- ICH GCP
- US Clinical Trials Registry
- 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 (GANYMEDE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75013
- Hôpital Pitié-Salpêtrière, AP-HP, Institut Pierre Louis d'Épidémiologie et de Santé Publique (iPLESP), INSERM 1136
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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;
Description
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).
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (%))
|
Through study completion, an average of 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Through study completion, an average of 12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 (%))
|
Through study completion, an average of 12 months
|
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 (%))
|
Through study completion, an average of 12 months
|
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 (%))
|
Through study completion, an average of 12 months
|
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 (%))
|
Through study completion, an average of 12 months
|
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 (%))
|
Through study completion, an average of 12 months
|
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 (%))
|
Through study completion, an average of 12 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ANRS 14058
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on People Living With HIV
-
Northwestern UniversityUniversity of Chicago; AIDS Foundation of ChicagoRecruitingPeople Living With HIVUnited States
-
Gérond'ifRecruitingElderly People Living at Home | With an Internet Connection at HomeFrance
-
Jean-Pierre RoutyRecruiting
-
National Center for Geriatrics and Gerontology,...GE HealthcareCompleted
-
University Medical Center GoettingenWithdrawnUtilization of Nursing, Medical and Therapeutical Care of People Living at Home With Care Needs
-
University of Erlangen-Nürnberg Medical SchoolGerman Federal Ministry of Education and Research; University of Erlangen-NürnbergCompletedIndependent Living | Old and Very Old People | FunctioningGermany
-
Centre Hospitalier le MansCompletedPatients Living With HIVFrance
-
Foundation for Innovative New Diagnostics, SwitzerlandSwiss Tropical & Public Health Institute; University of Cape Town; The HIV Netherlands... and other collaboratorsCompletedDiagnosis of Tuberculosis in People Living With HIVMalawi, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia
-
Beijing 302 HospitalRecruitingCOVID-19 | Vaccine | People Living With HIVChina
-
Hospital Comarcal de IncaCompletedElderly (People Aged 65 or More) | Polypharmacy (People Under Treatment With 5 or More Drugs)Spain
Clinical Trials on Self-completion of a questionnaire
-
ZIWIGMonitoring Force Group; iGenSeqRecruitingEndometriosisFrance, Belgium, Switzerland
-
Hospices Civils de LyonCompleted
-
Sussex Partnership NHS Foundation TrustUniversity of SussexNot yet recruitingEmotional Instability | Borderline PersonalityUnited Kingdom
-
Centre Hospitalier Universitaire DijonCompleted
-
Centre Hospitalier Universitaire DijonCompleted
-
Centre Hospitalier Universitaire de NīmesCompletedTraumatic Amputation | Leg Lower AmputationFrance
-
University Hospital, AngersUnknownIdiopathic Thrombocytopenic PurpuraFrance
-
University Hospital, AngersCompletedFood Allergy in Children | 6 Years Old MaximumFrance
-
University Hospital, BrestCompleted