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

NCT ID: NCT03963869

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-03

Study Completion Date

2021-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malaria

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Quasi-experimental cluster-assigned stepped-wedge study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Malaria Camps

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Malaria Camps

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Malaria Camps

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Community Welfare Society Hospital

UNKNOWN

Sponsor Role collaborator

Martin Luther Christian University

UNKNOWN

Sponsor Role collaborator

Indian Institute of Public Health, India

OTHER

Sponsor Role collaborator

National Institute of Research in Tribal Health

UNKNOWN

Sponsor Role collaborator

National Vector Borne Disease Control Programme

UNKNOWN

Sponsor Role collaborator

University Hospital, UmeƄ

OTHER

Sponsor Role collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role collaborator

New York University

OTHER

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jane Carlton, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

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Community Welfare Society Hospital

Rourkela, Odisha, India

Site Status

Countries

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India

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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19-00122

Identifier Type: -

Identifier Source: org_study_id

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