An interventional study of My Health, My Choice Web-Based Contraceptive Decision Tool and Usual Contraceptive Care in Contraceptive Usage, Contraceptive Behavior and Chronic Disease, sponsored by University of Michigan. Enrolling by invitation at 19 sites in 2 countries. Open to female participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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:
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:
Participants in the intervention arm will be asked to:
Fourteen outpatient clinics in the United States that provide birth control services, including primary care and obstetrics and gynecology clinics, will be enrolled. Each clinic will be randomly assigned to the My Health My Choice Group (intervention group) or the Usual Care group. Only patients who receive health care at enrolled clinics are eligible for study participation.
Participants must be aged 18-49 years, read English, fertile (able to get pregnant), 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.
Eligible participants will be enrolled over the phone. Enrolled participants will complete a baseline electronic survey about their demographics, health history, contraceptive use, and contraceptive knowledge before learning which study group they are in.
Study Activities for Participants in the Intervention Arm Only:
Study Activities for All Participants:
All surveys take about 5-10 minutes to complete. About 30 participants across all clinic sites will be asked to do an optional 1 hour exit interview by phone or teleconference.
Clinicians who provide contraceptive care, including residents who have finished their intern year, are eligible to participate. Eligible clinicians include doctors, nurse practitioners, physician assistants, and certified nurse midwives. Enrolled clinicians will complete a brief baseline and exit survey about their contraceptive counseling, the type of contraceptive methods they provide, and their contraceptive knowledge.
Activities for All Clinicians
Activities for Clinicians in the Intervention Arm Only
The Clinician Version of the My Health My Choice has information to help clinicians counsel patients with health conditions about the safety of different birth control methods. Clinicians can also review the "Birth Control Summary" of enrolled patients before or during the clinic visit.
All clinician surveys take 3-10 minutes to complete. About 30 clinician participants across all clinic sites will be asked to participate in an optional 1 hour exit interview by phone or teleconference.
After patients exit the study, an electronic health record (EHR) review will be done to find out if participants got birth control prescriptions or birth control devices during the study. The EHR review also includes checking if participants report plans to get permanent birth control (tubal sterilization for themselves or vasectomy for their partners).
The primary and secondary outcomes are patient-reported or patient-related outcomes. There are no primary or secondary outcomes for clinicians.
The study aims to enroll 725 patients and 70 clinicians (795 in total).
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's planned enrollment of 795 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
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:
Clinician Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: My Health, My Choice Web-Based Contraceptive Decision Tool
Participants will receive usual contraceptive care from a licensed provider (CNM, DO, MD, NP, PA).
Behavioral: Usual Contraceptive Care
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.
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.
Proportion of participants who report contraceptive nonuse at 3 months
This is a binary outcome (yes/no) that will be assessed at baseline, 1 month, and 3 months after the clinic visit. Participants will report use or nonuse of a contraceptive method in the last month. Contraceptive methods include all non-prescription methods, prescription methods, intrauterine devices (IUDs), the implant, tubal ligation/surgery, and vasectomy of their partner. If patients report use of the cervical cap, condoms, diaphragm, spermicides, vaginal gel, or withdrawal, their outcome will be determined by whether they used the method at last intercourse in the prior month. Only patients who did not want to get pregnant in the last month will be included in the calculation of this outcome.
Time frame: Baseline, 1 month, and 3 months after the clinic visit
Medical Eligibility Risk (MER) Category among participants who report contraceptive method use
The Medical Eligibility Risk (MER) Category will be determined for participants who report contraceptive use at baseline, 1 month, and 3 months. Based upon the patient's health history and reported contraceptive method, two contraceptive experts blinded to patient assignment will assign the MER per the U.S. Medical Eligibility Criteria Guidelines. This is a categorical measure with four MER Categories: * Category 1: the method can be used without restriction because there are no theoretical or proven risks * Category 2: the method can be used because the advantages outweigh any theoretical or proven risks * Category 3: in general, the method should be avoided because the theoretical or proven risks of a contraceptive method usually outweigh any advantages of use. * Category 4: the method should not be used because the theoretical or proven risks outweigh any advantages.
Time frame: Baseline, 1 month, and 3 months
Plan to share: Yes — All quantitative IPD collected during the trial will be de-identified and made available per the time frame and access criteria described below. The full study protocol and statistical analysis plan will also be published in an open-access peer reviewed journal and made available upon request at FAMMED-BirthControlStudy@med.umich.edu.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: All de-identified quantitative IPD and supporting information will be available beginning 1 year after publication of trial findings and for an additional 36 months. After this 36 month time period, the quantitative data will be available in the University of Michigan's Deep Blue Data Repository indefinitely, but without investigator support other than deposited metadata.
Access criteria: All de-identified quantitative IPD and supporting information will be made available without cost to researchers and analysts upon request to FAMMED-BirthControlStudy@med.umich.edu. These requests will be honored only under a data sharing agreement that requires the user's commitment to: 1) use the data only for research purposes; 2) not identify any individual participant; 3) secure the data using appropriate computer technology; and 4) destroy or return the data after analyses are completed. The information provided to users will not be used for commercial purposes and will not be redistributed to third parties. In addition to dissemination of findings via communication channels such as speaking engagements and publications, these data also may be distributed via online databases, spreadsheets, and other electronic media.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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