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Abstract
Introduction India’s contribution to the malaria burden was highest in South-East Asia Region in 2021, accounting for 79% of the estimated malaria cases and 83% of malaria-related deaths. Intensified Malaria Control Programme supported by Global Funds to Fight against AIDS, Tuberculosis and Malaria has deployed crucial interventions to reduce the overall burden of malaria in India. Evaluation of utilisation of malaria elimination interventions by the community and assessment of the healthcare system is underway in eleven high malaria endemic states in India. Health system preparedness for malaria elimination, logistics, and supply chain management of diagnostic kits and anti-malarial drugs in addition to the knowledge, attitude and practice of the healthcare workers is also being assessed.
Methods and analysis The study is being undertaken in 11 malaria endemic states with a variable annual parasite incidence of malaria. In total, 47 districts (administrative unit of malaria control operations) covering 37 976 households are to be interviewed and assessed. We present here the protocol following which the study is being undertaken at the behest and approval of Ministry of Health and Family Welfare in India.
Ethics and dissemination No patients were involved in the study. Study findings will be shared with Institutional ethics board of National Institute for Malaria Research New Delhi (NIMR) in a timely, comprehensive, accurate, unbiased, unambiguous and transparent manner and to the National Vector-borne Disease (Malaria) Control Programme officers and the Community public who participated. Important findings will be communicated through community outreach meetings which are existing in the Health system. Results will be informed to study participants via local fieldwork supervised by District Malaria Officers. Also findings will be published in reputed journals based on Indian Council of Medical Research (ICMR) publication policy.
The ICMR-NIMR ethics committee approved the study via letter No. NIMR/ECM/2023/Feb/14 dated 24 April 2023 for version 5. All standard ethical practices will be followed.
- Malaria
- Community-Based Participatory Research
- Health Surveys
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STRENGTHS AND LIMITATIONS OF THIS STUDY
The study focuses on the endemic states of the country.
Sampling based on robust statistical method.
In-built process indicator for survey using open data kit technology for data capture.
Includes overall objectives of national programme to generate evidence on impact of previous intervention for malaria control.
Native people/tribals who are not into the mainstream may encounter language comprehension challenges and sometimes may not participate, increasing the non-response rate for the survey.
Introduction
The World Malaria Report (2022) estimated 247 million malaria cases, accounting for approximately 0.62 million deaths from 84 malaria-endemic countries in 2021.1 The WHO’s South-East Asia Region (SEAR) represented just 2% of global malaria cases, with a substantial 76% drop in cases from 23 million in 2000 to approximately 5 million in 2021.1 2 India’s contribution to the malaria burden was highest in SEAR in 2021, accounting for 79% of the estimated malaria cases and 83% of malaria-related deaths.1 As of June 2023, 42 countries and one territory have been certified as malaria-free by the WHO.1 3 India is committed to eliminating malaria by 2030 and is making progress with a consistent decline in both total cases and deaths. Reported malaria cases have steadily decreased from 2.09 million in 2001 to 0.16 million in 2021.4 Additionally, malaria-related deaths declined from 1005 in 2001 to 90 in 2021.4 5
Despite adopting multi-pronged approaches to reduce the malaria burden in India,4 the country faces certain threats on its path to malaria elimination. One of the obstacles is the presence of high-endemic malaria pockets in hard-to-reach, forested and tribal areas, which act as disease reservoirs.6 All these factors could significantly impede the country’s malaria control efforts and therefore, require urgent attention. The National Framework for Malaria Elimination (NFME) in India (2016–2030) was formulated in alignment with the global goal of malaria elimination by 2030. This framework categorised all states/union territories (UTs) based on their malaria burden into category 1 (states with annual parasite incidence, ie, API less than 1 per 1000 population); category 2 (states with API less than 1 but some districts API more than 1 in 1000 population at risk) and category 3 (states with API≥1).5 Subsequently, national strategic plan (NSP 2017–2022) was released outlining the operational plan of malaria elimination activities with the district as the unit for administration. In this NSP, the categorisation of districts took place based on API. India is also the only non-African nation included in WHO’s programme on High Burden High Impact. In India, among the high endemic states, notable are—Chhattisgarh, Jharkhand, Madhya Pradesh, Odisha and seven northeastern states. The Global Fund to Fight AIDS, Tuberculosis, and Malaria (GFATM) has been supporting India’s malaria control programme since 2005. Since the declaration of elimination as a goal by 2030, Intensified Malaria Elimination Project (IMEP-I) has been implemented in seven northeastern states and Madhya Pradesh in first phase from 2018 to 2021 and in IMEP-II, in addition to seven north eastern states, four other endemic states, that is, Odisha, Jharkhand, Chhattisgarh and Madhya Pradesh spanning from April 2021 to 2024. The IMEP-II integrated multiple strategies, including active long lasting insecticide impregnated net (LLIN) distribution, mass screening, prompt treatment of cases and context-specific behaviour change communication activities. Moreover, planning, monitoring, evaluation and coordination have been strengthened in the region. In addition to these efforts, the programme emphasised the development of partnerships, training and capacity building to enhance service delivery in these project areas.6 7
