Contraceptive Use, Unintended Pregnancy
Conditions
Keywords
reproductive life planning, action planning, contraceptive use, unintended pregnancy
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.
Interventions
BEHAVIORALReproductive Life Planning (RLP)
BEHAVIORALContraceptive Action Planning
BEHAVIORALContraception information
Sponsors
Patient-Centered Outcomes Research Institute
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Contraceptive Use | 24 months | Percentage of surveys with any contraceptive use |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Contraceptive Method | 24 months | Percentage of surveys where most effective contraceptive method used |
| Contraceptive Method Satisfaction | 24 months | percentage of surveys where very satisfied with contraceptive method |
| Contraceptive Adherence | 24 months | Percentage of surveys where contraceptive adherence was high |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Reproductive Life Planning (RLP)
Contraception information | 329 |
| 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.
Reproductive Life Planning (RLP)
Contraceptive Action Planning
Contraception information | 329 |
| 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.
Contraception information | 326 |
| Total | 984 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 11 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Reproductive Life Planning Plus (RLP+) | Information-only Control | Reproductive Life Planning (RLP) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 329 Participants | 326 Participants | 329 Participants | 984 Participants |
| Age, Continuous | 27.08 years STANDARD_DEVIATION 6.13 | 27.28 years STANDARD_DEVIATION 5.92 | 27.02 years STANDARD_DEVIATION 5.95 | 27.13 years STANDARD_DEVIATION 5.99 |
| Region of Enrollment United States | 329 participants | 326 participants | 329 participants | 984 participants |
| Sex: Female, Male Female | 329 Participants | 326 Participants | 329 Participants | 984 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 329 | 0 / 329 | 0 / 326 |
| other Total, other adverse events | 0 / 329 | 0 / 329 | 0 / 326 |
| serious Total, serious adverse events | 0 / 329 | 0 / 329 | 0 / 326 |
Outcome results
Primary
Contraceptive Use
Percentage of surveys with any contraceptive use
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reproductive Life Planning (RLP) | Contraceptive Use | 93.43 percentage of surveys | Standard Deviation 20.59 |
| Reproductive Life Planning Plus (RLP+) | Contraceptive Use | 94.46 percentage of surveys | Standard Deviation 20.53 |
| Information-only Control | Contraceptive Use | 94.10 percentage of surveys | Standard Deviation 19.8 |
p-value: 195% CI: [0.56, 1.36]Regression, Logistic
p-value: 195% CI: [0.7, 1.83]Regression, Logistic
p-value: 0.5395% CI: [0.82, 2.08]Regression, Logistic
Secondary
Contraceptive Adherence
Percentage of surveys where contraceptive adherence was high
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reproductive Life Planning (RLP) | Contraceptive Adherence | 74.02 percentage of surveys | Standard Deviation 34.19 |
| Reproductive Life Planning Plus (RLP+) | Contraceptive Adherence | 73.27 percentage of surveys | Standard Deviation 35.54 |
| Information-only Control | Contraceptive Adherence | 76.37 percentage of surveys | Standard Deviation 32.69 |
p-value: 195% CI: [0.83, 1.37]Regression, Logistic
p-value: 195% CI: [0.81, 1.33]Regression, Logistic
p-value: 195% CI: [0.75, 1.25]Regression, Logistic
Secondary
Contraceptive Method Satisfaction
percentage of surveys where very satisfied with contraceptive method
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reproductive Life Planning (RLP) | Contraceptive Method Satisfaction | 58.22 percentage of surveys | Standard Deviation 39.39 |
| Reproductive Life Planning Plus (RLP+) | Contraceptive Method Satisfaction | 57.09 percentage of surveys | Standard Deviation 41.13 |
| Information-only Control | Contraceptive Method Satisfaction | 57.70 percentage of surveys | Standard Deviation 39.57 |
p-value: 195% CI: [0.84, 1.29]Regression, Logistic
p-value: 195% CI: [0.82, 1.26]Regression, Logistic
p-value: 195% CI: [0.79, 1.22]Regression, Logistic
Secondary
Effectiveness of Contraceptive Method
Percentage of surveys where most effective contraceptive method used
Time frame: 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reproductive Life Planning (RLP) | Effectiveness of Contraceptive Method | 60.66 percentage of surveys | Standard Deviation 45.11 |
| Reproductive Life Planning Plus (RLP+) | Effectiveness of Contraceptive Method | 63.93 percentage of surveys | Standard Deviation 43.91 |
| Information-only Control | Effectiveness of Contraceptive Method | 63.19 percentage of surveys | Standard Deviation 43.22 |
p-value: 0.4895% CI: [0.71, 1.09]Regression, Logistic
p-value: 195% CI: [0.87, 1.35]Regression, Logistic
p-value: 0.0795% CI: [0.99, 1.53]Regression, Logistic