miPlan: A Trial of miPlan Intervention vs. Standard of Care

Unintended Pregnancy Clinical Trial

Official title: miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care

Status Completed

Clinical Trial Summary

Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")—miPlan—to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care. The aim of this study is to understand miPlan's impact. The primary outcome is LARC uptake at clinic discharge. The secondary outcomes are contraceptive use at discharge, self-efficacy and decisional balance for highly effective contraception post-app use, contraceptive satisfaction, and intention to continue method use. The research will consist of baseline activities as well as a three-month follow-up call.

Clinical Trial Description

Using our experience in digital media, behavior theory, client-centered interventions, and family planning, we have prototyped a digital application ("app")—miPlan—to be used in the clinic waiting room prior to a contraceptive visit. The goal of this research is to refine the app and conduct a randomized controlled trial of the miPlan intervention vs. standard care contraceptive counseling. The aim of this study is to understand miPlan's impact in terms of contraceptive knowledge, intentions and behaviors. The primary outcome is LARC uptake, which will be measured via chart review at clinic discharge, i.e. immediately following a patient's family planning visit. The secondary outcomes are contraceptive use at discharge (measured via chart review immediately following patient's family planning visit), self-efficacy and decisional balance (both measured via adapted validated scales for each) for highly effective contraception post-app use (measured immediately following intervention and prior to contraceptive counseling session), contraceptive satisfaction (measured at 3 months post baseline), and intention to continue method use (measured at 3 months post baseline). The research will consist of baseline activities as well as a three-month follow-up call. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Unintended Pregnancy

• NCT number: NCT02396602
• Study type: Interventional
• Source: University of Chicago
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Completion date: August 2016