Indian Council of Medical Research which is the nodal research body of Ministry of Health and Family Welfare, undertook this study via its institute National Institute of Malaria Research. The study aims to assess the availability and utilisation of preventive and curative health services in selected high-burden endemic states. The specific objectives are: (a) to evaluate the availability, accessibility and utilisation of service delivery (both preventive and curative) at the community level; (b) to assess the community’s healthcare-seeking behaviour in response to febrile illness; (c) to estimate the availability and usage of LLINs and understand community perspective on the role of bednets in malaria control and to understand their preferences regarding its size and material; (d) to assess community’s knowledge, attitudes and practices concerning malaria prevention, control and treatment along with analysing the existing logistics and supply chain distribution in the malaria programme; (e) to evaluate the effectiveness of current monitoring, surveillance and Health Management Information System within the malaria programme. To understand the above, a comprehensive study to assess the community perspective and preparedness of the health system for malaria elimination is essential to augment the country’s malaria elimination efforts. Therefore, this dynamic protocol to suit all the aspects of the national programme was formulated which can be followed as a standard protocol for future such exercises in India and other countries with similar characteristics. The study is under progress in various districts.
Methods
This protocol has been prepared according to the Standard Protocol Items for Observational Studies.8
Study period
May 2023 to May 2024 (1 year).
Study design
This is a cross-sectional study focusing on community perspectives and health system assessment in malaria-endemic states of India. An interviewer-administered close-ended structured questionnaire using an open data kit (ODK) platform is designed as a data collection tool.
Study setting
The study is planned to be conducted in selected districts of eleven endemic states namely, Chhattisgarh, Jharkhand, Madhya Pradesh, Odisha (category 3 state—state in intensified control phase, defined as states/ UTs with an API of 1 case per 1000 population at risk or above), Manipur (category 1 state—states in elimination phase defined as state/ UTs including their districts reporting an API of less than 1 case per 1000 population at risk), Assam and Nagaland (category 2 state—state in pre-elimination phase, defined as states/ UTs with an API of less than 1 case per 1000 population at risk, but some of their districts are reporting an API of 1 case per 1000 population at risk or above), Arunachal Pradesh, Meghalaya, Mizoram, Tripura (category 3). This categorisation is according to NFME (2016–2030).
Sample size
Estimates from the previously published articles and unpublished Intensified Malaria Control Programme Phase-3 Household Survey 2018 report and others have been considered to calculate the sample size for the present study (online supplemental table 1). Health care-seeking behaviour of the community for febrile illness had the lowest prevalence, so the sample size calculation was based on that to yield the maximum sample size, which would enable comprehensive coverage for all the other indicators.
Supplemental material
Health-seeking behaviour for febrile illness in the Kolasib district of Mizoram, India, indicated that 35% of the households approached the government facility to seek treatment for febrile illness.9 Assuming that 35% of households approach government facilities in case of febrile illness, with a relative precision of 20% and a confidence interval (CI) of 95%, the required number of households with febrile illness to be enrolled at the state level was estimated to be 178. Assuming that at any given point of time (adjusting for the role of seasonality on occurrence of febrile illnesses) in the community, febrile illness would be on an average occurring at an approximate rate of 10%. Therefore, to achieve the target of 178 households, it was planned to survey 1780 households.
Since the study aims to collect the data through multi-stage sampling to account for heterogeneity in the data collection, a design effect of 1.5 was considered, and the sample size was inflated to 2670. Assuming for non-response rate of 20% during the data collection process, the sample size for the survey was fixed as 3204 households per state (rounded off to 3210). Therefore, a total of 35 310 households from 11 states are to be surveyed.
