NCT01986439

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9,256

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

9.3 years

First QC Date

October 31, 2013

Last Update Submit

April 13, 2015

Conditions

Unintended PregnancyTeen BirthsAbortionContraception

Outcome Measures

Primary Outcomes (1)

  • Distribution of contraceptive method chosen

    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 Outcomes (5)

  • Method Continuation

    6-month, 12 month, 24-month, and 36-month

  • Method Satisfaction

    12-month, 24-month, 36-month

  • Teen Pregnancy Rates

    1-year, 2-year, 3-year

  • Repeat Abortion Rates

    1-year, 2-year, 3-year

  • Sexually transmitted infection rates

    Baseline and 12-months

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • years of age
  • Primary residency in St. Louis City or County
  • Does not desire pregnancy during the next 1 year
  • Desires reversible contraception
  • Sexually active with a man within the past 6 months or intend to have sex with a man in the next 6 months
  • 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
  • Willing and able to undergo informed consent
  • Willing to comply with study protocol and 2-year follow-up schedule
  • Not currently pregnant, or meets one of the following criteria:
  • Currently pregnant, undergoing medical or surgical termination of pregnancy, and planning for post-abortion contraception
  • Currently pregnant with an abnormal pregnancy (miscarriage or ectopic pregnancy), undergoing medical or surgical management, and planning for post-pregnancy contraception
  • Currently pregnant, estimated gestational age of 36 weeks or greater, and planning for post-partum contraception.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (31)

  • Tepe M, Mestad R, Secura G, Allsworth JE, Madden T, Peipert JF. Association between tampon use and choosing the contraceptive vaginal ring. Obstet Gynecol. 2010 Apr;115(4):735-739. doi: 10.1097/AOG.0b013e3181d41c4a.

    PMID: 20308832RESULT

  • Secura GM, Allsworth JE, Madden T, Mullersman JL, Peipert JF. The Contraceptive CHOICE Project: reducing barriers to long-acting reversible contraception. Am J Obstet Gynecol. 2010 Aug;203(2):115.e1-7. doi: 10.1016/j.ajog.2010.04.017. Epub 2010 Jun 11.

    PMID: 20541171RESULT

  • Spain JE, Peipert JF, Madden T, Allsworth JE, Secura GM. The Contraceptive CHOICE Project: recruiting women at highest risk for unintended pregnancy and sexually transmitted infection. J Womens Health (Larchmt). 2010 Dec;19(12):2233-8. doi: 10.1089/jwh.2010.2146. Epub 2010 Sep 11.

    PMID: 20831439RESULT

  • Pittman ME, Secura GM, Allsworth JE, Homco JB, Madden T, Peipert JF. Understanding prescription adherence: pharmacy claims data from the Contraceptive CHOICE Project. Contraception. 2011 Apr;83(4):340-5. doi: 10.1016/j.contraception.2010.08.003. Epub 2010 Sep 17.

    PMID: 21397092RESULT

  • Peipert JF, Zhao Q, Allsworth JE, Petrosky E, Madden T, Eisenberg D, Secura G. Continuation and satisfaction of reversible contraception. Obstet Gynecol. 2011 May;117(5):1105-1113. doi: 10.1097/AOG.0b013e31821188ad.

    PMID: 21508749RESULT

  • Kittur ND, Secura GM, Peipert JF, Madden T, Finer LB, Allsworth JE. Comparison of contraceptive use between the Contraceptive CHOICE Project and state and national data. Contraception. 2011 May;83(5):479-85. doi: 10.1016/j.contraception.2010.10.001. Epub 2010 Nov 23.

    PMID: 21477693RESULT

  • Kossler K, Kuroki LM, Allsworth JE, Secura GM, Roehl KA, Peipert JF. Perceived racial, socioeconomic and gender discrimination and its impact on contraceptive choice. Contraception. 2011 Sep;84(3):273-9. doi: 10.1016/j.contraception.2011.01.004. Epub 2011 Feb 21.

    PMID: 21843693RESULT

  • Mestad R, Secura G, Allsworth JE, Madden T, Zhao Q, Peipert JF. Acceptance of long-acting reversible contraceptive methods by adolescent participants in the Contraceptive CHOICE Project. Contraception. 2011 Nov;84(5):493-8. doi: 10.1016/j.contraception.2011.03.001. Epub 2011 Apr 27.

