research data generated through SETA aimed to address scientific knowledge gaps concerning the severe typhoid fever and mortality, long-term host immune responses, and bacterial shedding and carriage associated with natural infection by invasive salmonellae. Conclusions. SETA supports public health policy on typhoid immunization strategy in Africa

Baseline Assessment of Public Health Surveillance in the Kingdom of Swaziland

ObjectiveTo assess essential support functions for Integrated DiseaseSurveillance and Response(IDSR) in the Kingdom of Swaziland andmake recommendations for a national IDSR Roadmap.IntroductionImplementation of the IDSR framework for fulfillment of theInternational Health Regulations (2005) ([IHR 2005]) has beenchallenging in Swaziland due to distribution of IDSR functions acrossunits within the Strategic Information Department (SID) and otherexternal departments within the Ministry of Health. We conducted aqualitative assessment and a Strength, Weaknesses, Opportunities andThreats (SWOT) analysis of current public health surveillance (PHS)support structures to inform implementation of IDSR.MethodsKey informant interviews, focus group discussions, and a deskreview were performed. Participants were personnel at essential units,departments and programs at the national level as well as at healthfacilities and clinics at regional and local levels. Transcripts werecoded into SWOT matrices using MAXQDA for each building blockof PHS: structures, workforce, resources, processes (detect, report,assess/analyze, respond, feedback), and informatics.ResultsSelected Strengths included existence of immediate notifiabledisease reporting through the Epidemic and Pandemic Response unit(EPR) and reporting of summary health facility data to the HealthManagement Information System (HMIS) unit and laboratorynetwork. Weaknesses included lack of clear roles and responsibilitiesfor IDSR among SID units, limited coordination between SID units,lack of data sharing, lack of Standard Operating Procedures (SOPs),uncoordinated case investigations and response, minimal analysisconducted for public health surveillance and limited feedback forreporters..Identified opportunities were political will for establishing ofroles and responsibilities and mechanisms for coordination anddata sharing. Threats were limited data access, limited funding forfeedback, lack of analysis for IDSR and paper-based reportingConclusionsCurrently there is limited use of surveillance data for decisionmaking due to lack of coordination. Findings were presented at adissemination meeting to representatives of relevant departments,and there was consensus on the need to clearly define the role andresponsibilities of different programs for IDSR. In March 2016, aconsensus meeting was held to designate roles and responsibilitiesfor IDSR, a direct result of this assessment. Additional resourcesand funding is needed to support these highly important initiatives toensure the safety and health security of the Swazi nation

Baseline Assessment of Public Health Surveillance in the Kingdom of Swaziland

ObjectiveTo assess essential support functions for Integrated DiseaseSurveillance and Response(IDSR) in the Kingdom of Swaziland andmake recommendations for a national IDSR Roadmap.IntroductionImplementation of the IDSR framework for fulfillment of theInternational Health Regulations (2005) ([IHR 2005]) has beenchallenging in Swaziland due to distribution of IDSR functions acrossunits within the Strategic Information Department (SID) and otherexternal departments within the Ministry of Health. We conducted aqualitative assessment and a Strength, Weaknesses, Opportunities andThreats (SWOT) analysis of current public health surveillance (PHS)support structures to inform implementation of IDSR.MethodsKey informant interviews, focus group discussions, and a deskreview were performed. Participants were personnel at essential units,departments and programs at the national level as well as at healthfacilities and clinics at regional and local levels. Transcripts werecoded into SWOT matrices using MAXQDA for each building blockof PHS: structures, workforce, resources, processes (detect, report,assess/analyze, respond, feedback), and informatics.ResultsSelected Strengths included existence of immediate notifiabledisease reporting through the Epidemic and Pandemic Response unit(EPR) and reporting of summary health facility data to the HealthManagement Information System (HMIS) unit and laboratorynetwork. Weaknesses included lack of clear roles and responsibilitiesfor IDSR among SID units, limited coordination between SID units,lack of data sharing, lack of Standard Operating Procedures (SOPs),uncoordinated case investigations and response, minimal analysisconducted for public health surveillance and limited feedback forreporters..Identified opportunities were political will for establishing ofroles and responsibilities and mechanisms for coordination anddata sharing. Threats were limited data access, limited funding forfeedback, lack of analysis for IDSR and paper-based reportingConclusionsCurrently there is limited use of surveillance data for decisionmaking due to lack of coordination. Findings were presented at adissemination meeting to representatives of relevant departments,and there was consensus on the need to clearly define the role andresponsibilities of different programs for IDSR. In March 2016, aconsensus meeting was held to designate roles and responsibilitiesfor IDSR, a direct result of this assessment. Additional resourcesand funding is needed to support these highly important initiatives toensure the safety and health security of the Swazi nation

