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

Trials. 2014 Nov 12;15:440. doi: 10.1186/1745-6215-15-440.

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-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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT01823861.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abortion, Induced*
  • Cambodia
  • Cell Phone*
  • Clinical Protocols
  • Contraception / methods*
  • Family Planning Services / methods*
  • Female
  • Humans
  • Outcome and Process Assessment, Health Care
  • Patient Compliance
  • Pregnancy
  • Pregnancy, Unplanned*
  • Pregnancy, Unwanted*
  • Research Design*
  • Self Report
  • Time Factors

Associated data

  • ClinicalTrials.gov/NCT01823861