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HIV InfectionPARCOURSNCT02566148

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

An observational study of HIV Infection and Chronic Hepatitis B, run by ANRS, Emerging Infectious Diseases.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for
HIV Infection, Chronic Hepatitis B
How many people
2,468 participants
Where
No sites listed yet
Study dates
Feb 2012to May 2013
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 59 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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).

Who may be able to join

  • - 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.

Who cannot join

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

About this study

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.

Read more

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.

Read the detailed description

The PARCOURS study was conducted to study how health trajectories and social and migratory paths are interlaced for migrants from sub-Saharan Africa living in France. This retrospective quantitative life-event survey was conducted from February 2012 to May 2013 in health-care facilities in the greater Paris metropolitan area (Ile-de-France), among three groups of migrants born in sub-Saharan Africa: one group receiving HIV care, one group with chronic hepatitis B, and a third group of people visiting primary-care centres. Recruitment took place at facilities randomly selected from an exhaustive list of HIV outpatient hospital clinics (n=24), hepatitis treatment clinics (n=20) and general practice medical centres (n=30).

Recruitment procedure for patients in each group:

Within each health care facility selected for the study, all health care professionals providing outpatient care to patients born in sub-Saharan Africa were asked to participate in the study. They identified eligible patients during consultations based on medical records, and offered study participation to all eligible patients, except when the patient was deemed unable to be interviewed (for mental health or physical health reasons or because were unable to be interviewed in one of the languages spoken by the interviewer). When the patient agreed to participate in the study, health care professionals gave her/him an information leaflet on the study and obtained written consent. They also gave the participant a card bearing an identification number to ensure data collection anonymity and confidentiality, and referred her/him to the Parcours interviewer at the end of the consultation. The Parcours interviewer conducted the interview right after the consultation, in face-to-face mode, in a dedicated room, with closed door to ensure privacy.

The health care professional could also suggest an appointment in the following days, always on site, to patients who agreed to participate in the study but were not immediately available.

Consideration of non-Francophone participants:

To take into account difficulties in participating in the survey due to poor or no knowledge of the French language, the patient questionnaire was available in French or English, and, by appointment, an interpreter could be made available to conduct the interview in an African language spoken by the respondent.

Type of data collected

Several data collection tools were used:

Information register :

In each service investigated, each health care professional participating in the study held an information register. Each page of the register had two parts, one with a detachable section specifying the correspondence between the identity of study patients and their identity number, and an anonymous one describing the main characteristics of eligible patients. During each consultation day, the health care professional listed in the register all eligible patients, their gender, age group, if the patient had worked at least one day in the previous month, a health indicator (last CD4 count for HIV + patients, last alanine transaminase (ALT) level for patients with hepatitis B, the fact of consulting in this facility for the first time for patients in the reference group), and participation in the survey (participant, not offered participation, refusal).

Life-event history questionnaire

Participants were interviewed using a standardized life-event history questionnaire administered by an interviewer face-to-face (average duration 55 minutes). The life-event questionnaire consisted of two parts:

  • A list of questions associated with a life event calendar (or biographical grid), which allowed identifying, recording and dating (per year) events in the lives of the respondents, from birth to the date of the survey, and in the various themes explored in the study.
  • A book of thematic modules, aimed at describing in-depth the events previously identified in the biographical grid (or some of them).

The life-event calendar has a very graphic and visual form, which makes it easier to remember, record and date the events in the lives of the respondents. In particular, it encourages and easily adapts to the process of remembering that works by association of ideas and connections between life-event areas and as such optimizes data collection, in terms of completeness and reliability of the data collected.

The themes explored in the life-event questionnaire were:

Gender, age ; Residential biography and housing history ; Place of birth and places of residence. ; Work history - Education and Resources ; Marital and family history ; History of testing ; General health and history of disease ; Arrival in France and stay in France ; Sexual and reproductive health ; Social networks, support networks

Medical questionnaire :

The health care professional completed the medical questionnaire, from the patient's medical record. For the HIV and hepatitis B groups, this questionnaire documented the chronological landmarks and key parameters of the disease and its treatment. For the reference group, it informed the reason for consultation, potential diseases at the time of the survey, and current treatments.

