Clinical trial NCT02735551: LARC Forward Contraceptive Counseling at MHCC
Official title: Effectiveness of LARC Forward Contraceptive Counseling and Same Day Placement in a Community College Population: A Randomized Intervention Project
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Contraception
Keywords: LARC
IUD
Contraceptive Implant
Contraception
Community college
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Bayer
name: Society of Family Planning
First posted: 2016-04-12
Enrollment: 3
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Reporting Ongoing Use and Satisfaction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gresham
country: United States
facility: Mount Hood Community College
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jacqueline Lamme, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.