A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- University of Michigan
- Study ID
- NCT07075536
- Status
- Enrolling By Invitation
Conditions
- Chronic Condition
- Chronic Conditions, Multiple
- Chronic Disease
- Contraceptive Behavior
- Contraceptive Usage
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 49 Years
- Healthy Volunteers
- Not accepted
Interventions
- My Health, My Choice Web-Based Contraceptive Decision Tool — BEHAVIORALThe 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.
- Usual Contraceptive Care — BEHAVIORALParticipants 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.
Study Details
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
Key Dates
- Start date
- Sep 15, 2025
- Status verified
- Mar 2026
- Primary completion
- Aug 31, 2028
- Completion
- Aug 31, 2028
Study Design
- Enrollment
- 795 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: My Health, My Choice Contraceptive Decision ToolParticipants 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).
- Placebo Comparator: Usual Contraceptive CareParticipants will receive usual contraceptive care from a licensed provider (CNM, DO, MD, NP, PA).
Primary Outcome Measure
Proportion of participants who report contraceptive nonuse at 3 months [ Time Frame: Baseline, 1 month, and 3 months after the clinic visit ]
Locations (18)
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