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

October 5, 2023 updated by: University of California, San Francisco

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2086

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, immediate post educational intervention session

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: Baseline, 12 months
Baseline, 12 months
Change in willingness to use long-acting reversible contraception (LARC) (questionnaire)
Time Frame: Baseline, immediate post educational intervention session
Baseline, immediate post educational intervention session
Change in LARC use over 12 months (questionnaire)
Time Frame: Baseline, 12 months
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
Baseline, 6 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unintended pregnancy incidence
Time Frame: 12 months
The researchers will measure pregnancy through questionnaires and urine pregnancy tests.
12 months
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
12 months
Change in receipt of public assistance (questionnaire)
Time Frame: Baseline, 12 months
Baseline, 12 months
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
12 months
Change in provider LARC practices (questionnaire)
Time Frame: Baseline, 12 months
Baseline, 12 months
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 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
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.
Baseline, 12 months
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.
Baseline, 12 months
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).
12 months
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.
12 months
Unintended pregnancy incidence
Time Frame: 3 years
The researchers will measure pregnancy through questionnaires and urine pregnancy tests.
3 years
Certificate or degree completion
Time Frame: 3 years
3 years
Change in receipt of public assistance (questionnaire)
Time Frame: Baseline, 3 years
Baseline, 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Cynthia C. Harper, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2018

Primary Completion (Actual)

May 31, 2023

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

March 21, 2018

First Submitted That Met QC Criteria

May 7, 2018

First Posted (Actual)

May 9, 2018

Study Record Updates

Last Update Posted (Estimated)

October 9, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A125604

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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