The Contraceptive Choice Project

• Conditions: Contraception; Unintended Pregnancy; Abortion; Teen Births

• Registration Number: NCT01986439
• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief Summary

The purpose of this project is to remove barriers to obtaining contraceptive methods, including the most effective and expensive methods. The study seeks to remove the financial and knowledge barriers and promote the most effective contraceptive methods to reduce unintended pregnancy rates at the population level.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 9256

Inclusion Criteria

1. 14-45 years of age

2. Primary residency in St. Louis City or County

3. Does not desire pregnancy during the next 1 year

4. Desires reversible contraception

5. Sexually active with a man within the past 6 months or intend to have sex with a man in the next 6 months

6. Is not currently using a contraceptive method, has begun using a new contraceptive method within the last 4 weeks, or is a current contraceptive method user who wants to switch to a NEW contraceptive method immediately

7. Willing and able to undergo informed consent

8. Willing to comply with study protocol and 2-year follow-up schedule

9. Not currently pregnant, or meets one of the following criteria:

   1. Currently pregnant, undergoing medical or surgical termination of pregnancy, and planning for post-abortion contraception
   2. Currently pregnant with an abnormal pregnancy (miscarriage or ectopic pregnancy), undergoing medical or surgical management, and planning for post-pregnancy contraception
   3. Currently pregnant, estimated gestational age of 36 weeks or greater, and planning for post-partum contraception.

Exclusion Criteria

1. History of hysterectomy or sterilization
2. Current participation in another research study that would interfere with the conduct of this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of contraceptive method chosen	Baseline	Distribution of methods (%) chosen at baseline enrollment, by method and stratified by Long-Acting Reversible Contraception (LARC: intrauterine device and implant) and non-LARC (depotmedroxyprogesterone acetate (DMPA), oral contraceptive pill (OCP), vaginal ring, transdermal patch).

Secondary Outcome Measures

Name	Time	Method
Method Continuation	6-month, 12 month, 24-month, and 36-month	% of women using each method at 6, 12-, 24, and 36 months post-enrollment. Hazard rates via survival analysis comparing LARC and non-LARC methods.
Method Satisfaction	12-month, 24-month, 36-month	% of women very or somewhat satisfied with method at 12, 24, and 36 months of use. Comparison of all methods and stratified by LARC and non-LARC methods.
Teen Pregnancy Rates	1-year, 2-year, 3-year	Number of pregnancies per participants 15-19 years of age. We will calculate an annual rate for each year from 2007-2013 and also calculate a rate for the cohort followed for 1 year, 2 years, and 3 years.
Repeat Abortion Rates	1-year, 2-year, 3-year	Number of abortions among participants 15-44 with a history of abortion. We will calculate an annual rate for each year from 2007-2013 and also calculate a rate for the cohort followed for 1 year, 2 years, and 3 years.
Sexually transmitted infection rates	Baseline and 12-months	Baseline prevalence rates (number positive divided by number tested) for chlamydia, gonorrhea, and trichomonas. 1-year incidence rates for the same infections among those who tested at 1-year.

Trial Locations

Locations (1)

Washington University in St. Louis School of Medicine; 🇺🇸 St. Louis, Missouri, United States