MedDataX Logo

Patient-centered Information on Permanent Contraception

NCT ID: NCT06296797

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives.

Participants will:

* Complete a baseline survey
* Receive access to web-based educational resources
* Complete a brief follow up survey immediately after exploring these web-based resources
* Complete a follow-up survey 3 months after enrolling

The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study evaluates the potential benefits of web-based resources to prepare patients considering tubal sterilization to effectively communicate their personal values and priorities to their clinicians, informed by recent patient centered outcomes research (PCOR) comparing interval tubal sterilization to long-acting reversible contraceptives. The investigators hypothesize that patients provided with information on the comparative safety and effectiveness of all available long acting contraceptives will be more likely to obtain contraceptive care that aligns with their personal preferences. The short-term goal of this work is to support patient-centered contraceptive care by increasing knowledge of and perceived access to all available long acting contraceptives among those who wish to avoid future pregnancy. The long-term goal of this work is to increase the proportion of women who are using a method of contraception that aligns with their personal preferences, reduce the proportion of women who regret having undergone a permanent contraceptive procedure, and reduce racial disparities in surgical sterilization.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Contraception Reproductive Behavior Contraception Behavior

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

tubal sterilization permanent contraception intrauterine device contraceptive implant vasectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Comparative information on tubal sterilization and other long-acting contraceptives

A new website comparing tubal sterilization to vasectomy and long-acting reversible contraceptives

Group Type EXPERIMENTAL

Advancing Access Website

Intervention Type BEHAVIORAL

A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.

Information on tubal sterilization

Participants will be shown an existing web page developed by Planned Parenthood for people considering tubal sterilization

Group Type ACTIVE_COMPARATOR

Control arm: Existing educational website

Intervention Type BEHAVIORAL

Information about tubal sterilization currently provided on the Planned Parenthood website

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Control arm: Existing educational website

Information about tubal sterilization currently provided on the Planned Parenthood website

Intervention Type BEHAVIORAL

Advancing Access Website

A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Comparisons of tubal sterilization to long-acting reversible contraceptives

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Self-reported fertility
* Have a strong desire to avoid future pregnancy
* Speak English or Spanish

Exclusion Criteria

* Current pregnancy
* The inability to speak English or Spanish
* Prior tubal sterilization or "Essure" procedure
* Menopause
* Infertility
* Hysterectomy
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Essential Access Health

OTHER

Sponsor Role collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eleanor Schwarz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Eleanor Schwarz, MD, MS

Role: CONTACT

Phone: 415-502-1826

Email: [email protected]

Hannah Begna, MS

Role: CONTACT

Phone: (510) 660-0915

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Eleanor Schwarz, MD, MS

Role: primary

Hannah Begna, MS

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

Schwarz EB, Lewis CA, Dove MS, Murphy E, Zuckerman D, Nunez-Eddy C, Tancredi DJ, McDonald-Mosley R, Sonalkar S, Hathaway M, Gariepy AM. Comparative Effectiveness and Safety of Intrauterine Contraception and Tubal Ligation. J Gen Intern Med. 2022 Dec;37(16):4168-4175. doi: 10.1007/s11606-022-07433-4. Epub 2022 Feb 23.

Reference Type BACKGROUND
PMID: 35194746 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R18HS029432

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

5R18HS029432-02

Identifier Type: AHRQ

Identifier Source: org_study_id

View Link