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

HIV Infections Clinical Trial

— MaHeVi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05002907
• Other study ID #: MaHeVi
• Status: Completed
• 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
• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2289
• Est. completion date: December 23, 2019
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidemiology
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C
• Hepatitis D
• HIV Infections
• Prevalence

Intervention

Other:
• Questionnaire
After signing the informed consent sheet, a standardized face-to-face questionnaire will be conducted by the doctor, nurse or coordinator to collect socio-demographic data, lifestyle data, sex life and other potential risk factors and knowledge about viral hepatitis.
• Biocollection
After answering the questionnaire, the nurse or the doctor will take a sample of capillary blood from the fingertip on the side of the distal phalanx of a middle or ring finger. The puncture site will be prepared by warming and massage to optimize blood flow and disinfected with a disposable 70% alcohol wipe. After drying, the puncture will be performed using a single use safety lancet. A total of 7 capillary blood spotswill be collected and deposited on the filter paper (each spot is about 50µL of capillary blood), 5 for the study and 2 for the biological collection.
• Delivery of results
After receiving the individual biological analysis results, in coded form (results only identified by the anonymity number), at the investigation center and lifting the anonymity by the coordinator of the study in each study center (in Cayenne or Paramaribo depending the country where the inclusion took place) with the help of the correspondance list, the participants' results will be delivered to the referral doctor of each health centre and the infectious disease specialist responsible for each area of inclusion. All positive participants will be contacted if they do not spontaneously come to retrieve their results (within approximately 1 month after result's availability), and invited to come to the health centre to retrieve their results individually and be oriented towards the heathcare circuit.
• Results and advices on transmission prevention methods
The results will be revealed by the health centre's doctor/infectiologist, individually and confidentially, with an explanation of the results and advices on transmission prevention methods.Non-immunized patients against HBV will be offered a status determination (Anti-HBs Ab quantification on whole blood sample) and if necessary a catch-up vaccination according to the national immunization schedule.
• Confirmation of results on a blood test (In the event of a positive result)
In case of a positive result, the doctor will explain the need to confirm these results on a blood test, prescribe the initial assessment and take an appointment with the infectious disease specialist. He will guide the patient towards accompaniment for the opening of medical coverage rights if necessary and support by an association if desired.
• Information for care
A document with all contact information for a comprehensive and specialized care (professionals and associations for access to medical coverage and support, associations proposing support, general practitioners and specialists) will be given to positive participants. Patient monitoring and treatment will be carried out according to the national guidelines in each country.
• Monitoring and treatment
Consequently, all positive participants will be able to be monitored and treated by a specialist of the disease. They will give post-test counselling and will conduct patient follow-up and treatment according to the usual standards of care of each country.

Locations

Country	Name	City	State
French Guiana	General Hospital of Cayenne	Cayenne
Suriname	Foundation for Scientific Research Suriname (SWOS)	Paramaribo

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier de Cayenne	Foundation for Scientific Research Suriname (SWOS) Paramaribo, Suriname

Countries where clinical trial is conducted

French Guiana,  Suriname, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current active HBV infection	Current active HBV infection determined by HBs Ag positivity	Through study completion, an average of 1 year
Primary	HBV infection carrier status	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	Through study completion, an average of 1 year
Primary	HCV infection	Anti-HCV Ab positivity confirmed by detection of HCV RNA	Through study completion, an average of 1 year
Primary	HDV infection	Positivity for anti-HDV total Ab (on HBsAg positive samples only) and confirmation by detection of HDV RN	Through study completion, an average of 1 year
Primary	HIV infection	Positive HIV p24 antigen and/or HIV antibodies (fourth-generation combined EIA), confirmed by HIV Ab positivity using Western-blot	Through study completion, an average of 1 year
Secondary	Questionnaire	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.	At Enrollment visit
Secondary	HBV, HCV and HDV genotyping and phylogenetics	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.	Through study completion, an average of 1 year