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

NCT02396602 | Completed

• 1 other identifier: 14-0599
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unintended Pregnancy

Outcome Measures

Primary Outcomes (1)

• LARC uptake

  uptake of the implant or IUD at time of intervention (measured via contraceptive method choice and delivery by checkbox)

  at time of intervention (baseline (0 weeks)

Secondary Outcomes (5)

• contraceptive use

  at time of intervention (baseline (0 weeks))

• change in self-efficacy for contraception at 12 weeks

  baseline (0 weeks) and 12 weeks

• change in decisional balance for highly effective methods at 12 weeks

  baseline (0 weeks) and 12 weeks

• contraceptive satisfaction

  12 weeks post-enrollment

• intention to continue method use

  12 weeks post enrollment

Study Arms (2)

Intervention

EXPERIMENTAL

After completing baseline the baseline questionnaire, women randomized to the intervention group will receive an iPad, along with a brief tutorial on iPad navigation, and use the miPlan app for up to 15 minutes. They will complete a post-intervention survey before proceeding to standard of care contraceptive counseling.

Behavioral: miPlan intervention

Control

NO INTERVENTION

After completing baseline the baseline questionnaire, women randomized to the control arm will proceed to standard of care contraceptive counseling.

Interventions

miPlan intervention BEHAVIORAL

miPlan mobile contraceptive counseling waiting room app intervention

Intervention

Eligibility Criteria

• Age: 15 Years - 29 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• African American or Latina female and sexually active with a male partner(s) within the past 6 months,
• age 15 to 29 years
• present for contraception initiation
• English speaking

You may not qualify if:

• not currently pregnant or intending pregnancy within the next 6 months
• and not currently using LARC
• not highly intending LARC at enrollment

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

Planned Parenthood Illinois, Englewood Health Center

Chicago, Illinois, 60636, United States

Location

Related Publications (1)

• Hebert LE, Hill BJ, Quinn M, Holl JL, Whitaker AK, Gilliam ML. Mobile contraceptive application use in a clinical setting in addition to standard contraceptive counseling: A randomized controlled trial. Contraception. 2018 Oct;98(4):281-287. doi: 10.1016/j.contraception.2018.07.001. Epub 2018 Jul 10.

  PMID: 30006030 DERIVED

Study Officials

• Melissa Gilliam, MD, MPH

  University of Chicago, Dept. of OBGYN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2015
• First Posted: March 24, 2015
• Study Start: February 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 25, 2016

Record last verified: 2016-08

Locations

US (1)