    PMID: 22018123RESULT

  • Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home screening compared with clinic-based screening for sexually transmitted infections. Obstet Gynecol. 2010 Apr;115(4):745-752. doi: 10.1097/AOG.0b013e3181d4450d.

    PMID: 20308834RESULT

  • Graseck AS, Secura GM, Allsworth JE, Madden T, Peipert JF. Home compared with clinic-based screening for sexually transmitted infections: a randomized controlled trial. Obstet Gynecol. 2010 Dec;116(6):1311-1318. doi: 10.1097/AOG.0b013e3181fae60d.

    PMID: 21099596RESULT

  • Shih SL, Kebodeaux CA, Secura GM, Allsworth JE, Madden T, Peipert JF. Baseline correlates of inconsistent and incorrect condom use among sexually active women in the contraceptive CHOICE Project. Sex Transm Dis. 2011 Nov;38(11):1012-9. doi: 10.1097/OLQ.0b013e318225f8c3.

    PMID: 21992976RESULT

  • Madden T, Secura GM, Allsworth JE, Peipert JF. Comparison of contraceptive method chosen by women with and without a recent history of induced abortion. Contraception. 2011 Dec;84(6):571-7. doi: 10.1016/j.contraception.2011.03.018. Epub 2011 May 4.

    PMID: 22078185RESULT

  • Madden T, Proehl S, Allsworth JE, Secura GM, Peipert JF. Naproxen or estradiol for bleeding and spotting with the levonorgestrel intrauterine system: a randomized controlled trial. Am J Obstet Gynecol. 2012 Feb;206(2):129.e1-8. doi: 10.1016/j.ajog.2011.09.021. Epub 2011 Sep 24.

    PMID: 22055339RESULT

  • Madden T, Grentzer JM, Secura GM, Allsworth JE, Peipert JF. Risk of bacterial vaginosis in users of the intrauterine device: a longitudinal study. Sex Transm Dis. 2012 Mar;39(3):217-22. doi: 10.1097/OLQ.0b013e31823e68fe.

    PMID: 22337109RESULT

  • Skala SL, Secura GM, Peipert JF. Factors associated with screening for sexually transmitted infections. Am J Obstet Gynecol. 2012 Apr;206(4):324.e1-6. doi: 10.1016/j.ajog.2012.02.020. Epub 2012 Feb 28.

    PMID: 22464074RESULT

  • Winner B, Peipert JF, Zhao Q, Buckel C, Madden T, Allsworth JE, Secura GM. Effectiveness of long-acting reversible contraception. N Engl J Med. 2012 May 24;366(21):1998-2007. doi: 10.1056/NEJMoa1110855.

    PMID: 22621627RESULT

  • Peipert JF, Madden T, Allsworth JE, Secura GM. Preventing unintended pregnancies by providing no-cost contraception. Obstet Gynecol. 2012 Dec;120(6):1291-7. doi: 10.1097/aog.0b013e318273eb56.

    PMID: 23168752RESULT

  • Secura GM, Desir FA, Mullersman JL, Madden T, Allsworth JE, Peipert JF. Predictors of male partner treatment for sexually transmitted infection. Sex Transm Dis. 2012 Oct;39(10):769-75. doi: 10.1097/OLQ.0b013e31825ec611.

    PMID: 23001263RESULT

  • McNicholas C, Peipert JF, Maddipati R, Madden T, Allsworth JE, Secura GM. Sexually transmitted infection prevalence in a population seeking no-cost contraception. Sex Transm Dis. 2013 Jul;40(7):546-51. doi: 10.1097/OLQ.0b013e31829529eb.

    PMID: 23965768RESULT

  • Eisenberg DL, Secura GM, Madden TE, Allsworth JE, Zhao Q, Peipert JF. Knowledge of contraceptive effectiveness. Am J Obstet Gynecol. 2012 Jun;206(6):479.e1-9. doi: 10.1016/j.ajog.2012.04.012. Epub 2012 Apr 6.

