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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Behavioral: Contraceptive Training and Education
* Behavioral: Placebo Nutrition Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Contraceptive Training and Education<br>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<br>* 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.<br>|
| Placebo Comparator: Nutrition Education<br>Students attending colleges assigned to this arm receive nutrition education about the impacts of sugar on health. | Behavioral: Placebo Nutrition Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Hormonal contraception, Long-acting reversible contraception, Condoms, Emergency contraception, Family planning services