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

Sponsor
University of Chicago (Other)
Overall Status
Completed
CT.gov ID
NCT02396602
Collaborator
(none)
225
Enrollment
1
Location
2
Arms
18
Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: miPlan intervention
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
225 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
miPlan: A Randomized Controlled Trial of miPlan Intervention vs. Standard of Care
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

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
miPlan mobile contraceptive counseling waiting room app intervention
No Intervention: Control

After completing baseline the baseline questionnaire, women randomized to the control arm will proceed to standard of care contraceptive counseling.

Outcome Measures

Primary Outcome Measures

  1. LARC uptake [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 Outcome Measures

  1. contraceptive use [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 [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 [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 [12 weeks post-enrollment]

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

  5. intention to continue method use [12 weeks post enrollment]

    intention to continue contraceptive method use (measured dichotomously)

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 29 Years
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Planned Parenthood Illinois, Englewood Health Center Chicago Illinois United States 60636

Sponsors and Collaborators

  • University of Chicago

Investigators

  • Principal Investigator: Melissa Gilliam, MD, MPH, University of Chicago, Dept. of OBGYN

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Chicago
ClinicalTrials.gov Identifier:
NCT02396602
Other Study ID Numbers:
  • 14-0599
First Posted:
Mar 24, 2015
Last Update Posted:
Aug 25, 2016
Last Verified:
Aug 1, 2016

Study Results

No Results Posted as of Aug 25, 2016