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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02938975 |
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Date of registration:
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05/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents for Malaria Prevention
URCT |
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Scientific title:
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Field Efficacy Of Insecticide Treated Uniforms And Skin Repellents To Reduce Malaria Incidence In Military Personnel On Active Duty In Regions Of Hyperendemicity |
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Date of first enrolment:
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November 2017 |
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Target sample size:
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1500 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02938975 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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Sarah J Moore, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ifakara Health Institute |
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Name:
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Mercy Nyika |
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Address:
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Telephone:
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+255788-720602 |
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Email:
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mnyika@ihi.or.tz |
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Affiliation:
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Name:
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Sarah J Moore, PhD |
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Address:
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Telephone:
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+255764802622 |
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Email:
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smoore@ihi.or.tz |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Member of a platoon passes physical examination - no underlying health risks females that
are not pregnant malaria negative at enrolment consents to participate
Exclusion Criteria:
Not assigned to a platoon underlying health risks - does not pass physical examination
pregnant female (pregnant females are not recruited into the army) malaria positive at
enrolment does not consent to participate
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Intervention(s)
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Other: Ultra 30 Insect Repellent Lotion (30% Lipo DEET)
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Other: Placebo lotion
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Other: Army combat uniform
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Other: Permethrin Factory-Treated Army Combat Uniforms
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Primary Outcome(s)
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Incidence of Plasmodium falciparum malaria through monthly measurement of malaria positivity by direct polymerase chain reaction (PCR) to detect parasite DNA
[Time Frame: Monthly active case detection for 12 months]
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Secondary Outcome(s)
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Incidence of clinical malaria through monthly measurement malaria positivity of SD Bioline Malaria Rapid Diagnostic Test to test for parasite antigen
[Time Frame: Active and passive case detection for 12 months]
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Compliance with intervention as measured through spot checking and weighing of repellent bottles
[Time Frame: Monthly assessment of intervention compliance with uniforms and lotions provided for 12 months]
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Protective efficacy of uniforms measured by reduction in Anopheles arabiensis bites among those wearing uniforms for a sub-sample of uniforms tested under laboratory conditions with free flying mosquitoes
[Time Frame: After 12 months]
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Secondary ID(s)
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BIT014 PR001 V01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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