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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: |
PACTR201804003343404 |
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Date of registration:
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22/04/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparing the effects of mass drug administration using Praziquantel drug with and without diagnosis on treatment compliance
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Scientific title:
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Integrating use of point-of-care Circulating Cathodic Antigen rapid diagnostic tests by Community Health Workers during Mass Drug Administration campaigns to improve uptake of praziquantel treatment among the adult population at Kome Island, North-Western Tanzania: A cluster randomized Community Trial |
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Date of first enrolment:
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01/08/2017 |
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Target sample size:
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5000 |
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Recruitment status: |
Recruiting |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3343 |
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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,Simple randomisation using a randomized table created by a computer software program,Numbered containers
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Phase:
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Not Applicable
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Countries of recruitment
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United Republic of Tanzania
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Contacts
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Name:
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Domenica
Morona |
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Address:
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Bugando Hills
+255
Mwanza
Tanzania |
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Telephone:
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+2552500881 |
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Email:
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dmorona@gmail.com |
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Affiliation:
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Director of Research and Innovation |
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Name:
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Safari
Kinung'hi |
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Address:
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Isamilo
+255
Mwanza
United Republic of Tanzania |
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Telephone:
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+255784318096 |
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Email:
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kinunghi_csm@hotmail.com |
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Affiliation:
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Principal Research Officer |
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Key inclusion & exclusion criteria
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Inclusion criteria: (i) aged 18 years and above
(ii) willing to participate and give written informed consent
(iii) Living in the study area
Exclusion criteria: i) Pregnant at the time of treatment
(ii) history of adverse reaction to praziquantel
(iii) Present with serious conditions at the time of treatment and not deemed fit to take treatment
Age minimum:
18 Year(s)
Age maximum:
70 Year(s)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Digestive System
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Digestive System
intestinal schistosomiasis
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intestinal schistosomiasis
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Intervention(s)
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diangosis using Point-of-care circulating cathodic antigen test
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Receive only praziquantel without diagnosis
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Primary Outcome(s)
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the proportion of study participants provided with praziquantel drug (treatment coverage) and geographical cluster (a service area of the community health workers) in the intervention and control arms
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Secondary Outcome(s)
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Community Health Workers (CHWs) ability to use POC-CCA rapid test accurately and safely
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Community members acceptability (these are people¿s perceptions and attitude on the two-treatment approach) of POC-CCA test results offered by community health workers
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Experience of Community Health Workers on the use of POC-CCA rapid diagnostic test
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Source(s) of Monetary Support
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Coalition for Operational Research on Neglected Tropical Diseases
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U.S. Agency for International Development
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Ethics review
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Status: Approved
Approval date: 10/05/2017
Contact:
Bugando Medical Centre/Catholic University of Health and Allied Sciences-IRB
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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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