The Contraceptive Choice Project

Contraception Clinical Trial

Official title:

The Contraceptive Choice Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01986439
• Other study ID #: 201101982
• Status: Active, not recruiting
• Phase: N/A
• First received: October 31, 2013
• Last updated: April 13, 2015
• Start date: August 2007
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 9256
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abortion
• Contraception
• Teen Births
• Unintended Pregnancy

Locations

Country	Name	City	State
United States	Washington University in St. Louis School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (29)

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. — View Citation

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):1311-8. doi: 10.1097/AOG.0b013e3181fae60d. — View Citation

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):745-52. doi: 10.1097/AOG.0b013e3181d4450d. — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.20 — View Citation

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. — View Citation

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):1083-91. doi: 10.1097/AOG.0b013e3182a91f45. — View Citation

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: http://10.1097/AOG.0b013e318273eb56. — View Citation

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):1105-13. doi: 10.1097/AOG.0b013e31821188ad. — View Citation

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 — View Citation

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: http://10.1097/AOG.0b013e31827499bd. — View Citation

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. — View Citation

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. — View Citation

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.0b — View Citation

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. — View Citation

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.20 — View Citation

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):330-6. doi: http://10.1097/AOG.0b013e31827e5898. — View Citation

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):735-9. doi: 10.1097/AOG.0b013e3181d41c4a. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Method Continuation	% 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	No
Secondary	Method Satisfaction	% 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	No
Secondary	Teen Pregnancy Rates	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	No
Secondary	Repeat Abortion Rates	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	No
Secondary	Sexually transmitted infection rates	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	No

External Links

•   CHOICE Project Website