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OpenTrials
Completed

NCT Number: NCT06447233

Patient Perspectives Medicaid Title XIX Sterilization Consent Form

The goal of this survey and interview study is to learn about patient experience consenting for permanent contraception using the Medicaid Title XIX Sterilization Consent form. The main questions it aims to answer are:

* To explore patient perspectives on and understanding of the current consenting process for obtaining permanent contraception as it relates to the Medicaid Title XIX Sterilization consent form. * To explore patient experience with the current consenting process, and thoughts regarding the ideal consenting process including how it would differ from the one currently in place, if at all.

Participants will complete a 10-15 minute survey and be offered participation in an in-depth one-on-one interview.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Columbia University

New York, 10032, United States

About this study

The United States has a long history of coerced sterilization which was influenced by the eugenics and population control movements of the early and mid-20th century, respectively. The Medicaid Title XIX Sterilization Consent Form was created in response to these forced sterilizations to protect patients, but in recent years there have been questions regarding whether these forms are instead creating barriers to care for already marginalized populations. Prior studies demonstrated decreased rates of completion of postpartum permanent contraception requests secondary to invalid consent forms and negative attitudes among OBGYNs, including concerns regarding the ethics behind the forms. To date, there is very limited literature exploring patient perspectives. This will be a mixed methods study in which bilingual surveys will be distributed via REDCap to patients seeking permanent contraception at Columbia University affiliated OBGYN practices and complete in-depth interviews exploring patient experiences consenting for permanent contraception, and what an ideal consenting process might look like to them.

Who can participate

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

Inclusion criteria

  • Seeking permanent contraception procedure through a Columbia University practice
  • English or Spanish speaking
  • Completed the Medicaid Title XIX Consent Form

Exclusion criteria

-Currently pregnant and seeking immediate postpartum permanent contraception

Treatment and study plan

Primary outcomes

  1. Patient experience with the Medicaid Title XIX Sterilization consent form

    Time frame: Day 1, up to 1 hour

    Patient perspectives on and understanding of the current consenting process for obtaining permanent contraception as it relates to the Medicaid Title XIX Sterilization consent form. Patients' responses to interview questions will be translated into coded data using Dedoose, and grouped coded data will inform patterns of patient experience. Quantitative software will be used to analyze survey responses using descriptive statistics.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Society of Family Planning

Registry information

Official study title

An Exploratory Analysis of Patient Perspectives Regarding the Medicaid Title XIX Sterilization Consent Form

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2024
Registry last updated
Apr 15, 2026

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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