Meningitis is an acute and potentially life-threatening condition that involves inflammation of the meninges, and it can be caused due to various infectious agents, primarily bacteria, viruses, and fungi. Among these, bacterial meningitis is particularly severe and demands urgent medical intervention to prevent long-term complications, such as neurological impairment, sensory deficits, and even death (1).

The burden of meningitis disproportionately affects low and middle-income countries (LMICs), where access to healthcare resources and vaccination programs are often limited (2). Studies indicate that Streptococcus pneumoniae, Haemophilus influenzae type b (Hib), and Neisseria meningitidis are the primary bacterial pathogens responsible for meningitis, particularly in LMIC regions. These pathogens contribute substantially to morbidity and mortality rates, especially among children under 5 years of age (3). In India, Streptococcus pneumoniae has been identified as the leading cause of bacterial meningitis in hospitalized children less than 5 years of age, accounting for approximately 82.9% of confirmed cases. The second most common pathogen, Hib, accounts for around 14.4% of cases, followed by Neisseria meningitidis at 2.7% (4).

Vaccination is the most effective strategy for countries to control infectious diseases (5). Vaccines against Hib, Streptococcus pneumoniae, and Neisseria meningitidis have significantly reduced bacterial meningitis in children globally. Many National Immunization Programs (NIPs) have adopted vaccines against these pathogens thereby greatly reducing the disease burden (6). The Hib vaccine is a part of the pentavalent vaccine and is available in over 193 countries, including India (7). The Pentavalent vaccine was introduced in a phased manner in India in 2011 and was initially launched in Tamil Nadu and Kerala, followed by the introduction in the other states (8). In 2015, The National Technical Advisory Group on Immunization (NTAGI), India recommended that a pneumococcal conjugate vaccine (PCV) be introduced into the Universal Immunization Program (UIP) (9). PCV-13 was introduced in a phased manner across 5 states in 2017 with plans for introduction in the other states. The roll-out was delayed due to the COVID-19 pandemic that affected the supply chain and staffing. However, irrespective of these challenges India successfully rolled out the first domestically produced PCV-10 to the entire nation during the ongoing pandemic in 2021 (10).

Prior to introduction of PCV in India, the country lacked a dedicated, nationwide surveillance platform for pneumococcal and other meningitis-causing pathogens, limiting the availability of data on the disease prevalence and the effectiveness of vaccination programs. In this context, the Indian Council of Medical Research (ICMR), in collaboration with the Gates Foundation, launched a project titled the “Strengthening Laboratory Surveillance for Pneumococcal Meningitis in India” in the year 2018. The aim of the study was to evaluate the impact of the PCV rollout on pneumococcal disease burden and to gather comprehensive data on circulating Streptococcus pneumoniae serotypes across the country. To achieve these aims, a meningitis surveillance network was launched which comprised sentinel sites with national representation (11). It was designed as a three-tiered hierarchical system. The lowest tier consists of 33 Clinical Recruitment Sites (CRS) which are tertiary level hospitals like medical colleges where children less than 5 years of age suspected of meningitis are being admitted in the Pediatric ICUs/ Pediatric neurology departments. Pediatricians from these departments identify and recruit participants. After obtaining informed consent from the parents of the children, clinical, demographic and vaccination data are being retrieved. Cerebrospinal fluid (CSF) samples are also being collected and sent to the microbiology lab of the tertiary centers for further processing and storage. These samples are then transported to the Regional Reference Laboratories (RRLs) which are the second level in the three-tier surveillance system. There are four RRLs which are tertiary care centers and ICMR institutes that are responsible for the testing of the CSF specimens for Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae. Each of the RRLs is linked to 4–6 CRS, to monitor their progress and conduct the lab assays on the CSF samples collected by them. The top tier consists of two National Apex Laboratories (NALs), each equipped to conduct advanced molecular diagnostics. Each NAL is linked to two RRLs and are carrying out S. pneumoniae serotyping using Taqman Array Card on the samples transported to them from RRLs after testing positive for S. pneumoniae. The serotyping data of the circulating pneumococcal strains helps to assess the vaccine efficacy. The data is managed by ICMR—National Institute of Epidemiology (NIE) which also functions as an RRL. While the overall implementation and monitoring of this sentinel surveillance network is being carried out by the ICMR Headquarter at Delhi, India. This was the first time ever a nationally representative meningitis sentinel surveillance network has been established in the country that spans across all 6 zones of India.

