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Completed

NCT Number: NCT03567382

Arresting Vertical Transmission of Hepatitis B Virus

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Vertical Transmission of Infectious Disease Virus Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tenofovir disoproxil fumarate

Drug

300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.

Other names: Viread

Monovalent HBV vaccine

Biological

Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.

Other names: Engerix-B

Primary outcomes

  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 two questions each measured using a 5-point Likert scale (range 1-5, highest score of 5 representing the highest acceptability). For example, the options for participant responses will include: "Very unacceptable" (1), "Somewhat unacceptable" (2), "No opinion" (3), "Somewhat acceptable" (4), "Very acceptable" (5) and "Did not allow study personnel to take my blood". Scores equal to or greater than 4 considered 80%.

  2. Number of Mothers With Infant Vaccination 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 single question measured using a 5-point Likert scale (range 1-5, highest score of 5 representing the highest acceptability). For example, the options for responses will include: "Very unacceptable" (1), "Somewhat unacceptable" (2), "No opinion" (3), "Somewhat acceptable" (4), "Very acceptable" (5) and "Did not allow study personnel to vaccinate my infant". Scores equal to or greater than 4 considered 80%.

Secondary outcomes

  1. Number of Infants With HBV Positivity at 6 Months of Life to Indicate 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Kinshasa School of Public Health
  • Ohio State University

Registry information

Official study title

Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study

Acronym: AVERT-HBV

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2018
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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