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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unintended Pregnancy

Intervention / Treatment
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* Behavioral: miPlan intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* miPlan mobile contraceptive counseling waiting room app intervention<br>|
| No Intervention: Control<br>After completing baseline the baseline questionnaire, women randomized to the control arm will proceed to standard of care contraceptive counseling. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| contraceptive use | use of contraceptive methods at time of intervention (measured via contraceptive method choice and delivery by checkbox) | at time of intervention (baseline (0 weeks)) | 
| change in self-efficacy for contraception at 12 weeks | change in self efficacy for contraceptive method use (measured via validated 5-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks | baseline (0 weeks) and 12 weeks | 
| change in decisional balance for highly effective methods at 12 weeks | change in decisional balance for highly effective methods (measured via validated 10-item attitudinal scale by Galavotti et al 1995) from baseline to 12 weeks | baseline (0 weeks) and 12 weeks | 
| contraceptive satisfaction | satisfaction with contraceptive method choice (measured by 4-point Likert scale) | 12 weeks post-enrollment | 
| intention to continue method use | intention to continue contraceptive method use (measured dichotomously) | 12 weeks post enrollment |