Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Life Course, HIV and Hepatitis B Among African Migrants Living in Ile-de-France (PARCOURS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02566148
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : May 15, 2017
Sponsor:
Collaborators:
Ministry of Health, France
Institut de Recherche pour le Developpement
Institut National de la Santé Et de la Recherche Médicale, France
Institut national de prevention et d'education pour la sante
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

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.


Condition or disease
HIV Infection Chronic Hepatitis B

  Show Detailed Description

Layout table for study information
Study Type : Observational
Actual Enrollment : 2468 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Life Course, HIV and Hepatitis B Among African Migrants Living in Ile-de-France
Study Start Date : February 2012
Actual Primary Completion Date : February 2012
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. Lapse of time from arrival in France to HIV testing [ Time Frame: From arrival in France until the date of first HIV testing or date of of data collection, whichever came first, up to 20 years ]
    Time (in years) to occurence of first HIV testing, from arrival in France

  2. Lapse of time from arrival in France to hepatitis B testing [ Time Frame: 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 ]
    Time (in years) to occurence of first hepatitis B testing, from arrival in France

  3. Lapse of time from HIV diagnostic to access to care [ Time Frame: 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 ]
    Time (in years) to occurence of entry into HIV care, from HIV diagnostic

  4. Lapse of time from hepatitis B diagnostic to access to care [ Time Frame: 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 ]
    Time (in years) to occurence of entry into Hepatitis B care, from hepatitis B diagnostic


Secondary Outcome Measures :
  1. Condom use [ Time Frame: twelve months before data collection ]
    Systematic condom use during the twelve months before the survey

  2. Evolution in concurrent sexual partnerships after migration in France [ Time Frame: At arrival in France, and then each year up to 20 years after arrival in France ]
    Proportion of the respondents who declared, retrospectively, concurrent partnerships at year of migration, one year after migration, 2 years after migration, 3 years after migration, etc... until 20 years after migration or year of data collection, whichever came first, assessed up to 20 years. (data were collected with a life-event grid).

  3. Evolution in occasional sexual partnerships after migration in France [ Time Frame: At arrival in France, and then each year up to 20 years after arrival in France ]
    Proportion of the respondents who declared, retrospectively, occasional partnerships at year of migration, one year after migration, 2 years after migration, 3 years after migration, etc... until 20 years after migration or year of data collection, whichever came first, assessed up to 20 years. (data were collected with a life-event grid).

  4. Evolution in transactional sexual partnerships after migration in France [ Time Frame: At arrival in France, and then each year up to 20 years after arrival in France ]
    Proportion of the respondents who declared, retrospectively, transactional partnerships at year of migration, one year after migration, 2 years after migration, 3 years after migration, etc... until 20 years after migration or year of data collection, whichever came first, assessed up to 20 years. (data were collected with a life-event grid).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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).
Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

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

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): NCT02566148


Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Ministry of Health, France
Institut de Recherche pour le Developpement
Institut National de la Santé Et de la Recherche Médicale, France
Institut national de prevention et d'education pour la sante
Investigators
Layout table for investigator information
Principal Investigator: Annabel Desgrées du Loû, PhD Institute of Research for Development, France

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT02566148     History of Changes
Other Study ID Numbers: ANRS PARCOURS
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: May 15, 2017
Last Verified: May 2017
Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Life-event survey
observational survey among migrants in France
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic