Clinical trial NCT03963869: Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive
Official title: A Quasi-Experimental Study to Assess the Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malaria
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Community Welfare Society Hospital
name: Martin Luther Christian University
name: Indian Institute of Public Health, India
name: National Institute of Research in Tribal Health
name: National Vector Borne Disease Control Programme
name: University Hospital, Umeå
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: New York University
First posted: 2019-05-28
Enrollment: 2463
Sex: ALL
Minimum age (years): 1
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental cluster-assigned stepped-wedge study
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Parasite presence
timeFrame: 24 Months
measure: Parasite species
timeFrame: 24 months
Secondary outcomes:
measure: Malaria as detected by RDT
timeFrame: 24 months
measure: Gametocyte density
timeFrame: 24 Months
measure: Hemoglobin
timeFrame: 24 months
measure: BMI
timeFrame: 24 months
measure: Body temperature
timeFrame: 24 months
measure: Mid-upper arm circumference
timeFrame: 24 months
measure: Plasmodium-specific serology
timeFrame: 24 months
measure: Plasmodium parasite genomic epidemiology
timeFrame: 24 months
Other outcomes:
Locations:
city: Rourkela
country: India
facility: Community Welfare Society Hospital
state: Odisha
Study officials:
affiliation: New York University
name: Jane Carlton, PhD
role: PRINCIPAL_INVESTIGATOR
References: