Information Access for Birth Control

Overseen By Hannah Begna, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Current pregnancy, Menopause, Infertility, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if providing detailed information online helps women who want to avoid pregnancy better understand their birth control options. It compares the effectiveness of tubal sterilization (a permanent procedure to prevent pregnancy) with long-acting reversible contraceptives (LARCs, such as IUDs or implants). Participants will explore either a new educational website, the Advancing Access Website (also known as the Patient-centered Information on Permanent Contraception Website), or an existing Planned Parenthood page, and then share their thoughts through surveys. Women who can have children, want to avoid future pregnancies, and speak English or Spanish are well-suited for this trial. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance educational resources for birth control options.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this educational method is safe for participants?

Research has shown that both tubal sterilization and long-acting reversible contraceptives (LARC) are safe and well-tolerated. Tubal sterilization, a permanent birth control method, is highly effective and safe for women. Many choose this option for its lasting solution without ongoing maintenance.

Similarly, LARC options, such as IUDs (intrauterine devices) and implants, have proven to be safe and effective. They provide long-term pregnancy protection and have been used by many women worldwide with few reported side effects.

In this trial, participants will use a website offering information to compare these two contraceptive methods. The study aims to understand how access to detailed, patient-centered information affects decision-making. No physical treatments are being tested, so there are no new safety concerns related to physical health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new website, Advancing Access, because it aims to provide comprehensive, side-by-side comparisons of birth control options like tubal sterilization, vasectomy, and long-acting reversible contraceptives. This approach is different from the standard of care, which often involves separate consultations or resources for each option. By bringing all this information into one accessible platform, the website could empower individuals to make more informed decisions about their reproductive health. This could improve understanding and accessibility, especially for those who may not have easy access to healthcare providers or extensive resources.

What evidence suggests that this trial's educational resources could improve perceived access to contraceptives?

Research shows that providing information tailored to individual needs can significantly aid in understanding and deciding on birth control options. In this trial, one group of participants will access a new website offering comparative information on tubal sterilization, vasectomy, and long-acting reversible contraceptives (LARC). Studies have found that when women receive detailed comparisons of these options, they make more informed choices about their reproductive health. By learning about the pros and cons of each method, women gain confidence in their decisions. Another group will view an existing web page developed by Planned Parenthood that focuses on tubal sterilization. The Advancing Access Website aims to enhance understanding by offering clear, research-based comparisons, equipping women with the knowledge needed to choose the best contraception method for them. ^{1 2 3 4 6}

Who Is on the Research Team?

Eleanor Schwarz, MD, MS

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for women who do not wish to become pregnant in the future. Participants should be considering their options for permanent contraception and willing to complete surveys about their perceptions of contraceptive access after using educational websites.

Inclusion Criteria

Self-reported fertility

I strongly do not want to become pregnant in the future.

Exclusion Criteria

I have gone through menopause.

Current pregnancy

Infertility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey and Educational Resource Access

Participants complete a baseline survey and receive access to web-based educational resources

1 week

1 visit (virtual)

Immediate Follow-up

Participants complete a brief follow-up survey immediately after exploring web-based resources

1 week

1 visit (virtual)

3-Month Follow-up

Participants complete a follow-up survey 3 months after enrolling to assess changes in knowledge and perceived access to contraceptives

3 months

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Advancing Access Website

Trial Overview The study tests if a new website with patient-centered information on tubal sterilization versus long-acting reversible contraceptives (LARC) affects women's views on contraceptive access, compared to an existing Planned Parenthood website.

How Is the Trial Designed?

Group I: Comparative information on tubal sterilization and other long-acting contraceptives Experimental Treatment 1 Intervention

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

Group II: Information on tubal sterilization Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Essential Access Health

Collaborator

Trials

7

Recruited

3,200+

Published Research Related to This Trial

Patients found the Bedsider online contraceptive support tool to be trustworthy, accessible, and empowering, indicating a positive reception among sexually active women interested in contraception.

In contrast, clinic providers and staff expressed concerns about the tool's legitimacy and applicability, which may hinder their willingness to recommend it, highlighting a disconnect between patient and provider perspectives on contraceptive information tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider perspectives on Bedsider.org, an online contraceptive information tool, in a low income, racially diverse clinic population. Gressel, GM., Lundsberg, LS., Illuzzi, JL., et al.[2015]

A survey of 828 women revealed that many are concerned about the safety of oral contraceptives, highlighting the need for better communication regarding their risks and benefits.

The patient-oriented package insert for oral contraceptives was generally well-received and considered useful, but there is a clear preference for receiving information from health professionals and printed materials rather than media sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral contraceptive patient information. A questionnaire study of attitudes, knowledge, and preferred information sources. Fleckenstein, L., Joubert, P., Lawrence, R., et al.[2019]

The integration of Bedsider.org, a web-based contraceptive decision support tool, into university health clinic visits was well-received by female students, with positive feedback on the information provided during their appointments.

After using Bedsider, there was an increase in the use of more effective contraceptive methods among sexually active participants, with 11% initiating or planning to receive long-acting reversible contraceptives (LARCs).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of using a web-based contraceptive support tool in a university health clinic. Giho, Y., Jones, KA., Dick, RN., et al.[2021]

The EngagedMD multimedia platform significantly enhances patient understanding and satisfaction regarding IVF and OI-IUI treatments, with 88% of patients feeling better prepared to consent and 83% reporting increased satisfaction with their care.

Providers also recognized the platform's benefits, with 63% agreeing it improved patient learning and standardized information dissemination, indicating its effectiveness in the informed consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the EngagedMD multimedia platform to improve informed consent for ovulation induction, intrauterine insemination, and in vitro fertilization. Madeira, JL., Rehbein, J., Christianson, MS., et al.[2019]

A nationwide survey of 2,669 women (1,720 current and 949 former oral contraceptive users) revealed that while most women received and read the patient insert with their oral contraceptives, only about one-third received the longer informational brochure from physicians, indicating a gap in comprehensive patient education.

The study found that directions for use and side effects were the most recalled pieces of information, and despite the availability of written materials, physician-patient interactions remained largely unchanged, suggesting that improving the delivery and accessibility of patient information could enhance understanding and safety in contraceptive use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of the effects of oral contraceptive patient information. Morris, LA., Mazis, M., Gordon, E.[2016]

Public comments on pharmacist-prescribed hormonal contraception were largely positive, highlighting benefits like increased access to healthcare and reduced unintended pregnancies, based on a review of 1060 comments from online articles.

However, there were concerns about the role of pharmacists and logistical challenges that need to be addressed for successful implementation, indicating a need for careful planning in expanding pharmacists' roles in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public perception of pharmacist-prescribed self-administered non-emergency hormonal contraception: An analysis of online social discourse. Irwin, AN., Stewart, OC., Nguyen, VQ., et al.[2022]

A national survey of oral contraceptive users revealed that women prefer longer, detailed information about their medication, particularly regarding safety and usage instructions.

Younger and more educated women were more likely to request and appreciate comprehensive brochures over shorter inserts, indicating a demand for thorough written drug information across all prescription medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient attitudes about two forms of printed oral contraceptive information. Mazis, M., Morris, LA., Gordon, E.[2019]

The use of the 'My Birth Control' decision support tool in contraceptive counseling led to more patient-centered discussions, with providers focusing on multiple methods of interest rather than just directing patients to one option.

Patients reported gaining knowledge from the tool, indicating its effectiveness in enhancing understanding and engagement during counseling sessions, without requiring extensive training for providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. Holt, K., Kimport, K., Kuppermann, M., et al.[2020]

The Choose Well initiative in South Carolina significantly improved perceptions of contraceptive access at federally qualified health centers (FQHCs) by enhancing training and funding for IUDs and implants, as reported by 34 staff members interviewed in 2018 and 2019.

Key factors for success included increased capacity for contraceptive counseling, streamlined workflows, and strong organizational buy-in, while challenges such as device costs and insurance coverage posed threats to sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraceptive Access at Federally Qualified Health Centers During the South Carolina Choose Well Initiative: A Qualitative Analysis of Staff Perceptions and Experiences. Ventura, LM., Beatty, KE., Khoury, AJ., et al.[2022]

A scoping review of 306 webpages about long-acting reversible contraception (LARC) revealed that while most provided key information, only half mentioned efficacy, and many lacked details on costs and access, which are crucial for informed decision-making.

Descriptions of side effects varied significantly across webpages, leading to potential confusion for users; this inconsistency highlights the need for comprehensive and reliable online health information to aid individuals in choosing contraceptive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Googling long-acting reversible contraception: A scoping review examining the information available online about intrauterine devices and contraceptive implants. Caddy, C., Coombe, J.[2023]

A contraception navigator program designed for adolescents in central Indiana emphasizes the importance of building trust and addressing patient-specific barriers to contraception access, as identified through co-design sessions with 35 adolescents and 11 community stakeholders.

Key elements of the program include providing various communication methods and support for understanding contraceptive side effects, which are crucial for making the process of obtaining contraception less intimidating for young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Youth Contraception Navigator Program: A Human-Centered Design Approach. Wilkinson, TA., Hawryluk, B., Moore, C., et al.[2023]

A study analyzing the website for the hormonal emergency contraception product Norlevo over two years showed a steady increase in visits, indicating a growing demand for information among users.

The most common concern among users was about spotting and menstrual bleeding after using emergency contraception, highlighting the need for better education and support regarding these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surfing on the morning after: analysis of an emergency contraception website. Gainer, E., Sollet, C., Ulmann, M., et al.[2019]

Citations

1. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06296797

Patient-centered Information on Permanent Contraception This study evaluates the potential benefits of web-based resources to prepare patients considering tubal sterilization to effectively communicate their ...

2. meddatax.com meddatax.com/clinical-trials/NCT06296797

Patient-centered Information on Permanent Contraception This study evaluates the potential benefits of web-based resources to prepare patients considering tubal sterilization to effectively ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06296797

Patient-centered Information on Permanent Contraception A website comparing tubal sterilization to long-acting reversible contraceptives informed by recent patient centered outcomes research. Other Names: Comparisons ...

4. withpower.com withpower.com/trial/phase-contraception-3-2024-3ca7e

Information Access for Birth Control The Advancing Access Website is unique because it provides patient-centered information on permanent contraception through an online platform, making it more ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408016/

Study protocol: ACCESS: (Advancing Contraceptive Equity ... Quantitative outcomes include the use of TM versus face-to-face visits for any contraceptive care, contraceptive method switching, no-show and cancellation ...

6. researchgate.net researchgate.net/publication/391290175_Future_reproductive_outcomes_and_contraceptive_access_in_the_first_year_postpartum_after_non-receipt_of_postpartum_permanent_contraception

Future reproductive outcomes and contraceptive access in ... Tubal sterilization is a highly effective, permanent, and safe method of contraception. Many women who desire postpartum sterilization do ...