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

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.

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-acting contraception (implant, intra-uterine device and permanent methods).To assess the long-term effect of the intervention, we plan to conduct additional 12-month follow-up by telephone self-report for all the primary and secondary outcomes used at 4 months. All participants provided informed consent for this additional follow-up when recruited to the trial. Outcome measures and analysis at 12 months will be similar to those at the 4-month follow-up. The primary outcomes of the trial will be the use of an effective modern contraceptive method at 4 months and at 12 months post-abortion. Secondary outcomes will include long-acting contraception use, self-reported pregnancy, repeat abortion and contraception use over the 12-month post-abortion period.

Restricting the primary analysis to those with follow-up data is the standard approach for trial analysis and will facilitate comparison with other trials of interventions designed to increase contraception uptake or use. Undertaking 12-month trial follow-up will allow us to evaluate the long-term effect of the intervention.

ClinicalTrials.gov NCT01823861.