LARC Forward Contraceptive Counseling at MHCC

NCT ID: NCT02735551

Last Updated: 2019-11-12

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-03-31

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.

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Prescription for Short-Acting Hormonal Contraception

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

Referral for Long Acting Reversible Contraception (LARC)

Intervention Type OTHER

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).

Group Type ACTIVE_COMPARATOR

Long Acting Reversible Contraception (LARC)

Intervention Type DRUG

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

Intervention Type DRUG

Referral for Long Acting Reversible Contraception (LARC)

Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)

Intervention Type 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

Intervention Type OTHER

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.
Minimum Eligible Age

17 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

Society of Family Planning

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jacqueline Lamme

Adjunct Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 29201430 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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OHSU IRB 15715

Identifier Type: -

Identifier Source: org_study_id

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