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Precariousness and Sexual Vulnerability of People From Haiti Living With or Without HIV in French Guiana (ParcoursHaiti)
| Condition or disease |
|---|
| HIV Seropositivity |
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 Type : | Observational |
| Estimated Enrollment : | 784 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| 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) |
| Actual Study Start Date : | November 4, 2021 |
| Estimated Primary Completion Date : | May 4, 2022 |
| Estimated Study Completion Date : | November 4, 2022 |
| Group/Cohort |
|---|
|
People living with HIV
a group of PLWHIV (n=392): women and men PLWHIV 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=392): women and men aged 18 to 60 years from Haiti
|
- 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
- the number of countries of residence [ Time Frame: at inclusion ]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
- level of precariousness [ Time Frame: at inclusion ]type of housing
- level of precariousness [ Time Frame: at inclusion ]type of resources
- level of precariousness [ Time Frame: at inclusion ]right to stay
- level of precariousness [ Time Frame: at inclusion ]type of health coverage
- level of precariousness [ Time Frame: at inclusion ]use of HIV and HBV screening year after year after arrival in French Guiana
- 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 ]Identification of factors associated with earlier screening among the social indicators mentioned above
- Attendance at preventive medicine facilities [ Time Frame: at inclusion ]Attendance at preventive medicine facilities
- delay between diagnosis and entry into care. [ Time Frame: at inclusion ]Description of prolonged disruptions in care. Associated factors.
- number of partners [ Time Frame: at inclusion ]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.
- description of clades of the Pol gene of the HIV genotyping sequence [ Time Frame: at inclusion ]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).
- birth control methods used [ Time Frame: at inclusion ]birth control methods used
- number of desired and unwanted pregnancies [ Time Frame: at inclusion ]number of desired and unwanted pregnancies
- number of voluntary termination of pregnancy [ Time Frame: at inclusion ]number of voluntary termination of pregnancy
- number of abandonment of care during the Covid-19 epidemic [ Time Frame: at inclusion ]number of abandonment of care during the Covid-19 epidemic
- number in break in follow-up and treatment during the Covid-19 epidemic [ Time Frame: at inclusion ]number in break in follow-up and treatment during the Covid-19 epidemic
- delay in care during the Covid-19 epidemic [ Time Frame: at inclusion ]delay in care during the Covid-19 epidemic
| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
For both 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
- 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 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)
Exclusion Criteria:
- Unable to answer the interviewer in French or Haitian Creole
- Persons under guardianship or trusteeship
| Contact: Nicolas MD Vignier, PhD | 05 94 39 53 85 | nicolas.vignier@ch-cayenne.fr | |
| Contact: Mathieu MD Nacher, PhD | 05 94 39 53 85 | mathieu.nacher@ch-cayenne.fr |
| French Guiana | |
| Centre Hospitalier de Cayenne | Recruiting |
| Cayenne, France, French Guiana, 97306 | |
| Contact: nicolas N Vignier, PhD nicolas.vignier@ch-cayenne.fr | |
| Contact: mathieu M Nacher, PhD mathieu.nacher@ch-cayenne.fr | |
| Principal Investigator: | Nicolas MD Vignier, PhD | Centre Hospitalier de Cayenne |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | October 25, 2021 | ||||||||
| First Posted Date | December 30, 2021 | ||||||||
| Last Update Posted Date | December 30, 2021 | ||||||||
| Actual Study Start Date | November 4, 2021 | ||||||||
| Estimated Primary Completion Date | May 4, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Precariousness and Sexual Vulnerability of People From Haiti Living With or Without HIV in French Guiana | ||||||||
| 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) | ||||||||
| Brief 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 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | A group of PLWHIV and a group of people from Haïti not living with HIV | ||||||||
| Condition | HIV Seropositivity | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
784 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | November 4, 2022 | ||||||||
| Estimated Primary Completion Date | May 4, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria: For both groups, patient :
For the HIV group
For the non-HIV group
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 60 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | French Guiana | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05174234 | ||||||||
| Other Study ID Numbers | Parcours d'Haïti | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Centre Hospitalier de Cayenne | ||||||||
| Study Sponsor | Centre Hospitalier de Cayenne | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Centre Hospitalier de Cayenne | ||||||||
| Verification Date | December 2021 | ||||||||