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

NCT ID: NCT02100124

Last Updated: 2018-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

987 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Contraceptive Use Unintended Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Reproductive Life Planning (RLP)

Intervention Type BEHAVIORAL

Contraception information

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Reproductive Life Planning (RLP)

Intervention Type BEHAVIORAL

Contraceptive Action Planning

Intervention Type BEHAVIORAL

Contraception information

Intervention Type BEHAVIORAL

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.

Group Type ACTIVE_COMPARATOR

Contraception information

Intervention Type BEHAVIORAL

Interventions

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Reproductive Life Planning (RLP)

Intervention Type BEHAVIORAL

Contraceptive Action Planning

Intervention Type BEHAVIORAL

Contraception information

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Chuang

Associate Professor of Medicine and Public Health Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia H Chuang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

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Penn State College of Medicine

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36126298 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27059507 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26307564 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26002807 (View on PubMed)

Other Identifiers

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CD-1304-6117

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CD-1304-6117

Identifier Type: -

Identifier Source: org_study_id

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