Innovative Model of Patient-Centered ConTraception
NCT02364037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1008
Last updated 2020-06-02
Summary
This study is testing models of contraceptive care that were developed as part of the Contraceptive CHOICE Project. CHOICE is a prospective cohort study of 9,256 women designed to: 1) promote the use of long-acting reversible contraceptive (LARC) methods which include interuterine devices (IUD) and subdermal implants; 2) remove financial barriers to contraception; 3) evaluate continuation of and satisfaction with reversible methods; and 4) reduce unintended pregnancies in the St. Louis region. CHOICE demonstrated that interventions such as comprehensive contraceptive counseling, increased access, and removal of financial barriers increase the uptake of LARC methods and reduce unintended pregnancy. The investigators objective is to determine whether the CHOICE model of contraceptive care can be equally successful in the real world of community clinics.
Conditions
- Contraception
- Unintended Pregnancy
Interventions
- BEHAVIORAL
-
CHOICE Project Structured Contraceptive Counseling
Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
- BEHAVIORAL
-
Contraceptive Education Session
Prior to Phase 2, health care providers at the recruitment sites will undergo a contraceptive education session with a focus on evidence-based provision of contraception including LARC (IUDs and implant) and same-day insertion.
- DEVICE
-
Cost Support for IUDs and implants
Women in Phase 2 of the study who desire an IUD or implant can receive one through the study at no cost if they do not have insurance coverage. If women have insurance that covers the device, her insurance will be billed for the cost of the device.
Sponsors & Collaborators
-
Family Care Health Centers
collaborator UNKNOWN -
Memphis Health Center
collaborator UNKNOWN -
A Step Ahead Foundation
collaborator OTHER -
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Tessa Madden, MD/MPH · Washington University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 14 Years
- Max Age
- 45 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-08-31
- Primary Completion
- 2017-01-01
- Completion
- 2017-10-31
Countries
- United States
Study Locations
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