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Table 2 Trial registration data

From: Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial

Data category Information
Primary registry and trial identification number, ID: NCT03036059
Date of registration in primary registry 26 January 2017
Secondary identifying numbers Ghana Health Service Ethics Review Committee: 04112/2016
Noguchi Memorial Institute for Medical Research IRB: CPN 062/16-17
Source(s) of monetary or material support EDCTP grant TMA 2015 CDF - 976
Primary sponsor Noguchi Memorial Institute for Medical Research
Contact for public queries DKdS
Contact for scientific queries DKdS, CSA, SAA
Public title Twice Yearly Treatment for the Control of LF
Scientific title Cluster Randomised Community-based Trial of Annual Versus Biannual Single-dose Ivermectin Plus Albendazole Against Wuchereria Bancrofti Infection in Human and Mosquito Populations
Country of recruitment Ghana
Health condition(s) or problem(s) studied Lymphatic filariasis
Interventions 400 μg/kg ivermectin + 400 mg albendazole tablets given once or twice a year
Key inclusion and exclusion criteria Inclusion criteria: residency in endemic community for at least 12 months; willingness to provide informed consent/assent; willingness to donate blood (per the protocol) Exclusion criteria: recent residents (<12 months) in the study districts; inability to give informed consent due to illness, serious medical problems or refusal to participate in the study; pregnancy; children below the age of 5 years
Study type Interventional allocation: randomised
Masking: no masking, open label
Date of first enrolment 19 May 2017
Target sample size 1440
Recruitment status Recruiting
Primary outcome(s) Change from baseline prevalence of lymphatic filariasis at 12, 24 and 30 months
Key secondary outcome(s) Longitudinal assessment of transmission dynamics of lymphatic filariasis. Evaluation of community acceptability of twice-yearly treatment. Feasibility of scale-up of twice-yearly treatment