A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions

Summary

Among people who do not want to get pregnant, some do not use any birth control. This is also called contraceptive nonuse. Common reasons for contraceptive nonuse include concerns about birth control safety or side effects. People with health conditions, such as diabetes or high blood pressure, also report worries about how different birth control methods might affect their health condition or medicines.

The goal of this clinical trial is to learn if a web tool called My Health, My Choice helps people with health conditions understand their birth control options and choose birth control that is right for them. The study will also look at the medical safety of birth control methods that participants decide to use. The main questions it aims to answer are:

• Does the My Health My Choice tool lower the number of participants who do not use any birth control method? (contraceptive nonuse)

In other words, does the My Health My Choice tool increase the number of participants who use any birth control method? (contraceptive use)

Participants who use the My Health, My Choice tool before a clinic visit with their clinician (Intervention Group) will be compared to participants who only go to a clinic visit with their clinician (Usual Care Group).

For this study, a "clinician" is any licensed health care provider who counsels about birth control, prescribes birth control, and/or inserts birth control devices.

All participants will:

* Complete 4-5 online surveys that take 5-10 minutes each, over a 3 month time period
* Be asked to go to a scheduled clinic visit with their health care provider
* A small group of participants (about 30) will be invited to a 1 hour exit interview

Participants in the intervention arm will be asked to:

• Use the My Health My Choice tool before their clinic visit

Conditions

• Contraceptive Usage
• Contraceptive Behavior
• Chronic Disease
• Chronic Condition
• Chronic Conditions, Multiple

Interventions

BEHAVIORAL

My Health, My Choice Web-Based Contraceptive Decision Tool

The My Health My Choice decision tool is a web-based interactive tool designed to educate patients with health conditions about their contraceptive options, elicit their personal preferences and contraceptive concerns, and help them prepare for a contraceptive discussion with their clinician. Patients can compare features of different contraceptive methods side-by-side and grouped by medical risk according to the Center for Disease Control and Prevention U.S. Medical Eligibility Criteria (US MEC). The tool generates an individualized Birth Control Summary for each patient user that records their "contraceptive favorites" and their questions for the clinician. Clinicians can use the Clinician Version of the tool to review the patient's Birth Control Summary and their medical eligibility for different contraceptive methods per the US MEC guidelines.

BEHAVIORAL

Usual Contraceptive Care

Participants will attend clinic visits per routine. Clinicians proceed with usual contraceptive care. All study activities and incentives for participants in the usual contraceptive care arm are the same as for participants in the intervention arm except for those related to the intervention itself.

Sponsors & Collaborators

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

  collaborator NIH

• DARTNet Institute

  collaborator OTHER_GOV

• University of Michigan

  lead OTHER

Principal Investigators

• Justine P Wu, MD, MPH · Department of Family Medicine, University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-15

Primary Completion

2028-08-31

Completion

2028-08-31

Countries

• United States
• Puerto Rico

Study Locations