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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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12 December 2020 |
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Main ID: |
NCT02461628 |
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Date of registration:
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28/05/2015 |
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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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Innovative Public-private Partnership to Target Subsidized Antimalarials in the Retail Sector (Aim 2)
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Scientific title:
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Innovative Partnership to Target Antimalarial Subsidies in the Retail Sector |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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40340 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02461628 |
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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: Health Services Research. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Wendy O'Meara, 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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Duke University |
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA
Intervention participation criteria:
- Client is older than 1 year
- Client has fever or history of fever or feeling unwell with a malaria-like illness
within the last 2 days
- Client or their parent/legal guardian (if under 18) consents to participate
Cross sectional survey participation criteria:
- Household representative in the intervention or control arm
- At least one member in the respondent's household with a history of fever or feeling
unwell with a malaria like illness within the last four weeks
- Respondent is older than 18 years
EXCLUSION CRITERIA
Intervention exclusion criteria:
- Client has signs of severe disease or other problem requiring immediate referral to a
health facility
- Client has already visited a health facility, taken or purchased antimalarials for the
current illness.
Cross sectional survey exclusion criteria:
• Households not in the intervention or control arms
Age minimum:
1 Year
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malaria
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Fever
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Intervention(s)
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Behavioral: Malaria RDT & conditional voucher for ACT from retail sector
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Primary Outcome(s)
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Number of Subjects With a Fever Who Receive a Malaria Test From Any Source
[Time Frame: 6 months, 12 months, 18 months]
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Secondary Outcome(s)
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Number of Participants Using ACT Who Had a Positive Test
[Time Frame: 6 months, 12 months, 18 months]
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Number of Participants Using an ACT Who Did Not Have a Test
[Time Frame: 6 months, 12 months, 18 months]
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Number of Subjects Who Received a Correct Dose of AL (Artemether Lumefantrine)
[Time Frame: 6 months, 12 months, 18 months]
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Number of Subjects With Fever That Received Correct Treatment
[Time Frame: 6 months, 12 months, 18 months]
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Secondary ID(s)
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Pro00063384
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5R01AI110478
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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