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 — 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.
  • 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.

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 Tool
    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).
  • Placebo Comparator: Usual Contraceptive Care
    Participants 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)

FacilityCityStateZIPSite coordinators
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) StudiesPhoenixArizona85004-
Pomona Valley Hospital Medical CenterPomonaCalifornia91767-
Full Circle Health Family Medicine Residency of Idaho - Nampa ProgramNampaIdaho83687-
University of Kansas Medical Center Department of Family Medicine & Community HealthKansas CityKansas66160-
MaineHealth Primary Care - Family Medicine - SanfordSanfordMaine04073-
Boston Medical Center's Department of Family MedicineBostonMassachusetts02119-
Department of Family Medicine Research OfficeAnn ArborMichigan48104-
Von Voigtlander Women's Hospital Obstetrics and Gynecology Clinic University of Michigan Health Michigan MedicineAnn ArborMichigan48109-
Michigan State University Health Care Family MedicineEast LansingMichigan48824-
WMed Health Family Medicine - Crosstown ParkwayKalamazooMichigan49008-
Munson HealthcareTraverse CityMichigan49684-
Ypsilanti Health Center University of Michigan Health Michigan MedicineYpsilantiMichigan48197-
Rutgers Robert Wood Johnson Medical School - Family Medicine at Monument SquareNew BrunswickNew Jersey08901-
Capital Health Family MedicineTrentonNew Jersey08638-
Mountain Area Health Education Center (MAHEC) Family Health Center at BiltmoreAshevilleNorth Carolina28803-
Cleveland Clinic - Complex Family Planning Clinics: Main Campus, Beachwood Family Health Center, Westlake Medical CampusClevelandOhio44195-
Ascent Center for Reproductive Health at the University of UtahSalt Lake CityUtah84112-
West Virginia University School of Medicine - Department of Family MedicineMorgantownWest Virginia26506-9600-

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