Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
3 participants
INTERVENTIONAL
2016-04-30
2017-03-31
Brief Summary
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Detailed Description
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During the study participants will undergo counseling to choose the method of birth control that is right for them. This will include watching an informational video and having a discussion with study staff. If participants choose pills, the patch the ring, or a diaphragm and do not have any contraindications to this method, they will receive a prescription for this method to be filled at the pharmacy of their choice. If participants choose Depo-Provera (the shot), they will receive their first shot on the day of their visit and a prescription for repeat shots every 3 months. If participants choose to have an IUD or Implant as their method of birth control, they will be randomized to one of two groups. There is a 50% chance of having the intrauterine device (IUD) or Implant placed immediately after the counseling session and a 50% chance of receiving a list of local clinics that can place the device at a later time.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Non-LARC Group: Short Acting Method
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice, as is the current practice for students who present for contraceptive services
Prescription for Short-Acting Hormonal Contraception
Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
Control Group: Referral for LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to referral for LARC placement to local clinic.
Referral for Long Acting Reversible Contraception (LARC)
Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
LARC Group: Same Day LARC Placement
All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention).
Long Acting Reversible Contraception (LARC)
Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
Interventions
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Long Acting Reversible Contraception (LARC)
Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
Referral for Long Acting Reversible Contraception (LARC)
Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
Prescription for Short-Acting Hormonal Contraception
Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
Eligibility Criteria
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Inclusion Criteria
* 17-30 years of age.
* Currently enrolled in a 2-year certificate program at Mount Hood Community College.
* At risk for pregnancy (sexually active with men or anticipate becoming sexually active in the next 6 months).
* Do not desire pregnancy within the next 12 months.
* No contraindications to LARC according to the Center for Disease Control and Prevention medical eligibility criteria (CDC MEC)
Exclusion Criteria
* Women who have had a tubal ligation or other sterilization procedure.
* Women who desire pregnancy within the next 12 months.
* Women currently already using a LARC method for contraception.
17 Years
30 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Bayer
INDUSTRY
Society of Family Planning
OTHER
Oregon Health and Science University
OTHER
Responsible Party
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Jacqueline Lamme
Adjunct Instructor
Principal Investigators
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Jacqueline Lamme, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Mount Hood Community College
Gresham, Oregon, United States
Countries
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References
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Lamme J, Edelman A, Padua E, Jensen JT. Evaluation of the challenges faced in increasing contraceptive access within a community college population. Contracept Reprod Med. 2017 Oct 23;2:25. doi: 10.1186/s40834-017-0051-8. eCollection 2017.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OHSU IRB 15715
Identifier Type: -
Identifier Source: org_study_id
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