NCT03519685

Brief Summary

The purpose of this study is to measure whether a training and education intervention for clinic staff and young women aged 18-25 on contraceptive methods, including intrauterine devices (IUDs) and the implant, will result in greater contraceptive knowledge and access among students in community colleges.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,086

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 21, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

April 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 9, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

5.1 years

First QC Date

March 21, 2018

Last Update Submit

June 11, 2025

Conditions

Keywords

ContraceptionHormonal contraceptionLong-acting reversible contraceptionCondomsEmergency contraceptionFamily planning services

Outcome Measures

Primary Outcomes (1)

  • Change in student knowledge of full range of contraceptive methods (questionnaire)

    The outcome is measured by whether student knows of reversible methods including male condom, female condom, oral contraceptive pill, transdermal patch, vaginal ring, Depo-provera injectable, intrauterine device, subdermal implant, and emergency contraception.

    Baseline, immediate post educational intervention session

Secondary Outcomes (4)

  • Change in student access to contraceptive services over 12 months, measured as whether student knows of or visited health services for contraceptives (questionnaire)

    Baseline, 12 months

  • Change in willingness to use long-acting reversible contraception (LARC) (questionnaire)

    Baseline, immediate post educational intervention session

  • Change in LARC use over 12 months (questionnaire)

    Baseline, 12 months

  • Dual condom use at last sex, measured by student report of condom use together with another method of birth control at last vaginal sex (questionnaire)

    Baseline, 6 months, 12 months

Other Outcomes (13)

  • Unintended pregnancy incidence

    12 months

  • Certificate or degree completion (ordinal outcome including categories for on-time progression for graduation, delayed progression or dropout), measured by student report (questionnaire)

    12 months

  • Change in receipt of public assistance (questionnaire)

    Baseline, 12 months

  • +10 more other outcomes

Study Arms (2)

Contraceptive Training and Education

EXPERIMENTAL

Colleges assigned to this arm receive a one-day UCSF Continuing Medical Education (CME # MMC18087) accredited training on contraceptives and technical assistance. The training is for staff at the student health center and local health centers where they refer for contraceptive services. Students attending colleges assigned to this arm receive education about contraceptive methods and how to access services.

Behavioral: Contraceptive Training and Education

Nutrition Education

PLACEBO COMPARATOR

Students attending colleges assigned to this arm receive nutrition education about the impacts of sugar on health.

Behavioral: Placebo Nutrition Education

Interventions

Staff at the student health center and local health centers where they refer for contraceptive services will receive a CME-accredited education and training session and technical assistance. The one-day session emphasizes evidence-based and patient-centered contraceptive counseling and provision. Students attending colleges assigned to the intervention arm will receive materials and resources designed to educate young people about contraceptive methods and where to access services.

Contraceptive Training and Education

Students attending colleges assigned to the nutrition education arm will receive materials and resources designed to educate young people about the impacts of sugar on health.

Nutrition Education

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • This study involves two groups of human subjects: students at 28 community colleges and staff at the student health center and referral clinics.
  • Students must be:
  • Female;
  • Age 18-25;
  • Speaks English;
  • Sexually active (vaginal sex with a male partner) in the last year;
  • Not currently pregnant;
  • Does not want to become pregnant in the next 12 months;
  • At risk of pregnancy (including not sterilized);
  • Enrolled in the current term at the participating community college;
  • First-time college students, meaning no college enrollment prior to the current academic year; and
  • Willing to be contacted by email and telephone over the next 12 months.
  • Clinic staff must:
  • Be employed by a participating clinic; and
  • Offer clinical care, counseling or education for contraception at the clinic.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94118, United States

Location

Related Publications (28)

  • Stanwood NL, Bradley KA. Young pregnant women's knowledge of modern intrauterine devices. Obstet Gynecol. 2006 Dec;108(6):1417-22. doi: 10.1097/01.AOG.0000245447.56585.a0.

    PMID: 17138775BACKGROUND
  • Frost JJ, Lindberg LD, Finer LB. Young adults' contraceptive knowledge, norms and attitudes: associations with risk of unintended pregnancy. Perspect Sex Reprod Health. 2012 Jun;44(2):107-16. doi: 10.1363/4410712. Epub 2012 May 8.

    PMID: 22681426BACKGROUND
  • Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S43-8. doi: 10.2105/AJPH.2013.301416. Epub 2013 Dec 19.

