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

Area of Science:

• Reproductive Health
• Clinical Trials Methodology
• Contraception Research

Background:

• The MObile Technology for Improved Family Planning (Mobi-FPP) study is updating its statistical analysis plan and incorporating long-term follow-up.
• Additional funding and a decision to restrict the primary analysis to participants with available follow-up data prompted these changes.
• All modifications were finalized before the dataset was sealed.

Purpose of the Study:

• To outline modifications to the Mobi-FPP study's statistical analysis plan.
• To detail plans for extended 12-month follow-up to assess long-term intervention effects.
• To ensure comparability with other family planning intervention trials.

Main Methods:

• Primary analysis restricted to participants with 4-month follow-up data on the primary outcome.
• Sensitivity analysis using an extreme-case scenario for participants lost to follow-up.
• Additional 12-month follow-up via telephone self-report for all primary and secondary outcomes, with participant consent obtained at enrollment.

Main Results:

• Primary outcomes at 4 and 12 months include the use of an effective modern contraceptive method.
• Secondary outcomes encompass long-acting contraception use, self-reported pregnancy, and repeat abortion.
• The study will assess the intervention's effect on various contraceptive methods, including long-acting options.

Conclusions:

• Restricting the primary analysis to available follow-up data aligns with standard trial practices and enhances inter-trial comparability.
• The planned 12-month follow-up will provide crucial data on the intervention's long-term effectiveness in increasing contraception uptake and use.