AzTrials
AzTrials

Contraceptive UsageNCT07075536

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

A study testing My Health, My Choice Web-Based Contraceptive Decision Tool and Usual Contraceptive Care in people with Contraceptive Usage and Contraceptive Behavior, run by University of Michigan at 19 sites in 2 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
What is being tested?
My Health, My Choice Web-Based Contraceptive Decision Tool and Usual Contraceptive Care
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
795 participants
Where
19 sitesin 2 countries
Study dates
15 Sep 2025to Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

19 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

19 sites in 2 countries

United States18 sites

  • Department of Family Medicine Research Office

    Ann Arbor, Michigan, 48104

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

    Ann Arbor, Michigan, 48109

  • Mountain Area Health Education Center (MAHEC) Family Health Center - Biltmore Site and Enka Site

    Asheville, North Carolina, 28803

  • Boston Medical Center's Department of Family Medicine

    Boston, Massachusetts, 02119

  • Cleveland Clinic - Complex Family Planning Clinic

    Cleveland, Ohio, 44195

  • Michigan State University Health Care Family Medicine

    East Lansing, Michigan, 48824

  • WMed Health Family Medicine - Crosstown Parkway

    Kalamazoo, Michigan, 49008

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

    Kansas City, Kansas, 66160

  • West Virginia University School of Medicine - Department of Family Medicine

    Morgantown, West Virginia, 26506-9600

  • Full Circle Health Family Medicine Residency of Idaho - Nampa Program

    Nampa, Idaho, 83687

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

    New Brunswick, New Jersey, 08901

  • 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

  • Pomona Valley Hospital Medical Center Family Medicine Residency Program

    Pomona, California, 91767

  • Ascent Center for Reproductive Health at the University of Utah

    Salt Lake City, Utah, 84112

  • MaineHealth Primary Care - Family Medicine - Sanford

    Sanford, Maine, 04073

  • Munson Healthcare

    Traverse City, Michigan, 49684

  • Capital Health Family Medicine

    Trenton, New Jersey, 08618

  • Ypsilanti Health Center University of Michigan Health Michigan Medicine

    Ypsilanti, Michigan, 48197

Other trials in United States

Puerto Rico1 site

  • University of Puerto Rico Department of Obstetrics and Gynecology

    San Juan, 00936-5067

Other trials in Puerto Rico

About this study

Official title: A Web-based Contraceptive Decision Support Tool for Individuals With Health Conditions: A Cluster Randomized Controlled Trial With Mixed Methods

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:

Read more
  • 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
Read the detailed description

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:

  • Before their scheduled clinic visit, open and use the My Health My Choice tool via a password-protected weblink on a mobile device, computer
  • Complete a brief electronic survey about their experience using the My Health My Choice web tool.

Study Activities for All Participants:

  • Go to their scheduled clinic visit with their clinician
  • Complete a survey shortly after the clinic visit
  • Complete a survey 1 month after the clinic visit
  • Complete a survey 3 months after the clinic visit

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

  • Complete a baseline survey
  • Complete an exit survey
  • Provide care to enrolled patients at their scheduled visits
  • Complete a brief survey after each visit with an enrolled patient

Activities for Clinicians in the Intervention Arm Only

  • Before or during the scheduled clinic visit, open and use Clinician Version of the My Health My Choice tool via a password-protected weblink on a mobile device, computer

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).

Being tested
My Health, My Choice Web-Based Contraceptive Decision Tool, Usual Contraceptive Care
Keywords
Contraceptive Use, Contraceptive decision making, Shared Decision Making, Person-Centered Contraceptive Counseling, Decisional Conflict, Web-Based Tool
Medical subject headings
Contraception Behavior, Chronic Disease, Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • My Health, My Choice Web-Based Contraceptive Decision ToolBehavioural

    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 CareBehavioural

    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 groups in NCT07075536
Study groupRoleWhat they receive
My Health, My Choice Contraceptive Decision ToolExperimentalParticipants 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).
Receives: Behavioral: My Health, My Choice Web-Based Contraceptive Decision Tool
Usual Contraceptive CarePlacebo comparatorParticipants will receive usual contraceptive care from a licensed provider (CNM, DO, MD, NP, PA).
Receives: Behavioral: Usual Contraceptive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)

  1. 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.