    PMID: 24354819BACKGROUND
  • Trieu SL, Bratton S, Hopp Marshak H. Sexual and reproductive health behaviors of California community college students. J Am Coll Health. 2011;59(8):744-50. doi: 10.1080/07448481.2010.540764.

    PMID: 21950256BACKGROUND
  • Harper CC, Rocca CH, Thompson KM, Morfesis J, Goodman S, Darney PD, Westhoff CL, Speidel JJ. Reductions in pregnancy rates in the USA with long-acting reversible contraception: a cluster randomised trial. Lancet. 2015 Aug 8;386(9993):562-8. doi: 10.1016/S0140-6736(14)62460-0. Epub 2015 Jun 16.

    PMID: 26091743BACKGROUND
  • Sundstrom B, Baker-Whitcomb A, DeMaria AL. A qualitative analysis of long-acting reversible contraception. Matern Child Health J. 2015 Jul;19(7):1507-14. doi: 10.1007/s10995-014-1655-0.

    PMID: 25424456BACKGROUND
  • Thompson KM, Rocca CH, Kohn JE, Goodman S, Stern L, Blum M, Speidel JJ, Darney PD, Harper CC. Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial. Am J Public Health. 2016 Mar;106(3):541-6. doi: 10.2105/AJPH.2015.303001. Epub 2016 Jan 21.

    PMID: 26794168BACKGROUND
  • Landry DJ, Wei J, Frost JJ. Public and private providers' involvement in improving their patients' contraceptive use. Contraception. 2008 Jul;78(1):42-51. doi: 10.1016/j.contraception.2008.03.009. Epub 2008 May 29.

    PMID: 18555817BACKGROUND
  • Gibbs SE, Rocca CH, Bednarek P, Thompson KMJ, Darney PD, Harper CC. Long-Acting Reversible Contraception Counseling and Use for Older Adolescents and Nulliparous Women. J Adolesc Health. 2016 Dec;59(6):703-709. doi: 10.1016/j.jadohealth.2016.07.018. Epub 2016 Sep 21.

    PMID: 27665153BACKGROUND
  • El Ayadi AM, Rocca CH, Kohn JE, Velazquez D, Blum M, Newmann SJ, Harper CC. The impact of an IUD and implant intervention on dual method use among young women: Results from a cluster randomized trial. Prev Med. 2017 Jan;94:1-6. doi: 10.1016/j.ypmed.2016.10.015. Epub 2016 Oct 20.

    PMID: 27773708BACKGROUND
  • Rocca CH, Thompson KM, Goodman S, Westhoff CL, Harper CC. Funding policies and postabortion long-acting reversible contraception: results from a cluster randomized trial. Am J Obstet Gynecol. 2016 Jun;214(6):716.e1-8. doi: 10.1016/j.ajog.2015.12.009. Epub 2015 Dec 12.

    PMID: 26692178BACKGROUND
  • Harper CC, Henderson JT, Raine TR, Goodman S, Darney PD, Thompson KM, Dehlendorf C, Speidel JJ. Evidence-based IUD practice: family physicians and obstetrician-gynecologists. Fam Med. 2012 Oct;44(9):637-45.

    PMID: 23027156BACKGROUND
  • Kost K, Singh S, Vaughan B, Trussell J, Bankole A. Estimates of contraceptive failure from the 2002 National Survey of Family Growth. Contraception. 2008 Jan;77(1):10-21. doi: 10.1016/j.contraception.2007.09.013. Epub 2007 Dec 3.

    PMID: 18082661BACKGROUND
  • Rocca CH, Harper CC. Do racial and ethnic differences in contraceptive attitudes and knowledge explain disparities in method use? Perspect Sex Reprod Health. 2012 Sep;44(3):150-8. doi: 10.1363/4415012. Epub 2012 Jun 26.

    PMID: 22958659BACKGROUND
  • Finer LB, Zolna MR. Declines in Unintended Pregnancy in the United States, 2008-2011. N Engl J Med. 2016 Mar 3;374(9):843-52. doi: 10.1056/NEJMsa1506575.

    PMID: 26962904BACKGROUND
  • Thompson KM, Stern L, Gelt M, Speidel JJ, Harper CC. Counseling for IUDs and implants: are health educators and clinicians on the same page? Perspect Sex Reprod Health. 2013 Dec;45(4):191-5. doi: 10.1363/4519113. Epub 2013 Oct 28.

