Arresting Vertical Transmission of Hepatitis B Virus

Hepatitis B Clinical Trial

— AVERT-HBV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03567382
• Other study ID #: 17-2090
• Secondary ID: IGHID 11720
• Status: Completed
• Phase: Phase 4
• Start date: September 24, 2018
• Est. completion date: August 15, 2020

Study information

• Verified date: January 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 179
• Est. completion date: August 15, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hepatitis
• Hepatitis A
• Hepatitis B
• Infection
• Vertical Transmission of Infectious Disease

Intervention

Drug:
• Tenofovir Disoproxil Fumarate
300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.

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.

Locations

Country	Name	City	State
Congo, The Democratic Republic of the	Kinshasa School of Public Health	Kinshasa

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Kinshasa School of Public Health, Ohio State University

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Lab Testing Acceptability Survey Scores >80%	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%.	Upon completion of the exit survey, or up to 12 months
Primary	Number of Mothers With Infant Vaccination Acceptability Survey Scores >80%	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%.	Upon completion of the exit survey, or up to 12 months
Secondary	Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV	Mother-to-child transmission of HBV is defined as HBsAg positivity in the infant at 6 months of life.	Measured at 6 months after birth
Secondary	Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy	Adherence to tenofovir therapy is defined as <20% of pills remaining on monthly pill counts for high-risk mothers with HBV receiving tenofovir	Pill counts to be measured monthly. Total adherence averaged over 6-month treatment period.
Secondary	Number of Infants Receiving Timely Birth Dose Vaccination	Timeliness of infant HBV vaccination is defined as >90% of infants receiving birth dose vaccine within 24 hours of life	Within 24 hours after birth