Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201804003343404 Date of Approval: 22/04/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing the effects of mass drug administration using Praziquantel drug with and without diagnosis on treatment compliance
Official scientific title 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
Brief summary describing the background and objectives of the trial The major limitation of the community mass drug administration against schistosomiasis is that treatment is offered without diagnosis. This affects compliance to treatment among adult individuals. To improve uptake and compliance to praziquantel treatment, this study introduces point-of-care circulating cathodic antigen test, a rapid test for schistosoma mansoni to community MDA, to allow community health workers to diagnose intestinal schistosomiasis and offer treatment based on test results. The primary objective is to assess if introducing point-of-care Circulating Cathodic Antigen (POC-CCA) rapid test to community based mass drug administration through community health workers will increase access, compliance and coverage to treatment among adult individuals at Kome Island in North-Western Tanzania, an area on the Lake Victoria highly endemic for schistosomiasis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,intestinal schistosomiasis
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/08/2017
Actual trial start date 10/10/2017
Anticipated date of last follow up 30/05/2018
Actual Last follow-up date 30/04/2018
Anticipated target sample size (number of participants) 5000
Actual target sample size (number of participants) 4500
Recruitment status Recruiting
Publication URL No publication to date
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group diangosis using Point-of-care circulating cathodic antigen test Praziquantel drugs (40mg/kg body weight) Once Praziquantel drugs are offered based on test results 2250
Control Group Receive only praziquantel without diagnosis Praziquantel (40mg/kg body weight Once Control group receives praziquantel drug from community health workers in a norm practices without diagnosis in mass drug administration 2250 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
(i) aged 18 years and above (ii) willing to participate and give written informed consent (iii) Living in the study area 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 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2017 Bugando Medical Centre/Catholic University of Health and Allied Sciences-IRB
Ethics Committee Address
Street address City Postal code Country
Bugando Hills Mwanza +255 United Republic of Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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 Primary outcome measured at the end of the study
Secondary Outcome Community Health Workers (CHWs) ability to use POC-CCA rapid test accurately and safely At the end of the study
Secondary Outcome 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 Measured at the end of the study
Secondary Outcome Experience of Community Health Workers on the use of POC-CCA rapid diagnostic test At the end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Community treatment points Kome Island Mwanza +255 United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
U.S. Agency for International Development Ronald reagan Building, DC-20523-10000 WASHINGTON DC-20523-10000 United States of America
Coalition for Operational Research on Neglected Tropical Diseases 325 Swanton Way,Decatur Georgia 30030 +1 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Catholic University of Health and Allied Sciences Bugando Hills Mwanza +255 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
National Institute for Medical Research Isamilo Mwanza +255 United Republic of Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Humphrey Mazigo humphreymazigo@gmail.com +255786060067 Bugando Hills
City Postal code Country Position/Affiliation
Mwanza +255 Tanzania Senior Lecturer and Principal Investigator
Role Name Email Phone Street address
Public Enquiries Domenica Morona dmorona@gmail.com +2552500881 Bugando Hills
City Postal code Country Position/Affiliation
Mwanza +255 Tanzania Director of Research and Innovation
Role Name Email Phone Street address
Scientific Enquiries Safari Kinung'hi kinunghi_csm@hotmail.com +255784318096 Isamilo
City Postal code Country Position/Affiliation
Mwanza +255 United Republic of Tanzania Principal Research Officer
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information