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

Penn State Health

Status: Completed

Conditions: Unintended Pregnancy; Contraceptive Use

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02100124

CD-1304-6117 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 987 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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987 participants in 3 patient groups

Reproductive Life Planning (RLP)

Experimental group

Description:

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.

Treatment:

Behavioral: Contraception information

Behavioral: Reproductive Life Planning (RLP)

Reproductive Life Planning Plus (RLP+)

Experimental group

Description:

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

Treatment:

Behavioral: Contraceptive Action Planning

Behavioral: Contraception information

Behavioral: Reproductive Life Planning (RLP)

Information-only control

Active Comparator group

Description:

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

Treatment:

Behavioral: Contraception information