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NCT Number: NCT06296797

Patient-centered Information on Permanent Contraception

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.

Recruiting

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Key information

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Agatha Okobi

CONTACT

[email protected]

Eleanor Schwarz, MD, MS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Control arm: Existing educational website

Behavioral

Information about tubal sterilization currently provided on the Planned Parenthood website

Advancing Access Website

Behavioral

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

Other names: Comparisons of tubal sterilization to long-acting reversible contraceptives

Primary outcomes

  1. Perceived Access to Long Acting Contraceptives

    Time frame: Immediately after introduction to website and at 3 months follow-up

    A 9-item, multi-dimensional measure assessing awareness, availability, accessibility, affordability, and acceptability of contraceptive options including tubal sterilization, vasectomy, the subdermal implant, hormonal intrauterine device, and hormone-free intrauterine device. A summative score ranging from 0 to 48 points will be calculated for each participant at baseline and follow up. Investigators hypothesize there will be greater improvements from baseline to follow up in the intervention than control arm.

Secondary outcomes

  1. Person-Centered Contraceptive Counseling Measure

    Time frame: 3 month follow-up

    4-items including: Letting me say what mattered to me about my birth control, Taking my preferences about my birth control seriously, Giving me enough information to make the best decision about my birth control method, Respecting me as a person, with responses range from 1 ("Strongly Disagree") to 5 ("Strongly Agree"). Investigators hypothesize there will be greater improvements from baseline in the intervention than control arm.

  2. Consumer Assessment of Healthcare Providers and Systems

    Time frame: 3 months follow-up

    Response options on a 10-point Likert scale, ranging from poor (0) to excellent (10).

    Investigators hypothesize there will be greater improvements from baseline in the intervention than control arm.

  3. Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI)

    Time frame: immediately after introduction to website and 3 months follow-up

    To create a score on the 5 item contraceptive "PEPPI scale" ranging from 5 (lowest possible score) to 25 (representing highest patient-perceived self-efficacy), each item begins with "How confident are participants in their ability to… ", and subjects respond to each question on a scale of 1 to 5, with 5 representing "very confident," and 1 representing "not at all confident" Investigators hypothesize there will be greater improvements from baseline to follow up in the intervention than control arm.

  4. Knowledge of Long-Acting Contraceptives

    Time frame: Immediately after introduction to website and at 3 month follow-up

    10 items adapted from the previously used Tubal Sterilization Knowledge Questionnaire items developed by Hall et al. Answers will be coded as correct vs. incorrect (with "Don't Know" being coded as an incorrect response) to create a knowledge score. Investigators will calculate change in knowledge scores on follow up surveys compared to baseline. Investigators hypothesize there will be greater improvements from baseline in the intervention than control arm.

  5. Use of preferred method of contraception

    Time frame: 3 month follow-up

    3 items detailed in prior publication (PUBMED Number: 27710196)

  6. Would recommend website to a friend

    Time frame: Immediately after introduction to website, and at 3 month follow up

    5 items designed to evaluate usability of website and recommendations to friends. E.g., "Using a scale of 0 (not at all) to 10 (extremely likely), participants will indicate how likely they are to recommend this website to a friend who is considering getting her tubes tied? (0-10)"

Other outcomes

  1. Suggestions for how to improve web-based resources for people considering permanent contraception.

    Time frame: immediately following introduction to website and at 3 months follow-up

    Open-ended question regarding ease-of-use and helpfulness of the web-based program. These responses will provide ongoing information to help guide future adaptations and dissemination.

Study contacts

Contact information is provided by the study sponsor or research team.

Agatha Okobi

CONTACT

[email protected]

(510) 660-0915

Eleanor Schwarz, MD, MS

CONTACT

[email protected]

415-502-1826

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Essential Access Health

Registry information

Official study title

Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2024
Registry last updated
Jan 26, 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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