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Clinical Trials/NCT03519685
NCT03519685CompletedNot Applicable

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

University of California, San Francisco1 site in 1 country2,086 target enrollmentStarted: April 9, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,086
Locations
1
Primary Endpoint
Change in student knowledge of full range of contraceptive methods (questionnaire)

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 25 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

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:
  • •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.

Arms & Interventions

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.

Intervention: Contraceptive Training and Education (Behavioral)

Nutrition Education

Placebo Comparator

Students attending colleges assigned to this arm receive nutrition education about the impacts of sugar on health.

Intervention: Placebo Nutrition Education (Behavioral)

Outcomes

Primary Outcomes

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.

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)(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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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