Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive
CSCMi20
A Quasi-Experimental Study to Assess the Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive
1 other identifier
interventional
2,463
1 country
1
Brief Summary
The Odisha State Malaria Control Program (India) has introduced 'malaria camps' where teams of health workers visit villages to educate the population, enhance vector control with long-lasting insecticide nets (LLINs) and indoor residual spraying (IRS), and perform village-wide screening with rapid diagnostic tests and treatment for malaria. The long-term goal of this project is to evaluate the effectiveness of malaria camps (MCs) by determining if they reduce malaria, and to characterize malaria transmission in MCs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 28, 2019
CompletedStudy Start
First participant enrolled
August 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedJanuary 11, 2022
December 1, 2021
1.3 years
May 22, 2019
December 21, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Parasite presence
The standard molecular method of (conventional) PCR + gel electrophoresis will be used to measure parasite presence. All reactions are run with Plasmodium positive controls and negative controls. 10% of samples are QC-ed at second independent site. The results can be continuous and categorical. Continuous variables will be transformed into categorical variables, so that infections can be sub-divided into symptomatic or asymptomatic.
24 Months
Parasite species
The standard molecular method of (conventional) PCR + gel electrophoresis will be used to measure parasite species. All reactions are run with Plasmodium positive controls and negative controls. 10% of samples are QC-ed at second independent site.
24 months
Secondary Outcomes (8)
Malaria as detected by RDT
24 months
Gametocyte density
24 Months
Hemoglobin
24 months
BMI
24 months
Body temperature
24 months
- +3 more secondary outcomes
Study Arms (3)
Arm A: New Malaria Camp (MC) village
EXPERIMENTALReceives MC intervention in year 1 and year 2. Each individual will be followed up 3 times (baseline and follow-ups 1, 2, and 3; 4 visits per individual) in the 2 year time frame of phase 1.
Arm B: No Malaria Camp (MC) village
ACTIVE COMPARATORReceives Standard Malaria Control in Year 1 and MC intervention in Year 2. Each individual will be followed up 3 times (baseline and follow-ups 1, 2, and 3; 4 visits per individual) in the 2 year time frame of phase 1.
Arm C: Old Malaria Camp (MC) village
ACTIVE COMPARATORVillages already in receipt of MCs prior to study initiation to study longer term effects. Each individual will be followed up 3 times (baseline and follow-ups 1, 2, and 3; 4 visits per individual)) in the 2 year time frame of phase 1.
Interventions
The Govt. of India Malaria Control Programme (MCP) of Odisha provides ITNs and IRS, and trains community health workers (ASHAs) on the diagnosis and treatment of malaria, providing them with antimalarial drugs so that malaria treatment is available even in remote villages. Faced with a persistent burden of malaria in forest villages, the MCP recently introduced malaria camps (MCs) combining focused screening and treatment in villages with intensified vector control. The program includes one round of testing and treatment for the whole village population before the monsoon season, followed by one round of screening and treating of fever cases only during the monsoon season.
Eligibility Criteria
You may qualify if:
- Written informed consent by individuals greater than 17 years old, or consent by a parent/guardian of children 1-6 years old, or assent of individuals from 7-17 years old along with consent from his or her parent or legal guardian.
- A complete understanding of study procedures/protocols, as delineated in the consent and assent forms and information sheets.
- Individuals have the ability and are willing to comply with study procedures for the entire length of the study.
You may not qualify if:
- Individuals less than 12 months or more than 69 years of age will be excluded.
- Persons who do not understand the study or are physically unable to make monthly visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Community Welfare Society Hospitalcollaborator
- Martin Luther Christian Universitycollaborator
- Indian Institute of Public Health, Indiacollaborator
- National Institute of Research in Tribal Healthcollaborator
- National Vector Borne Disease Control Programmecollaborator
- University Hospital, Umeåcollaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- New York Universitycollaborator
Study Sites (1)
Community Welfare Society Hospital
Rourkela, Odisha, 769042, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jane Carlton, PhD
New York University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2019
First Posted
May 28, 2019
Study Start
August 3, 2019
Primary Completion
November 30, 2020
Study Completion
March 31, 2021
Last Updated
January 11, 2022
Record last verified: 2021-12