The implementation of this robust surveillance system for meningitis, presented with several challenges. Effective surveillance requires substantial financial investment, trained personnel, and adequate infrastructure, all of which can be limited in resource-constrained regions. Additionally, data collection for meningitis cases is complicated by underreporting, lack of vaccination data, especially in rural and underserved areas, where access to healthcare facilities and diagnostic tools are often limited. Addressing these challenges necessitated a multifaceted approach, involving the collaboration, coordination and effective communication between different stakeholders.

This project was launched by ICMR in collaboration with Gates foundation in the year 2018 for a duration of 5 years. However, it was fully initiated only in 2019 following the obtainment of all clearances. The project did face a setback due to the COVID-19, however it continued functioning during the pandemic as feasible and was fully functional post the pandemic. The project was initially planned to conclude in June 2023 and in this regard it was decided to conduct an exploratory qualitative analysis in order to document the facilitators and challenges faced in the implementation of this surveillance network. This qualitative evaluation was conducted from March to June 2023, however transcription, data analysis and report preparation was conducted from October 2023 to March 2024. Due to the setback faced by COVID-19, the project has been granted a no-cost extension till June 2026, following which it is planned to be integrated with the routine surveillance network of Infectious Disease Research and Diagnostic Laboratory.

Therefore, the objective of this analysis was to conduct an exploratory qualitative evaluation of the experiences of the stakeholders involved in the implementation of this meningitis surveillance network. This analysis seeks to offer insights into the complexities of establishing a nationally representative sentinel meningitis surveillance system by identifying the facilitators and challenges faced by the stakeholders and also documents the strategies that were put in place to establish this network.

In order to capture a holistic over view of the facilitators and challenges faced in the implementation of the meningitis surveillance network, the study participants were selected from all the three tiers using multi-stage purposive sampling. This qualitative evaluation was conducted toward the end of the project period in order to capture the challenges experienced throughout the different phases of project implementation. Since there are only 2 NALs each responsible for carrying out advanced molecular tests on samples and there are 4 RRLs that are overseeing the activities of the CRSs all these sites were purposively selected for this evaluation. Out of the 33 CRS, 8 of them were selected in consultation with the Principal Investigators of the RRLs who were responsible for overseeing the activities of the CRS. In order to get the perspectives of both the good and poor performing CRSs, all the CRSs were initially grouped based on their location across the 6 zones of India. From each of the 6 zones, the Principal Investigators of the RRLs responsible for the CRS allotted to them were asked to classify the CRS based on their performance. Multiple indicators were used to assess the performance of the CRS such as number of suspected cases of meningitis, in patient admission of meningitis cases and collection of CSF samples, confirmed cases of Streptococcus pneumonia at the CRS sites. In addition, other factors that were crucial for successful project implementation such as obtainment of participant informed consent forms, vaccination data retrieval, sample collection and transportation, data entry etc. were also considered. Based on these indicators, the PI’s of the RRLs classified the performance of the CRS as good and poor performers. Four CRS with high scores and four with the lowest scores were selected for this qualitative evaluation.

At each selected site, the key informants were purposively selected based on the role they played in the project in order to capture the facilitators and challenges they faced at each stage, i.e., study participant identification, enrolment, data and sample collection, laboratory analysis, data entry and analysis. The study implementers who are the main stakeholders in the project were contacted and prior appointments were taken for conducting the interviews. The Key Informant Interviews (KIIs) were conducted after obtaining informed consent and permissions to record the interviews. The KIIs were conducted virtually using in depth interview guides which were developed after extensive formative research. The guides were developed keeping in mind the different activities that are being conducted in this surveillance network. Separate questions were prepared for each of the stakeholders based on the work being carried out by them so that a complete picture of the facilitators and challenges faced for setting up such a nationwide surveillance network can be captured. KIIs were conducted till data saturation was attained with no further information being shared. The details of the selected study sites and participants are shown in Figure 1.

The study was conducted by investigators trained in qualitative research from the Indian Council of Medical Research (ICMR) Headquarters. Approval of the institutional ethics committee was obtained from these institutes before study initiation.

All interviews were conducted in English, and the audio files were transcribed verbatim by the project team. The two investigators responsible for data analysis, then cross checked the transcribed data with the audio recordings to ensure that the data was completely captured with no deletions or additions, thereby ensuring quality of the transcribed data. Transcripts were then read and re-read multiple times in order to gain familiarity with the data. An inductive approach was used to code the data manually. The codes were entered into a common code book which was used by the two investigators responsible for data analysis. New codes were added as and when it appeared on reviewing the transcripts after discussion and agreement by both the investigators thereby maintaining the uniformity of the codes. Using this common code book, all transcripts were coded and emerging patterns in the form of themes and sub themes were identified and grouped together under specific domains. The grouped data in the form of quotes was then charted into a framework without losing the essence of the data. This charting exercise helped to summarize the data by category from each transcript and it also enabled a process of cross-comparison between the different interviews. This framework was independently reviewed by both the researchers to draw conclusions in order to increase the validity of the findings. The discrepancies that evolved were resolved through discussion till consensus was reached between the researchers. Conclusions were drawn by comparing and triangulating the data between and within the 2 NALs, 4 RRLs, 4 high and 4 low performing CRSs. This helped the researchers not only to identify similar patterns and to look into divergent findings but it also lead to achieving data saturation. Data and researcher triangulation methods enabled to increase the validity and reliability of the study findings.

A total of 25 Key Informant Interviews (KIIs) were conducted among the project team members hence forth referred as study implementers that included Heads of Departments, Principal Investigators (PIs), Co-Principal Investigators (Co-PIs) who were either pediatricians or microbiologists, Scientists, Research Assistants (RAs), data managers, statisticians etc. These study implementers were spread across 14 different institutes that were representative of each of the three tiers of the surveillance network. The KIIs were conducted till data saturation was obtained with no new themes arising. A summary of the results of this qualitative exploratory analysis is depicted in Figure 2.

The KIIs with the different study implementers began with questions regarding their job responsibilities and work satisfaction. It was observed that all study implementers were well versed with their job responsibilities and were in general satisfied that they were contributing to a project of national importance. Following this, the participants were asked about the different steps in implementation of the surveillance network, the first being participant recruitment into the project.

This study was able to identify the challenges and facilitators faced in the implementation of a nationwide Laboratory Surveillance network for Pneumococcal Meningitis in India. The lessons learnt from this study will be useful for consideration while planning the execution of future such surveillance networks in the country as well as other countries.

The key to the success of any surveillance system is the use of an appropriate case definition that is sensitive enough to identify the study participants so that no one gets left out and at the same time it is not too broad to lose its specificity. As per WHO, case definitions are needed to ensure that surveillance data are comparable between countries. Also, case definitions have a crucial impact on the sensitivity and the positive predictive value of a surveillance system. In this project too, the WHO definition was used for meningitis surveillance which included numerous symptoms such as fever, neck stiffness, bulging fontanelle, altered or reduced level of consciousness, prostration, lethargy, convulsions and any clinical suspicion of meningitis by the physician (12, 13). Majority of the medical officers felt this definition to be very broad and lacked specificity. They felt that most often, eliciting the history of prostration and lethargy from the parents was difficult. Hence the definition needs to be made more specific.

One of the reasons for the successful implementation of this network was the appropriate selection of sentinel sites which had dedicated investigators who adhered to the protocol to recruit study participants. The WHO interim global epidemiological surveillance standards also highlight that system stability, feasibility and representativeness are the most important factors to be considered while choosing a sentinel site. The guideline also goes on to state that when multiple sentinel sites are being considered, sites should represent diverse populations or climate zones since this will provide information about transmission patterns among sub-populations with unique demographic or socio-economic characteristics. The guideline also states that there is no ideal number of sentinel sites in a country but that countries should start with one or a few sentinel sites and only expand if they function well (14). The site selections and implementation for this surveillance network too was conducted taking into consideration these factors and network expanded slowly in a phased manner across various geographies of the country.

