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Trial record 5 of 9 for:    bacterial vaginosis | NICHD | NIH

The Contraceptive Choice Project

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jeffrey Peipert, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01986439
First received: October 31, 2013
Last updated: April 13, 2015
Last verified: April 2015
  Purpose
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
Unintended Pregnancy
Teen Births
Abortion
Contraception

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Contraceptive Choice Project

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA
vaginal swab specimens for chlamydia, gonorrhea, trichomoniasis, and bacterial vaginosis. Blood specimens for HIV and syphilis.

Enrollment: 9256
Study Start Date: August 2007
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women of reproductive age who reside in the St. Louis metropolitan region.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986439

Locations
United States, Missouri
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
  More Information

Additional Information:
Publications:

Responsible Party: Jeffrey Peipert, Robert J. Terry Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01986439     History of Changes
Other Study ID Numbers: 201101982
Study First Received: October 31, 2013
Last Updated: April 13, 2015

Additional relevant MeSH terms:
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 27, 2017