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

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ClinicalTrials.gov Identifier: NCT03519685
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Cynthia Harper, University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Contraception Behavioral: Contraceptive Training and Education Behavioral: Placebo Nutrition Education Not Applicable

Detailed Description:
In the US, young women aged 18-25 years experience high rates of unintended pregnancy and have limited knowledge of contraception or their pregnancy risks. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: UCSF College Health Study: A Cluster Randomized Trial on Contraceptive Training and Education at Community Colleges
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arm Intervention/treatment
Experimental: Contraceptive Training and Education
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
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 Comparator: Nutrition Education
Students attending colleges assigned to this arm receive nutrition education about the impacts of sugar on health.
Behavioral: 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.




Primary Outcome Measures :
  1. Change in student knowledge of full range of contraceptive methods (questionnaire) [ Time Frame: Baseline, immediate post educational intervention session ]
    The outcome is measure by whether student knows these reversible methods including male condom, female condom, oral contraceptive pill, transdermal patch, vaginal ring, Depo-provera injectable, intrauterine device, subdermal implant, and emergency contraception.


Secondary Outcome Measures :
  1. 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 ]
  2. Change in willingness to use long-acting reversible contraception (LARC) (questionnaire) [ Time Frame: Baseline, immediate post educational intervention session ]
  3. Change in LARC use over 12 months (questionnaire) [ Time Frame: Baseline, 12 months ]
  4. 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 ]

Other Outcome Measures:
  1. Unintended pregnancy incidence [ Time Frame: 12 months ]
    The researchers will measure pregnancy through questionnaires and urine pregnancy tests.

  2. Certificate or degree completion (ordinal outcome including categories for on-time progression for graduation, delayed progression or dropout), measured by student report (questionnaire) [ Time Frame: 12 months ]
  3. Change in receipt of public assistance (questionnaire) [ Time Frame: Baseline, 12 months ]
  4. 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) [ Time Frame: 12 months ]
  5. Change in provider LARC practices (questionnaire) [ Time Frame: Baseline, 12 months ]
  6. Sub-analyses for change in student knowledge of full range of contraceptive methods (questionnaire) [ Time Frame: Baseline, immediate post educational intervention session, 6 months ]
    The outcome is measure by whether student knows these 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).

  7. 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) [ Time Frame: Baseline, 12 months ]
    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.

  8. Sub-analyses for changes in LARC use over 12 months, measured by whether student is using an IUD or implant (questionnaire) [ Time Frame: Baseline, 12 months ]
    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.

  9. Sub-analyses for unintended pregnancy [ Time Frame: 12 months ]
    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).

  10. 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) [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

This study involves two groups of human subjects: students at 20 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519685


Contacts
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Contact: Cynthia Harper, PhD 415-502-4092 cynthia.harper@ucsf.edu

Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco

Publications:
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.

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Responsible Party: Cynthia Harper, Professor, Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03519685     History of Changes
Other Study ID Numbers: A125604
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cynthia Harper, University of California, San Francisco:
Contraception
Hormonal contraception
Long-acting reversible contraception
Condoms
Emergency contraception
Family planning services

Additional relevant MeSH terms:
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Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs