Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive (CSCMi20)

NYU Langone Health

Status: Completed

Conditions: Malaria

Treatments: Other: Malaria Camps

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03963869

19-00122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,463 patients

Sex: All

Ages: 1 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,463 participants in 3 patient groups

Arm A: New Malaria Camp (MC) village

Experimental group

Description:

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.

Treatment:

Other: Malaria Camps

Arm B: No Malaria Camp (MC) village

Active Comparator group

Description:

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.

Treatment:

Other: Malaria Camps

Arm C: Old Malaria Camp (MC) village

Active Comparator group

Description:

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.

Treatment:

Other: Malaria Camps