HIV SeropositivityParcoursHaitiNCT05174234
Precariousness and Sexual Vulnerability of People From Haiti Living With or Without HIV in French Guiana
An observational study of HIV Seropositivity, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
French Guiana, a French territory located in South America, faces several social challenges including financial insecurity, unemployment and significant immigration. The degraded living conditions of migrants arriving in the territory are likely to put them in a situation of sexual vulnerability that could increase… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Seropositivity
- How many people
- 2,189 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 4 Nov 2021to 31 May 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A group of PLWHIV and a group of people from Haïti not living with HIV
Who may be able to join
- For the 3 groups, patient :
- Born in Haiti, regardless of current nationality and date of arrival in France
- Aged between 18 and 60 years' old
- Arrived in French Guiana for more than 3 months
- Not opposed to participating in the study
- For the HIV group
Show all 14Show fewer
- Living with HIV and diagnosed for more than 3 months, regardless of their status regarding hepatitis B and C
- Be followed by one of the study's partner physicians in the hospitals of Cayenne, Kourou or Saint Laurent du Maroni
- For the HBV group
- Living with HBV and diagnosed for more than 3 months, regardless of their status regarding HIV and hepatitis C
- Be followed by one of the study's partner physicians in the hospitals of Cayenne, Kourou or Saint Laurent du Maroni
- For the non-HIV group
- Declared not to be infected with HIV, regardless of their status with respect to hepatitis B and C
- Being followed by one of the study's partner physicians or being recruited in the public space of one of the cities targeted by the study (Cayenne, Matoury, Rémire-Montjoly, Macouria, Kourou, Montsinery-Tonnegrande, Saint-Laurent-du-Maroni or Mana)
Who cannot join
- Unable to answer the interviewer in French or Haitian Creole
- Persons under guardianship or trusteeship
Trial locations and contacts
1 site in 1 country.
French Guiana1 site
Centre Hospitalier de Cayenne
Cayenne, France, 97306
About this study
Official title: Precariousness and Sexual Vulnerability During the Life Course and Migration of People From Haiti Living With or Without HIV in French Guiana (PARCOURS D'HAÏTI)
French Guiana, a French territory located in South America, faces several social challenges including financial insecurity, unemployment and significant immigration. The degraded living conditions of migrants arriving in the territory are likely to put them in a situation of sexual vulnerability that could increase their risk of acquiring HIV (human immunodeficiency virus). This study proposes to conduct a survey of a group of people living with HIV in French Guiana who were born in Haiti and a group of Haitian people who are not HIV positive. With the help of interviewers who speak Haitian Creole, it will allow us to better understand the life paths of people from Haiti and their periods of vulnerability. Investigators will also focus on the use of testing and retention in care for those living with HIV. The results of this work will allow for the mobilization of resources and better adjustment of social support, prevention and care interventions implemented in French Guiana for migrant populations and/or those in precarious situations.
Read the detailed description
French Guiana is a French overseas territory located in the Amazon basin of South America. It faces several challenges with dynamic demographics, poverty affecting nearly half of the population and significant immigration (more than a third of the Guianese population). People from Haiti represent 25% of foreigners living in French Guiana (census data, INSEE). This follows several waves of migration, including the major one dating from 2015. They are also over-represented among people living with HIV (PLWHIV). Work analyzing the slope of CD4 decrease and phylogeographic analyses suggests that a large proportion of HIV infections occur in French Guiana. The living conditions of Haitians after the arrival in French Guiana are often degraded, combining financial, administrative and housing precariousness. These conditions could increase the risk of having sex at risk of acquiring HIV and sexually transmitted infections when they occur in a context of social or sexual vulnerability or of priced intercourse in a context of survival. The 2013 ANRS-Parcours survey highlighted this sexual vulnerability among immigrants from sub-Saharan Africa living in Ile-de-France, using a biographical methodology which allowed comparing living conditions with the sexuality of people.
The present project proposes to set up a cross-sectional epidemiological and biographical study among PLWHIV from Haiti and people born in Haiti who declare not to be infected by HIV. The aim of the study will be to assess the frequency of unsafe sex (including forced sex) after the arrival in French Guiana of people from Haiti and their association with living conditions and the acquisition of HIV infection, year by year. It looks for better understand the living conditions of Haitians people after their arrival in French Guiana, to shed light on the use of screening and the determinants of late diagnoses, the delay in entering care but also the retention in care after the diagnosis, especially during the particular period of the Covid 19 epidemic. PLWHIV will also be offered a phylogenetic study to better understand HIV transmission.
Recruitment will focus on a group of PLWHIV from Haiti followed at the Cayenne, Kourou or Saint-Laurent du Maroni hospital and a group of people born in Haiti uninfected followed by general medicine, the health center for the poor (Permanence d'Accès aux Soins de Santé) or by the Prevention Health Center of French Red Cross in the municipalities of Cayenne, Matoury, Macouria or Kourou. Social, demographic and administrative data relating to the migratory journey, sexuality, the use of screening, the tools of diversified prevention, entry and retention in care will be collected. Part of the information will be collected each year since arriving in France using a biographical grid.
The results of this study are likely to improve the understanding of the situations of sexual vulnerability of immigrants from Haiti with a view to setting up a course in sexual health integrating an offer of screening and medicalized prevention to reduce the risk of HIV infection, STIs (sexually transmitted infections), unwanted sexual intercourse and unwanted pregnancies. They will articulate with the work already underway to develop a prevention and care offer directly within the informal settlements where a population mainly from Haiti lives.
It will also help to better understand the journey of Haitian PLWHIV after their diagnosis and produce information useful for the implementation of actions likely to prevent patients from being lost to follow-up.
- Conditions
- HIV Seropositivity
- Keywords
- hiv, haiti, french guiana, sexual health
- Medical subject headings
- HIV Seropositivity, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People living with HIV | a group of PLWHIV (n=400): women and men aged 18 to 60 years old from Haiti followed at the Cayenne Hospital, the Kourou Hospital or the West Guyanese Hospital (Saint Laurent du Maroni) | |
| People not living with HIV | a group of immigrants from Haiti not known to be infected with HIV (n=1600): women and men aged 18 to 60 years from Haiti | |
| People living with HBV | a group of PLWHBV (n=400): women and men aged 18 to 60 years old from Haiti followed at the Cayenne Hospital, the Kourou Hospital or the West Guyanese Hospital (Saint Laurent du Maroni) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of unsafe sex
Frequency of unsafe sex (including forced and paid sex) after arrival in French Guiana of people from Haiti and its association with their living conditions and acquisition of HIV infection
Measured: at inclusion
Secondary outcomes (17)
the number of countries of residence
the number of countries of residence during the lifetime and the duration of residence in each country, as well as access to health coverage and first screening in years of increased migration from Haiti
Measured: at inclusion
level of precariousness
type of housing
Measured: at inclusion
level of precariousness
type of resources
Measured: at inclusion
level of precariousness - right to stay
right to stay
Measured: at inclusion
level of precariousness - health coverage
type of health coverage
Measured: at inclusion
level of precariousness - use of STI screening
use of HIV and HBV screening year after year after arrival in French Guiana
Measured: at inclusion
delay between arrival in French Guiana and the first screening for sexually transmitted infections (STIs) and HIV diagnosis for positive persons
Identification of factors associated with earlier screening among the social indicators mentioned above
Measured: at inclusion
Attendance at preventive medicine facilities
Attendance at preventive medicine facilities
Measured: at inclusion
delay between diagnosis and entry into care.
Description of prolonged disruptions in care. Associated factors.
Measured: at inclusion
number of partners
number of partners in the course of a lifetime and in the last twelve months, long relationships, occasional relationships, economic-sexual exchanges, forced relationships, recourse to paid sex year after year.
Measured: at inclusion
description of clades of the Pol gene of the HIV genotyping sequence
list of clades of the Pol gene of the HIV genotyping sequence (Pol gene sequence) performed at the beginning of the care of participants living with HIV (phylogenetic analysis).
Measured: at inclusion
birth control methods used
birth control methods used
Measured: at inclusion
number of desired and unwanted pregnancies
number of desired and unwanted pregnancies
Measured: at inclusion
number of voluntary termination of pregnancy
number of voluntary termination of pregnancy
Measured: at inclusion
number of abandonment of care during the Covid-19 epidemic
number of abandonment of care during the Covid-19 epidemic
Measured: at inclusion
number in break in follow-up and treatment during the Covid-19 epidemic
number in break in follow-up and treatment during the Covid-19 epidemic
Measured: at inclusion
delay in care during the Covid-19 epidemic
delay in care during the Covid-19 epidemic
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start4 Nov 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV SeropositivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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-control
- Time perspective
- Cross-sectional
- Enrolment
- 2,189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MD Vignier, PhD, Principal investigator, Centre Hospitalier de Cayenne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174234
- Sponsor's protocol ID
- Parcours d'Haïti
- Acronym
- ParcoursHaiti
- Status last verified
- Jul 2024
- First submitted
- 25 Oct 2021
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alcouffe L, Tareau MA, Brun Rambaud G, Lucarelli A, Boutrou M, Thorey C, Cantalupi G, Kpossou K, Huber F, Rabier S, Rochemont DR, Blaise T, Thomas E, Jean G, Pierre Louis R, Zephirin A, Basurko C, Djossou F, Cisse H, Faurous W, Drouaud Q, Mergeay-Fabre M, Adenis A, Nacher M, Vignier N. Sexual Health Determinants During the Life Course and Migration of Haitian-Origin People in French Guiana: Protocol for the Parcours d'Haiti Biographical and Transdisciplinary Study. JMIR Res Protoc. 2025 Jun 12;14:e63586. doi: 10.2196/63586.
PubMed 40505127
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precariousness and Sexual Vulnerability During the Life Course and Migration of People From Haiti Living With or Without HIV in French Guiana (PARCOURS D'HAÏTI)
- ClinicalTrials.gov ID
- NCT05174234
- Acronym / sponsor ID
- ParcoursHaiti / Parcours d'Haïti
- Conditions
- HIV Seropositivity
- Keywords
- hiv, haiti, french guiana, sexual health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,189 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
French Guiana, a French territory located in South America, faces several social challenges including financial insecurity, unemployment and significant immigration. The degraded living conditions of migrants arriving in the territory are likely to put them in a situation of sexual vulnerability that could increase their risk of acquiring HIV (human immunodeficiency virus). This study proposes to conduct a survey of a group of people living with HIV in French Guiana who were born in Haiti and a group of Haitian people who are not HIV positive. With the help of interviewers who speak Haitian Creole, it will allow us to better understand the life paths of people from Haiti and their periods of vulnerability. Investigators will also focus on the use of testing and retention in care for those living with HIV. The results of this work will allow for the mobilization of resources and better adjustment of social support, prevention and care interventions implemented in French Guiana for migrant populations and/or those in precarious situations.
Detailed description
French Guiana is a French overseas territory located in the Amazon basin of South America. It faces several challenges with dynamic demographics, poverty affecting nearly half of the population and significant immigration (more than a third of the Guianese population). People from Haiti represent 25% of foreigners living in French Guiana (census data, INSEE). This follows several waves of migration, including the major one dating from 2015. They are also over-represented among people living with HIV (PLWHIV). Work analyzing the slope of CD4 decrease and phylogeographic analyses suggests that a large proportion of HIV infections occur in French Guiana. The living conditions of Haitians after the arrival in French Guiana are often degraded, combining financial, administrative and housing precariousness. These conditions could increase the risk of having sex at risk of acquiring HIV and sexually transmitted infections when they occur in a context of social or sexual vulnerability or of priced intercourse in a context of survival. The 2013 ANRS-Parcours survey highlighted this sexual vulnerability among immigrants from sub-Saharan Africa living in Ile-de-France, using a biographical methodology which allowed comparing living conditions with the sexuality of people.
The present project proposes to set up a cross-sectional epidemiological and biographical study among PLWHIV from Haiti and people born in Haiti who declare not to be infected by HIV. The aim of the study will be to assess the frequency of unsafe sex (including forced sex) after the arrival in French Guiana of people from Haiti and their association with living conditions and the acquisition of HIV infection, year by year. It looks for better understand the living conditions of Haitians people after their arrival in French Guiana, to shed light on the use of screening and the determinants of late diagnoses, the delay in entering care but also the retention in care after the diagnosis, especially during the particular period of the Covid 19 epidemic. PLWHIV will also be offered a phylogenetic study to better understand HIV transmission.
