ContraceptionNCT06296797
Patient-centered Information on Permanent Contraception
A study testing Advancing Access Website in people with Contraception and Reproductive Behavior, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception, Reproductive Behavior, Contraception Behavior
- What is being tested?
- Advancing Access Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2024to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Self-reported fertility
- Have a strong desire to avoid future pregnancy
- Speak English or Spanish
Who cannot join
- Current pregnancy
- The inability to speak English or Spanish
- Prior tubal sterilization or "Essure" procedure
- Menopause
- Infertility
- Hysterectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Eleanor Schwarz, MD, MS, eleanor.schwarz@ucsf.edu
Agatha Okobi, agatha.okobi@ucsf.edu
About this study
Official title: Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization
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:
Read more
- 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.
Read the detailed description
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
- Contraception, Reproductive Behavior, Contraception Behavior
- Being tested
- Control arm: Existing educational website, Advancing Access Website
- Keywords
- tubal sterilization, permanent contraception, intrauterine device, contraceptive implant, vasectomy
- Medical subject headings
- Reproductive Behavior, Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control arm: Existing educational websiteBehavioural
Information about tubal sterilization currently provided on the Planned Parenthood website
Advancing Access WebsiteBehavioural
Also called Comparisons of tubal sterilization to long-acting reversible contraceptives
A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research.
| Study group | Role | What they receive |
|---|---|---|
| Comparative information on tubal sterilization and other long-acting contraceptives | Experimental | A new website comparing tubal sterilization to vasectomy and long-acting reversible contraceptives Receives: Behavioral: Advancing Access Website |
| Information on tubal sterilization | Active comparator | Participants will be shown an existing web page developed by Planned Parenthood for people considering tubal sterilization Receives: Behavioral: Control arm: Existing educational website |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Access to Long Acting Contraceptives
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.
Measured: Immediately after introduction to website and at 3 months follow-up
Secondary outcomes (6)
Person-Centered Contraceptive Counseling Measure
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.
Measured: 3 month follow-up
Consumer Assessment of Healthcare Providers and Systems
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.
Measured: 3 months follow-up
Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI)
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.
Measured: immediately after introduction to website and 3 months follow-up
Knowledge of Long-Acting Contraceptives
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.
Measured: Immediately after introduction to website and at 3 month follow-up
Use of preferred method of contraception
3 items detailed in prior publication (PUBMED Number: 27710196)
Measured: 3 month follow-up
Would recommend website to a friend
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)"
Measured: Immediately after introduction to website, and at 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Essential Access Health, Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Eleanor Schwarz, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296797
- Sponsor's protocol ID
- 5R18HS029432-02
- Other IDs
- R18HS029432
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2024
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35194746
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disseminating PCOR Findings to Reduce Racial Disparities in Surgical Sterilization
- ClinicalTrials.gov ID
- NCT06296797
- Acronym / sponsor ID
- 5R18HS029432-02
- Conditions
- Contraception, Reproductive Behavior, Contraception Behavior
- Keywords
- tubal sterilization, permanent contraception, intrauterine device, contraceptive implant, vasectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Essential Access Health, Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comparative information on tubal sterilization and other long-acting contraceptives | Experimental | Behavioral: Advancing Access WebsiteA new website comparing tubal sterilization to vasectomy and long-acting reversible contraceptives |
| Information on tubal sterilization | Active comparator | Behavioral: Control arm: Existing educational websiteParticipants will be shown an existing web page developed by Planned Parenthood for people considering tubal sterilization |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Self-reported fertility
- Have a strong desire to avoid future pregnancy
- Speak English or Spanish
Key exclusion criteria (6 listed)
- Current pregnancy
- The inability to speak English or Spanish
- Prior tubal sterilization or "Essure" procedure
- Menopause
- Infertility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control arm: Existing educational websiteInformation about tubal sterilization currently provided on the Planned Parenthood website | Behavioural | Information on tubal sterilization |
| Advancing Access WebsiteAlso: Comparisons of tubal sterilization to long-acting reversible contraceptivesA website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research. | Behavioural | Comparative information on tubal sterilization and other long-acting contraceptives |
Primary outcome
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.
6 secondary outcomes
Person-Centered Contraceptive Counseling Measure
Time frame: 3 month follow-up
Consumer Assessment of Healthcare Providers and Systems
Time frame: 3 months follow-up
Patients' Perceived Efficacy in Patient-Physician Interactions (PEPPI)
Time frame: immediately after introduction to website and 3 months follow-up
Knowledge of Long-Acting Contraceptives
Time frame: Immediately after introduction to website and at 3 month follow-up
Use of preferred method of contraception
Time frame: 3 month follow-up
Would recommend website to a friend
Time frame: Immediately after introduction to website, and at 3 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Background: PubMed 35194746Schwarz 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eleanor Schwarz, MD, MS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advancing Access Website in people with Contraception and Reproductive Behavior, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleanor Schwarz, MD, MS (415-502-1826, eleanor.schwarz@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Access to Long Acting Contraceptives (time frame: Immediately after introduction to website and at 3 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06296797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.