Arresting Vertical Transmission of Hepatitis B Virus
- Conditions
- Hepatitis BVertical Transmission of Infectious Disease
- Interventions
- Drug: Tenofovir Disoproxil FumarateBiological: Monovalent HBV vaccine
- Registration Number
- NCT03567382
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description High-risk HBV dyads Monovalent HBV vaccine 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. Low-risk HBV dyads Monovalent HBV vaccine 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. High-risk HBV dyads Tenofovir Disoproxil Fumarate 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Lab Testing Acceptability Survey Scores >80% 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%.
Number of Mothers With Infant Vaccination Acceptability Survey Scores >80% 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 Outcome Measures
Name Time Method Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV 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.
Number of Infants Receiving Timely Birth Dose Vaccination 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
Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy 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
Trial Locations
- Locations (1)
Kinshasa School of Public Health
🇨🇩Kinshasa, Congo, The Democratic Republic of the