Sexual HealthECOSSENCT06825247
Assessment of the Psychosocial Sexual Health Competencies of Young Adults Born in France (including Those Whose Parents Were Born Abroad), and Proposal of a Sexual Health Promotion Model Adapted to the Needs Identified.
An observational study of Sexual Health, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
Every year, between 4,000 and 6,000 people discover their seropositivity to the human immunodeficiency virus (HIV). The dynamics of new discoveries vary according to sexual orientation and birthplace. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- Sexual Health
- How many people
- 1,500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to Nov 2025
- Phase
- Observational
- 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 29 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adults born in France and living in Pays de Loire
Who may be able to join
- Aged from 18 to 29 years
- Born in France or its territories,
- Be able to read and write French.
Who cannot join
- They are under guardianship,
- They refuse to take part in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Le Mans
Le Mans, 72000
Hikombo HITOTO, MD, 0243434343, hhitoto@ch-lemans.fr
About this study
Every year, between 4,000 and 6,000 people discover their seropositivity to the human immunodeficiency virus (HIV). The dynamics of new discoveries vary according to sexual orientation and birthplace. MSM born in France show the sharpest improvement, while heterosexuals born in France show a more moderate decline, and intravenous drug users (IDUs) are still at a low ebb.
There is little fine-grained data available on a national scale to explain these dynamics among people living with HIV (PLHIV).
Read more
The acquisition of Psychosocial Competencies in sexual health is a prerequisite for good sexual health. It is important for all young people, and all the more so for young people from immigrant backgrounds, whom we hypothesize, despite the limited existing literature, to be more vulnerable due to the influence of their origins, their parents' culture or language barrier, or even religion.
The primary research question: What psychosocial skills should be included in a sexual health education program for young people born in France (including those born to migrant parents), to enable them to enjoy good sexual health in adulthood?
- Conditions
- Sexual Health
- Keywords
- sexual health, psychosocial skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young adults born in France and living in Pays de Loire | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health education models
Design health education models adapted to the sexual health needs of young adults born in France and living in the Pays de Loire region
Measured: from enrollment of first patient to end of all interviews (3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Jun 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825247
- Sponsor's protocol ID
- CHM-2022/S10/16
- Acronym
- ECOSSE
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Psychosocial Sexual Health Competencies of Young Adults Born in France (including Those Whose Parents Were Born Abroad), and Proposal of a Sexual Health Promotion Model Adapted to the Needs Identified.
- ClinicalTrials.gov ID
- NCT06825247
- Acronym / sponsor ID
- ECOSSE / CHM-2022/S10/16
- Conditions
- Sexual Health
- Keywords
- sexual health, psychosocial skills
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 13 Feb 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.
Every year, between 4,000 and 6,000 people discover their seropositivity to the human immunodeficiency virus (HIV). The dynamics of new discoveries vary according to sexual orientation and birthplace. MSM born in France show the sharpest improvement, while heterosexuals born in France show a more moderate decline, and intravenous drug users (IDUs) are still at a low ebb.
There is little fine-grained data available on a national scale to explain these dynamics among people living with HIV (PLHIV).
The acquisition of Psychosocial Competencies in sexual health is a prerequisite for good sexual health. It is important for all young people, and all the more so for young people from immigrant backgrounds, whom we hypothesize, despite the limited existing literature, to be more vulnerable due to the influence of their origins, their parents' culture or language barrier, or even religion.
The primary research question: What psychosocial skills should be included in a sexual health education program for young people born in France (including those born to migrant parents), to enable them to enjoy good sexual health in adulthood?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults born in France and living in Pays de Loire | – | – |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adults born in France and living in Pays de Loire
Key inclusion criteria (3 listed)
- Aged from 18 to 29 years
- Born in France or its territories,
- Be able to read and write French.
Key exclusion criteria (2 listed)
- They are under guardianship,
- They refuse to take part in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health education models
Time frame: from enrollment of first patient to end of all interviews (3 years)
Design health education models adapted to the sexual health needs of young adults born in France and living in the Pays de Loire region
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 13 Feb 2025.
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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?
An observational study of Sexual Health, run by Centre Hospitalier le Mans at 1 site in France.
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 3 inclusion and 2 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 13 Feb 2025. 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 France. 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 Christelle JADEAU (+33244710781, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health education models (time frame: from enrollment of first patient to end of all interviews (3 years)). 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 13 Feb 2025.