- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03963869
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
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Odisha
-
Rourkela, Odisha, India, 769042
- Community Welfare Society Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: New Malaria Camp (MC) village
Receives 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. |
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.
|
Active Comparator: Arm B: No Malaria Camp (MC) village
Receives 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. |
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.
|
Active Comparator: Arm C: Old Malaria Camp (MC) village
Villages 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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parasite presence
Time Frame: 24 Months
|
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
Time Frame: 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Malaria as detected by RDT
Time Frame: 24 months
|
Malaria as detected by a rapid diagnostic test
|
24 months
|
Gametocyte density
Time Frame: 24 Months
|
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
|
Hemoglobin
Time Frame: 24 months
|
Hemoglobin will be measured by POC testing which provides both continuous and categorical data (when analyzed by local standards) regarding anemia status.
|
24 months
|
BMI
Time Frame: 24 months
|
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
|
Body temperature
Time Frame: 24 months
|
Body temperature will be measured with a digital thermometer placed under the participant's tongue reported in degrees Fahrenheit.
|
24 months
|
Mid-upper arm circumference
Time Frame: 24 months
|
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
|
Plasmodium-specific serology
Time Frame: 24 months
|
Measured by a high-throughput bead-based cytometric assay provides continuous and categorical (seropositive vs. seronegative) results.
|
24 months
|
Plasmodium parasite genomic epidemiology
Time Frame: 24 months
|
Plasmodium infections will be characterized for their mixed clonality, genetic diversity, and molecular force of infection by MinIon or Illumina NextGen sequencing.
|
24 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jane Carlton, PhD, New York University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-00122
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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