Clinical trial NCT02396602: miPlan: A Trial of miPlan Intervention vs. Standard of Care
Official title: miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unintended Pregnancy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 225
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: LARC uptake
timeFrame: at time of intervention (baseline (0 weeks)
Secondary outcomes:
measure: contraceptive use
timeFrame: at time of intervention (baseline (0 weeks))
measure: change in self-efficacy for contraception at 12 weeks
timeFrame: baseline (0 weeks) and 12 weeks
measure: change in decisional balance for highly effective methods at 12 weeks
timeFrame: baseline (0 weeks) and 12 weeks
measure: contraceptive satisfaction
timeFrame: 12 weeks post-enrollment
measure: intention to continue method use
timeFrame: 12 weeks post enrollment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Planned Parenthood Illinois, Englewood Health Center
state: Illinois
Study officials:
affiliation: University of Chicago, Dept. of OBGYN
name: Melissa Gilliam, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.