Anonymity of data:

The identity number on the anonymity card given by the health care professional to the patient was the only participant identifier for the different survey questionnaires (thematic book and life-event calendar, medical questionnaire). The interviewer did not know the identity of the patient. No personally identifiable data was collected directly or indirectly for eligible individuals not offered participation or individuals refusing study participation. The general characteristics collected on the register among refusals were collected in the form of classes, and not precisely, thus not allowing for later identification.

Ethical approvals :

The survey was approved by the Advisory Committee for Data Processing in Health Research (CCTIRS) (approval on 13 April 2011) and by the National Commission on Informatics and Liberties (CNIL) (CD-2011-484 approval on 7 December 2011).

Data collection :

Between 30/01/2012 and 31/12/2012, 1,829 individuals infected with HIV and meeting the eligibility criteria presented at the participating services, among which 141 were not offered participation by their physician (111 for health reasons and 30 for language problems). Of the 1,688 individuals offered participation, 762 refused or abandoned during the questionnaire. In total, 926 individuals were included.

Between 15/02/2012 and 31/05/2013, 1,169 individuals infected with hepatitis B and meeting the eligibility criteria presented at the participating services, among which 17 were not offered participation by their physician and 8 abandoned during the questionnaire due to language problems. In total, among the 1,135 individuals offered participation, 779 were included.

Between 15/02/2012 and 31/05/2013, 1,184 meeting the eligibility criteria presented at the participating primary health care facilities. Among these, 124 were not offered participation by their physician (91 for health reasons and 33 for language problems). Among the 1,060 individuals offered participation, 297 refused or abandoned during the questionnaire. In total, 763 individuals were included.

Among all services and groups, the number of refusals due to language problems was 71 (30 in HIV group, 8 in Hepatitis B group and 33 in reference group), to which can be added 10 interviews interrupted due to poor understanding of French (8 in hepatitis B group and 2 in reference group).

Weighting :

In order to take into account the sample design and non-participation, data was weighted according to each individual's probability of inclusion in the survey (i.e. considering the probability of inclusion in the sample for each health care facility, the number of half-days of weekly consultations in each facility included and the individual study participation per half-day of included consultations).

Keywords
Life-event survey, observational survey among migrants in France
Medical subject headings
HIV Infections, Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02566148
Study groupRoleWhat they receive
HIV groupgroup living with HIV
Hepatitis B groupgroup living with chronic hepatitis B
Reference groupgroup who has neither HIV nor hepatitis B

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lapse of time from arrival in France to HIV testing

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

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

  2. 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

    Measured: 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

  3. Lapse of time from HIV diagnostic to access to care

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

    Measured: 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

  4. 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

    Measured: 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)
  1. Condom use

    Systematic condom use during the twelve months before the survey

    Measured: twelve months before data collection

  2. Evolution in concurrent sexual partnerships after migration 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).

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

  3. Evolution in occasional sexual partnerships after migration 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).

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

  4. Evolution in transactional sexual partnerships after migration 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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2015 (estimated)
  2. Study startFeb 2012
  3. Primary completionFeb 2012
  4. Study completionMay 2013

Resources

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
Case only
Time perspective
Retrospective
Enrolment
2,468 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02566148
Sponsor's protocol ID
ANRS PARCOURS
Acronym
PARCOURS
Status last verified
May 2017
First submitted
19 Jun 2015
Last updated
15 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 29982518
  • 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.

    PubMed 29437866
  • 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.

    PubMed 29307383

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection and Chronic Hepatitis B, run by ANRS, Emerging Infectious Diseases.

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 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

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). The study lists 4 primary outcomes in all. 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 NCT02566148, which also lists 3 linked publications.

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 15 May 2017.

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PARCOURS Clinical Trial NCT02566148 | AzTrials