Men Who Have Sex With MenGANYMEDENCT04684758
HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study
An observational study of Men Who Have Sex With Men and People Living With HIV, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Men Who Have Sex With Men, People Living With HIV
- What is being tested?
- Self-completion of a questionnaire
- How many people
- 1,048 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
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;
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Pitié-Salpêtrière, AP-HP, Institut Pierre Louis d'Épidémiologie et de Santé Publique (iPLESP), INSERM 1136
Paris, 75013
About this 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.
Read the 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.
- Conditions
- Men Who Have Sex With Men, People Living With HIV
- Being tested
- Self-completion of a questionnaire
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-completion of a questionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-migration proportion of HIV acquisition in born-abroad HIV-positive MSM living in Ile-de-France
Estimation of the post-migration proportion of HIV acquisition in born-abroad HIV-positive MSM living in Ile-de-France (proportion of participants, n (%))
Measured: Through study completion, an average of 12 months
Secondary outcomes (1)
Timing of HIV infection for people infected in France
Estimation of the timing of HIV infection for people infected in France (years, median, IQR)
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start14 Apr 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Men Who Have Sex With MenStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684758
- Sponsor's protocol ID
- ANRS 14058
- Acronym
- GANYMEDE
- Status last verified
- Jul 2022
- First submitted
- 3 Dec 2020
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Palich R, Arias-Rodriguez A, Duracinsky M, Le Talec JY, Rousset Torrente O, Lascoux-Combe C, Lacombe K, Ghosn J, Viard JP, Pialoux G, Ohayon M, Duvivier C, Velter A, Ben Mechlia M, Beniguel L, Grabar S, Melchior M, Assoumou L, Supervie V; GANYMEDE study group; Collaborators. High proportion of post-migration HIV acquisition in migrant men who have sex with men receiving HIV care in the Paris region, and associations with social disadvantage and sexual behaviours: results of the ANRS-MIE GANYMEDE study, France, 2021 to 2022. Euro Surveill. 2024 Mar;29(11):2300445. doi: 10.2807/1560-7917.ES.2024.29.11.2300445.
PubMed 38487889
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Acquisition and Life Course of Born-abroad Men Who Have Sex With Men Living in Ile-de-France: the GANYMEDE Study
- ClinicalTrials.gov ID
- NCT04684758
- Acronym / sponsor ID
- GANYMEDE / ANRS 14058
- Conditions
- Men Who Have Sex With Men, People Living With HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,048 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Dec 2020 (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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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;
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-completion of a questionnaireThe 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. | Other | – |
Primary outcome
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 (%))
1 secondary outcome
Timing of HIV infection for people infected in France
Time frame: Through study completion, an average of 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 38487889Palich R, Arias-Rodriguez A, Duracinsky M, Le Talec JY, Rousset Torrente O, Lascoux-Combe C, Lacombe K, Ghosn J, Viard JP, Pialoux G, Ohayon M, Duvivier C, Velter A, Ben Mechlia M, Beniguel L, Grabar S, Melchior M, Assoumou L, Supervie V; GANYMEDE study group; Collaborators. High proportion of post-migration HIV acquisition in migrant men who have sex with men receiving HIV care in the Paris region, and associations with social disadvantage and sexual behaviours: results of the ANRS-MIE GANYMEDE study, France, 2021 to 2022. Euro Surveill. 2024 Mar;29(11):2300445. doi: 10.2807/1560-7917.ES.2024.29.11.2300445.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Men Who Have Sex With Men and People Living With HIV, run by ANRS, Emerging Infectious Diseases 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 6 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: finished, as of the sponsor's last update on 22 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04684758, which also lists 1 linked publication.
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 22 Jul 2022.