LARC Forward Contraceptive Counseling at MHCC

Oregon Health & Science University (OHSU)

Status and phase: Terminated; Phase 4

Conditions: Contraception

Treatments: Other: Prescription for Short-Acting Hormonal Contraception; Drug: Long Acting Reversible Contraception (LARC); Other: Referral for Long Acting Reversible Contraception (LARC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02735551

OHSU IRB 15715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 17 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

Non-LARC Group: Short Acting Method

Active Comparator group

Description:

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

Treatment:

Other: Prescription for Short-Acting Hormonal Contraception

Control Group: Referral for LARC Placement

Active Comparator group

Description:

All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to referral for LARC placement to local clinic.

Treatment:

Other: Referral for Long Acting Reversible Contraception (LARC)

LARC Group: Same Day LARC Placement

Active Comparator group

Description:

All groups will receive the same standardized contraceptive counseling ("LARC forward counseling"). Randomized to same day LARC placement (intervention).

Treatment:

Drug: Long Acting Reversible Contraception (LARC)