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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02396602
Enrollment
225
Registered
2015-03-24
Start date
2015-02-28
Completion date
2016-08-31
Last updated
2016-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unintended Pregnancy

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.

Interventions

BEHAVIORALmiPlan intervention

miPlan mobile contraceptive counseling waiting room app intervention

Sponsors

University of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 29 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
LARC uptakeat time of intervention (baseline (0 weeks)uptake of the implant or IUD at time of intervention (measured via contraceptive method choice and delivery by checkbox)

Secondary

MeasureTime frameDescription
contraceptive useat time of intervention (baseline (0 weeks))use of contraceptive methods at time of intervention (measured via contraceptive method choice and delivery by checkbox)
change in self-efficacy for contraception at 12 weeksbaseline (0 weeks) and 12 weekschange in self efficacy for contraceptive method use (measured via validated 5-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks
change in decisional balance for highly effective methods at 12 weeksbaseline (0 weeks) and 12 weekschange in decisional balance for highly effective methods (measured via validated 10-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks
contraceptive satisfaction12 weeks post-enrollmentsatisfaction with contraceptive method choice (measured by 4-point Likert scale)
intention to continue method use12 weeks post enrollmentintention to continue contraceptive method use (measured dichotomously)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026