    PMID: 22521458RESULT

  • Madden T, Mullersman JL, Omvig KJ, Secura GM, Peipert JF. Structured contraceptive counseling provided by the Contraceptive CHOICE Project. Contraception. 2013 Aug;88(2):243-9. doi: 10.1016/j.contraception.2012.07.015. Epub 2012 Sep 5.

    PMID: 22959396RESULT

  • Xu H, Wade JA, Peipert JF, Zhao Q, Madden T, Secura GM. Contraceptive failure rates of etonogestrel subdermal implants in overweight and obese women. Obstet Gynecol. 2012 Jul;120(1):21-6. doi: 10.1097/AOG.0b013e318259565a.

    PMID: 22678035RESULT

  • Rosenstock JR, Peipert JF, Madden T, Zhao Q, Secura GM. Continuation of reversible contraception in teenagers and young women. Obstet Gynecol. 2012 Dec;120(6):1298-305. doi: 10.1097/aog.0b013e31827499bd.

    PMID: 23168753RESULT

  • Nault AM, Peipert JF, Zhao Q, Madden T, Secura GM. Validity of perceived weight gain in women using long-acting reversible contraception and depot medroxyprogesterone acetate. Am J Obstet Gynecol. 2013 Jan;208(1):48.e1-8. doi: 10.1016/j.ajog.2012.10.876. Epub 2012 Oct 24.

    PMID: 23103344RESULT

  • Stuart JE, Secura GM, Zhao Q, Pittman ME, Peipert JF. Factors associated with 12-month discontinuation among contraceptive pill, patch, and ring users. Obstet Gynecol. 2013 Feb;121(2 Pt 1):330-336. doi: 10.1097/AOG.0b013e31827e5898.

    PMID: 23344283RESULT

  • Vickery Z, Madden T, Zhao Q, Secura GM, Allsworth JE, Peipert JF. Weight change at 12 months in users of three progestin-only contraceptive methods. Contraception. 2013 Oct;88(4):503-8. doi: 10.1016/j.contraception.2013.03.004. Epub 2013 Mar 18.

    PMID: 23582238RESULT

  • O'Neil-Callahan M, Peipert JF, Zhao Q, Madden T, Secura G. Twenty-four-month continuation of reversible contraception. Obstet Gynecol. 2013 Nov;122(5):1083-1091. doi: 10.1097/AOG.0b013e3182a91f45.

    PMID: 24104781RESULT

  • Grunloh DS, Casner T, Secura GM, Peipert JF, Madden T. Characteristics associated with discontinuation of long-acting reversible contraception within the first 6 months of use. Obstet Gynecol. 2013 Dec;122(6):1214-21. doi: 10.1097/01.AOG.0000435452.86108.59.

    PMID: 24201685RESULT

  • McNicholas CP, Madden T, Zhao Q, Secura G, Allsworth JE, Peipert JF. Cervical lidocaine for IUD insertional pain: a randomized controlled trial. Am J Obstet Gynecol. 2012 Nov;207(5):384.e1-6. doi: 10.1016/j.ajog.2012.09.018. Epub 2012 Sep 20.

    PMID: 23107081RESULT

  • Leroy-Melamed M, Zhao Q, Belmonte MA, Archer J, Peipert JF. Contraceptive Preference, Continuation Rates, and Unintended Pregnancies in Patients with Comorbidities: A Prospective Cohort Study. J Womens Health (Larchmt). 2021 Oct;30(10):1469-1475. doi: 10.1089/jwh.2020.8536. Epub 2021 Jan 6.

    PMID: 33404367DERIVED

  • Bernard C, Zhao Q, Peipert JF. Dual method use among long-acting reversible contraceptive users. Eur J Contracept Reprod Health Care. 2018 Apr;23(2):97-104. doi: 10.1080/13625187.2018.1445850. Epub 2018 Mar 27.

    PMID: 29582687DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

vaginal swab specimens for chlamydia, gonorrhea, trichomoniasis, and bacterial vaginosis. Blood specimens for HIV and syphilis.

Study Officials

  • Jeffrey F Peipert, MD PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Robert J. Terry Professor

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 18, 2013

Study Start

August 1, 2007

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 14, 2015

Record last verified: 2015-04

Locations

US(1)