Epidemiology of Hepatitis B, C and D and HIV Along the Maroni River Bordering French Guiana and Suriname (MaHeVi)
NCT05002907 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2289
Last updated 2023-06-07
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.
Conditions
- Hepatitis B
- Hepatitis C
- Hepatitis D
- HIV Infections
- Prevalence
- Epidemiology
Interventions
- 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.
- OTHER
-
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.
- OTHER
-
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.
- OTHER
-
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.
- OTHER
-
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.
- OTHER
-
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.
- OTHER
-
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.
Sponsors & Collaborators
-
Foundation for Scientific Research Suriname (SWOS) Paramaribo, Suriname
collaborator UNKNOWN -
Centre Hospitalier de Cayenne
lead OTHER
Principal Investigators
-
Mathieu NACHER, MD, PhD · Centre Hospitalier de Cayenne
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-01-01
- Primary Completion
- 2019-02-08
- Completion
- 2019-12-23
Countries
- French Guiana
- Suriname
Study Locations
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