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

Unintended Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02396602
• Other study ID #: 14-0599
• Status: Completed
• Phase: N/A
• First received: February 16, 2015
• Last updated: August 24, 2016
• Start date: February 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 29 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Unintended Pregnancy

Intervention

Behavioral:
• miPlan intervention
miPlan mobile contraceptive counseling waiting room app intervention

Locations

Country	Name	City	State
United States	Planned Parenthood Illinois, Englewood Health Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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))	No
Secondary	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	No
Secondary	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	No
Secondary	contraceptive satisfaction	satisfaction with contraceptive method choice (measured by 4-point Likert scale)	12 weeks post-enrollment	No
Secondary	intention to continue method use	intention to continue contraceptive method use (measured dichotomously)	12 weeks post enrollment	No