Recruitment will focus on a group of PLWHIV from Haiti followed at the Cayenne, Kourou or Saint-Laurent du Maroni hospital and a group of people born in Haiti uninfected followed by general medicine, the health center for the poor (Permanence d'Accès aux Soins de Santé) or by the Prevention Health Center of French Red Cross in the municipalities of Cayenne, Matoury, Macouria or Kourou. Social, demographic and administrative data relating to the migratory journey, sexuality, the use of screening, the tools of diversified prevention, entry and retention in care will be collected. Part of the information will be collected each year since arriving in France using a biographical grid.
The results of this study are likely to improve the understanding of the situations of sexual vulnerability of immigrants from Haiti with a view to setting up a course in sexual health integrating an offer of screening and medicalized prevention to reduce the risk of HIV infection, STIs (sexually transmitted infections), unwanted sexual intercourse and unwanted pregnancies. They will articulate with the work already underway to develop a prevention and care offer directly within the informal settlements where a population mainly from Haiti lives.
It will also help to better understand the journey of Haitian PLWHIV after their diagnosis and produce information useful for the implementation of actions likely to prevent patients from being lost to follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| People living with HIV | – | –a group of PLWHIV (n=400): women and men aged 18 to 60 years old from Haiti followed at the Cayenne Hospital, the Kourou Hospital or the West Guyanese Hospital (Saint Laurent du Maroni) |
| People not living with HIV | – | –a group of immigrants from Haiti not known to be infected with HIV (n=1600): women and men aged 18 to 60 years from Haiti |
| People living with HBV | – | –a group of PLWHBV (n=400): women and men aged 18 to 60 years old from Haiti followed at the Cayenne Hospital, the Kourou Hospital or the West Guyanese Hospital (Saint Laurent du Maroni) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A group of PLWHIV and a group of people from Haïti not living with HIV
Key inclusion criteria (14 listed)
- Born in Haiti, regardless of current nationality and date of arrival in France
- Aged between 18 and 60 years' old
- Arrived in French Guiana for more than 3 months
- Not opposed to participating in the study
- For the HIV group
Key exclusion criteria (2 listed)
- Unable to answer the interviewer in French or Haitian Creole
- Persons under guardianship or trusteeship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of unsafe sex
Time frame: at inclusion
Frequency of unsafe sex (including forced and paid sex) after arrival in French Guiana of people from Haiti and its association with their living conditions and acquisition of HIV infection
17 secondary outcomes
the number of countries of residence
Time frame: at inclusion
level of precariousness
Time frame: at inclusion
level of precariousness
Time frame: at inclusion
level of precariousness - right to stay
Time frame: at inclusion
level of precariousness - health coverage
Time frame: at inclusion
level of precariousness - use of STI screening
Time frame: at inclusion
delay between arrival in French Guiana and the first screening for sexually transmitted infections (STIs) and HIV diagnosis for positive persons
Time frame: at inclusion
Attendance at preventive medicine facilities
Time frame: at inclusion
delay between diagnosis and entry into care.
Time frame: at inclusion
number of partners
Time frame: at inclusion
description of clades of the Pol gene of the HIV genotyping sequence
Time frame: at inclusion
birth control methods used
Time frame: at inclusion
number of desired and unwanted pregnancies
Time frame: at inclusion
number of voluntary termination of pregnancy
Time frame: at inclusion
number of abandonment of care during the Covid-19 epidemic
Time frame: at inclusion
number in break in follow-up and treatment during the Covid-19 epidemic
Time frame: at inclusion
delay in care during the Covid-19 epidemic
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 40505127Alcouffe L, Tareau MA, Brun Rambaud G, Lucarelli A, Boutrou M, Thorey C, Cantalupi G, Kpossou K, Huber F, Rabier S, Rochemont DR, Blaise T, Thomas E, Jean G, Pierre Louis R, Zephirin A, Basurko C, Djossou F, Cisse H, Faurous W, Drouaud Q, Mergeay-Fabre M, Adenis A, Nacher M, Vignier N. Sexual Health Determinants During the Life Course and Migration of Haitian-Origin People in French Guiana: Protocol for the Parcours d'Haiti Biographical and Transdisciplinary Study. JMIR Res Protoc. 2025 Jun 12;14:e63586. doi: 10.2196/63586.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas MD Vignier, PhD principal investigator
Centre Hospitalier de Cayenne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Seropositivity, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 14 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in French Guiana. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Frequency of unsafe sex (time frame: at inclusion). 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 NCT05174234, which also lists 1 linked publication.
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 29 Jul 2024.