NCT02100124

Brief Summary

The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
987

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

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

November 16, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

July 11, 2018

Completed
Last Updated

July 11, 2018

Status Verified

September 1, 2017

Enrollment Period

2.4 years

First QC Date

November 16, 2013

Results QC Date

September 19, 2017

Last Update Submit

September 19, 2017

Conditions

Keywords

reproductive life planningaction planningcontraceptive useunintended pregnancy

Outcome Measures

Primary Outcomes (1)

  • Contraceptive Use

    Percentage of surveys with any contraceptive use

    24 months

Secondary Outcomes (3)

  • Effectiveness of Contraceptive Method

    24 months

  • Contraceptive Method Satisfaction

    24 months

  • Contraceptive Adherence

    24 months

Study Arms (3)

Reproductive Life Planning (RLP)

EXPERIMENTAL

RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.

Behavioral: Reproductive Life Planning (RLP)Behavioral: Contraception information

Reproductive Life Planning Plus (RLP+)

EXPERIMENTAL

RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.

Behavioral: Reproductive Life Planning (RLP)Behavioral: Contraceptive Action PlanningBehavioral: Contraception information

Information-only control

ACTIVE COMPARATOR

The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.

Behavioral: Contraception information

Interventions

Reproductive Life Planning (RLP)Reproductive Life Planning Plus (RLP+)
Reproductive Life Planning Plus (RLP+)
Information-only controlReproductive Life Planning (RLP)Reproductive Life Planning Plus (RLP+)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • not currently pregnant
  • sexually active with a male partner in the past 6 months OR anticipate being sexually active with a male partner in the next 6 months
  • does not intend pregnancy in the next 12 months
  • has Internet access and email address

You may not qualify if:

  • tubal sterilization
  • hysterectomy
  • partner with vasectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (4)

  • Zheng A, Nelson HN, McCall-Hosenfeld JS, Lehman EB, Chuang CH. Recent Intimate Partner Violence and Oral Contraceptive Pill Adherence in a Cohort of Reproductive-Aged Women. J Womens Health (Larchmt). 2022 Dec;31(12):1703-1709. doi: 10.1089/jwh.2021.0622. Epub 2022 Sep 20.

  • Lauring JR, Lehman EB, Deimling TA, Legro RS, Chuang CH. Combined hormonal contraception use in reproductive-age women with contraindications to estrogen use. Am J Obstet Gynecol. 2016 Sep;215(3):330.e1-7. doi: 10.1016/j.ajog.2016.03.047. Epub 2016 Apr 5.

  • Chuang CH, Velott DL, Weisman CS, Sciamanna CN, Legro RS, Chinchilli VM, Moos MK, Francis EB, Confer LN, Lehman EB, Armitage CJ. Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial. Womens Health Issues. 2015 Nov-Dec;25(6):641-8. doi: 10.1016/j.whi.2015.06.010. Epub 2015 Aug 22.

  • Weisman CS, Lehman EB, Legro RS, Velott DL, Chuang CH. How do pregnancy intentions affect contraceptive choices when cost is not a factor? A study of privately insured women. Contraception. 2015 Nov;92(5):501-7. doi: 10.1016/j.contraception.2015.05.007. Epub 2015 May 19.

Results Point of Contact

Title
Dr. Cynthia Chuang
Organization
Penn State College of Medicine

Study Officials

  • Cynthia H Chuang, MD, MSc

    Penn State College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Public Health Sciences

Study Record Dates

First Submitted

November 16, 2013

First Posted

March 31, 2014

Study Start

April 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

July 11, 2018

Results First Posted

July 11, 2018

Record last verified: 2017-09

Locations