MObile Technology for Improved Family Planning: update to randomised controlled trial protocol.

ABSTRACT:

Background

This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up. These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data. The changes were agreed prior to finalising the statistical analysis plan and sealing the dataset.

Methods/design

The primary analysis will now be restricted to subjects with data on the primary outcome at 4-month follow-up. The extreme-case scenario, where all those lost to follow-up are counted as non-adherent, will be used in a sensitivity analysis. In addition to the secondary outcomes outlined in the protocol, we will assess the effect of the intervention on long

SUBMITTER: Smith C 

PROVIDER: S-EPMC4234840 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature