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Seroprevalence of Chikungunya at the End of the First Chikungunya Outbreak in the French Antilles Within a Sample of Patients Treated for a HIV Infection (ChikVIH)

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ClinicalTrials.gov Identifier: NCT02553369
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:

Late 2013, the first indigenous cases of chikungunya have been observed in the French Antilles. At the end of May 2014, almost all of the islands of the Caribbean were affected by the outbreak.

During the large epidemic which affected the Island of La Réunion in 2005/2006, the attack rate was 38%. The most active period was three months.

In this context, knowledge of the attack rate and the epidemic in the Caribbean is an important issue for outbreak management and modeling work.

As the chikungunya virus had never circulated in the Caribbean, determining the seroconversion rate can be achieved by realizing a seroprevalence survey among the general population at the end of the outbreak. Another simple method is to estimate the rate in a cohort of patients followed regularly and whose habitat is distributed throughout the territory studied.

The follow up of patients infected by the human immunodeficiency virus (HIV) in the French West Indies is almost exclusively performed in hospitals in department of Infectious and Tropical Diseases.The high prevalence of HIV and homogeneous distribution of infected patients on all of our territories, allow to hypothesize that the risk of transmission of arboviruses by exposure to mosquito bites is comparable to the general population. This patient cohort is well suited to study the emergence of Chikungunya in the French West Indie .

Primary objective :

To estimate the cumulative incidence at the end of the first Chikungunya outbreak in the French West Indies by estimating the prevalence of specific antibodies of chikungunya virus in a sample (randomly constituted) from patients infected by HIV and representative of the general population of Martinique and Guadeloupe

Secondary objective :

To estimate the frequency of asymptomatic infections by the chikungunya virus in the studied population To estimate the frequency of chronic forms of chikungunya in the studied population


Condition or disease Intervention/treatment
HIV Infections Chikungunya Virus Infection Other: Biological sample collection

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Study Type : Observational
Actual Enrollment : 388 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroprevalence of Chikungunya at the End of the First Chikungunya Outbreak in the French Antilles Within a Sample of Patients Treated for a HIV Infection
Study Start Date : February 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya HIV/AIDS

Group/Cohort Intervention/treatment
Enrolled patients
Patient randomly enrolled in the study within a cohort of patient followed for HIV infection.
Other: Biological sample collection
A blood sample is collected during a follow up visit for HIV infection.




Primary Outcome Measures :
  1. Presence or not of chikungunya virus-specific immunoglobulin G antibodies (Elisa test) [ Time Frame: 1 day ]
    Presence or not of chikungunya virus-specific immunoglobulin G antibodies


Secondary Outcome Measures :
  1. Change From Baseline in Pain [ Time Frame: 6 , 12 , 18 months after the first symptoms of chikungunya virus infection ]
    Score range from 0 (No pain) to 10 (worst possible pain)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patient followed for HIV infection at the 2 investigator centers.
Criteria

Inclusion Criteria:

  • Adult (> 18 years old)
  • Followed for HIV infection at the 2 investigators centers (1 located at Martinique and 1 at Guadeloupe)
  • resident in Martinique /Guadeloupe ( French West Indies)
  • informed consent signed by the patient

Exclusion Criteria:

  • patient who lived more than 6 month in an risk area for chikungunya virus infection
  • patient with or documented chronic rheumatism
  • patient who has received a blood transfusion during year 2013 or patient who is supposed to receive a blood transfusion during the study
  • patient who has planned to live outside French West Indies during the follow up period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553369


Locations
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France
CHU de Guadeloupe
Pointe-à-Pitre, Guadeloupe, France, 97159
Centre Hospitalier Universitaire de Fort-de-France
Fort-de-France, Martinique, France, 97200
Sponsors and Collaborators
University Hospital Center of Martinique

Publications:

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT02553369     History of Changes
Other Study ID Numbers: 14/B/18
2014-A01504-43 ( Registry Identifier: ID RCB )
2014/82 ( Registry Identifier: N° CPP )
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Chikungunya Fever
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Virus Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Alphavirus Infections
Togaviridae Infections