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.
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
- Conditions the study is for
- Contraceptive Usage, Contraceptive Behavior, Chronic Disease
- What is being tested?
- My Health, My Choice Web-Based Contraceptive Decision Tool and Usual Contraceptive Care
- Type of treatment
- Lifestyle or therapy programme
- 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
Puerto Rico1 site
University of Puerto Rico Department of Obstetrics and Gynecology
San Juan, 00936-5067
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).
- Conditions
- Contraceptive Usage, Contraceptive Behavior, Chronic Disease, Chronic Condition, Chronic Conditions, Multiple
- 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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Usual Contraceptive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted20 Jul 2025
- Study start15 Sep 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Contraceptive UsageStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), DARTNet Institute
- Responsible party
- Principal investigator, Justine Wu, University of Michigan
- Investigators
- Justine P Wu, MD, MPH, Principal investigator, Department of Family Medicine, University of Michigan
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 15031246Dehlendorf 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 26827879Thompson 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 29061624Murray 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 12568061Murphy 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 23185138Stacey 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 32428429Kang 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 31287901Dehlendorf 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 30763545Chor 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 21664511Judge 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 29111146ACOG 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 30681537Fox 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 30342632Russo 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 25646873Wu 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Web-based Contraceptive Decision Support Tool for Individuals With Health Conditions: A Cluster Randomized Controlled Trial With Mixed Methods
- ClinicalTrials.gov ID
- NCT07075536
- Acronym / sponsor ID
- HUM00234187
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 795 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), DARTNet Institute
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| My Health, My Choice Contraceptive Decision Tool | Experimental | Behavioral: My Health, My Choice Web-Based Contraceptive Decision ToolParticipants 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). |
| Usual Contraceptive Care | Placebo comparator | Behavioral: Usual Contraceptive CareParticipants will receive usual contraceptive care from a licensed provider (CNM, DO, MD, NP, PA). |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My Health, My Choice Web-Based Contraceptive Decision ToolThe 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. | Behavioural | My Health, My Choice Contraceptive Decision Tool |
| Usual Contraceptive CareParticipants 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. | Behavioural | Usual Contraceptive Care |
Primary outcome
Proportion of participants who report contraceptive nonuse at 3 months
Time frame: Baseline, 1 month, and 3 months after the clinic visit
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.
1 secondary outcome
Medical Eligibility Risk (MER) Category among participants who report contraceptive method use
Time frame: Baseline, 1 month, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 15031246Campbell 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.
- Background: PubMed 26827879Dehlendorf 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.
- Background: PubMed 29061624Thompson 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.
- Background: PubMed 12568061Murray 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.
- BackgroundMurphy DM. Planning the Trial. Design and Analysis of Group-Randomized Trials. Oxford University Press; 1998:19-65
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- My Health My Choice Study WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justine P Wu, MD, MPH principal investigator
Department of Family Medicine, University of Michigan
19 sites in 2 countries: see every site and its status.
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 last refreshed its copy on 6 Nov 2026.