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临床试验/NCT05002907
NCT05002907已完成不适用

Epidemiology of Hepatitis B, C and D and HIV Along the Maroni River Bordering French Guiana and Suriname (MaHeVi)

Centre Hospitalier de Cayenne2 个研究点 分布在 2 个国家目标入组 2,289 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,289
试验地点
2
主要终点
Current active HBV infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Planning to stay on the Maroni river for at least 2 months after inclusion
  • Signed informed consent

排除标准

  • Consent withdrawal

结局指标

主要结局

Current active HBV infection

时间窗: Through study completion, an average of 1 year

Current active HBV infection determined by HBs Ag positivity

HBV infection carrier status

时间窗: Through study completion, an average of 1 year

Acute hepatitis B, chronic active hepatitis B, possible inactive chronic hepatitis B and resolved hepatitis B, determined by HBs Ag and total anti-HBcAb and if HBs Ag is positive by Anti-HBcIgM, HBV DNA and HBe Ag

HDV infection

时间窗: Through study completion, an average of 1 year

Positivity for anti-HDV total Ab (on HBsAg positive samples only) and confirmation by detection of HDV RN

HCV infection

时间窗: Through study completion, an average of 1 year

Anti-HCV Ab positivity confirmed by detection of HCV RNA

HIV infection

时间窗: Through study completion, an average of 1 year

Positive HIV p24 antigen and/or HIV antibodies (fourth-generation combined EIA), confirmed by HIV Ab positivity using Western-blot

次要结局

  • Questionnaire(At Enrollment visit)
  • HBV, HCV and HDV genotyping and phylogenetics(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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