Clinical trial NCT05002907: Epidemiology of Hepatitis B, C and D and HIV Along the Maroni River Bordering French Guiana and Suriname (MaHeVi)
Official title: Epidemiology of Hepatitis B, C and D and HIV Along the Maroni River Bordering French Guiana and Suriname (MaHeVi)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Hepatitis C
Hepatitis D
HIV Infections
Prevalence
Epidemiology
Keywords: Epidemiology
Prevalence
Hepatitis B
Hepatitis C
Hepatitis D
HIV Infections
Phylogenetic
Molecular Biology
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: Foundation for Scientific Research Suriname (SWOS) Paramaribo, Suriname
First posted: 2021-08-12
Enrollment: 2289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Consent withdrawal

Primary outcomes:
measure: Current active HBV infection
timeFrame: Through study completion, an average of 1 year
measure: HBV infection carrier status
timeFrame: Through study completion, an average of 1 year
measure: HCV infection
timeFrame: Through study completion, an average of 1 year
measure: HDV infection
timeFrame: Through study completion, an average of 1 year
measure: HIV infection
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Questionnaire
timeFrame: At Enrollment visit
measure: HBV, HCV and HDV genotyping and phylogenetics
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cayenne
country: French Guiana
facility: General Hospital of Cayenne
city: Paramaribo
country: Suriname
facility: Foundation for Scientific Research Suriname (SWOS)
Study officials:
affiliation: Centre Hospitalier de Cayenne
name: Mathieu NACHER, MD, PhD
role: STUDY_DIRECTOR
References: