Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05002907 |
Other study ID # |
MaHeVi |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2018 |
Est. completion date |
December 23, 2019 |
Study information
Verified date |
July 2021 |
Source |
Centre Hospitalier de Cayenne |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
MaHeVi is a multicenter, cross-sectional, population-based study which will include 2500
adults in the health care centers / missions located on the 2 sides of the Maroni River. All
major inhabitants of the river border between French Guiana and Suriname may participate,
after an extensive communication campaign.The main objective is to estimate the prevalence
and status of infection with hepatitis B (HBV), hepatitis C (HCV), D (VHD) and HIV in the
general adult population of the Maroni River, border between French Guiana and Suriname.
After signing the informed consent and pre-test counseling, capillary blood will be collected
on blotting paper. Participants will be interviewed on infection risk factors. Positivity for
HBsAg, total anti-HBcAb, anti-HCV Ab, total anti-HDV Ab(for HBsAg positive) and HIV p24 Ag or
anti-HIV Ab (confirmed by molecular biology for hepatitis and Western Blot for HIV) will
inform respectively on the HBV, HCV, HDV and HIV infection status.
Description:
HBV, HCV and HDV are viruses with parenteral, sexual and mother-to-child transmission,
associated with high morbidity and mortality. They are responsible for the majority of hepato
cellular carcinoma. More than 1.4 million people die each year of complications associated
with these infections. Most people do not know their chronic viral hepatitis status which
leads to frequent late stage diagnosis of the disease. Treatments allow viral control or
suppression of HBV and HCV. The knowledge of the status can reduce transmission,early
effective treatment and avoid or delay late complications. In South America, the prevalence
of HBV varies widely but is high (> 8%) in the Amazon basin. In some areas a third of HBsAg
carriers are also infected with HDV, a major co morbidity factor. French Guiana and Suriname
are part of the Amazon biome and are populated by a mosaic of communities. The few available
data suggest high variability in hepatitis B and C prevalence in the different communities.
The Maroni River is inhabited by Maroon (descendants of slaves of African origin who escaped
from Surinamese plantations) and Amerindian communities (indigenous). Reliable data
prevalence of HBV, HCV and HIV are lacking in these remote, mobile and vulnerable
populations. The infection risk is high, due to low vaccination coverage against HBV, low
screening rate and delayed access to care and treatment. There are no data on HDV in this
region. In terms of public health, it is of great importance to explore the epidemic of viral
hepatitis in the Maroni population pool because the lack of data is an obstacle to the
planning of adapted and efficient health interventions.
This multicenter, cross-sectional, population-based study will include 2500 adults in the
health care centers / missions located on the 2 sides of the Maroni River. All major
inhabitants of the river may participate, after an extensive communication campaign. After
signing the informed consent and pre-test counseling, capillary blood will be collected on
blotting paper. Participants will be interviewed on infection risk factors. Positivity for
HBsAg, total anti-HBcAb, anti-HCV Ab, total anti-HDV Ab(for HBsAg positive) and HIV p24 Ag or
anti-HIV Ab (confirmed by molecular biology for hepatitis and Western Blot for HIV) will
inform respectively on the HBV, HCV, HDV and HIV infection status. Positive participants will
be analyzed in molecular biology (viral load and genotyping). The results will be provided
individually and confidentially to participants; positive patients will receive standard care
following national guidelines.