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Hepatitis BMaHeViNCT05002907

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

An observational study of Hepatitis B and Hepatitis C, run by Centre Hospitalier de Cayenne at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Hepatitis B, Hepatitis C, Hepatitis D
What is being tested?
Questionnaire, Biocollection and Delivery of results
Type of treatment
Vaccines
How many people
2,289 participants
Where
2 sitesin 2 countries
Study dates
1 Jan 2018to 23 Dec 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Consent withdrawal

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

French Guiana1 site
  • General Hospital of Cayenne

    Cayenne, 97306

Other trials in French Guiana

Suriname1 site
  • Foundation for Scientific Research Suriname (SWOS)

    Paramaribo

About this study

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.

Read the 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.

Being tested
Questionnaire, Biocollection, Delivery of results, Results and advices on transmission prevention methods, Confirmation of results on a blood test (In the event of a positive result)
Keywords
Epidemiology, Prevalence, Hepatitis B, Hepatitis C, Hepatitis D, HIV Infections, Phylogenetic, Molecular Biology
Medical subject headings
Hepatitis B, Hepatitis C, Hepatitis D, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    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.

  • BiocollectionOther

    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 resultsOther

    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 methodsOther

    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)Other

    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 careOther

    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 treatmentOther

    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.

Study groups in NCT05002907
Study groupRoleWhat they receive
General adult population living along the Maroni River in French Guiana and SurinameGeneral 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 .
Receives: Other: Questionnaire; Other: Biocollection; Other: Delivery of results; Other: Results and advices on transmission prevention methods; Other: Confirmation of results on a blood test (In the event of a positive result); Other: Information for care; Other: Monitoring and treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Current active HBV infection

    Current active HBV infection determined by HBs Ag positivity

    Measured: Through study completion, an average of 1 year

  2. 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

    Measured: Through study completion, an average of 1 year

  3. HCV infection

    Anti-HCV Ab positivity confirmed by detection of HCV RNA

    Measured: Through study completion, an average of 1 year

  4. HDV infection

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

    Measured: Through study completion, an average of 1 year

  5. HIV infection

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

    Measured: Through study completion, an average of 1 year

Secondary outcomes (2)
  1. 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.

    Measured: At Enrollment visit

  2. 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.

    Measured: Through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2021
  2. Study start1 Jan 2018
  3. Primary completion8 Feb 2019
  4. Study completion23 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05002907
Sponsor's protocol ID
MaHeVi
Acronym
MaHeVi
Status last verified
Jul 2021
First submitted
27 Jul 2021
Last updated
7 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis B and Hepatitis C, run by Centre Hospitalier de Cayenne at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in French Guiana, Suriname. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Current active HBV infection (time frame: Through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.

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