The other major step toward participant enrolment was to get informed consent for data collection and CSF sample collection in order to capture the different circulating serotypes in the country. However, obtaining consent and retrieval of proper clinical history were difficult since most of them were from rural areas and were illiterate. Since the parents often rushed to these centers with very sick children, they mostly did not carry any discharge history or details of the medicines given to the child, thereby making it difficult to understand if antibiotics were provided prior to the current hospital visit or not. The parents also did not carry the vaccination cards with them making vaccination history retrieval very difficult. The children were mostly very sick and dehydrated at the time of reporting resulting in a dry tap or low volume of CSF making CSF analysis challenging. In order to overcome these challenges, the investigators had repeated discussions with the parents to gather information and convince them about giving consent for CSF taping. The investigators also reached out after the child got discharged to get the vaccination data through WhatsApp and also by contacting the local health care workers. However this still remained a major challenge in the implementation of the surveillance network. Going forward, these challenges may be overcome by the new Government of India initiatives that are under process such as the Integrated Child Health Record (ICHR) (15) and the U-WIN Portal for digitalization of medical records for children which are gaining momentum (16). These initiatives aim to streamline and improve healthcare for children by leveraging technology to create secure, accessible digital records, offering benefits like real-time access to medical history, vaccination schedules, and growth milestones. The U-WIN Portal, launched in October 2024, is developed for the complete digitization of vaccination services, and maintaining vaccination records for pregnant women and children from birth to 17 years under the Universal Immunization Program. The citizen-centric services of the digital platform include ‘Anytime Access’ and ‘Anywhere’ vaccination services, self-registration by citizens using the U-WIN web-portal or the U-WIN citizen mobile application, automated SMS alerts, universal QR-based e-Vaccination Certificate and utility to create their Ayushman Bharat Health Account (ABHA) ID for themselves and child ABHA ID for their children (17). Therefore going forward, the ICHR and U-WIN platforms may be utilized for the follow up the medical records and vaccination data of the children.

Another crucial step in setting up a national laboratory surveillance network by the creation of a hierarchical system of laboratories starting with a basic laboratory at the periphery from where samples are collected and basic tests are done for patient management. Followed by further processing of samples, storage and transportation to higher laboratories for serotyping and analysis. Since, this network only included tertiary care centers, basic laboratory facilities were all available at all the CRSs and RRLs facilities hence it did not require any additional investments. The National apex laboratories selected for the study were one of the best in the country, however they required support for the establishment of laboratory assays for TAQMAN based serotyping for which technical support and lab support in the assay kits, reagents, primers & probes were being provided by the external funders and agencies. However, this was not found to be a major lacunae of this surveillance network, because the project depended on external support. Therefore, for the establishment of a sustainable lab surveillance network it is important that diagnostic tests, reagents, primers and probes are all manufactured indigenously and not being dependent on external agencies. Hence, for the establishment of a successful model it is crucial that it should be self-sufficient and sustainable. Even though this network was established on external funding and technical support, going forward it is planned to be merged with the routine surveillance network of Infectious Disease Research and Diagnostic Laboratory (IRDLs) (18)whose data is fed into to the Integrated Health Information Platform (IHIP). These IRDLs are fully supported and funded by the Department of Health Research, Ministry of Health & Family Welfare, Government of India (19). Additionally, training and capacity building sessions are being undertaken for laboratories to conduct PCV serotyping and efforts are being made to make this lab surveillance network self-sustainable by providing in-house lab materials.

