NCT03402217

Brief Summary

This study will evaluate a smart phone-based application ("app") designed to inform pregnant women ages 15-25 about their contraception options. The goal of this research will be to evaluate the usability, feasibility and acceptability of this app.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

May 18, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

May 3, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

January 5, 2018

Results QC Date

May 28, 2020

Last Update Submit

May 2, 2024

Conditions

Keywords

ContraceptionPost Partum Contraception

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Application

    Feasibility, acceptability and usability of application. Mean of each item is reported. Each item has a possible score of 1-5, 1 = strongly disagree; 5= strongly agree. Higher scores indicate a better results for all items except "I found the app too complex to understand," "I think I would need tech support to use this app," "I thought there was too much inconsistency in app," "I found the app cumbersome to use," and "I needed to learn a lot before I could get going," where a lower score is a better result.

    Immediately post intervention

Secondary Outcomes (8)

  • Prior Method Use

    Pre-Survey

  • Number of Pregnancies (Including Current)

    Pre-Survey

  • Contraception Knowledge

    Pre-Survey

  • Patient Activation

    Pre-Survey, immediately post intervention

  • Information, Motivation and Behavioral Skills

    immediately post intervention

  • +3 more secondary outcomes

Other Outcomes (1)

  • Sociodemographic Information

    Pre-Survey

Interventions

This is a theory-based smart phone-based application designed to provide immediate postpartum contraception information to young women aged 15-25.

Eligibility Criteria

Age15 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

-Recruitment will occur at local primary care clinics.

You may qualify if:

  • Pregnant
  • Identify as African American or Black
  • English as primary language

You may not qualify if:

  • Not pregnant
  • Not identifying as African American or Black
  • Language other than English as primary language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60605, United States

Location

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Limitations and Caveats

Difficulty with recruiting eligible participants from clinic waiting rooms led to lower enrollment numbers than initially planned.

Results Point of Contact

Title
Ellen McCammon
Organization
Ci3 at the University of Chicago

Study Officials

  • Melissa Gilliam, MD, MPH

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 18, 2018

Study Start

May 18, 2018

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

May 3, 2024

Results First Posted

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations