NCT02234271

Brief Summary

The primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

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

Study Start

First participant enrolled

September 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 26, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

11 months

First QC Date

August 26, 2014

Last Update Submit

September 4, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Contraception choice

    Choice of birth control selected by participant was recorded into electronic database system and compared between the two groups.

    Participants were followed for the duration of their clinic visit which was up to one day

Secondary Outcomes (1)

  • Knowledge of contraception method chosen

    Participants were followed for the duration of their clinic visit which was up to one day

Study Arms (2)

Health Educator Arm

ACTIVE COMPARATOR

Health Educator for contraception information

Other: Health Educator Counseling

Mobile Health Application Arm

EXPERIMENTAL

Plan A Birth Control - iPad based application for contraception information

Other: Mobile Health Application

Interventions

Mobile Health application for contraception information

Mobile Health Application Arm

Counseling via health educator

Health Educator Arm

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age
  • literate in English
  • not at that time using a contraceptive method
  • willing to switch to a new reversible contraceptive method
  • currently sexually active with a male partner and
  • intending to avoid pregnancy for at least one year

You may not qualify if:

  • women not at risk for unintended pregnancy
  • those who were pregnant
  • seeking pregnancy within the next 12 months
  • history of surgical sterilization or
  • a current partner who had had a vasectomy
  • using long acting reversible birth control method
  • menopausal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Medical Clinic

Los Angeles, California, 90095, United States

Location

Related Publications (1)

  • Sridhar A, Chen A, Forbes ER, Glik D. Mobile application for information on reversible contraception: a randomized controlled trial. Am J Obstet Gynecol. 2015 Jun;212(6):774.e1-7. doi: 10.1016/j.ajog.2015.01.011. Epub 2015 Jan 9.

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Officials

  • Aparna Sridhar, MD, MPH

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

August 26, 2014

First Posted

September 9, 2014

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 9, 2014

Record last verified: 2014-09

Locations