NCT04684758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,048

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 28, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 14, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

1.2 years

First QC Date

December 3, 2020

Last Update Submit

July 21, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (%))

    Through study completion, an average of 12 months

Secondary Outcomes (1)

  • Timing of HIV infection for people infected in France

    Through study completion, an average of 12 months

Other Outcomes (6)

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

    Through study completion, an average of 12 months

  • Motivations and migratory processes

    Through study completion, an average of 12 months

  • Vulnerability factors

    Through study completion, an average of 12 months

  • +3 more other outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 99 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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;

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Paris, 75013, France

Location

MeSH Terms

Conditions

Homosexuality

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehavior

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

December 28, 2020

Study Start

April 14, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations