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Completed

NCT Number: NCT02364037

Innovative Model of Patient-Centered ConTraception

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.

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Key information

Conditions

Contraception Unintended Pregnancy

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Family Care Health Center Carondelet, St Louis, Missouri, United States

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About this study

This project involves comparing two models of contraceptive care; 'enhanced care' which is usual care plus the CHOICE structured contraceptive counseling, and the 'complete CHOICE' group which includes the structured contraceptive counseling as well as provider training and cost support for IUDs and implants. Participants will be enrolled at three partner community clinics by a staff member (site coordinator) dedicated to the research study. All participants will undergo contraceptive counseling as well as a baseline survey with the coordinator. Participants will complete telephone surveys at 3, 6, and 12 months post-enrollment and will be asked about contraceptive method chosen, satisfaction and continuation of the method, and any pregnancies experienced since enrollment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 14-45 years of age
  • Does not desire pregnancy during the next 12 months
  • Desires reversible contraception
  • Sexually active with a man within the past 6 months or intend to have sex with a man in the next 3 months
  • Willing and able to undergo informed consent
  • Willing to comply with study protocol and 1-year follow-up schedule
  • Not currently pregnant
  • Current patient at Family Care Carondelet, Family Care Forest Park Southeast, Memphis Health Center

Exclusion criteria

  • Has undergone a female sterilization procedure such as tubal ligation or hysterectomy
  • Has one sexual partner who has undergone a vasectomy procedure
  • Speaks language other than English or Spanish
  • Currently using an IUD or implant as her contraceptive method

Treatment and study plan

CHOICE Project Structured Contraceptive Counseling

Behavioral

Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.

Contraceptive Education Session

Behavioral

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.

Cost Support for IUDs and implants

Device

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.

Primary outcomes

  1. Unintended Pregnancy

    Time frame: 12 months

    The number of self-reported unintended pregnancies.

Secondary outcomes

  1. Contraceptive Method Use Upon Enrollment Completion

    Time frame: On the day of enrollment

    This measure indicates the contraceptive method that the patient left with after the clinical visit on the day of enrollment. Patients could have received desired new method, received a bridge method, stayed on current method, or received no method.

  2. Desired Contraceptive Method at Enrollment Visit

    Time frame: On the day of enrollment

    This could be a new method, an existing method, or nothing if participant did not choose a method

  3. Participants Choosing Long-Acting Reversible Contraception (LARC) at Enrollment Visit

    Time frame: On the day of enrollment

    Number of women choosing an IUD or implant as their preferred contraceptive method

  4. Same Day LARC Insertion

    Time frame: On the day of enrollment

    Of the participants who chose LARC as their preferred method, the number who received the device the same day as their enrollment visit.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • A Step Ahead Foundation
  • Family Care Health Centers
  • Memphis Health Center
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Implementation of Patient-Centered Contraception Provision in Community Settings

Acronym: IMPACCT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2015
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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