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Completed

NCT Number: NCT04684758

HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study

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.

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Key information

Conditions

Men Who Have Sex With Men Behavior Homosexuality People Living With HIV Sexual Behavior Sexuality

Age range

18 year–99 year

Sex eligibility

Male

Study type

Observational

Primary location

Hôpital Pitié-Salpêtrière, AP-HP, Institut Pierre Louis d'Épidémiologie et de Santé Publique (iPLESP), INSERM 1136

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Self-completion of a questionnaire

Other

The questionnaire will be 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, if necessary.

Primary outcomes

  1. Post-migration proportion of HIV acquisition in born-abroad HIV-positive MSM living in Ile-de-France

    Time frame: Through study completion, an average of 12 months

    Estimation of the post-migration proportion of HIV acquisition in born-abroad HIV-positive MSM living in Ile-de-France (proportion of participants, n (%))

Secondary outcomes

  1. Timing of HIV infection for people infected in France

    Time frame: Through study completion, an average of 12 months

    Estimation of the timing of HIV infection for people infected in France (years, median, IQR)

Other outcomes

  1. Phylogenetic analysis in participants having acquired HIV before and after the migration, between them and with other populations

    Time frame: Through study completion, an average of 12 months

    Comparing the viral sequence from participant samples, will allow to estimate the proportion of viral sequences included in viral clusters comprising viral sequences from patients born in France and born outside France (proportion of participants, n (%))

  2. Motivations and migratory processes

    Time frame: Through study completion, an average of 12 months

    Analyses of participant questionnaires, will identify the motivations and the migratory processes in the global context of the country of origin (proportion of participants per item, based on responses to questionnaire, n (%))

  3. Vulnerability factors

    Time frame: Through study completion, an average of 12 months

    To determine the vulnerability factors for HIV infection, including social inequalities in health, in the country of origin, during the migration, and in France (proportion of participants per item, based on responses to questionnaire, n (%))

  4. Health contacts

    Time frame: Through study completion, an average of 12 months

    Description of health contacts, if any, with health system before HIV diagnosis (proportion of participants per item, based on responses to questionnaire (%))

  5. Missed opportunities of pre-exposure prophylaxis

    Time frame: Through study completion, an average of 12 months

    Description of missed opportunities of pre-exposure prophylaxis access (proportion of participants per item, based on responses to questionnaire, n (%))

  6. HIV healthcare

    Time frame: Through study completion, an average of 12 months

    Description of HIV care, including antiretroviral treatment and viral suppression coverage (proportion of participants, n (%))

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France

Registry information

Acronym: GANYMEDE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2020
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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