ContraceptionNCT07320651
Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults
A study testing Encounter decision aid and Standard counseling in people with Contraception and Menstrual Management, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Decision aids are educational tools designed to help people participate in decision-making about health care choices, by providing evidence-based information, promoting patient-centered care, and supporting patient autonomy and engagement. Read more about this study
- Who is it for?
- Ages 12 to 25 years, women only
- Conditions the study is for
- Contraception, Menstrual Management
- What is being tested?
- Encounter decision aid and Standard counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Sep 2025to Jan 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 12 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
Dehlia Moussaoui, +41 22 372 33 87, dehlia.moussaoui@hug.ch
About this study
Official title: Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults: A Cluster-Randomized Trial
Decision aids are educational tools designed to help people participate in decision-making about health care choices, by providing evidence-based information, promoting patient-centered care, and supporting patient autonomy and engagement. Our research team developed an Encounter Decision Aid (EDA) exploring treatment options for menstrual management in adolescents and young adults (AYAs), in accordance with the latest International Patient Decision Aids Standards and the Ottawa Decision Support Framework.
In this cluster-randomized controlled trial, we aim to evaluate the effectiveness of this EDA on patient-centered outcome measures in AYAs considering treatment for menstrual management and/or contraception compared to standard counseling.
- Conditions
- Contraception, Menstrual Management
- Being tested
- Encounter decision aid, Standard counseling
- Keywords
- decision aid, menstrual management, contraception, shared decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encounter decision aidOther
The intervention will involve the use of an encounter decision aid (EDA) during the clinical encounter. This paper-based tool was developed through an iterative process at HUG by our multidisciplinary team, comprising clinicians, specialized nurses, clinical researchers, graphic designer, stakeholders and patient representatives.
Standard counselingOther
The control intervention consists of standard consultation with usual counseling.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Other: Standard counseling |
| intervention group | Experimental | Not described Receives: Other: Encounter decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS).
Decisional conflict is defined as a state of uncertainty about a course of action and is measured by the Decisional Conflict Scale. It is recognized as a core component of the quality of the decision-making process. The Decisional Conflict Scale low literacy (LL-DCS) is a validated score that includes 10 items which are scored on a 0 to 4 scale; the items scores are summed, divided by 10, and then multiplied by 25. The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.
Measured: immediately after the clinical encounter
Secondary outcomes (9)
Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (LL-DCS).
Decisional conflict is defined as a state of uncertainty about a course of action and is measured by the Decisional Conflict Scale. It is recognized as a core component of the quality of the decision-making process. The Decisional Conflict Scale low literacy (LL-DCS) is a validated score that includes 10 items which are scored on a 0 to 4 scale; the items scores are summed, divided by 10, and then multiplied by 25. The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.
Measured: at 3 months post-clinical encounter
Patient knowledge.
Score on a 7-item true/false questionnaire on hormonal treatment and contraception, assessed right after the clinical encounter.
Measured: immediately after the clinical encounter
Knowledge retention
Reassessment of knowledge using the same questionnaire (score on a 7-item true/false questionnaire on hormonal treatment and contraception) at 3 month-follow up.
Measured: knowledge questionnaire at 3 months post-intervention
Patient and healthcare provider satisfaction with the decision-making process
- Patient satisfaction rated on a 5-point Likert scale, indicating how strongly they would recommend the decision-making approach.
- Clinician satisfaction rated on a 5-point Likert scale (where higher scores indicating greater satisfaction). Satisfaction will be defined as the proportion scoring ≥4 ("very satisfied" and extremely satisfied").
Measured: immediately after the clinical encounter
Patient involvement in decision-making
measured by the self-reported collaboRATE scale (three brief questions that patients complete following the clinical encounter)
Measured: immediately after the clinical encounter (10-point Likert scale).
Patient involvement in decision-making
assessed via the OPTION-5 instrument (where independent observer rate clinician behaviors on a standardized scale (0-100), applied to a video recording of the clinical encounter).
Measured: immediately after the clinical encounter
Participant treatment preference before the clinical encounter
self-reported answer to the question: "Which treatment would you like to start?"
Measured: Baseline
Participant treatment preference after the clinical encounter
self-reported answer to the question: "Which treatment would you like to start?"
Measured: Immediately after the clinical encounter
Medication continuation
self-reported answer to the question: "if a medication was prescribed following your previous gynecological appointment, are you still currently using it?" yes or no
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start2 Sep 2025
- Primary completionOct 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dehlia Moussaoui, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07320651
- Sponsor's protocol ID
- 2025-00733
- Other IDs
- 2025
- Status last verified
- Dec 2025
- First submitted
- 31 Aug 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Shared Decision-Making in Menstrual Management and Contraception for Adolescents and Young Adults: A Cluster-Randomized Trial
- ClinicalTrials.gov ID
- NCT07320651
- Acronym / sponsor ID
- 2025-00733
- Conditions
- Contraception, Menstrual Management
- Keywords
- decision aid, menstrual management, contraception, shared decision-making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 6 Jan 2026 (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.
Decision aids are educational tools designed to help people participate in decision-making about health care choices, by providing evidence-based information, promoting patient-centered care, and supporting patient autonomy and engagement. Our research team developed an Encounter Decision Aid (EDA) exploring treatment options for menstrual management in adolescents and young adults (AYAs), in accordance with the latest International Patient Decision Aids Standards and the Ottawa Decision Support Framework.
In this cluster-randomized controlled trial, we aim to evaluate the effectiveness of this EDA on patient-centered outcome measures in AYAs considering treatment for menstrual management and/or contraception compared to standard counseling.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Standard counseling |
| intervention group | Experimental | Other: Encounter decision aid |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Encounter decision aidThe intervention will involve the use of an encounter decision aid (EDA) during the clinical encounter. This paper-based tool was developed through an iterative process at HUG by our multidisciplinary team, comprising clinicians, specialized nurses, clinical researchers, graphic designer, stakeholders and patient representatives. | Other | intervention group |
| Standard counselingThe control intervention consists of standard consultation with usual counseling. | Other | control group |
Primary outcome
Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS).
Time frame: immediately after the clinical encounter
Decisional conflict is defined as a state of uncertainty about a course of action and is measured by the Decisional Conflict Scale. It is recognized as a core component of the quality of the decision-making process. The Decisional Conflict Scale low literacy (LL-DCS) is a validated score that includes 10 items which are scored on a 0 to 4 scale; the items scores are summed, divided by 10, and then multiplied by 25. The total score ranges from 0 to 100, with higher scores indicating greater decisional conflict.
9 secondary outcomes
Patient decisional conflict at 3 months, using the low literacy Decisional Conflict Scale (LL-DCS).
Time frame: at 3 months post-clinical encounter
Patient knowledge.
Time frame: immediately after the clinical encounter
Knowledge retention
Time frame: knowledge questionnaire at 3 months post-intervention
Patient and healthcare provider satisfaction with the decision-making process
Time frame: immediately after the clinical encounter
Patient involvement in decision-making
Time frame: immediately after the clinical encounter (10-point Likert scale).
Patient involvement in decision-making
Time frame: immediately after the clinical encounter
Participant treatment preference before the clinical encounter
Time frame: Baseline
Participant treatment preference after the clinical encounter
Time frame: Immediately after the clinical encounter
Medication continuation
Time frame: at 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 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encounter decision aid and Standard counseling in people with Contraception and Menstrual Management, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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. 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?
Contact Dehlia Moussaoui (+41 22 372 33 87, dehlia.moussaoui@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient decisional conflict measured using the Decisional Conflict Scale low literacy (LL-DCS). (time frame: immediately after the clinical encounter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.