Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive

Malaria Clinical Trial

— CSCMi20  

Official title:

A Quasi-Experimental Study to Assess the Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03963869
• Other study ID #: 19-00122
• Status: Completed
• Phase: N/A
• Start date: August 3, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: December 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The persistently high malaria burden in the remote forested areas of Odisha, India has led to the introduction of 'malaria camps' by the Odisha State Malaria Control Program 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 camps appear to be very effective but this is hard to assess in the context of ongoing changes such as LLIN introduction. 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. The major objective to achieve this is through a quasi-experimental study (i.e., pretest-post-test control group design) of the effectiveness of the intervention, to determine if MCs reduce the prevalence of clinical and asymptomatic malaria as detected by PCR. In the first year, villages will be assigned across three study arms: arm 1 to receive new MCs; arm 2 is a control with no MCs but with standard malaria control; and arm 3 consists of villages already in receipt of MCs to study longer term effects. In the second year, both arm 1 and arm 2 villages will receive the intervention (i.e., a non-randomized stepped-wedge design). MC effectiveness will be evaluated from epidemiologic surveys and PCR detection of malaria prevalence with and without MCs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2463
• Est. completion date: March 31, 2021
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 69 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Malaria

Intervention

Other:
• Malaria Camps
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.

Locations

Country	Name	City	State
India	Community Welfare Society Hospital	Rourkela	Odisha

Sponsors (9)

Lead Sponsor	Collaborator
NYU Langone Health	Community Welfare Society Hospital, Indian Institute of Public Health, India, Martin Luther Christian University, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Research in Tribal Health, National Vector Borne Disease Control Programme, New York University, University Hospital, Umeå

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Malaria as detected by RDT	Malaria as detected by a rapid diagnostic test	24 months
Secondary	Gametocyte density	Measured by quantifying the number of gametocyte infected erythrocytes and dividing by the number of leukocytes or by quantitative reverse transcriptase real time PCR. Both results can be measured continuously and categorically (data will be transformed). To account for a mixed-infection (either by species or by multiple strains) we will take the gametocyte to trophozoite ratio to reduce any apparent bias.	24 Months
Secondary	Hemoglobin	Hemoglobin will be measured by POC testing which provides both continuous and categorical data (when analyzed by local standards) regarding anemia status.	24 months
Secondary	BMI	Height in cm will be measured with a height measuring tape. Weight in kg will be measured with a scale. Participants will be asked to remove shoes and shawls or cardigans, or other clothing that can be removed without ethical concerns.; BMI will be calculated as (kilograms/meters squared). Measures will be adjusted by age using the WHO Multicentre Growth Reference Study Group's 2006 WHO Child Growth Standards: Length/height-for-age, weight-for-age, weight-for-length, weight-for-height and body mass index-for-age: Methods and development.; Categorical BMI measurements will be based on standards for Asian Indians: Misra A, Chowbey P, Makkar BM, et al. Consensus Statement for Diagnosis of Obesity, Abdominal Obesity and the Metabolic Syndrome for Asian Indians and Recommendations for Physical Activity, Medical and Surgical Management.	24 months
Secondary	Body temperature	Body temperature will be measured with a digital thermometer placed under the participant's tongue reported in degrees Fahrenheit.	24 months
Secondary	Mid-upper arm circumference	Mid-Upper Arm Circumference (MUAC) Mid-Upper Arm Circumference (MUAC) is the circumference of the left upper arm, measured at the mid-point between the tip of the shoulder and the tip of the elbow (olecranon process and the acromium). Participants will be asked to remove any clothes that may hinder the measurement (preferable directly on skin, but tight clothes can be accepted if they are difficult to remove).; MUAC will be measured in cm to one decimal using a Myotape/tape measure.	24 months
Secondary	Plasmodium-specific serology	Measured by a high-throughput bead-based cytometric assay provides continuous and categorical (seropositive vs. seronegative) results.	24 months
Secondary	Plasmodium parasite genomic epidemiology	Plasmodium infections will be characterized for their mixed clonality, genetic diversity, and molecular force of infection by MinIon or Illumina NextGen sequencing.	24 months