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

Study Overview
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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.

Official Title
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Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning

Conditions
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Contraceptive Use, Unintended Pregnancy

Intervention / Treatment
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* Behavioral: Reproductive Life Planning (RLP)
* Behavioral: Contraceptive Action Planning
* Behavioral: Contraception information


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reproductive Life Planning (RLP)<br>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)<br> <br> Behavioral: Contraception information<br> <br> |
| Experimental: Reproductive Life Planning Plus (RLP+)<br>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)<br> <br> Behavioral: Contraceptive Action Planning<br> <br> Behavioral: Contraception information<br> <br> |
| Active Comparator: Information-only control<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reproductive life planning, action planning, contraceptive use, unintended pregnancy