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LARC Forward Contraceptive Counseling at MHCC

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ClinicalTrials.gov Identifier: NCT02735551
Recruitment Status : Terminated (Inadequate participant enrollment during recruitment period.)
First Posted : April 12, 2016
Results First Posted : January 3, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
Bayer
Society of Family Planning
Information provided by (Responsible Party):
Jacqueline Lamme, Oregon Health and Science University

Study Description
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Brief Summary:
This prospective randomized controlled study will evaluate if Long Acting Reversible Contraceptive (LARC) forward counseling in combination with same-day LARC placement increases overall LARC uptake within a community college population compared to LARC forward counseling and referral to a secondary clinic for LARC placement. The study will be conducted at Mount Hood Community College (MHCC) in Oregon. Participants will be enrolled into three groups. All groups will receive the same standardized contraceptive counseling ("LARC forward counseling") and participants will be able to choose between a LARC method and short-acting method of birth control.

Condition or disease Intervention/treatment Phase
Contraception Drug: Long Acting Reversible Contraception (LARC) Other: Referral for Long Acting Reversible Contraception (LARC) Other: Prescription for Short-Acting Hormonal Contraception Phase 4

Detailed Description:

The purpose of this study is to evaluate the benefit of an on-campus birth control counseling and services clinic. Currently there are no health services that provide access to birth control located on the Mount Hood Community College (MHCC) campus. We are offering a temporary 'Birth Control Resource Center' for eligible students. All forms of birth control in this study are FDA approved.

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effectiveness of LARC Forward Contraceptive Counseling and Same Day Placement in a Community College Population: A Randomized Intervention Project
Study Start Date : April 2016
Actual Primary Completion Date : March 13, 2017
Actual Study Completion Date : March 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Other: 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
Active Comparator: 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.
 Other: Referral for Long Acting Reversible Contraception (LARC)
Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
Active Comparator: 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).
 Drug: Long Acting Reversible Contraception (LARC)
Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants Reporting Ongoing Use and Satisfaction [ Time Frame: 3 months ]
    Proportion of Long Acting Reversible Contraception (LARC) uptake among women, by group assignment. This will be evaluated based on participants' self-reported ongoing use and satisfaction by group assignment on the 3-month questionnaire after the initial visit. 3 months following placement of LARC device, initiation of short acting method, and those in the control group, participants will complete a questionnaire in order to assess ongoing use and satisfaction of their contraceptive method. This will be measured on the 3-month questionnaire.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English or Spanish-speaking women.
  • 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 are not currently sexually active with men and who do not anticipate becoming sexually active with a male partner in the next 6 months.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02735551


Locations
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United States, Oregon
Mount Hood Community College
Gresham, Oregon, United States, 97030
Sponsors and Collaborators
Oregon Health and Science University
Merck Sharp & Dohme LLC
Bayer
Society of Family Planning
Investigators
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Principal Investigator: Jacqueline Lamme, MD Oregon Health and Science University
  Study Documents (Full-Text)

Documents provided by Jacqueline Lamme, Oregon Health and Science University:
Study Protocol and Statistical Analysis Plan  [PDF] January 31, 2017

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jacqueline Lamme, Adjunct Instructor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02735551    
Other Study ID Numbers: OHSU IRB 15715
First Posted: April 12, 2016    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: November 12, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jacqueline Lamme, Oregon Health and Science University:
LARC
IUD
Contraceptive Implant
Contraception
Community college