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In this controlled trial, cluster randomization will be performed at the ward level.
All eligible communities and health services within each trial cluster were invited to participate.
The effectiveness of the intervention will be measured by performing a cluster randomized controlled trial (cluster RCT).
However, if, within each cluster, the physician has to recruit patients to be included in the trial, cluster size distribution may then be difficult to hypothesize.
All trial participants identified as HIV-infected are referred to a local TasP trial clinic situated in the trial cluster in which they live.
Using the last national census, we then identified sufficient eligible villages to provide a total population of about 40,000 inhabitants per trial cluster.
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After the completion of the intervention, a follow-up survey was conducted in all trial clusters.
Prospective multicentre controlled trial cluster-randomised to POCT-assisted diagnosis and conventional diagnosis (controls).
The effect evaluation of SMS involves a pragmatic 2-armed cluster-randomised controlled trial (cluster-RCT) with PNs as the unit of randomisation.
We have designed this Phase III cluster trial to deal with contamination issues which we explored and identified in our Phase II trial: cluster-randomised trials are recommended for situations where systems level interventions such as collaborative care are to be tested [ 47] since patient-randomised trials may be vulnerable to contamination from the intervention to control patients.
This trial cluster-randomizes rheumatology practices from the existing Corrona network of private and academic sites rather than patients within sites or individual investigators to provide either T2T or usual care (UC) for qualified patients who meet the 2010 revised American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis and have moderate to high disease activity.
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