ContraceptionNCT03519685
UCSF College Health Study on Contraceptive Training and Education at Community Colleges
A study testing Contraceptive Training and Education in people with Contraception, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Contraceptive Training and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,086 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Apr 2018to 29 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Show all 20Show fewer
- 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.
Who cannot join
- Students and clinic staff will be excluded if they do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94118
About this study
Official title: UCSF College Health Study: A Cluster Randomized Trial on Contraceptive Training and Education at Community Colleges
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.
Read the detailed 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.
- Conditions
- Contraception
- Being tested
- Contraceptive Training and Education, Placebo Nutrition Education
- Keywords
- Contraception, Hormonal contraception, Long-acting reversible contraception, Condoms, Emergency contraception, Family planning services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive Training and EducationBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Placebo Nutrition Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Baseline, 12 months
Change in willingness to use long-acting reversible contraception (LARC) (questionnaire)
Measured: Baseline, immediate post educational intervention session
Change in LARC use over 12 months (questionnaire)
Measured: 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)
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start9 Apr 2018
- Primary completion31 May 2023
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia C. Harper, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519685
- Sponsor's protocol ID
- A125604
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2018
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17138775Frost 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.
PubMed 22681426Finer 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.
PubMed 24354819Trieu 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.
PubMed 21950256Harper 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.
PubMed 26091743Sundstrom 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.
PubMed 25424456Thompson 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.
PubMed 26794168Landry 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.
PubMed 18555817Gibbs 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.
PubMed 27665153El 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.
PubMed 27773708Rocca 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.
PubMed 26692178Harper 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.
PubMed 23027156Kost 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.
PubMed 18082661Rocca 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.
PubMed 22958659Finer 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.
PubMed 26962904
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UCSF College Health Study: A Cluster Randomized Trial on Contraceptive Training and Education at Community Colleges
- ClinicalTrials.gov ID
- NCT03519685
- Acronym / sponsor ID
- A125604
- Conditions
- Contraception
- Keywords
- Contraception, Hormonal contraception, Long-acting reversible contraception, Condoms, Emergency contraception, Family planning services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,086 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Contraceptive Training and Education | Experimental | Behavioral: Contraceptive Training and EducationColleges 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. |
| Nutrition Education | Placebo comparator | Behavioral: Placebo Nutrition EducationStudents attending colleges assigned to this arm receive nutrition education about the impacts of sugar on health. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- This study involves two groups of human subjects: students at 28 community colleges and staff at the student health center and referral clinics.
- Female;
- Age 18-25;
- Speaks English;
- Sexually active (vaginal sex with a male partner) in the last year;
Key exclusion criteria (1 listed)
- Students and clinic staff will be excluded if they do not meet the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contraceptive Training and EducationStaff 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. | Behavioural | Contraceptive Training and Education |
| Placebo Nutrition EducationStudents 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. | Behavioural | Nutrition Education |
Primary outcome
Change in student knowledge of full range of contraceptive methods (questionnaire)
Time frame: Baseline, immediate post educational intervention session
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.
4 secondary outcomes
Change in student access to contraceptive services over 12 months, measured as whether student knows of or visited health services for contraceptives (questionnaire)
Time frame: Baseline, 12 months
Change in willingness to use long-acting reversible contraception (LARC) (questionnaire)
Time frame: Baseline, immediate post educational intervention session
Change in LARC use over 12 months (questionnaire)
Time frame: 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)
Time frame: Baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Background: PubMed 17138775Stanwood 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.
- Background: PubMed 22681426Frost 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.
- Background: PubMed 24354819Finer 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.
- Background: PubMed 21950256Trieu 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.
- Background: PubMed 26091743Harper 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.
- Background: PubMed 25424456Sundstrom 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.
- Background: PubMed 26794168Thompson 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.
- Background: PubMed 18555817Landry 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.
- Background: PubMed 27665153Gibbs 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.
- Background: PubMed 27773708El 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.
- Background: PubMed 26692178Rocca 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.
- Background: PubMed 23027156Harper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia C. Harper, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraceptive Training and Education in people with Contraception, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in student knowledge of full range of contraceptive methods (questionnaire) (time frame: Baseline, immediate post educational intervention session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03519685, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.