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Malaria Survey in the Tak Province Refugee Camps

Primary Purpose

Malaria

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Questionnaire
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malaria focused on measuring Refugee camps, Household residence, Treated bednets, PCR

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Head of household and all family members
  • Overnight guests
  • Age > 12 months
  • Willing to participate in the study and sign informed consent

Exclusion Criteria:

  • All children < 1 year
  • Anyone reported history of abnormal blood coagulation
  • Anyone who does not consent to participate in the survey

Sites / Locations

  • Refugee Camps

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Household

Arm Description

In each camp, the camp residences are divided into different sections (as clusters for sampling) by camp registration. In the first stage, sections are selected using Population-proportion-to size (PPS) method. In the second stage, households are randomly selected from the household list in each section provided by NGO and local committee. When a household is not responding, a nearest household on the north will be used as replacement. All family members and overnight guests aged above 5 years in the selected household will be invited for venous blood sample (2 ml); for children aged 1-5 years old, the blood sample (100 microL) will be obtained by finger prick; children younger than 1 year old are excluded. The head of household will be invited for a short questionnaire.

Outcomes

Primary Outcome Measures

Malaria prevalence
Comparison of malaria prevalence by conventional microscopy and RT-PCR to determine the malaria epidemiology in the population

Secondary Outcome Measures

Determine the percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs
• percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs) per 2 persons
Determine the percentage of refugees sleeping under an ITN/LLIN previous night
Percentage of refugees sleeping under an ITN/LLIN previous night
Determine the percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination
The percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination
Determine percentage of refugees who stay overnight outside the camp
The percentage of refugees who stay overnight outside the camp

Full Information

First Posted
July 10, 2013
Last Updated
April 27, 2016
Sponsor
University of Oxford
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1. Study Identification

Unique Protocol Identification Number
NCT01902797
Brief Title
Malaria Survey in the Tak Province Refugee Camps
Official Title
Malaria Survey in the Tak Province Refugee Camps
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oxford

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
According to the World Malaria Report, there were significant decreases in the number of P.falciparum (PF) malaria cases worldwide in the past decade. On the Thai-Myanmar border where transmission is low and seasonal and where incidence of Multi-drugs resistant P.falciparum parasites is the highest, the same trend has been observed with a clear decline in malaria episodes and the ratio of P. falciparum/P. vivax (PF/PV. Economic development, unprecedented financial support, renewed efforts in vector control, a wider use of rapid diagnosic tests (RDTs) for malaria and the deployment of artemisinin based combination treatments (ACT) are the main contributing factors to those successes against malaria. However the emergence in Cambodia and on the Thai-Myanmar border of P.falciparum isolates that exhibit resistance to artesunate is threatening those gains . This is characterized by a slow parasite clearance rate observed in patients treated with artesunate. At the same time, recent SMRU surveys along the Thai-Burmese border using a new cutting-edge technology i.e. highly sensitive quantitative Real Time PCR (RT-PCR) able to detect very low parasitaemia (10 parasites per ml), found up to a 3-5 fold increase in the prevalence of malaria compared to what is found with the usual diagnostic tools such as microscopy, RDT or even conventional PCR. It seems that a large number of asymptomatic carriers with very low parasites counts (a large potential malaria reservoir) go undetected. If confirmed, this might pose the greatest obstacle for malaria elimination in the region and containment of artemisinin resistance. The purpose of the survey is to further study and understand the epidemiology of malaria in the refugee camp population using cutting-edge technology (RT-PCR) .
Detailed Description
According to the World Malaria Report, there were significant decreases in the number of P.falciparum (PF) malaria cases worldwide in the past decade. On the Thai-Myanmar border where transmission is low and seasonal and where incidence of Multi-drugs resistant P.falciparum parasites is the highest, the same trend has been observed with a clear decline in malaria episodes and the ratio of P. falciparum/P. vivax (PF/PV). Economic development, unprecedented financial support, renewed efforts in vector control, a wider use of rapid diagnosic tests (RDTs) for malaria and the deployment of artemisinin based combination treatments (ACT) are the main contributing factors to those successes against malaria. However the emergence in Cambodia and on the Thai-Myanmar border of P.falciparum isolates that exhibit resistance to artesunate is threatening those gains . This is characterized by a slow parasite clearance rate observed in patients treated with artesunate. At the same time, recent SMRU surveys along the Thai-Burmese border using a new cutting-edge technology i.e. highly sensitive quantitative Real Time PCR (RT-PCR) able to detect very low parasitaemia (10 parasites per ml), found up to a 3-5 fold increase in the prevalence of malaria compared to what is found with the usual diagnostic tools such as microscopy, RDT or even conventional PCR. It seems that a large number of asymptomatic carriers with very low parasites counts (a large potential malaria reservoir) go undetected. If confirmed, this might pose the greatest obstacle for malaria elimination in the region and containment of artemisinin resistance. The purpose of the survey is to further study and understand the epidemiology of malaria in the refugee camp population using cutting-edge technology (RT-PCR) . The necessity of research in Humans With the double mission of malaria elimination and artemisinin-resistance containment, there are intensive malaria activities currently implemented in the refugee camps in the Tak province (a province in Thailand that is on the Thai-Burmese border). The malaria risk among the refugee camp is higher than the Thai residences inside Thailand. To avoid resource wastage, it is thus essential to conduct a simple questionnaire to understand the current situation of malaria prevention in the camps, especially information regarding the mosquito net ownership and usage (mosquito net distribution has been a major malaria prevention activity among the NGOs in the camps). PCR method is being used more and more in recent year due to its sensitivity compared to slide reading. PCR is considered being able to capture more cases with sub-microscopic infection. However, the current PCR methods conventionally used in malaria survey usually use finger prick to obtain only few microliters of capillary blood , the detectable level of parasitaemia is therefore limited due to minimal amount of blood from which Plasmodium DNA can be extracted. Thus the RT-PCR method proposed here using 2ml venous blood well compensates these shortcomings. The comparison of test results of conventional microscopy (currently still as the universal golden standard in the clinics) and RT-PCR will not only enable detection of both symptomatic and asymptomatic malaria cases but help define the epidemiology apart from our conventional understanding of malaria. Thus this study is necessary and is strategically important for the next roadmap development of malaria elimination and resistance containment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Refugee camps, Household residence, Treated bednets, PCR

