NCT06825247

Brief 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. 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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

February 13, 2025

Status Verified

February 1, 2025

Enrollment Period

3.4 years

First QC Date

February 10, 2025

Last Update Submit

February 10, 2025

Conditions

Keywords

sexual healthpsychosocial skills

Outcome Measures

Primary Outcomes (1)

  • 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

    from enrollment of first patient to end of all interviews (3 years)

Study Arms (1)

Young adults born in France and living in Pays de Loire

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young adults born in France and living in Pays de Loire

You may qualify if:

  • Aged from 18 to 29 years
  • Born in France or its territories,
  • Be able to read and write French.

You may not qualify if:

  • They are under guardianship,
  • They refuse to take part in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Le Mans

Le Mans, 72000, France

RECRUITING

Central Study Contacts

Christelle JADEAU

CONTACT

Hikombo HITOTO, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

February 13, 2025

Study Start

June 1, 2022

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

February 13, 2025

Record last verified: 2025-02

Locations