University of California, San Francisco
San Francisco, California, 94143, United States
Location status: Recruiting
NCT Number: NCT06296797
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.
Interested in participating?
Request Info21 year–45 year
Female
Interventional
Not applicable
San Francisco, California, 94143, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Information about tubal sterilization currently provided on the Planned Parenthood website
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
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.
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.
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.
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.
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.
Time frame: 3 month follow-up
3 items detailed in prior publication (PUBMED Number: 27710196)
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)"
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.
Contact information is provided by the study sponsor or research team.
Agatha Okobi
CONTACT
Eleanor Schwarz, MD, MS
CONTACT
University of California, San Francisco
Other
Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization
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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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