Patient Perspectives Medicaid Title XIX Sterilization Consent Form

April 13, 2026 updated by: Columbia University

An Exploratory Analysis of Patient Perspectives Regarding the 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The study participants will be patients seeking care at Columbia University affiliated OBGYN practices. The Columbia University affiliated OBGYN practices serve the Washington Heights and Inwood communities of New York City. The patient population is majority Hispanic and foreign-born. Approximately half of patients seeking permanent contraception are Spanish speaking.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Society of Family Planning

Investigators

  • Principal Investigator: Erika Levi, MD MPH, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2024

Primary Completion (Actual)

May 20, 2025

Study Completion (Actual)

May 20, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU9746

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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