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Enrolling By Invitation
NCT07075536
A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Conditions: Contraceptive Usage, Contraceptive Behavior, Chronic Disease, Chronic Condition, Chronic Conditions, Multiple
Sex: Female
Ages: 18 Years – 49 Years
Healthy volunteers: No
Phase: NA
Enrollment: 795
Sponsor: University of Michigan
Location: University of Arizona College of Medicine - Phoenix Department of Family, Community and Preventive Medicine - Research Division & Arizona Developing Experience with Practice-Based Research Network (PBRN) Studies Phoenix Arizona
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
Eligibility Criteria
Patient Inclusion Criteria:
* Between the ages of 18 and 49
* Assigned female sex at birth, regardless of gender identity
* Presumed to be fertile (have an intact uterus/tube/ovary; premenopausal)
* Have at least one index health condition, characteristic or medication usage (full list of 60+ eligible conditions, characteristics, and 50+ medications available upon request); and want to talk about birth control at an upcoming clinic visit with their clinician
* Able to read in English
* Access to mobile phone, computer, or tablet with internet capabilities
* Not currently pregnant
* Desire to talk to their clinician about starting, switching, or adding a contraceptive method for the purpose of preventing pregnancy
Patient Exclusion Criteria:
* Trying to get pregnant in the next 12 months
* Presumed infertile for any surgical or medical reason (e.g., postmenopausal, hysterectomy, chemotherapy)
There are additional clarifications regarding patient eligibility, such as a full list of eligible medical diagnoses and medicines, that can be found in the protocol.
Clinician Inclusion Criteria:
• Any licensed clinician who provides contraceptive care at a participating clinic, including physicians, physician assistants, certified nurse midwives, nurse practitioners. (For clinicians, there are no restrictions based upon age, gender identify or sex).
Clinician Exclusion Criteria:
• Physician interns (PGY-1) are not eligible
Source: ClinicalTrials.gov (NCT07075536). StuddyBuddy aggregates publicly available trial information.