The Contraceptive Choice Project

Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
Overall Status
Unknown status
CT.gov ID
NCT01986439
Collaborator
(none)
9,256
1
112
82.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9256 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Contraceptive Choice Project
    Study Start Date :
    Aug 1, 2007
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    14 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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:

    10. Currently pregnant, undergoing medical or surgical termination of pregnancy, and planning for post-abortion contraception

    11. Currently pregnant with an abnormal pregnancy (miscarriage or ectopic pregnancy), undergoing medical or surgical management, and planning for post-pregnancy contraception

    12. 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University in St. Louis School of Medicine St. Louis Missouri United States 63110

    Sponsors and Collaborators

    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    Investigators

    • Principal Investigator: Jeffrey F Peipert, MD PhD, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Jeffrey Peipert, Robert J. Terry Professor, Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01986439
    Other Study ID Numbers:
    • 201101982
    First Posted:
    Nov 18, 2013
    Last Update Posted:
    Apr 14, 2015
    Last Verified:
    Apr 1, 2015

    Study Results

    No Results Posted as of Apr 14, 2015