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The Contraceptive Choice Project

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ClinicalTrials.gov Identifier: NCT01986439
Recruitment Status : Unknown
Verified April 2015 by Jeffrey Peipert, Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
First Posted : November 18, 2013
Last Update Posted : April 14, 2015
Sponsor:
Information provided by (Responsible Party):
Jeffrey Peipert, Washington University School of Medicine

Tracking Information
First Submitted Date October 31, 2013
First Posted Date November 18, 2013
Last Update Posted Date April 14, 2015
Study Start Date August 2007
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 11, 2013)
Distribution of contraceptive method chosen [ Time Frame: 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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 11, 2013)
  • Method Continuation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Contraceptive Choice Project
Official Title The Contraceptive Choice Project
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
vaginal swab specimens for chlamydia, gonorrhea, trichomoniasis, and bacterial vaginosis. Blood specimens for HIV and syphilis.
Sampling Method Non-Probability Sample
Study Population Women of reproductive age who reside in the St. Louis metropolitan region.
Condition
  • Unintended Pregnancy
  • Teen Births
  • Abortion
  • Contraception
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: November 11, 2013)
9256
Original Actual Enrollment Same as current
Estimated Study Completion Date December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 14 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01986439
Other Study ID Numbers 201101982
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jeffrey Peipert, Washington University School of Medicine
Study Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborators Not Provided
Investigators
Principal Investigator: Jeffrey F Peipert, MD PhD Washington University School of Medicine
PRS Account Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Verification Date April 2015