MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning (MyNewOptions)

September 19, 2017 updated by: Cynthia Chuang, Milton S. Hershey Medical Center

Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Most US families want 2 children, resulting in the average woman spending 3 decades of her life trying to avoid pregnancy. However, most women have at least one unintended pregnancy, resulting in 1.5 million abortions and 1.7 million unintended births annually. Women and couples try to avoid unintended pregnancy for a range of personal, social, and economic reasons, but also due to the increased physical and mental health effects for children that result from unintended pregnancy. Healthcare reform now requires that private health insurance companies cover all FDA-approved contraceptive methods with no copays or deductibles to the patient, creating a great opportunity for women with health insurance to get contraceptive methods they previously could not afford. In this study, women with health insurance will be randomly assigned to one of three groups: (1) Reproductive Life Planning (RLP)-women will complete a reproductive life plan that guides them to think about if and when they would want any future pregnancies, and to determine what contraceptive method(s) are best suited to them; (2) Reproductive Life Planning Plus (RLP+) which additionally includes "if-then planning," where women determine what they will do when they encounter difficult situations that make it difficult to use their contraceptive method perfectly; or (3) an information-only control group. The online format of the study allows for the potential of wide dissemination. The RLP and RLP+ interventions are expected to result in greater likelihood of contraceptive use, continuity of contraceptive use, and contraceptive adherence, and thus reduce overall risk of unintended pregnancy.

Study Type

Interventional

Enrollment (Actual)

987

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • tubal sterilization
  • hysterectomy
  • partner with vasectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Reproductive Life Planning (RLP)
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
EXPERIMENTAL: Reproductive Life Planning Plus (RLP+)
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: Contraception information
Behavioral: Contraceptive Action Planning
ACTIVE_COMPARATOR: Information-only control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Contraceptive Use
Time Frame: 24 months
Percentage of surveys with any contraceptive use
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Contraceptive Method
Time Frame: 24 months
Percentage of surveys where most effective contraceptive method used
24 months
Contraceptive Method Satisfaction
Time Frame: 24 months
percentage of surveys where very satisfied with contraceptive method
24 months
Contraceptive Adherence
Time Frame: 24 months
Percentage of surveys where contraceptive adherence was high
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Collaborators

Patient-Centered Outcomes Research Institute

Investigators

  • Principal Investigator: Cynthia H Chuang, MD, MSc, Penn State College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

November 16, 2013

First Submitted That Met QC Criteria

March 26, 2014

First Posted (ESTIMATE)

March 31, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 11, 2018

Last Update Submitted That Met QC Criteria

September 19, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-1304-6117 (OTHER_GRANT: PCORI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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