LARC Forward Contraceptive Counseling at MHCC

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of LARC Forward Contraceptive Counseling and Same Day Placement in a Community College Population: A Randomized Intervention Project

Conditions
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Contraception

Intervention / Treatment
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* Drug: Long Acting Reversible Contraception (LARC)
* Other: Referral for Long Acting Reversible Contraception (LARC)
* Other: Prescription for Short-Acting Hormonal Contraception


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-LARC Group: Short Acting Method<br>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<br>* 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<br>|
| Active Comparator: Control Group: Referral for LARC Placement<br>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)<br>* Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)<br>|
| Active Comparator: LARC Group: Same Day LARC Placement<br>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)<br>* Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Reporting Ongoing Use and Satisfaction | 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. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LARC, IUD, Contraceptive Implant, Contraception, Community college