The population proportion to size (PPS) technique was applied with district population size of year 2020 in 238 districts of 11 states, a total of 44 districts were selected (online supplemental table 2). Since smaller states in population size like Meghalaya, Tripura and Nagaland, were missed in PPS selection, these were represented with additional districts (for representation based on API). In each district, 808 households shall be surveyed. Therefore, to accommodate the districts from all these states in the sample, a final sample size of 37 976 households covering 47 districts from 11 states was estimated (online supplemental table 3)(figure 1).
Districts selected in 11 study states.
Sampling procedure
The multi-stage sampling technique is applied. The selection of the study area within each selected district will be determined by both the burden of malaria (ranging from low to high) and rural-urban settings. Within each selected district, two community health centres (CHCs) will be selected based on API load. Within each of these selected CHCs, two primary health centres (PHCs) will be selected. Furthermore, two villages will be selected from each PHC/CHC. The process of village selection criteria is to consider malaria positivity over the past 5 years. Subsequently, villages will be selected from each CHC/PHC for the survey. The proportion of rural to urban households in the district will be 7:1 (rural villages and urban wards). In each village, 101 households will be surveyed accounting for 808 households within each district (figure 2).
Flow chart of household selection. CHC, community health centre; PHC, primary health centre; PPS, population proportion to size.
Since it is planned to survey 101 households from each village, in villages where less than 101 households will be available, a sampling frame will be prepared by merging the nearby one or two villages. Every alternate household will be surveyed in each village. However, in those villages where the houses are scattered and are difficult to reach, continuous enumeration of the households shall be conducted.
Participants
To be eligible for participation in the study, respondents should be above 18 years of age, of any gender and must have been residing in the household for at least the last 6 months. If the respondent cannot read and write, his/her thumb impression will be obtained in the presence of a witness who will also countersign the consent form.
Variables
The study aims at data collection through module 1, which will be deployed at the community level for household data collection. Modules 2, 3 and 4 have been prepared for data acquisition from District Malaria Officers (DMOs), District Vector Borne Disease Control Consultant, ASHA, ANM and other health workers (table 1).
Details of study objectives, study population and outcomes
Module 1 has been designed to gather the information related to the routine sociodemographic and economic data of the respondents. The accessibility of the healthcare facilities available to the community will be evaluated by collecting the data on variables like distance and type of the nearest health facility from the household.
The data related to the availability and maintenance of M1–M4, VC1–VC6 forms and the frequency of their submission, records related to the distribution of LLIN and the availability of information, education, communication (IEC) material will also be collected. In addition, the data related to the availability of the logistics for malaria diagnosis and the frequency of monitoring activities done by them will also be acquired.
Patient and public involvement
No patients wll be involved in the studies.
Results will be informed to study participants via local fieldwork is supervised by DMOs.
Data source and collection techniques
Data capturing for module 1 will be done through face-to-face interviews by the trained research team. The data collection will be done in electronic format through handheld mobile tablets and using the ODK platform. ODK is employed to efficiently monitor interviewers by enabling real-time data collection, GPS tracking and performance assessments, improving accountability and decision-making.
The research team will be trained in survey data collection methods, interview techniques and the use of ODK. The team will comprise members proficient in the local language of the states and districts where the survey will be done. Pilot testing of the questionnaire will also be done at these trainings and the research team will administer the questionnaire in 10 households during this phase. The responses collected by the research team during pilot testing will be evaluated for any potential problem in the conduct of the study and the questionnaire. The principal and coinvestigators of the study on a real-time basis will supervise each research team.
Data management
A dedicated team of statisticians, social scientists and epidemiologists will monitor the real-time data captured through ODK. Any deviation from the study protocol, if noticed, will be communicated to the research team. Errors observed in data collection will be addressed adequately. The data will be checked for completeness and missing data will be checked for randomness. The data collected through ODK will then be exported in a Comma Separated Format (CSV) file, which will then be imported into statistical software for analysis. The data collected will be recoded into numeric form for data analysis. Throughout the process of data management and analysis, confidentiality of the respondents will be maintained.
Bias
Inherent to cross-sectional surveys, some recall and Berkesonian bias is expected, and all efforts are made to reduce them by training the field staff in eliciting proper responses for the questions.
