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Compliance with the above procedures was checked via written logs of nutritional intake, and participants were asked to replicate nutritional practices for subsequent trials (adherence = 100%).
In recent PrEP trials, adherence rates approached only 70% [ 25, 26].
In the ideal world of RCT trials, adherence to randomization condition occurs more smoothly.
As is common in randomized controlled trials, adherence was good and showed little variability (see Waller, 2009).
Reasons for failure to improve survival including potential delays in diagnosis, accrual to trials, adherence to therapy and lack of improvement in treatment strategies all need to be considered.
Clinical trials of PrEP and ARV-based microbicides have demonstrated that although adherence to visits was high in all trials, adherence to product measured objectively through detection of drug varied considerably [ 16– 18, 20, 46].
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Although the ITT analysis is, and will likely remain, the gold standard for evaluating effectiveness in microbicide trials, adherence-adjusted analyses offer the potential for more powerful tests and richer understanding of trial data and their implications.
Strengths of WHIMS-Y include balance in baseline risk factors between treatment groups, standardized and masked data collection, and high rates of retention and on-trial adherence and exposure.
In this clinical trial, adherence to nevirapine prophylaxis in infants was assessed by maternal verbal reports.
In order to maximise the trial adherence subsequent trial medication will be administered in the patient's home by trial personnel.
In addition to potential bias from intervals with unknown adherence, the choice of summary measure used to report trial adherence can provide a misleading estimate of product use.
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