Community-Based Cohort Study of Hidden Malaria Infections, Diagnostic Gaps, & Mosquito Vector Dynamics in Odisha, India

NCT07770048 | Recruiting

• 2 other identifiers: 30518U19AI181587
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this prospective cohort study is to understand the factors responsible for the persistence of malaria transmission in some areas despite intensive control efforts. The study will measure the prevalence and incidence of asymptomatic and sub-patent Plasmodium infections and examine the factors that contribute to persistent transmission among residents of malaria-endemic areas of Odisha, India. The main questions the study aims to answer are: Do asymptomatic and sub-patent Plasmodium infections contribute to persistent malaria transmission in endemic areas of Odisha? What is the frequency of false-negative results and incorrect species identification when microscopy and rapid diagnostic tests (RDTs) are compared with PCR? How is malaria epidemiology changing over time across areas with different transmission patterns, including shifts in Plasmodium species? What is the prevalence of asymptomatic gametocyte carriers, and how might they contribute to ongoing transmission? What are the characteristics and distribution of mosquito vectors in and around households, and how do they relate to transmission patterns? Can novel host- and parasite-derived biomarkers improve the detection of malaria infections, including asymptomatic cases? Participants will provide blood samples for malaria testing by microscopy, RDT and PCR. A subset will provide additional samples for biomarker analysis as part of a nested sub-study. Participants will be followed over time to measure malaria infection prevalence, incidence and changes in transmission patterns. They will also take part in household-level assessments, including surveys and mosquito vector monitoring around their homes.

Conditions

Malaria, Asymptomatic Parasitaemia

Outcome Measures

Primary Outcomes (3)

• Prevalence and incidence of Plasmodium infection - Project 1

  Prevalence and incidence of Plasmodium infection among study participants, determined by polymerase chain reaction (PCR)-based detection of Plasmodium species in finger-prick blood samples collected during longitudinal community surveys. The study will estimate the prevalence, incidence and persistence of asymptomatic, subpatent and submicroscopic infections, together with species-specific infections.

  Nine time points between Years 1 and 5, including one baseline visit and eight follow-up visits conducted every six months.

• Diagnostic performance of malaria microscopy and rapid diagnostic tests compared with PCR - Project 1

  Diagnostic performance of malaria microscopy and rapid diagnostic tests (RDTs) compared with PCR, assessed by false-negative and false-positive results, positive and negative predictive values, and species concordance for Plasmodium detection.

  Baseline and follow-up visits conducted every six months over five years.

• Novel circulating infection biomarkers of host and parasite origin - Biomarker Sub-study, Project 2

  Identification and quantification of circulating host- and parasite-derived biomarkers associated with malaria infection, using multiplex and molecular assays in longitudinal blood samples collected from the biomarker sub-cohort

  Sixteen time points between Years 1 and 5, with eight time points each for Groups A and B.

Study Arms (2)

Project 1

This prospective, community-based cohort will enrol approximately 3,000 participants from 15 villages across three districts of Odisha, India: Keonjhar, Boudh and Malkangiri, with five villages selected from each district. Participants aged 12 months to 69 years will be followed for four years, with study visits every six months before and after the monsoon season. At each visit, participants will undergo clinical assessment and finger-prick blood collection for malaria testing by rapid diagnostic test (RDT), microscopy and PCR. Samples will also be used for haemoglobin measurement and for the collection of plasma and erythrocytes for molecular and serological analyses, to monitor malaria epidemiology and transmission dynamics.

Project 2

This nested prospective sub-cohort will enroll approximately 1,000 participants selected from the parent cohort across six villages, with two villages selected from each district. Participants will be recruited from three villages, one per district, beginning at the 12-month visit of the parent study in Year 2, and from the remaining three villages, one per district, in Year 3. Participants will undergo more frequent longitudinal sampling to characterise malaria transmission and infection dynamics using sero-epidemiology and circulating host- and parasite-derived biomarkers. Finger-prick blood samples will be collected for rapid diagnostic testing (RDT), microscopy, PCR-based detection of Plasmodium infection, and bead-based assays measuring anti-Plasmodium antibodies and other infection biomarkers. Concurrent entomological assessments conducted as part of the parent cohort will provide context on vector dynamics in relation to observed infection patterns and transmission.

Eligibility Criteria

• Age: 12 Months - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Community residents living in selected rural villages in three districts of Odisha, India (Keonjhar, Boudh, and Malkangiri), representing different malaria transmission settings. Participants include males and females aged 12 months to 69 years who are enrolled through household-based community surveys and followed longitudinally to assess malaria infection, transmission dynamics, and biomarkers of infection. There are no restrictions based on residency duration, pregnancy status, social class, or underlying health conditions. For participants with severe anemia, study procedures are limited to finger-prick blood sampling in accordance with the study protocol.

