MalariaCSCMi20NCT03963869
Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive
A study testing Malaria Camps in people with Malaria, run by NYU Langone Health at 1 site in India.
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… Read more about this study
- Who is it for?
- Ages 1 year to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Malaria Camps
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,463 participants
- Where
- 1 siteIndia
- Study dates
- 3 Aug 2019to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Quasi-Experimental Study to Assess the Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Malaria Camps
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malaria CampsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: New Malaria Camp (MC) village | Experimental | 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. Receives: Other: Malaria Camps |
| Arm B: No Malaria Camp (MC) village | Active comparator | 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. Receives: Other: Malaria Camps |
| Arm C: Old Malaria Camp (MC) village | Active comparator | 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. Receives: Other: Malaria Camps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 Months
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.
Measured: 24 months
Secondary outcomes (8)
Malaria as detected by RDT
Malaria as detected by a rapid diagnostic test
Measured: 24 months
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.
Measured: 24 Months
Hemoglobin
Hemoglobin will be measured by POC testing which provides both continuous and categorical data (when analyzed by local standards) regarding anemia status.
Measured: 24 months
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.
Measured: 24 months
Body temperature
Body temperature will be measured with a digital thermometer placed under the participant's tongue reported in degrees Fahrenheit.
Measured: 24 months
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.
Measured: 24 months
Plasmodium-specific serology
Measured by a high-throughput bead-based cytometric assay provides continuous and categorical (seropositive vs. seronegative) results.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start3 Aug 2019
- Primary completion30 Nov 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Quasi-experimental cluster-assigned stepped-wedge study
- Masking
- None (open label)
- Enrolment
- 2,463 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Community Welfare Society Hospital, Martin Luther Christian University, Indian Institute of Public Health, India, National Institute of Research in Tribal Health, National Vector Borne Disease Control Programme, University Hospital, Umeå, National Institute of Allergy and Infectious Diseases (NIAID), New York University
- Responsible party
- Sponsor
- Investigators
- Jane Carlton, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963869
- Sponsor's protocol ID
- 19-00122
- Acronym
- CSCMi20
- Status last verified
- Dec 2021
- First submitted
- 22 May 2019
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Historically we submit all of our data to public databases.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Quasi-Experimental Study to Assess the Effectiveness of Malaria Camps as Part of the Odisha State Malaria Elimination Drive
- ClinicalTrials.gov ID
- NCT03963869
- Acronym / sponsor ID
- CSCMi20 / 19-00122
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,463 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Community Welfare Society Hospital, Martin Luther Christian University, Indian Institute of Public Health, India, National Institute of Research in Tribal Health, National Vector Borne Disease Control Programme, University Hospital, Umeå, National Institute of Allergy and Infectious Diseases (NIAID), New York University
- Study start
- 3 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Quasi-experimental cluster-assigned stepped-wedge study
| Arm | Type | Receives |
|---|---|---|
| Arm A: New Malaria Camp (MC) village | Experimental | Other: Malaria CampsReceives 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. |
| Arm B: No Malaria Camp (MC) village | Active comparator | Other: Malaria CampsReceives 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. |
| Arm C: Old Malaria Camp (MC) village | Active comparator | Other: Malaria CampsVillages 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. |
Who may qualify
- Ages
- 1 year to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Malaria CampsThe 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. | Other | Arm A: New Malaria Camp (MC) village, Arm B: No Malaria Camp (MC) village, Arm C: Old Malaria Camp (MC) village |
Primary outcome
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.
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.
8 secondary outcomes
Malaria as detected by RDT
Time frame: 24 months
Gametocyte density
Time frame: 24 Months
Hemoglobin
Time frame: 24 months
BMI
Time frame: 24 months
Body temperature
Time frame: 24 months
Mid-upper arm circumference
Time frame: 24 months
Plasmodium-specific serology
Time frame: 24 months
Plasmodium parasite genomic epidemiology
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Individual participant dataSharing planned: Undecided. Historically we submit all of our data to public databases.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane Carlton, PhD principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malaria Camps in people with Malaria, run by NYU Langone Health at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parasite presence (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.