With regard to programme fidelity, programmes run in one of the allocated sites did not meet the standards for running FLNP in all respects.
We attempted an analysis of results by programme fidelity and also by area, and no statistically significant differences between the groups were found.
71 The most important challenges were well-recognised threats to health promotion and disease-prevention trials; those of poor exposure among the intervention group, contamination of the control group and varying programme fidelity.
The Bill and Melinda Gates foundation, as funder should be very satisfied with the rapid scale up, programme fidelity and uptake of this programme, including large scale behavior changes.
16 Participants achieved a sufficient dosage of the cognitive behavioural therapy intervention, programme fidelity was good, recruitment and retention were high, and the study had sufficient power to detect the a priori hypothesised clinically significant between group differences.
This was to enable enrolment to the FNP (for those randomised to the intervention arm) in line with the programme fidelity requirements (60% of clients to be enrolled by 16 weeks gestation, and all by 28 weeks [ 47, 48, 72]).
The clinicians completed a standardised consultation form, recording the duration of the consultation and key components of the programme (history, diagnoses, management) to maximise programme fidelity.
(c) The challenge of programme me fidelity.
The need for such modifications suggests that programme fidelity may not always be an appropriate goal since conceptions of domestic abuse are culturally shaped and levels of gender equality and awareness of gender abuse differ between communities and societies.
Programme fidelity, the participants' responsiveness to the programme, and implementation strategies are investigated as well.