    Measured: Baseline, 1 month, and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2025
  2. Study start15 Sep 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
795 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07075536
Sponsor's protocol ID
HUM00234187
Other IDs
5R01HD110570-02
Status last verified
Aug 2026
First submitted
9 Jul 2025
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Campbell MK, Elbourne DR, Altman DG; CONSORT group. CONSORT statement: extension to cluster randomised trials. BMJ. 2004 Mar 20;328(7441):702-8. doi: 10.1136/bmj.328.7441.702. No abstract available.

    PubMed 15031246

  • Dehlendorf C, Henderson JT, Vittinghoff E, Grumbach K, Levy K, Schmittdiel J, Lee J, Schillinger D, Steinauer J. Association of the quality of interpersonal care during family planning counseling with contraceptive use. Am J Obstet Gynecol. 2016 Jul;215(1):78.e1-9. doi: 10.1016/j.ajog.2016.01.173. Epub 2016 Jan 28.

    PubMed 26827879

  • Thompson R, Manski R, Donnelly KZ, Stevens G, Agusti D, Banach M, Boardman MB, Brady P, Colon Bradt C, Foster T, Johnson DJ, Li Z, Norsigian J, Nothnagle M, Olson AL, Shepherd HL, Stern LF, Tosteson TD, Trevena L, Upadhya KK, Elwyn G. Right For Me: protocol for a cluster randomised trial of two interventions for facilitating shared decision-making about contraceptive methods. BMJ Open. 2017 Oct 22;7(10):e017830. doi: 10.1136/bmjopen-2017-017830.

    PubMed 29061624

  • Murray DM, Blistein JL. Methods to reduce the impact of intraclass correlation in group-randomized trials. Eval Rev. 2003 Feb;27(1):79-103. doi: 10.1177/0193841X02239019.

    PubMed 12568061

  • Murphy DM. Planning the Trial. Design and Analysis of Group-Randomized Trials. Oxford University Press; 1998:19-65

  • Weijer C, Grimshaw JM, Eccles MP, McRae AD, White A, Brehaut JC, Taljaard M; Ottawa Ethics of Cluster Randomized Trials Consensus Group. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials. PLoS Med. 2012;9(11):e1001346. doi: 10.1371/journal.pmed.1001346. Epub 2012 Nov 20.

    PubMed 23185138

  • 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.

    PubMed 32428429

  • 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.

    PubMed 31287901

  • Dehlendorf C, Fitzpatrick J, Fox E, Holt K, Vittinghoff E, Reed R, Campora MP, Sokoloff A, Kuppermann M. Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Am J Obstet Gynecol. 2019 Jun;220(6):565.e1-565.e12. doi: 10.1016/j.ajog.2019.02.015. Epub 2019 Feb 11.

    PubMed 30763545

  • Chor J, Rankin K, Harwood B, Handler A. Unintended pregnancy and postpartum contraceptive use in women with and without chronic medical disease who experienced a live birth. Contraception. 2011 Jul;84(1):57-63. doi: 10.1016/j.contraception.2010.11.018. Epub 2011 Jan 20.

    PubMed 21664511

  • Judge CP, Zhao X, Sileanu FE, Mor MK, Borrero S. Medical contraindications to estrogen and contraceptive use among women veterans. Am J Obstet Gynecol. 2018 Feb;218(2):234.e1-234.e9. doi: 10.1016/j.ajog.2017.10.020. Epub 2017 Oct 27.

    PubMed 29111146

  • 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.

    PubMed 30681537

  • 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.

    PubMed 30342632

  • Russo JA, Chen BA, Creinin MD. Primary care physician familiarity with U.S. medical eligibility for contraceptive use. Fam Med. 2015 Jan;47(1):15-21.

    PubMed 25646873

  • Wu JP, Gundersen DA, Pickle S. Are the Contraceptive Recommendations of Family Medicine Educators Evidence-Based? A CERA Survey. Fam Med. 2016 May;48(5):345-52.

    PubMed 27159092

Questions about this trial

What is this clinical trial studying?

A study testing My Health, My Choice Web-Based Contraceptive Decision Tool and Usual Contraceptive Care in people with Contraceptive Usage and Contraceptive Behavior, run by University of Michigan at 19 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07075536, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in