Clinical trial NCT04684758: HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study
Official title: HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Men Who Have Sex With Men
People Living With HIV
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-12-28
Enrollment: 1048
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Cis-gender men who report having sex with men;
* Over 18 years of age;
* Type 1 HIV infected;
* Born in a country other than France and arrived in France at the age of 15 at the earliest;

Brief summary: In France, men who have sex with men (MSM) born abroad are the most affected population by HIV, in terms of HIV incidence and prevalence of undiagnosed infections. Close to 50% of born-abroad HIV-infected MSM are living in the region of Ile-de-France, which is the metropolitan area of Paris. Recent European data, not including France, suggest that born-abroad MSM have the highest rate of post-migration HIV acquisition. Many vulnerability factors could explain le burden of HIV in this group of the population.

A better understanding of vulnerability factors related to post-migration HIV acquisition should allow to improve HIV prevention and screening strategies among born-abroad MSM living in France. This, in turn, should reduce the burden of HIV in this population in France.

Detailed description: A better understanding of vulnerability factors related to post-migration HIV acquisition should allow to improve HIV prevention and screening strategies among born-abroad MSM living in France. This, in turn, should reduce the burden of HIV in this population in France.

Multicenter, cross-sectional, two-year study in the region Ile-de-France. The study is based on the self-completion of a questionnaire, built after an exploratory qualitative study.

Constitution of a representative sample of born-abroad HIV-infected MSM from patients followed up for HIV in Paris area. Questionnaires will collect data needed to estimate the post-migration HIV acquisition rates, and will explore contextual and individual factors leading to high exposure to HIV.

The participants will complete a questionnaire translated into 5 languages (English, Spanish, Portuguese, Arabic, and Russian) in order to allow almost all of the participants to answer the survey themselves, without assistance. In order to not exclude those who cannot read, or those who do not master any of the 6 languages offered, the questionnaire may be administered with the assistance of a member of the research team of the associated center, including through a telephone interpretation service. A brief eCRF will collect clinical and biological data, and historical viral sequences in associated virology departments, when available.

Eligibility criteria: Inclusion Criteria:

* Cis-gender men who report having sex with men;
* Over 18 years of age;
* Type 1 HIV infected;
* Born in a country other than France and arrived in France at the age of 15 at the earliest;
* Followed in Ile-de-France for their HIV infection and having consulted at least once in the participating center during the last 12 months;
* Non-opposition to the collection of their health data, after being well informed of the study and the patient rights in accordance with RGPD and LIL (French regulation)

Exclusion Criteria:

* Somatic or psychiatric pathology making it impossible to participate in an investigation;
* Communication disorder making it impossible to read (or oral responses in the event of assisted questionnaire completion).

Primary outcomes:
measure: Post-migration proportion of HIV acquisition in born-abroad HIV-positive MSM living in Ile-de-France
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
measure: Timing of HIV infection for people infected in France
timeFrame: Through study completion, an average of 12 months
Other outcomes:
measure: Phylogenetic analysis in participants having acquired HIV before and after the migration, between them and with other populations
timeFrame: Through study completion, an average of 12 months
measure: Motivations and migratory processes
timeFrame: Through study completion, an average of 12 months
measure: Vulnerability factors
timeFrame: Through study completion, an average of 12 months
measure: Health contacts
timeFrame: Through study completion, an average of 12 months
measure: Missed opportunities of pre-exposure prophylaxis
timeFrame: Through study completion, an average of 12 months
measure: HIV healthcare
timeFrame: Through study completion, an average of 12 months
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière, AP-HP, Institut Pierre Louis d'Épidémiologie et de Santé Publique (iPLESP), INSERM 1136
Study officials:
References: