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NCT Number: NCT02396602

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

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.

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Key information

Conditions

Unintended Pregnancy

Age range

15 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood Illinois, Englewood Health Center

Chicago, Illinois, 60636, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

miPlan intervention

Behavioral

miPlan mobile contraceptive counseling waiting room app intervention

Primary outcomes

  1. LARC uptake

    Time frame: at 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 outcomes

  1. contraceptive use

    Time frame: at time of intervention (baseline (0 weeks))

    use of contraceptive methods at time of intervention (measured via contraceptive method choice and delivery by checkbox)

  2. change in self-efficacy for contraception at 12 weeks

    Time frame: baseline (0 weeks) and 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

  3. change in decisional balance for highly effective methods at 12 weeks

    Time frame: baseline (0 weeks) and 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

  4. contraceptive satisfaction

    Time frame: 12 weeks post-enrollment

    satisfaction with contraceptive method choice (measured by 4-point Likert scale)

  5. intention to continue method use

    Time frame: 12 weeks post enrollment

    intention to continue contraceptive method use (measured dichotomously)

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 24, 2015
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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