Epidemiology of Hepatitis B, C and D and HIV Along the Maroni River Bordering French Guiana and Suriname (MaHeVi)
- Conditions
- PrevalenceHepatitis DHIV InfectionsEpidemiologyHepatitis BHepatitis C
- Interventions
- Other: QuestionnaireOther: BiocollectionOther: Delivery of resultsOther: Results and advices on transmission prevention methodsOther: Confirmation of results on a blood test (In the event of a positive result)Other: Information for careOther: Monitoring and treatment
- Registration Number
- NCT05002907
- Lead Sponsor
- Centre Hospitalier de Cayenne
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2289
- Age ≥ 18 years
- Planning to stay on the Maroni river for at least 2 months after inclusion
- Signed informed consent
- Consent withdrawal
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description General adult population living along the Maroni River in French Guiana and Suriname Delivery of results General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey . General adult population living along the Maroni River in French Guiana and Suriname Questionnaire General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey . General adult population living along the Maroni River in French Guiana and Suriname Biocollection General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey . General adult population living along the Maroni River in French Guiana and Suriname Results and advices on transmission prevention methods General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey . General adult population living along the Maroni River in French Guiana and Suriname Confirmation of results on a blood test (In the event of a positive result) General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey . General adult population living along the Maroni River in French Guiana and Suriname Information for care General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey . General adult population living along the Maroni River in French Guiana and Suriname Monitoring and treatment General adult population living along the Maroni River in French Guiana and Suriname, upstream from Apatou. All adults (men and women) 18 years or older of both sexes will be able to participate in the study, in French Guiana and Suriname. Participation will be based on volunteering and signing informed consent. The acceptability and diversity of recruitment will be improved by seeking community support through community leaders and local associations and through appropriate communication (radio spots, posters in health centers and public establishments) before the survey .
- Primary Outcome Measures
Name Time Method Current active HBV infection Through study completion, an average of 1 year Current active HBV infection determined by HBs Ag positivity
HBV infection carrier status 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 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 Through study completion, an average of 1 year Anti-HCV Ab positivity confirmed by detection of HCV RNA
HIV infection 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
- Secondary Outcome Measures
Name Time Method Questionnaire At Enrollment visit To describe social and demographic characteristics of infected people and to identify specific risk factors (determinants) associated with HBV, HCV and HIV infection like unsafe sex practices (early sexual initiation, multiple sex partners, not using a condom, traumatic sexual practices, STDs), body modifications (tattoo, piercing, scarifications or bouglous) performed with unsterile equipment, previous blood transfusion or dialysis, sharing personal hygiene equipment like tooth-brush, razor or nail clipper. This will be analyzed using the responses to the questionnaire.
HBV, HCV and HDV genotyping and phylogenetics Through study completion, an average of 1 year Viral sequences will be used for Bayesian analysis of phylogeny and phylogeography. Most recent common ancestor, spreading, risk factors and geographical association will be analyzed for all genotypes.
Trial Locations
- Locations (2)
General Hospital of Cayenne
🇬🇫Cayenne, French Guiana
Foundation for Scientific Research Suriname (SWOS)
🇸🇷Paramaribo, Suriname