NCT05174234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,189

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 4, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

1.6 years

First QC Date

October 25, 2021

Last Update Submit

July 26, 2024

Conditions

Keywords

hivhaitifrench guianasexual health

Outcome Measures

Primary Outcomes (1)

  • 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

    at inclusion

Secondary Outcomes (17)

  • the number of countries of residence

    at inclusion

  • level of precariousness

    at inclusion

  • level of precariousness

    at inclusion

  • level of precariousness - right to stay

    at inclusion

  • level of precariousness - health coverage

    at inclusion

  • +12 more secondary outcomes

Study Arms (3)

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)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

A group of PLWHIV and a group of people from Haïti not living with HIV

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • Unable to answer the interviewer in French or Haitian Creole
  • Persons under guardianship or trusteeship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Cayenne

Cayenne, France, 97306, French Guiana

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HIV SeropositivityAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Nicolas MD Vignier, PhD

    Centre Hospitalier de Cayenne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2021

First Posted

December 30, 2021

Study Start

November 4, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations