The Contraceptive Choice Project

April 13, 2015 updated by: Jeffrey Peipert, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

9256

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University in St. Louis School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women of reproductive age who reside in the St. Louis metropolitan region.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-month, 12 month, 24-month, and 36-month
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.
12-month, 24-month, 36-month
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.
1-year, 2-year, 3-year
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.
1-year, 2-year, 3-year
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.
Baseline and 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 11, 2013

First Posted (Estimate)

November 18, 2013

Study Record Updates

Last Update Posted (Estimate)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 201101982

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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