Study Summary
This trial will test whether providing training and education to clinic staff and young women on contraceptive methods will lead to increased knowledge and access to these methods, specifically IUDs and implants, among community college students.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 4 Secondary · Reporting Duration: 3 years
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)
Likelihood of finding good job after college measured by questionnaire item asking student if she thinks she will find a good job after college (measured with Likert scale: very likely, likely, unlikely, very unlikely)
Sub-analyses for certificate or degree completion (ordinal outcome including categories for on-time progression for graduation, delayed progression or dropout), measured by student report (questionnaire)
Sub-analyses for unintended pregnancy
3 years
Certificate or degree completion
Unintended pregnancy incidence
Baseline, 12 months
Change in LARC use over 12 months (questionnaire)
Change in provider LARC practices (questionnaire)
Contraceptive Agents
Sub-analyses for change in student access to contraceptive services over 12 months, measured as whether student knew of or visited health services for contraceptives (questionnaire)
Sub-analyses for changes in LARC use over 12 months, measured by whether student is using an IUD or implant (questionnaire)
Baseline, 3 years
Change in receipt of public assistance (questionnaire)
Month 12
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, immediate post educational intervention session
Change in student knowledge of full range of contraceptive methods (questionnaire)
Long-Acting Reversible Contraception
Month 6
Sub-analyses for change in student knowledge of full range of contraceptive methods (questionnaire)
Trial Safety
Safety Progress
Side Effects for
Levora
6%Cervical dysplasia
6%Nausea
4%Upper respiratory infection
4%Nasopharyngitis
3%Sinusitis
1%Murine Typhus
1%Convulsion
1%Sinus Congestion
Trial Design
2 Treatment Groups
Contraceptive Training and Education
1 of 2
Nutrition Education
1 of 2
Experimental Treatment
Non-Treatment Group
2072 Total Participants · 2 Treatment Groups
Primary Treatment: Contraceptive Training and Education · Has Placebo Group · N/A
Contraceptive Training and Education
Behavioral
Experimental Group · 1 Intervention: Contraceptive Training and Education · Intervention Types: BehavioralNutrition Education
Behavioral
PlaceboComparator Group · 1 Intervention: Placebo Nutrition Education · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,283 Previous Clinical Trials
11,575,673 Total Patients Enrolled
Cynthia C. Harper, PhDPrincipal InvestigatorUniversity of California, San Francisco
Eligibility Criteria
Age 18 - 25 · Female Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:and first-generation college students, meaning neither of their parents completed a four-year degree, comprise nearly half of today’s undergraduate student population
I do not want to become pregnant in the next 12 months.
Attended the participating community college in a previous term
The student is currently enrolled in the current term at the participating community college and also attended the participating community college in a previous term.
This study looks at two groups of people: students at 28 community colleges and staff at the student health center and referral clinics.
I can speak English
I have had vaginal sex with a male partner in the last year.
may be pregnant
I am not currently pregnant, but I may be pregnant.
References
- Trieu, Sang Leng, Sally Bratton, and Helen Hopp Marshak. 2011. “Sexual and Reproductive Health Behaviors of California Community College Students”. Journal of American College Health. Informa UK Limited. doi:10.1080/07448481.2010.540764.
- Frost, Jennifer J., Laura Duberstein Lindberg, and Lawrence B. Finer. 2012. “Young Adults' Contraceptive Knowledge, Norms and Attitudes: Associations with Risk of Unintended Pregnancy”. Perspectives on Sexual and Reproductive Health. Guttmacher Institute. doi:10.1363/4410712.
- Sundstrom, Beth, Annalise Baker-Whitcomb, and Andrea L. DeMaria. 2014. “A Qualitative Analysis of Long-acting Reversible Contraception”. Maternal and Child Health Journal. Springer Science and Business Media LLC. doi:10.1007/s10995-014-1655-0.
- Finer, Lawrence B., and Mia R. Zolna. 2016. “Declines in Unintended Pregnancy in the United States, 2008–2011”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmsa1506575.
- El Ayadi, Alison M., Corinne H. Rocca, Julia E. Kohn, Denisse Velazquez, Maya Blum, Sara J. Newmann, and Cynthia C. Harper. 2017. “The Impact of an IUD and Implant Intervention on Dual Method Use Among Young Women: Results from a Cluster Randomized Trial”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2016.10.015.
- Rocca, Corinne H., Kirsten M.J. Thompson, Suzan Goodman, Carolyn L. Westhoff, and Cynthia C. Harper. 2016. “Funding Policies and Postabortion Long-acting Reversible Contraception: Results from a Cluster Randomized Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2015.12.009.
- Harper, Cynthia C., Laura Stratton, Tina R. Raine, Kirsten Thompson, Jillian T. Henderson, Maya Blum, Debbie Postlethwaite, and J. Joseph Speidel. 2013. “Counseling and Provision of Long-acting Reversible Contraception in the US: National Survey of Nurse Practitioners”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2013.10.005.
- Stanwood, Nancy L., and Karen A. Bradley. 2006. “Young Pregnant Women’s Knowledge of Modern Intrauterine Devices”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.aog.0000245447.56585.a0.
