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

Not Applicable

Completed

• Conditions: Unintended Pregnancy; Contraceptive Use

• Registration Number: NCT02100124
• Lead Sponsor: Milton S. Hershey Medical Center

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.

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 Timeline

• Study First Submitted: 2013-11-16
• Study First Submitted QC: 2014-03-26
• Study First Posted: 2014-03-31
• Study Start: 2014-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-09
• Results First Submitted: 2017-09-19
• Results First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-19
• Results First Posted: 2018-07-11
• Last Update Posted: 2018-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 987

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Contraceptive Use	24 months	Percentage of surveys with any contraceptive use

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Penn State College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States