Statistical analysis plan
The data will be analysed in SPSS V.29.0. Mean, median, SD and IQR will be used to describe the continuous data. Frequency and percentage will describe the categorical data. To explore the association between independent and outcome variables, a χ2 test will be used. Multivariate logistic regression analysis will evaluate the relationship between demographic, socioeconomic, knowledge, attitude and practice regarding malaria and its impact on the usage and acceptability of LLIN. All the tests will be done at a 5% level of significance and 95% CIs will be produced for crude and adjusted estimates.
Discussion
The objectives listed in the proposal are focused towards malaria elimination and in line with the activities articulated by WHO for malaria control and elimination. The use and emphasis on demographic and health survey (DHS) is part of malaria national programmes. Global and national policymakers increasingly rely on epidemiological data and mathematical modelling to optimise health decisions at the subnational level.10 The present study emphasises on parameters which also assist in optimising outpatient malaria case management, reducing testing compliance gaps and eliminating overtreatment of test negative patients.11 The present study focuses on such DHS data with relevant parameters being conducted in high burden states, provides a strong basis for the country to plan towards malaria elimination by 2030.
The demand for technology use in healthcare has led to attempts at integration of digital applications with surveillance programmes to digitally monitor community and healthcare workers, thereby supporting surveys and other field activities.12 13 While inadequate, incomplete, aggregated and paper-based data surveillance and collection is considered to be weak and sluggish6 real-time data collection, including para data like timestamps and geo-referencing,14 shall be captured in the present study through ODK platform, which is essential for effective monitoring and analysis. The technology is used as a process indicator in this ongoing protocol and we consider it as a strength of the present study.
Analysis of the health system preparedness for malaria elimination, logistics, and supply chain management of diagnostic kits and anti-malarial drugs in addition to the knowledge, attitude and practice of the healthcare workers will add value to the evaluation we have planned. India is in line with other countries like China, Sri Lanka, Salvador, Algeria, Argentina, Uzbekistan, Paraguay, Maldives and Armenia, which focused on effective vector control strategies, disease surveillance, spreading awareness, accurate diagnostics, real-time surveillance to achieve the goal of malaria elimination by 2027.15 The results of this study will provide robust and rigorous evidence of the likely community perceptions and preparedness of our health system for malaria control and elimination in these selected states.
Ethics and dissemination
No patients will be involved in the study. Study findings will be shared with Institutional ethics board of National Institute for Malaria Research New Delhi (NIMR) in a timely, comprehensive, accurate, unbiased, unambiguous and transparent manner and to the National Vector-borne Disease Control Programme officers and the community public who participated. Important findings will be communicated through community outreach meetings which are existing in the health system. Results will be informed to study participants via local fieldworks supervised by DMOs.
Study findings will be shared with National Centre for Vector Borne Disease Control and GFATM based on data sharing agreement. Also findings will be published in reputed journals based on Indian Council of Medical Research (ICMR) publication policy.
The ICMR-NIMR ethics committee approved the study via letter no. NIMR/ECM/2023/Feb/14 dated 24 April 2023 for version 5. All standard ethical practices will be followed.
Ethics statements
Patient consent for publication
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
SBM and VHC contributed equally.
Correction notice This article has been corrected since it was first published. Equal contribution statement has been added.
Contributors SBM and VHC carried out the concept development, design, data compilation, literature search, manuscript development, proof reading, study tool development, training of field staff. RSinghal and KS carried out with data compilation, literature search, proof reading in addition manuscript was developed by RSinghal. SNN and PKT performed concept development, design, data compilation, literature search, manuscript development, proof reading. In addition, SNN oversaw the training of field staff. Concept development, data compilation, literature search, manuscript development was completed by PiyushS. AE worked on with concept development, design, manuscript development, proof reading. Data compilation, literature search and proof reading were completed by SPS, DPS, WAM and CPY. SKG worked in concept development, data compilation and data quality monitoring, and proof reading. PallikaS, CSA and VPC performed literature search, proof reading, data quality monitoring, study tool development. TJ, AS, ARA and AG worked on the design modifications, overall monitoring and senior authoring. MR, RSharma worked in concept development, design, data compilation, literature search. Adding to it securing funding, manuscript development, proof reading, study tool development was performed by MR.
Funding The study has been funded by the Ministry of Health and Family Welfare, National Centre for Vector Borne Disease Control (NCVBDC), India.
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Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.