Helping teens and young adults choose menstrual care and birth control
Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults: A Cluster-Randomized Trial
This project will try an Encounter Decision Aid to help adolescents and young adults (ages 12–25) make decisions about menstrual management and contraception during outpatient visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 12 Years to 25 Years |
| Sex | Female |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT07320651 on ClinicalTrials.gov |
What this trial studies
This cluster-randomized trial compares an Encounter Decision Aid (EDA) to standard counseling for adolescents and young adults considering initiation or switching of hormonal treatments for menstrual management or contraception at Geneva University Hospitals. Clinics or providers are randomized to use the EDA during consultations or to continue usual counseling, and patient-centered outcomes such as decision quality, decisional conflict, and satisfaction are measured. The EDA was developed following International Patient Decision Aid Standards and the Ottawa Decision Support Framework to present evidence-based options and support shared decision-making. Participants must be able to understand French and give informed consent or be accompanied by a legal guardian where required.
Who should consider this trial
Good fit: Adolescents and young adults aged 12–25 who present to the specified outpatient gynecology clinics at Geneva University Hospitals and are considering starting or switching hormonal medication for menstrual management or contraception, and who can provide informed consent in French, are ideal candidates.
Not a fit: Patients who cannot read or understand French, have major sensory or cognitive impairments that preclude using the decision aid without a guardian, or who are not considering hormonal options are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the tool could help young patients make clearer, more informed choices that align with their preferences and improve satisfaction with care.
How similar studies have performed: Decision-aid interventions in contraceptive and other preference-sensitive decisions have previously improved knowledge and reduced decisional conflict, although evidence specifically focused on adolescent menstrual management is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adolescents and young adults aged 12-25 years old * presenting to an outpatient consultation at "Unité de policlinique de gynécologie" or "Consultation de gynécologie pédiatrique" at HUG * considering initiation or switch to hormonal medication for menstrual management and/or contraception * able to give informed consent as documented by signature or accompanied by a legal guardian who can provide consent if required. Exclusion Criteria: * individuals who cannot read and understand French to a degree that would prevent participation in informed consent and study-related materials. * individuals who have major sensory disability, such as visual or hearing impairment, that would compromise their ability to give written informed consent and use the EDA, in the absence of their legal guardian. * individuals with cognitive or psychiatric conditions significantly impairing decision making capacity, unless accompanied by a legal guardian. * patients currently participating in another clinical trial related to contraceptive decision-making, to avoid potential interference.
Where this trial is running
Geneva, Canton of Geneva
- Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Dehlia Moussaoui
- Email: dehlia.moussaoui@hug.ch
- Phone: +41 22 372 33 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.