    PMID: 24325290BACKGROUND
  • Harper CC, Stratton L, Raine TR, Thompson K, Henderson JT, Blum M, Postlethwaite D, Speidel JJ. Counseling and provision of long-acting reversible contraception in the US: national survey of nurse practitioners. Prev Med. 2013 Dec;57(6):883-8. doi: 10.1016/j.ypmed.2013.10.005. Epub 2013 Oct 12.

    PMID: 24128950BACKGROUND
  • Rocca CH, Goodman S, Grossman D, Cadwallader K, Thompson KMJ, Talmont E, Speidel JJ, Harper CC. Contraception after medication abortion in the United States: results from a cluster randomized trial. Am J Obstet Gynecol. 2018 Jan;218(1):107.e1-107.e8. doi: 10.1016/j.ajog.2017.09.020. Epub 2017 Oct 3.

    PMID: 28986072BACKGROUND
  • Kavanaugh ML, Jerman J, Finer LB. Changes in Use of Long-Acting Reversible Contraceptive Methods Among U.S. Women, 2009-2012. Obstet Gynecol. 2015 Nov;126(5):917-927. doi: 10.1097/AOG.0000000000001094.

    PMID: 26444110BACKGROUND
  • Moore PJ, Adler NE, Kegeles SM. Adolescents and the contraceptive pill: the impact of beliefs on intentions and use. Obstet Gynecol. 1996 Sep;88(3 Suppl):48S-56S. doi: 10.1016/0029-7844(96)00244-x.

    PMID: 8752228BACKGROUND
  • Trussell J. Contraceptive efficacy. In: Hatcher R, Trussell J, Nelson A, Cates W, Kowal D, Policar M, eds. Contraceptive technology, 20th edn. New York: Ardent Media, 2011: 779-863.

    BACKGROUND
  • Whitaker AK, Johnson LM, Harwood B, Chiappetta L, Creinin MD, Gold MA. Adolescent and young adult women's knowledge of and attitudes toward the intrauterine device. Contraception. 2008 Sep;78(3):211-7. doi: 10.1016/j.contraception.2008.04.119. Epub 2008 Jul 3.

    PMID: 18692611BACKGROUND
  • Golden SD, Earp JA. Social ecological approaches to individuals and their contexts: twenty years of health education & behavior health promotion interventions. Health Educ Behav. 2012 Jun;39(3):364-72. doi: 10.1177/1090198111418634. Epub 2012 Jan 20.

    PMID: 22267868BACKGROUND
  • Foster DG, Biggs MA, Ralph L, Gerdts C, Roberts S, Glymour MM. Socioeconomic Outcomes of Women Who Receive and Women Who Are Denied Wanted Abortions in the United States. Am J Public Health. 2018 Mar;108(3):407-413. doi: 10.2105/AJPH.2017.304247. Epub 2018 Jan 18.

    PMID: 29345993BACKGROUND
  • Dehlendorf C, Henderson JT, Vittinghoff E, Steinauer J, Hessler D. Development of a patient-reported measure of the interpersonal quality of family planning care. Contraception. 2018 Jan;97(1):34-40. doi: 10.1016/j.contraception.2017.09.005. Epub 2017 Sep 18.

    PMID: 28935217BACKGROUND
  • Morse SM, Yarger J, Hopkins K, Hecht HK, Rossetto I, Perez LAT, Raymond-Flesch M, Tyler L, Lizarraga M, Hargrave-Bouagnon A, Harper CC. Intimate partner violence and delays in obtaining contraception among young people in California and Texas. Contraception. 2025 Dec;152:111203. doi: 10.1016/j.contraception.2025.111203. Epub 2025 Sep 4.

  • Harper CC, Yarger J, Mangurian C, Hopkins K, Rossetto I, Elmes S, Hecht HK, Sanchez A, Hernandez R, Shokat M, Steinberg JR. Mental Health Distress and Delayed Contraception Among Older Adolescents and Young Adults. J Womens Health (Larchmt). 2024 Jul;33(7):870-878. doi: 10.1089/jwh.2023.0549. Epub 2024 Mar 11.

  • Yarger J, Hopkins K, Elmes S, Rossetto I, De La Melena S, McCulloch CE, White K, Harper CC. Perceived Access to Contraception via Telemedicine Among Young Adults: Inequities by Food and Housing Insecurity. J Gen Intern Med. 2023 Feb;38(2):302-308. doi: 10.1007/s11606-022-07669-0. Epub 2022 Jun 3.

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Cynthia C. Harper, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2018

First Posted

May 9, 2018

Study Start

April 9, 2018

Primary Completion

May 31, 2023

Study Completion

May 29, 2024

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations