My Health, My Choice for Birth Control

Enrolling by invitation at 13 trial locations

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Trying to get pregnant, Infertile, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web tool called My Health, My Choice to determine if it assists individuals with health concerns in selecting and using appropriate birth control. The tool aims to decrease the number of people not using any birth control by providing tailored information about options and safety. Participants with conditions such as diabetes or high blood pressure who wish to discuss birth control at an upcoming clinic visit can join. They will either use the tool before their visit or receive usual care from their healthcare provider. As an unphased trial, this study offers participants a unique opportunity to contribute to research that could improve decision-making in birth control options.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It seems the focus is on using a web tool to help choose birth control, so you likely won't need to change your medications, but it's best to confirm with the trial organizers.

What prior data suggests that the My Health, My Choice tool is safe?

Research has shown that the My Health, My Choice tool is an online platform designed to help people understand their birth control options, especially for those with health conditions. This tool educates users about contraception choices in a safe and informed manner. Being online and interactive, it poses no safety concerns. It primarily serves as an educational aid to assist people in making informed decisions about birth control. Users can confidently use this tool, as it aims to enhance understanding without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "My Health, My Choice" contraceptive decision tool because it empowers individuals to make informed choices about birth control through a web-based platform. Unlike traditional contraceptive care, which relies solely on consultations with healthcare providers, this tool offers personalized support before a clinic visit, potentially enhancing patient confidence and satisfaction. By providing tailored information in a secure, accessible format, this tool aims to streamline the decision-making process and improve overall contraceptive care experiences.

What evidence suggests that the My Health, My Choice tool is effective for increasing contraceptive use?

Research has shown that online tools like My Health, My Choice can help people make informed decisions about birth control. In this trial, participants in the intervention arm will use the My Health, My Choice web-based contraceptive decision tool before their clinic visit. Studies on similar tools have found that they can increase contraceptive use by providing personalized information and addressing concerns about safety and side effects. These tools are especially useful for people with health conditions, as they consider individual health needs and preferences. By simplifying the understanding of options, they support better decision-making about birth control. Early findings suggest that using such a tool before seeing a healthcare provider can lead to higher contraceptive use. ^{1 3 6 7 8}

Who Is on the Research Team?

Justine P Wu, MD, MPH

Principal Investigator

Department of Family Medicine, University of Michigan

Are You a Good Fit for This Trial?

This trial is for people who don't want to get pregnant and have chronic health conditions like diabetes or high blood pressure. They should be interested in learning about safe birth control options that won't interfere with their health or medications.

Inclusion Criteria

Presumed to be fertile (have an intact uterus/tube/ovary; premenopausal)

Able to read in English

Access to mobile phone, computer, or tablet with internet capabilities

Exclusion Criteria

Trying to get pregnant in the next 12 months

I am considered infertile due to medical or surgical reasons.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm use the My Health My Choice tool before their clinic visit

1 day

1 visit (virtual)

Clinic Visit

Participants attend a scheduled clinic visit with their clinician

1 day

1 visit (in-person)

Follow-up

Participants complete surveys at baseline, 1 month, and 3 months after the clinic visit to assess contraceptive use and medical eligibility risk

3 months

3 surveys (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• My Health, My Choice Web-Based Contraceptive Decision Tool

Trial Overview The study tests a web tool called 'My Health, My Choice,' designed to help participants choose suitable birth control methods. It compares the effectiveness of this tool with usual contraceptive care provided during clinic visits.

How Is the Trial Designed?

Group I: My Health, My Choice Contraceptive Decision Tool Experimental Treatment 1 Intervention

Participants in the intervention arm will use a web-based, password-protected contraceptive decision support tool (My Health My Choice) prior to a clinic visit with a licensed clinician who provides contraceptive care (CNM, DO, MD, NP, PA).

Group II: Usual Contraceptive Care Placebo Group 1 Intervention

Participants will receive usual contraceptive care from a licensed provider (CNM, DO, MD, NP, PA).

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

DARTNet Institute

Collaborator

Trials

5

Recruited

13,700+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07075536

Study Details | NCT07075536 | A Web-Based Tool to Help ... The My Health My Choice decision tool is a web-based interactive tool designed to educate patients with health conditions about their contraceptive options, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9946780/

Evaluation of an Online Decision Aid for Selection ... We developed a prototype contraception decision aid, My Contraceptive Choice (MCC). This article reports an evaluation study of the MCC tool.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772628223000833

Development of My Decision/Mi Decisión, a web-based ... This is a novel and timely web-based decision tool for tubal sterilization, when demand for permanent contraception is rapidly increasing post-Dobbs.

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70555?af=R

Online decision aids for contraceptive choices in women with ... The “My Contraceptive Choice” decision aid, which takes into account the presence of chronic conditions such as hypertension, mental disorders, ...

5. researchprotocols.org researchprotocols.org/2018/4/e107/

A Web-Based Decision Tool to Improve Contraceptive ... Conclusions: This protocol describes the first phase of a multiphase mixed methods study to develop and implement a Web-based decision tool that ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10983306/

A contraceptive decision tool for people with medical ... MHMC is a theory-informed, web-based and interactive tool that helps patients understand and compare their contraceptive options in context of their medical ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5932336/

A Web-Based Decision Tool to Improve Contraceptive ... A theory-driven, Web-based tool that incorporates the US MEC (provider-level intervention) within the vehicle of a contraceptive decision tool for women with ...

8. researchgate.net researchgate.net/publication/396428976_A_Web-Based_Contraception_Decision_Tool_for_Individuals_with_Health_Conditions_A_Protocol_for_a_Mixed_Methods_Cluster_Randomized_Controlled_Trial_in_US_Outpatient_Clinics_Preprint

A Web-Based Contraception Decision Tool for Individuals ... My Health My Choice (MHMC) is a web-based decision support tool that helps patients understand their contraceptive options in context of ...