Similar successful implementation of laboratory surveillance for bacterial meningitis have been documented in Vietnam and Ghana. The Vietnam Meningitis Encephalitis Surveillance Network was established in 1998 and it was implemented in two hospitals in Ho Chi Minh City to monitor bacterial meningitis in children under five. This network was supported by the National Institute of Hygiene and Epidemiology, the World Health Organization (WHO), and the US Centers for Disease Control and Prevention Representative Office in Vietnam which provided both financial and technical support (20). Similarly in Ghana, in 2008, WHO set up the Global Invasive Bacterial Vaccine-preventable Diseases surveillance network that focussed on meningitis surveillance at 2 sentinel sites (21). From these documented evidences, it is evident that in the initial stages of implementation of such nationwide laboratory surveillance networks Low and Middle-Income Countries (LMICs) often require substantial support from global health agencies such as the WHO, along with specialized technical assistance from experienced international partners for establishing robust sentinel surveillance systems. During the initial phases, external collaborators play a critical role in capacity building, infrastructure development, training of local personnel, and establishing standardized surveillance protocols and data management frameworks. However, to ensure long-term sustainability and national ownership, it is essential that these systems gradually transition to local leadership and financing. Over time, external support should intentionally be phased out, enabling the country to independently manage, maintain, and scale the surveillance network as part of routine public health operations.

Two other crucial requirements for establishing a surveillance network is the need for a data management team and a central project coordination unit (22). In this project, the data management team was hosted at the ICMR NIE where the data collected on the ReDCap database from this entire network was stored in a separate server. This team consisted of experienced laboratory experts, epidemiologists and statisticians who are continuously reviewing the data, carrying out statistical analysis and reviewing the circulating PCV strains in the country. Last but not the least, for the smooth implementation and functioning of such a large surveillance network there needs to be a central coordination unit who is responsible for coordinating with the NALs, RRLs, CRSs, NIE and external agencies for the implementation of the project. This unit is responsible for fund release, coordination of the activities under the project, capacity building activities and supervision of data management activities. Therefore, while setting up such a surveillance system, these two components are also crucial components along with the lab network. The strengths of this evaluation study was that it was able to document the implementation of the network across all the tiers and all stakeholders. However, the study did not capture the perspectives of the funders and the CDC laboratory technical team. Other limitations of the study was that this was a qualitative study using purposive sampling thereby making the findings context specific with limited generalizability to other sites. This evaluation was conducted by study coordinators at the ICMR Headquarters, thereby resulting in potential study respondent bias. However, all efforts were made to create trust among the respondents for sharing the ground realities they faced while implementing the surveillance network. Additionally, data and researcher triangulation methods enabled to increase the validity and reliability of the study findings. Since, study participants were trained medical / research staff, the interviews were all conducted in English and was transcribed verbatim, no data was lost due to translation inconsistences.

This nationwide laboratory Surveillance for Pneumococcal Meningitis was implemented in the year 2018 with the aim to evaluate the impact of the PCV rollout on pneumococcal disease burden and to gather comprehensive data on circulating Streptococcus pneumoniae serotypes across the country. Since, this network covered most part of the country, the data from this study is being routinely reviewed and used by the National Technical Advisory Group on Immunization of India for making policy decisions regarding vaccine strain change. Therefore this network was found to be successfully implemented because it was providing valuable evidence for decision making by the policy makers.

Therefore, the implementation of this nationwide laboratory surveillance across the country has been successful irrespective of the many challenges it faced. This network has been immensely useful for gathering evidence for making policy decisions regarding the use of PCV. This is a classic example of a successful externally funded project that has now transitioned into an in-country sustainable model. The lessons learnt from this study have been documented so that this learning can be replicated by others who are planning to implement such surveillance networks in their countries. As per our experience, it is important to have a decentralized system of sentinel laboratory surveillance network with an inbuilt data management system and central coordination unit to oversee the activities of the network. Even if external technical and funding support is taken for the establishment of such networks, it is very important to plan and prepare beforehand a sustainable plan of transition and integration into the country’s surveillance system. If not, it would result in the demolition of the network once the funding retracts. Based on our experiences, we strongly recommend that every country establish a national laboratory surveillance networks to monitor the circulating pneumococcal serotypes and other high burden vaccine preventable serotypes so that evidence-based decisions can be made regarding the type of vaccines that are being used in a country.