- Gibbs, Susannah E., Corinne H. Rocca, Paula Bednarek, Kirsten M.J. Thompson, Philip D. Darney, and Cynthia C. Harper. 2016. “Long-acting Reversible Contraception Counseling and Use for Older Adolescents and Nulliparous Women”. Journal of Adolescent Health. Elsevier BV. doi:10.1016/j.jadohealth.2016.07.018.
- Moore, P. 1996. “Adolescents and the Contraceptive Pill: The Impact of Beliefs on Intentions and Use”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/0029-7844(96)00244-x.
- Harper, Cynthia C, Corinne H Rocca, Kirsten M Thompson, Johanna Morfesis, Suzan Goodman, Philip D Darney, Carolyn L Westhoff, and J Joseph Speidel. 2015. “Reductions in Pregnancy Rates in the USA with Long-acting Reversible Contraception: A Cluster Randomised Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(14)62460-0.
- Thompson, Kirsten M. J., Corinne H. Rocca, Julia E. Kohn, Suzan Goodman, Lisa Stern, Maya Blum, J. Joseph Speidel, Philip D. Darney, and Cynthia C. Harper. 2016. “Public Funding for Contraception, Provider Training, and Use of Highly Effective Contraceptives: A Cluster Randomized Trial”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2015.303001.
- Thompson, Kirsten M.J., Lisa Stern, Marsha Gelt, J. Joseph Speidel, and Cynthia C. Harper. 2013. “Counseling for Iuds and Implants: Are Health Educators and Clinicians on the Same Page?”. Perspectives on Sexual and Reproductive Health. Guttmacher Institute. doi:10.1363/4519113.
- Golden, Shelley D., and Jo Anne L. Earp. 2012. “Social Ecological Approaches to Individuals and Their Contexts”. Health Education & Behavior. SAGE Publications. doi:10.1177/1090198111418634.
- Finer, Lawrence B., and Mia R. Zolna. 2014. “Shifts in Intended and Unintended Pregnancies in the United States, 2001–2008”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2013.301416.
- Rocca, Corinne H., and Cynthia C. Harper. 2012. “Do Racial and Ethnic Differences in Contraceptive Attitudes and Knowledge Explain Disparities in Method Use?”. Perspectives on Sexual and Reproductive Health. Guttmacher Institute. doi:10.1363/4415012.
- Whitaker, Amy K., Lisa M. Johnson, Bryna Harwood, Laurel Chiappetta, Mitchell D. Creinin, and Melanie A. Gold. 2008. “Adolescent and Young Adult Women's Knowledge of and Attitudes Toward the Intrauterine Device”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2008.04.119.
- Dehlendorf, Christine, Jillian T. Henderson, Eric Vittinghoff, Jody Steinauer, and Danielle Hessler. 2018. “Development of a Patient-reported Measure of the Interpersonal Quality of Family Planning Care”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2017.09.005.
- Rocca, Corinne H., Suzan Goodman, Daniel Grossman, Kara Cadwallader, Kirsten M.J. Thompson, Elizabeth Talmont, J. Joseph Speidel, and Cynthia C. Harper. 2018. “Contraception After Medication Abortion in the United States: Results from a Cluster Randomized Trial”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2017.09.020.
- Foster, D. G., M. A. Biggs, L. Ralph, C. Gerdts, S. Roberts, and M. M. Glymour. 2022. “Socioeconomic Outcomes of Women Who Receive and Women Who Are Denied Wanted Abortions in the United States”. American Journal of Public Health. American Public Health Association. doi:10.2105/ajph.2017.304247.
- Landry, David J., Junhow Wei, and Jennifer J. Frost. 2008. “Public and Private Providers' Involvement in Improving Their Patients' Contraceptive Use”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2008.03.009.
- Kost, Kathryn, Susheela Singh, Barbara Vaughan, James Trussell, and Akinrinola Bankole. 2008. “Estimates of Contraceptive Failure from the 2002 National Survey of Family Growth”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2007.09.013.
- Luchowski, Alicia T., Britta L. Anderson, Michael L. Power, Greta B. Raglan, Eve Espey, and Jay Schulkin. 2014. “Obstetrician–gynecologists and Contraception: Long-acting Reversible Contraception Practices and Education”. Contraception. Elsevier BV. doi:10.1016/j.contraception.2014.02.004.
- Kavanaugh, Megan L., Jenna Jerman, and Lawrence B. Finer. 2015. “Changes in Use of Long-acting Reversible Contraceptive Methods Among U.S. Women, 2009–2012”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000001094.
- 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.
- Yarger, Jennifer, Kristine Hopkins, Sarah Elmes, Irene Rossetto, Stephanie De La Melena, Charles E. McCulloch, Kari White, and Cynthia C. Harper. 2022. “Perceived Access to Contraception via Telemedicine Among Young Adults: Inequities by Food and Housing Insecurity”. Journal of General Internal Medicine. Springer Science and Business Media LLC. doi:10.1007/s11606-022-07669-0.
- 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.
- 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.
- 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.
- 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. 2022 Jun 3:1-7. doi: 10.1007/s11606-022-07669-0. Online ahead of print.
- 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. Erratum In: J Adolesc Health. 2018 Jan;62(1):121.
- 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.
- 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.
- 2018. "UCSF College Health Study on Contraceptive Training and Education at Community Colleges". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03519685.
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