Clinical trial NCT03567382: Arresting Vertical Transmission of Hepatitis B Virus
Official title: Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B
Vertical Transmission of Infectious Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Kinshasa School of Public Health
name: Ohio State University
First posted: 2018-06-25
Enrollment: 179
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Lab Testing Acceptability Survey Scores >80%
timeFrame: Upon completion of the exit survey, or up to 12 months
measure: Number of Mothers With Infant Vaccination Acceptability Survey Scores >80%
timeFrame: Upon completion of the exit survey, or up to 12 months
Secondary outcomes:
measure: Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV
timeFrame: Measured at 6 months after birth
measure: Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy
timeFrame: Pill counts to be measured monthly. Total adherence averaged over 6-month treatment period.
measure: Number of Infants Receiving Timely Birth Dose Vaccination
timeFrame: Within 24 hours after birth
Other outcomes:
Locations:
city: Kinshasa
country: Congo, The Democratic Republic of the
facility: Kinshasa School of Public Health
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Steven Meshnick, MD
role: STUDY_DIRECTOR
affiliation: University of North Carolina, Chapel Hill
name: Peyton Thompson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson P, Morgan CE, Ngimbi P, Mwandagalirwa K, Ravelomanana NLR, Tabala M, Fathy M, Kawende B, Muwonga J, Misingi P, Mbendi C, Luhata C, Jhaveri R, Cloherty G, Kaba D, Yotebieng M, Parr JB. Arresting vertical transmission of hepatitis B virus (AVERT-HBV) in pregnant women and their neonates in the Democratic Republic of the Congo: a feasibility study. Lancet Glob Health. 2021 Nov;9(11):e1600-e1609. doi: 10.1016/S2214-109X(21)00304-1. Epub 2021 Aug 17.