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
908 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Household
Arm Type
Experimental
Arm Description
In each camp, the camp residences are divided into different sections (as clusters for sampling) by camp registration. In the first stage, sections are selected using Population-proportion-to size (PPS) method. In the second stage, households are randomly selected from the household list in each section provided by NGO and local committee. When a household is not responding, a nearest household on the north will be used as replacement. All family members and overnight guests aged above 5 years in the selected household will be invited for venous blood sample (2 ml); for children aged 1-5 years old, the blood sample (100 microL) will be obtained by finger prick; children younger than 1 year old are excluded. The head of household will be invited for a short questionnaire.
Intervention Type
Other
Intervention Name(s)
Questionnaire
Intervention Description
Participants will be invited to complete questionnaires and those who are over 5 year of age will be asked to give blood samples.
Primary Outcome Measure Information:
Title
Malaria prevalence
Description
Comparison of malaria prevalence by conventional microscopy and RT-PCR to determine the malaria epidemiology in the population
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Determine the percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs
Description
• percentage of households with at least one long lasting insecticide treated nets (LLIN) or insecticide treated nets (ITNs) per 2 persons
Time Frame
1 day
Title
Determine the percentage of refugees sleeping under an ITN/LLIN previous night
Description
Percentage of refugees sleeping under an ITN/LLIN previous night
Time Frame
1 day
Title
Determine the percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination
Description
The percentage of refugees who can recall at least 1 key messages on malaria control and containment/elimination
Time Frame
1 day
Title
Determine percentage of refugees who stay overnight outside the camp
Description
The percentage of refugees who stay overnight outside the camp
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Head of household and all family members Overnight guests Age > 12 months Willing to participate in the study and sign informed consent Exclusion Criteria: All children < 1 year Anyone reported history of abnormal blood coagulation Anyone who does not consent to participate in the survey
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephane Proux, PhD
Organizational Affiliation
Shoklo Malaria Research Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Refugee Camps
City
Mae Sot
State/Province
Tak
ZIP/Postal Code
63110
Country
Thailand

12. IPD Sharing Statement

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Malaria Survey in the Tak Province Refugee Camps

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