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Arresting Vertical Transmission of Hepatitis B Virus (AVERT-HBV)

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ClinicalTrials.gov Identifier: NCT03567382
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
Kinshasa School of Public Health
Ohio State University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
The purpose of this pilot study is to demonstrate the feasibility of adding HBV screening and treatment of pregnant women to the existing HIV PMTCT platform in order to prevent mother-to-child transmission of hepatitis B virus.

Condition or disease Intervention/treatment Phase
Hepatitis B Vertical Transmission of Infectious Disease Drug: Tenofovir Disoproxil Fumarate Biological: Monovalent HBV vaccine Phase 4

Detailed Description:
Hepatitis B virus (HBV) is a leading cause of chronic liver disease globally, with devastating complications such as cirrhosis, hepatocellular carcinoma and death. Vertical transmission (VT) of HBV is a worldwide public health concern because infected children are at high risk of developing chronic liver disease. It is a particular problem in the Democratic Republic of the Congo (DRC); preliminary data suggest that approximately 3% of children have HBV infection due to VT. However, VT is preventable. Pregnant women with risk factors can be identified and treatments given which can virtually eliminate transmission. Unfortunately, despite the high burden of HBV, neither HBV testing of pregnant women nor interventions to prevent HBV VT are routinely performed in the DRC and elsewhere in sub-Saharan Africa. This pilot feasibility study will address this healthcare gap by identifying women with HBV early in their pregnancies and intervening to prevent VT by (1) treating mothers with high-risk HBV (defined as HBeAg positivity and/or HBV viremia >10^6) with tenofovir and (2) providing HBV vaccine to HBV-exposed infants within 24 hours of birth. This pilot study will piggyback onto an existing study that is evaluating the DRC's HIV Prevention of Maternal-to-Child Transmission Option B+ (PMTCT+) strategy. Combining programs to prevent VT of HBV and HIV enables using the same personnel and infrastructure to implement both interventions. Furthermore, tenofovir, used to treat HBV infections, is already used in the DRC to treat HIV. Researchers hypothesize that utilizing the existing PMTCT+ infrastructure in the DRC will provide a cost-effective platform to prevent HBV VT. If effective, this model of treatment will inform future public health efforts and wider policy recommendations that can be applied in the DRC and throughout the Sub-Saharan African region to reduce the burden of HBV.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: High-risk HBV dyads
Mothers with high-risk HBV (defined as viral load >10^6 and/or HBeAg positivity) will be treated with tenofovir disoproxil fumarate (TDF) to further reduce the risk of vertical transmission of HBV. All HBV-exposed infants (regardless of mother's status of high- or low-risk HBV) will receive monovalent HBV vaccine within 24 hours of life.
Drug: Tenofovir Disoproxil Fumarate
300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.
Other Name: Viread

Biological: Monovalent HBV vaccine
Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.
Other Name: Engerix-B

Experimental: Low-risk HBV dyads
Mothers with low risk HBV (defined as a viral load <10^6 and negative HBeAg) will not receive tenofovir disoproxil fumarate therapy during or after pregnancy. Their infants will still receive monovalent HBV vaccine within 24 hours of life.
Biological: Monovalent HBV vaccine
Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.
Other Name: Engerix-B




Primary Outcome Measures :
  1. Number of Participants with Lab Testing Acceptability Survey Scores >80% [ Time Frame: Upon completion of the exit survey, or up to 12 months ]
    The acceptability of laboratory testing approach to participants will be defined as >80% acceptability on a 5-point Likert scale by survey responses (higher scores will reflect greater acceptability). For example, the options for participant responses will include: "Very unacceptable", "Somewhat unacceptable", "No opinion", "Somewhat acceptable", "Very acceptable" and "Did not allow study personnel to take my blood".

  2. Number of Participants with Intervention Acceptability Survey Scores >80% [ Time Frame: Upon completion of the exit survey, or up to 12 months ]
    The acceptability of the intervention approach to participants will be defined as >80% acceptability on a 5-point Likert scale by survey responses (higher scores will reflect greater acceptability). For example, the options for responses will include: "Very unacceptable", "Somewhat unacceptable", "No opinion", "Somewhat acceptable", "Very acceptable" and "Did not allow study personnel to vaccinate my infant".


Secondary Outcome Measures :
  1. Incidence of mother-to-child transmission of HBV [ Time Frame: Measured at 6 months after birth ]
    Mother-to-child transmission of HBV is defined as HBsAg positivity in the infant at 6 months of life.

  2. Number of mothers with high-risk HBV demonstrating adherence to tenofovir therapy [ Time Frame: Pill counts to be measured monthly. Total adherence averaged over 6-month treatment period. ]
    Adherence to tenofovir therapy is defined as <20% of pills remaining on monthly pill counts for high-risk mothers with HBV receiving tenofovir

  3. Number of infants receiving timely birth dose vaccination [ Time Frame: Within 24 hours after birth ]
    Timeliness of infant HBV vaccination is defined as >90% of infants receiving birth dose vaccine within 24 hours of life



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Pregnant women receiving care at Binza and Kingasani maternity centers presenting prior to 24 weeks gestation
  • Infants born to HBV-positive women

Exclusion criteria:

  • Participants who are severely sick and who require prolonged hospitalization.
  • Any women who do not intend to stay in Kinshasa for prenatal care through delivery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03567382


Contacts
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Contact: Peyton Wilson, MD 919-445-0854 peyton_wilson@med.unc.edu

Locations
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Congo, The Democratic Republic of the
Kinshasa School of Public Health Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Emile Okitolonda, MD    243 999945183    okitow@yahoo.fr   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Kinshasa School of Public Health
Ohio State University
Investigators
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Principal Investigator: Steven Meshnick, MD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03567382     History of Changes
Other Study ID Numbers: 17-2090
IGHID 11720 ( Other Identifier: UNC Institute for Global Health and Infectious Diseases )
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis B
Tenofovir
Communicable Diseases
Infection
Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents