UCSF College Health Study on Contraceptive Training and Education at Community Colleges

Contraception Clinical Trial

Official title:

UCSF College Health Study: A Cluster Randomized Trial on Contraceptive Training and Education at Community Colleges

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03519685
• Other study ID #: A125604
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 9, 2018
• Est. completion date: May 2024

Study information

• Verified date: October 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In the US, young women aged 18-25 years have limited knowledge of contraception or pregnancy risks and often experience challenges in accessing reproductive health care. They have little familiarity with the full range of contraceptives, particularly long-acting reversible contraception (LARC) including the IUD and implant. This campus-level, multiple component intervention provides evidence-based contraceptive training and education to clinic staff and students in this age group attending community colleges in California and Texas.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2086
• Est. completion date: May 2024
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

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.

For colleges to be eligible to be study sites, they must:

• Be an accredited community college;
• Not share health center staff with a participating college site;
• Have no active LARC intervention; and
• Enroll students ages 18-25 years.

Exclusion Criteria:

• Students and clinic staff will be excluded if they do not meet the inclusion criteria.

Related Conditions & MeSH terms

• Contraception

Intervention

Behavioral:
• Contraceptive Training and Education
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.
• Placebo Nutrition 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.

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (25)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Unintended pregnancy incidence	The researchers will measure pregnancy through questionnaires and urine pregnancy tests.	12 months
Other	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
Other	Change in receipt of public assistance (questionnaire)		Baseline, 12 months
Other	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)		12 months
Other	Change in provider LARC practices (questionnaire)		Baseline, 12 months
Other	Sub-analyses for 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. The researchers will assess the outcome of student contraceptive knowledge by sociodemographic factors (age, race/ethnicity, parental education, health insurance, receipt of public assistance) and reproductive characteristics (parity, pregnancy intentions, male partner, prior contraceptive use).	Baseline, immediate post educational intervention session, 6 months
Other	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)	The researchers will assess the outcome of contraceptive access by sociodemographic factors (age, race/ethnicity, parental education, health insurance, receipt of public assistance) and reproductive characteristics (parity, pregnancy intentions, male partner, prior contraceptive use). The researchers will also test interaction of the intervention with race/ethnicity, parental education, and health insurance.	Baseline, 12 months
Other	Sub-analyses for changes in LARC use over 12 months, measured by whether student is using an IUD or implant (questionnaire)	The researchers will assess the outcome of LARC use over 12 months by sociodemographic factors (age, race/ethnicity, health insurance), reproductive characteristics (parity, pregnancy intentions, prior contraceptive use) and women's autonomy in contraceptive decision-making including perceptions of bias in education and counseling.	Baseline, 12 months
Other	Sub-analyses for unintended pregnancy	The researchers will assess the outcome of unintended pregnancy by sociodemographic factors (age, race/ethnicity, parental education, health insurance, receipt of public assistance) and reproductive characteristics (parity, pregnancy intentions, male partner, prior contraceptive use).	12 months
Other	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)	The researchers will assess the ordinal educational outcome variable by age, race/ethnicity, parental education, and poverty. The researchers will also test interaction of the intervention with race/ethnicity, parental education, and poverty.	12 months
Other	Unintended pregnancy incidence	The researchers will measure pregnancy through questionnaires and urine pregnancy tests.	3 years
Other	Certificate or degree completion		3 years
Other	Change in receipt of public assistance (questionnaire)		Baseline, 3 years
Primary	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	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
Secondary	Change in willingness to use long-acting reversible contraception (LARC) (questionnaire)		Baseline, immediate post educational intervention session
Secondary	Change in LARC use over 12 months (questionnaire)		Baseline, 12 months
Secondary	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