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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201702002012425 |
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Date of registration:
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02/02/2017 |
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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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Twice Yearly Treatment for the Control of LF
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Scientific title:
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Cluster Randomized Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations |
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Date of first enrolment:
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01/03/2017 |
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Target sample size:
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1440 |
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Recruitment status: |
Pending |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=2012 |
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Study type:
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Interventional |
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Study design:
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Parallel: different groups receive different interventions at same time during study,Randomised,Computerized random number generation,No allocation concealment
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Phase:
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Not Applicable
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Susan
Adu-Amankwah |
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Address:
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University of Ghana
Legon-Accra
Ghana |
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Telephone:
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+233244734811 |
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Email:
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sadu-amankwah@noguchi.ug.edu.gh |
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Affiliation:
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Clinical Trials Coordinator |
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Name:
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Dziedzom
de Souza |
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Address:
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University of Ghana
Legon-Accra
Ghana |
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Telephone:
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+233244434966 |
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Email:
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ddesouza@noguchi.ug.edu.gh |
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Affiliation:
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Research Fellow |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Residency in the disease endemic community for at least 12 months
2. Willingness to provide informed consent/assent
3. Willingness to donate blood (per the protocol)
Exclusion criteria: 1. Recent residents (<12 months)
2. Inability to give informed consent
3. Pregnant and lactating women
4. Children below the age of 5.
Age minimum:
5 Year(s)
Age maximum:
90 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphatic Filariasis
Lymphatic Filariasis
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Lymphatic Filariasis
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Intervention(s)
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Expanded frequency group
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Control group
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Primary Outcome(s)
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Change from baseline prevalence of Lymphatic Filariasis at 24 months
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Secondary Outcome(s)
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Evaluation of community acceptability of twice-yearly treatment, through questionnaires and focus group discussions
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Longitudinal assessment of transmission dynamics of Lymphatic Filariasis for modelling the impact of treatment
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Feasibility of scale-up of twice-yearly treatment, through questionnaires and focus group discussions
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Secondary ID(s)
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NCT03036059
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Source(s) of Monetary Support
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EDCTP
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Ethics review
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Status: Approved
Approval date: 04/01/2017
Contact:
NMIMR IRB
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Status: Approved
Approval date: 11/04/2017
Contact:
Ghana Health Service Ethics Review Committee
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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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