NCT02566148

Brief Summary

Populations from Sub-Saharan Africa represent one of the most dynamic immigration flows in France and are among the most exposed to HIV infection and hepatitis B. The Parcours study aims to understand, among sub-Saharan African migrants, how social and individual factors combine in the course of migration and settlement in France, and influence the risk of infection, access to prevention and care, and the effectiveness of care for both HIV and hepatitis B diseases. The research was conducted in Ile-de-France, where 60% of sub-Saharan African migrants reside. It consists in a cross-sectional observational survey, using a life-event history approach that reproduces the sequence of different life and health events, and contributes to explain the present situation (type of disease management, patient's quality of life) in light of all the elements of the past trajectory (administrative, familial, socio-economic, professionals). A representative survey was conducted between February 2012 and May 2013 in health care facilities in Ile-de-France, among three groups of migrants from Sub-Saharan Africa: a group living with HIV, a group living with chronic hepatitis B and a group who has neither of these diseases. For each group, stratified random sampling was used. The survey was conducted in 24 hospital services providing HIV care, 20 health care facilities providing hepatitis B care, and 30 primary health care facilities. Were eligible all patients attending these health care facilities, born in a Sub-Saharan African country and with Sub-Saharan African citizenship at birth, aged 18 to 59 years, with an HIV diagnosis (HIV group) or chronic hepatitis B diagnosis (hepatitis B group) more than three months prior or not diagnosed with HIV or chronic Hepatitis B (reference group). Among the patients offered participation, 926 HIV-infected patients, 779 patients infected by hepatitis B, and 763 patients without these two diseases participated in the study. For all participants, detailed information on socio-demographic characteristics; migration and life conditions in France; social, sexual and reproductive life history; and screening and care history were collected using a life-event history questionnaire administered face-to-face by a specialized interviewer. Health care professionals documented clinical information from the medical records. Data was collected anonymously.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,468

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

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

Study Start

First participant enrolled

February 1, 2012

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 2, 2015

Completed
Last Updated

May 15, 2017

Status Verified

May 1, 2017

Enrollment Period

Same day

First QC Date

June 19, 2015

Last Update Submit

May 12, 2017

Conditions

Keywords

Life-event surveyobservational survey among migrants in France

Outcome Measures

Primary Outcomes (4)

  • Lapse of time from arrival in France to HIV testing

    Time (in years) to occurence of first HIV testing, from arrival in France

    From arrival in France until the date of first HIV testing or date of of data collection, whichever came first, up to 20 years

  • Lapse of time from arrival in France to hepatitis B testing

    Time (in years) to occurence of first hepatitis B testing, from arrival in France

    From arrival in France until the date of first hepatitis B testing or date of of data collection, whichever came first, up to 20 years

  • Lapse of time from HIV diagnostic to access to care

    Time (in years) to occurence of entry into HIV care, from HIV diagnostic

    From first HIV diagnostic until the date of entry into care for HIV or date of of data collection, whichever came first, up to 20 years

  • Lapse of time from hepatitis B diagnostic to access to care

    Time (in years) to occurence of entry into Hepatitis B care, from hepatitis B diagnostic

    From first hepatitis B diagnostic until the date of entry into care for hepatitis or date of of data collection, whichever came first, up to 20 years

Secondary Outcomes (4)

  • Condom use

    twelve months before data collection

  • Evolution in concurrent sexual partnerships after migration in France

    At arrival in France, and then each year up to 20 years after arrival in France

  • Evolution in occasional sexual partnerships after migration in France

    At arrival in France, and then each year up to 20 years after arrival in France

  • Evolution in transactional sexual partnerships after migration in France

    At arrival in France, and then each year up to 20 years after arrival in France

Study Arms (3)

HIV group

group living with HIV

Hepatitis B group

group living with chronic hepatitis B

Reference group

group who has neither HIV nor hepatitis B

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Migrants from Sub-Saharan Africa living in Ile-de-France (Paris area) and visiting health care facilities: people living with HIV/AIDS (HIV group), people with chronic hepatitis B (hepatitis B group), and people who have neither of these conditions and consult within primary health care facilities in Ile-de-France (reference group).

You may qualify if:

  • \- For the 3 groups:
  • Be born in a Sub-Saharan African country and with Sub-Saharan African citizenship at birth,
  • Visit the health care facility for one's own health.
  • For the HIV group: To have been diagnosed for HIV more than 3 months ago, regardless of co-infections
  • For the hepatitis B group: To have been diagnosed with a chronic hepatitis B (AgHBs+) more than 3 months ago and not be HIV co-infected
  • For the primary care group: Not be known by the consulting physician as infected by HIV or Hepatitis B.

You may not qualify if:

  • to have been diagnosed for HIV or hepatitis B less than 3 months ago.
  • major cognitive or health impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Vignier N, Dray Spira R, Pannetier J, Ravalihasy A, Gosselin A, Lert F, Lydie N, Bouchaud O, Desgrees Du Lou A, Chauvin P; PARCOURS Study Group. Refusal to provide healthcare to sub-Saharan migrants in France: a comparison according to their HIV and HBV status. Eur J Public Health. 2018 Oct 1;28(5):904-910. doi: 10.1093/eurpub/cky118.

  • Gosselin A, Desgrees du Lou A, Lelievre E; PARCOURS Study Group. How to use sequence analysis for life course epidemiology? An example on HIV-positive Sub-Saharan migrants in France. J Epidemiol Community Health. 2018 Jun;72(6):507-512. doi: 10.1136/jech-2017-209739. Epub 2018 Feb 2.

  • Pannetier J, Ravalihasy A, Lydie N, Lert F, Desgrees du Lou A; Parcours study group. Prevalence and circumstances of forced sex and post-migration HIV acquisition in sub-Saharan African migrant women in France: an analysis of the ANRS-PARCOURS retrospective population-based study. Lancet Public Health. 2018 Jan;3(1):e16-e23. doi: 10.1016/S2468-2667(17)30211-6. Epub 2017 Nov 23.

Related Links

MeSH Terms

Conditions

HIV InfectionsHepatitis B, Chronic

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis BHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Annabel Desgrées du Loû, PhD

    Institute of Research for Development, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2015

First Posted

October 2, 2015

Study Start

February 1, 2012

Primary Completion

February 1, 2012

Study Completion

May 1, 2013

Last Updated

May 15, 2017

Record last verified: 2017-05