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

NCT07075536 | Enrolling By Invitation DMC

• 2 other identifiers: HUM002341875R01HD110570-02
• Study Type: interventional
• Target: 795
• Locations: 1 country
• Sites: 18

Brief 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

Keywords

Contraceptive Use; Contraceptive decision making; Shared Decision Making; Person-Centered Contraceptive Counseling; Decisional Conflict; Web-Based Tool

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 1 month, and 3 months after the clinic visit

Secondary Outcomes (1)

• Medical Eligibility Risk (MER) Category among participants who report contraceptive method use

  Baseline, 1 month, and 3 months

Study Arms (2)

My Health, My Choice Contraceptive Decision Tool

EXPERIMENTAL

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

Usual Contraceptive Care

PLACEBO COMPARATOR

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

Behavioral: Usual Contraceptive Care

Interventions

Usual Contraceptive Care BEHAVIORAL

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.

Usual Contraceptive Care

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

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.

My Health, My Choice Contraceptive Decision Tool

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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).
• Physician interns (PGY-1) are not eligible

Sponsors & Collaborators

• University of Michigan: lead
• DARTNet Institute: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (18)

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, 85004, United States

Location

Pomona Valley Hospital Medical Center

Pomona, California, 91767, United States

Location

Full Circle Health Family Medicine Residency of Idaho - Nampa Program

Nampa, Idaho, 83687, United States

Location

University of Kansas Medical Center Department of Family Medicine & Community Health

Kansas City, Kansas, 66160, United States

Location

MaineHealth Primary Care - Family Medicine - Sanford

Sanford, Maine, 04073, United States

Location

Boston Medical Center's Department of Family Medicine

Boston, Massachusetts, 02119, United States

Location

Department of Family Medicine Research Office

Ann Arbor, Michigan, 48104, United States

Location

Von Voigtlander Women's Hospital Obstetrics and Gynecology Clinic University of Michigan Health Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Michigan State University Health Care Family Medicine

East Lansing, Michigan, 48824, United States

Location

WMed Health Family Medicine - Crosstown Parkway

Kalamazoo, Michigan, 49008, United States

Location

Munson Healthcare

Traverse City, Michigan, 49684, United States

Location

Ypsilanti Health Center University of Michigan Health Michigan Medicine

Ypsilanti, Michigan, 48197, United States

Location

Rutgers Robert Wood Johnson Medical School - Family Medicine at Monument Square

New Brunswick, New Jersey, 08901, United States

Location

Capital Health Family Medicine

Trenton, New Jersey, 08638, United States

Location

Mountain Area Health Education Center (MAHEC) Family Health Center at Biltmore

Asheville, North Carolina, 28803, United States

Location

Cleveland Clinic - Complex Family Planning Clinics: Main Campus, Beachwood Family Health Center, Westlake Medical Campus

Cleveland, Ohio, 44195, United States

Location

Ascent Center for Reproductive Health at the University of Utah

Salt Lake City, Utah, 84112, United States

Location

West Virginia University School of Medicine - Department of Family Medicine

Morgantown, West Virginia, 26506-9600, United States

Location

Related Publications (16)

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• Stacey D, Legare F, Boland L, Lewis KB, Loiselle MC, Hoefel L, Garvelink M, O'Connor A. 20th Anniversary Ottawa Decision Support Framework: Part 3 Overview of Systematic Reviews and Updated Framework. Med Decis Making. 2020 Apr;40(3):379-398. doi: 10.1177/0272989X20911870.

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• Kang MM, Guetterman TC, Prussack JK, Ursu A, Wu JP. Contraceptive Care for Women With Medical Conditions: A Qualitative Study to Identify Potential Best Practices for Primary Care Physicians. Fam Med. 2019 Jul;51(7):559-566. doi: 10.22454/FamMed.2019.499467.

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  PMID: 30763545 BACKGROUND

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• ACOG Practice Bulletin No. 206 Summary: Use of Hormonal Contraception in Women With Coexisting Medical Conditions. Obstet Gynecol. 2019 Feb;133(2):396-399. doi: 10.1097/AOG.0000000000003073.

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• Fox E, Reyna A, Malcolm NM, Rosmarin RB, Zapata LB, Frederiksen BN, Moskosky SB, Dehlendorf C. Client Preferences for Contraceptive Counseling: A Systematic Review. Am J Prev Med. 2018 Nov;55(5):691-702. doi: 10.1016/j.amepre.2018.06.006.

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  PMID: 41461082 DERIVED

Related Links

• My Health My Choice Study Website

MeSH Terms

Conditions

Contraception Behavior; Chronic Disease; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Justine P Wu, MD, MPH

  Department of Family Medicine, University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The lead biostatistician will generate the allocation sequence and assign clinics to the intervention arm or usual care arm. To prevent unequal distribution of clinics that have greater expertise in contraceptive care, clinics with family planning specialists will be balanced between the two arms. Because of the cluster RCT design, allocation concealment is impractical. To minimize the risk of recruitment bias, differential dropouts, and bias, group assignments will be revealed to patient and clinician participants only after they have been consented and taken the baseline survey. The study team and statistical team will be blinded to group assignment when evaluating outcomes. This approach is consistent with the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a two-arm, parallel cluster randomized controlled trial using mixed methods (the collection and integration of quantitative and qualitative data) to compare the intervention (My Health My Choice decision tool) to usual contraceptive care in 14 outpatient clinics that provide contraceptive services. Randomization occurs at the clinic level to prevent contamination across patients and clinicians in the same clinic.

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

US (18)