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Qualitative research undertaken at the pretrial stage has the potential to impact on the main trial as well as future trials.
The feasibility phase of the study will specifically inform and test the recruitment rate for the main trial as well as assess the acceptability of the process of consent.
When adjusting for this difference in baseline characteristics, it did not change the interpretation of the findings in the main trial, as reported elsewhere [ 24].
The subset of patients used for the analysis of the biomarkers maintained the demographic characteristics of the main trial, as discussed in Results.
In partnership with the CAC we plan to introduce participatory theatre in selected wards during the main trial as part of an expanded community mobilisation strategy and by incorporating elements from the HIV-Stigma Toolkit developed by The CHANGE Project [ 40], we hope to dispel rumours, prevent misconceptions and help to alleviate discrimination experienced by women participating in the trial.
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For studies with multiple study reports, we used the main trial report as the primary data extraction source.
Some activities would be expected to occur only prior to the main trial, such as intervention development, and all of these articles were undertaken pretrial.
This may cause operating characteristics of the main trial, such as the type I error rate, to deviate from the planned values.
If this modification had not been made prior to the first group randomisation, data from the first pilot site could not have been carried forward to the main trial dataset as the trial design of the pilot would have differed significantly from that used in the main trial.
The main trial will run, as described below, with the addition of a qualitative substudy assessing patients' experience of giving consent for the trial and the acceptability of the trial procedures to patients and staff.
Further details of sample characteristics at baseline, as well as main trial outcomes, may be found in the UKATT Research Team (2005).
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