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

The University of Chicago

Status: Completed

Conditions: Unintended Pregnancy

Treatments: Behavioral: miPlan intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02396602

14-0599

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: Female

Ages: 15 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: miPlan intervention

Control

No Intervention group

Description:

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