You may qualify if:

• Individuals 12 months to 69 years, all social classes, and all types of health status will be enrolled

You may not qualify if:

• Individuals unable or unwilling to provide informed consent (or parental consent/assent for minors) Individuals unable to comply with study procedures or follow-up visits according to investigator judgement

Sponsors & Collaborators

• Community Welfare Society Hospital (CWSH), Rourkela, Odisha, India: collaborator
• ICMR-National Institute of Health Research, Bhubaneswar, Odisha, India: collaborator
• London School of Hygiene and Tropical Medicine: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

ICMR-National Institute of Health Research

Bhubaneswar, Odisha, 751023, India

RECRUITING

Community Welfare Society Hospital (CWSH)

Raurkela, Odisha, 769042, India

RECRUITING

Related Publications (5)

• Longley RJ, White MT, Takashima E, Brewster J, Morita M, Harbers M, Obadia T, Robinson LJ, Matsuura F, Liu ZSJ, Li-Wai-Suen CSN, Tham WH, Healer J, Huon C, Chitnis CE, Nguitragool W, Monteiro W, Proietti C, Doolan DL, Siqueira AM, Ding XC, Gonzalez IJ, Kazura J, Lacerda M, Sattabongkot J, Tsuboi T, Mueller I. Development and validation of serological markers for detecting recent Plasmodium vivax infection. Nat Med. 2020 May;26(5):741-749. doi: 10.1038/s41591-020-0841-4. Epub 2020 May 11.

  PMID: 32405064 BACKGROUND

• Khan N, Awasthi G, Das A. How can the complex epidemiology of malaria in India impact its elimination? Trends Parasitol. 2023 Jun;39(6):432-444. doi: 10.1016/j.pt.2023.03.006. Epub 2023 Apr 6.

  PMID: 37031071 BACKGROUND

• Kumari P, Sinha S, Gahtori R, Yadav CP, Pradhan MM, Rahi M, Pande V, Anvikar AR. Prevalence of Asymptomatic Malaria Parasitemia in Odisha, India: A Challenge to Malaria Elimination. Am J Trop Med Hyg. 2020 Oct;103(4):1510-1516. doi: 10.4269/ajtmh.20-0018.

  PMID: 32783792 BACKGROUND

• van Eijk AM, Sutton PL, Ramanathapuram L, Sullivan SA, Kanagaraj D, Priya GSL, Ravishankaran S, Asokan A, Sangeetha V, Rao PN, Wassmer SC, Tandel N, Patel A, Desai N, Choubey S, Ali SZ, Barla P, Oraon RR, Mohanty S, Mishra S, Kale S, Bandyopadhyay N, Mallick PK, Huck J, Valecha N, Singh OP, Pradhan K, Singh R, Sharma SK, Srivastava HC, Carlton JM, Eapen A. The burden of submicroscopic and asymptomatic malaria in India revealed from epidemiology studies at three varied transmission sites in India. Sci Rep. 2019 Nov 19;9(1):17095. doi: 10.1038/s41598-019-53386-w.

  PMID: 31745160 BACKGROUND

• Carlton JM, Eapen A, Kessler A, Anvikar AR, Hoffmann A, Singh OP, Sullivan SA, Albert S, Sahu PK, Mohanty S, Wassmer SC. Advances in Basic and Translational Research as Part of the Center for the Study of Complex Malaria in India. Am J Trop Med Hyg. 2022 Oct 11;107(4_Suppl):97-106. doi: 10.4269/ajtmh.21-1333. Print 2022 Oct 11.

  PMID: 36228919 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

Finger-prick blood samples will be collected from participants during study visits for malaria diagnostic testing and laboratory analyses. Samples will be used for rapid diagnostic testing (RDT), microscopy, polymerase chain reaction (PCR)-based detection of Plasmodium species, haemoglobin measurement and serological assays. Plasma and erythrocyte fractions will be retained for molecular analyses of parasite and host biomarkers, including circulating biomarkers associated with malaria infection and transmission. Samples may also be used for genetic analyses of malaria parasites and for the evaluation of diagnostic markers.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Samuel Wassmer, PhD

  London School of Hygiene & Tropical Medicine, London

  PRINCIPAL INVESTIGATOR

• Sanjib Mohanty, MBBS MD

  Community Welfare Society Hospital, Odisha, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Wassmer, PhD

CONTACT

+44 7930357115; sam.wassmer@lshtm.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Malaria Pathogenesis

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 18, 2026
• Study Start: May 2, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: De-identified individual participant data and supporting documents will be available beginning after publication of the primary study results. Data will remain available for up to 5 years following publication, subject to institutional data governance and data sharing policies.
• Access Criteria: De-identified individual participant data and supporting documents, including the study protocol, statistical analysis plan, informed consent forms and analytic code, will be made available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed and approved by the study investigators and participating institutions. Access will be provided through a controlled data-sharing mechanism and may require a data-use agreement to ensure appropriate use of the data and protection of participant confidentiality. Only the data necessary to address the approved research question will be shared.

Locations

IN (2)