Clinical trial NCT03519685: UCSF College Health Study on Contraceptive Training and Education at Community Colleges
Official title: UCSF College Health Study: A Cluster Randomized Trial on Contraceptive Training and Education at Community Colleges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: Contraception
Hormonal contraception
Long-acting reversible contraception
Condoms
Emergency contraception
Family planning services
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2018-05-09
Enrollment: 2086
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in student knowledge of full range of contraceptive methods (questionnaire)
timeFrame: Baseline, immediate post educational intervention session
Secondary outcomes:
measure: Change in student access to contraceptive services over 12 months, measured as whether student knows of or visited health services for contraceptives (questionnaire)
timeFrame: Baseline, 12 months
measure: Change in willingness to use long-acting reversible contraception (LARC) (questionnaire)
timeFrame: Baseline, immediate post educational intervention session
measure: Change in LARC use over 12 months (questionnaire)
timeFrame: Baseline, 12 months
measure: 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)
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
measure: Unintended pregnancy incidence
timeFrame: 12 months
measure: Certificate or degree completion (ordinal outcome including categories for on-time progression for graduation, delayed progression or dropout), measured by student report (questionnaire)
timeFrame: 12 months
measure: Change in receipt of public assistance (questionnaire)
timeFrame: Baseline, 12 months
measure: 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)
timeFrame: 12 months
measure: Change in provider LARC practices (questionnaire)
timeFrame: Baseline, 12 months
measure: Sub-analyses for change in student knowledge of full range of contraceptive methods (questionnaire)
timeFrame: Baseline, immediate post educational intervention session, 6 months
measure: 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)
timeFrame: Baseline, 12 months
measure: Sub-analyses for changes in LARC use over 12 months, measured by whether student is using an IUD or implant (questionnaire)
timeFrame: Baseline, 12 months
measure: Sub-analyses for unintended pregnancy
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: Unintended pregnancy incidence
timeFrame: 3 years
measure: Certificate or degree completion
timeFrame: 3 years
measure: Change in receipt of public assistance (questionnaire)
timeFrame: Baseline, 3 years
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Cynthia C. Harper, PhD
role: PRINCIPAL_INVESTIGATOR
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