Innovative Model of Patient-Centered ConTraception

NCT02364037 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1008

Last updated 2020-06-02

Study results available
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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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02364037 on ClinicalTrials.gov