Developing a Tool to Cost Gaps in Implementation of IHR (2005) Core Capacities

In May 2013, over 100 WHO Member States (MS) reported not having met their national International Health Regulations (2005) core capacity requirements. Many MS need support in identifying activities and associated costs to support building capacity. WHO developed a costing tool organized by the IHR (2005) Core Capacities and public health core functions. The tool will provide users with estimated annualized costs for developing and sustaining public health activities relevant to IHR (2005) implementation. Providing National Focal Points with costs estimates and generalized plans of action facilitates allocation of funds and development of IHR capacities and public health functions

The Monitoring and Evaluation of a Multicountry Surveillance Study, the Severe Typhoid Fever in Africa Program

BACKGROUND: There is limited information on the best practices for monitoring multicountry epidemiological studies. Here, we describe the monitoring and evaluation procedures created for the multicountry Severe Typhoid Fever in Africa (SETA) study. METHODS: Elements from the US Food and Drug Administration (FDA) and European Centre for Disease Prevention and Control (ECDC) recommendations on monitoring clinical trials and data quality, respectively were applied in the development of the SETA monitoring plan. The SETA core activities as well as the key data and activities required for the delivery of SETA outcomes were identified. With this information, a list of key monitorable indicators was developed using on-site and centralized monitoring methods, and a dedicated monitoring team was formed. The core activities were monitored on-site in each country at least twice per year and the SETA databases were monitored centrally as a collaborative effort between the International Vaccine Institute and study sites. Monthly reports were generated for key indicators and used to guide risk-based monitoring specific for each country. RESULTS: Preliminary results show that monitoring activities have increased compliance with protocol and standard operating procedures. A reduction in blood culture contamination following monitoring field visits in two of the SETA countries are preliminary results of the impact of monitoring activities. CONCLUSIONS: Current monitoring recommendations applicable to clinical trials and routine surveillance systems can be adapted for monitoring epidemiological studies. Continued monitoring efforts ensure that the procedures are harmonized across sites. Flexibility, ongoing feedback, and team participation yield sustainable solutions.status: publishe

The Monitoring and Evaluation of a Multicountry Surveillance Study, the Severe Typhoid Fever in Africa Program

Background. There is limited information on the best practices for monitoring multicountry epidemiological studies. Here, we describe the monitoring and evaluation procedures created for the multicountry Severe Typhoid Fever in Africa (SETA) study. Methods. Elements from the US Food and Drug Administration (FDA) and European Centre for Disease Prevention and Control (ECDC) recommendations on monitoring clinical trials and data quality, respectively were applied in the development of the SETA monitoring plan. The SETA core activities as well as the key data and activities required for the delivery of SETA outcomes were identified. With this information, a list of key monitorable indicators was developed using on-site and centralized monitoring methods, and a dedicated monitoring team was formed. The core activities were monitored on-site in each country at least twice per year and the SETA databases were monitored centrally as a collaborative effort between the International Vaccine Institute and study sites. Monthly reports were generated for key indicators and used to guide risk-based monitoring specific for each country. Results. Preliminary results show that monitoring activities have increased compliance with protocol and standard operating procedures. A reduction in blood culture contamination following monitoring field visits in two of the SETA countries are preliminary results of the impact of monitoring activities. Conclusions. Current monitoring recommendations applicable to clinical trials and routine surveillance systems can be adapted for monitoring epidemiological studies. Continued monitoring efforts ensure that the procedures are harmonized across sites. Flexibility, ongoing feedback, and team participation yield sustainable solutions

The Surveillance for Enteric Fever in Asia Project (SEAP), Severe Typhoid Fever Surveillance in Africa (SETA), Surveillance of Enteric Fever in India (SEFI), and Strategic Typhoid Alliance Across Africa and Asia (STRATAA) Population-based Enteric Fever Studies: A Review of Methodological Similarities and Differences

Building on previous multicountry surveillance studies of typhoid and others salmonelloses such as the Diseases of the Most Impoverished program and the Typhoid Surveillance in Africa Project, several ongoing blood culture surveillance studies are generating important data about incidence, severity, transmission, and clinical features of invasive Salmonella infections in sub-Saharan Africa and South Asia. These studies are also characterizing drug resistance patterns in their respective study sites. Each study answers a different set of research questions and employs slightly different methodologies, and the geographies under surveillance differ in size, population density, physician practices, access to healthcare facilities, and access to microbiologically safe water and improved sanitation. These differences in part reflect the heterogeneity of the epidemiology of invasive salmonellosis globally, and thus enable generation of data that are useful to policymakers in decision-making for the introduction of typhoid conjugate vaccines (TCVs). Moreover, each study is evaluating the large-scale deployment of TCVs, and may ultimately be used to assess post-introduction vaccine impact. The data generated by these studies will also be used to refine global disease burden estimates. It is important to ensure that lessons learned from these studies not only inform vaccination policy, but also are incorporated into sustainable, low-cost, integrated vaccine-preventable disease surveillance systems.status: publishe