HIV Infection Clinical Trial
Official title:
Life Course, HIV and Hepatitis B Among African Migrants Living in Ile-de-France
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.
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).
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