LARC Forward Contraceptive Counseling at MHCC

NCT02735551 | Terminated Phase 4 Results

• 1 other identifier: OHSU IRB 15715
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

LARC; IUD; Contraceptive Implant; Contraception; Community college

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Non-LARC Group: Short Acting Method

ACTIVE COMPARATOR

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

Control Group: Referral for LARC Placement

ACTIVE COMPARATOR

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)

LARC Group: Same Day LARC Placement

ACTIVE COMPARATOR

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)

Interventions

Long Acting Reversible Contraception (LARC) DRUG

Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon

LARC Group: Same Day LARC Placement

Referral for Long Acting Reversible Contraception (LARC) OTHER

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

Control Group: Referral for LARC Placement

Prescription for Short-Acting Hormonal Contraception 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

Non-LARC Group: Short Acting Method

Eligibility Criteria

• Age: 17 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• English or Spanish-speaking women.
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Merck Sharp & Dohme LLC: collaborator
• Bayer: collaborator
• Society of Family Planning: collaborator

Study Sites (1)

Mount Hood Community College

Gresham, Oregon, 97030, United States

Location

Related Publications (1)

• 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.

  PMID: 29201430 DERIVED

MeSH Terms

Interventions

Long-Acting Reversible Contraception; Referral and Consultation; Prescriptions

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics; Professional Practice; Organization and Administration; Health Services Administration; Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Ob/Gyn Regulatory Specialist
• Organization: Oregon Health & Science University

mccrimmo@ohsu.edu

5034940757

Study Officials

• Jacqueline Lamme, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Instructor

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: April 12, 2016
• Study Start: April 1, 2016
• Primary Completion: March 13, 2017
• Study Completion: March 31, 2017
• Last Updated: November 12, 2019
• Results First Posted: January 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)