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

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ClinicalTrials.gov Identifier: NCT04684758
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : October 4, 2021
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
ANRS, Emerging Infectious Diseases

Study Description
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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.


Condition or disease Intervention/treatment
Men Who Have Sex With Men People Living With HIV Other: Self-completion of a questionnaire

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study
Actual Study Start Date : April 14, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Groups and Cohorts
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Intervention Details:
  • Other: Self-completion of a questionnaire
    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.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 (%))


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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;
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04684758


Contacts
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Contact: Romain PALICH 01 42 16 01 71 romain.palich@aphp.fr
Contact: Virginie SUPERVIE 01 85 34 72 56 virginie.supervie@inserm.fr

Locations
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France
Hôpital Pitié-Salpêtrière, AP-HP, Institut Pierre Louis d'Épidémiologie et de Santé Publique (iPLESP), INSERM 1136 Recruiting
Paris, France, 75013
Contact: Romain PALICH    01 42 16 01 71    romain.palich@aphp.fr   
Contact: Virginie SUPERVIE    01 85 34 72 56    virginie.supervie@inserm.fr   
Sponsors and Collaborators
ANRS, Emerging Infectious Diseases
Institut National de la Santé Et de la Recherche Médicale, France
More Information
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Responsible Party: ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier: NCT04684758    
Other Study ID Numbers: ANRS 14058
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No