Contraceptive Training and Education for Birth Control

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Birth ControlContraceptive Training and Education - Behavioral
Eligibility
18 - 25
Female
What conditions do you have?
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Study Summary

This trial will test whether providing training and education to clinic staff and young women on contraceptive methods will lead to increased knowledge and access to these methods, specifically IUDs and implants, among community college students.

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 3 years

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)
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)
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)
Sub-analyses for unintended pregnancy
3 years
Certificate or degree completion
Unintended pregnancy incidence
Baseline, 12 months
Change in LARC use over 12 months (questionnaire)
Change in provider LARC practices (questionnaire)
Contraceptive Agents
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)
Sub-analyses for changes in LARC use over 12 months, measured by whether student is using an IUD or implant (questionnaire)
Baseline, 3 years
Change in receipt of public assistance (questionnaire)
Month 12
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, immediate post educational intervention session
Change in student knowledge of full range of contraceptive methods (questionnaire)
Long-Acting Reversible Contraception
Month 6
Sub-analyses for change in student knowledge of full range of contraceptive methods (questionnaire)

Trial Safety

Side Effects for

Levora
6%Cervical dysplasia
6%Nausea
4%Upper respiratory infection
4%Nasopharyngitis
3%Sinusitis
1%Murine Typhus
1%Convulsion
1%Sinus Congestion
This histogram enumerates side effects from a completed 2011 Phase 3 trial (NCT01236768) in the Levora ARM group. Side effects include: Cervical dysplasia with 6%, Nausea with 6%, Upper respiratory infection with 4%, Nasopharyngitis with 4%, Sinusitis with 3%.

Trial Design

2 Treatment Groups

Contraceptive Training and Education
1 of 2
Nutrition Education
1 of 2

Experimental Treatment

Non-Treatment Group

2072 Total Participants · 2 Treatment Groups

Primary Treatment: Contraceptive Training and Education · Has Placebo Group · N/A

Contraceptive Training and Education
Behavioral
Experimental Group · 1 Intervention: Contraceptive Training and Education · Intervention Types: Behavioral
Nutrition Education
Behavioral
PlaceboComparator Group · 1 Intervention: Placebo Nutrition Education · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,283 Previous Clinical Trials
11,575,673 Total Patients Enrolled
Cynthia C. Harper, PhDPrincipal InvestigatorUniversity of California, San Francisco

Eligibility Criteria

Age 18 - 25 · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
and first-generation college students, meaning neither of their parents completed a four-year degree, comprise nearly half of today’s undergraduate student population
I do not want to become pregnant in the next 12 months.
Attended the participating community college in a previous term The student is currently enrolled in the current term at the participating community college and also attended the participating community college in a previous term.
This study looks at two groups of people: students at 28 community colleges and staff at the student health center and referral clinics.
I can speak English
I have had vaginal sex with a male partner in the last year.
may be pregnant I am not currently pregnant, but I may be pregnant.
References