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| ID | Type | Description | Link |
|---|---|---|---|
| IGHID 11720 | Other Identifier | UNC Institute for Global Health and Infectious Diseases |
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| Name | Class |
|---|---|
| Kinshasa School of Public Health | OTHER |
| Ohio State University | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-risk HBV dyads | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir Disoproxil Fumarate | Drug | 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Meshnick, MD | University of North Carolina, Chapel Hill | Study Director |
| Peyton Thompson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kinshasa School of Public Health | Kinshasa | Democratic Republic of the Congo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34416175 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-risk Mothers | 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. Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. |
| FG001 | Low-risk Mothers | 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. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. |
| FG002 | Infants Born to High-risk Mothers | Infants born to mothers with high-risk HBV |
| FG003 | Infants Born to Low-risk Mothers | Infants born to mothers with low-risk HBV |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data were not collected for the Infant Arm/Groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | High-risk Mothers | 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. Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | There were a total of 53 mothers (7 high-risk and good 46 low-risk) who completed the 6-month study visit, thus this is the total number of mothers who completed the exit survey. One survey was completed per mother/infant dyad. | Posted | Count of Participants | Participants | Upon completion of the exit survey, or up to 12 months |
|
The participants were monitored for adverse events over the duration of treatment (an average of 6 months for High-risk Mothers taking tenofovir therapy, and an average of 3 days or the duration of hospital stay for infants after receiving hepatitis B vaccination). Since Low-risk Mothers did not receive a study intervention, adverse event data was not overtly sought unless self-reported by participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-risk Mothers | 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. Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rebound elevation of ALT and HBV DNA after discontinuation of Tenofovir | Hepatobiliary disorders | Non-systematic Assessment | ALT = alanine aminotransferase DNA = deoxyribonucleic acid |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peyton Thompson, MD, MSCR | University of North Carolina at Chapel Hill | 919-445-0854 | peyton_thompson@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2018 | Jan 11, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| C075654 | Engerix-B |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| 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. |
|
|
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. |
| 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 |
| Withdrawal by Subject |
|
| BG001 | Low-risk Mothers | 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. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Gestational age at enrollment, Continuous | Mean | Standard Deviation | weeks |
|
| Total pregnancies, Continuous | Mean | Standard Deviation | pregnancies |
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| Number of living children, Continuous | Mean | Standard Deviation | living children |
|
| Marital status, Categorical | Count of Participants | Participants |
|
| Highest Education, Categorical | Count of Participants | Participants |
|
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. Tenofovir Disoproxil Fumarate: 300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. |
| OG001 | Low-risk Mothers | 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. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. |
|
|
| 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%. | There were a total of 53 mothers (7 high-risk and 46 low-risk) who completed the 6-month study visit, thus this is the total number of mothers who completed the exit survey. One survey was completed per mother/infant dyad. | Posted | Count of Participants | Participants | 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. | A total of 88 infants were born to mothers in the study, but only 53 infants (7 born to high-risk mothers and 46 born to low-risk mothers) were followed through 6 months of life and tested for HBsAg at that time. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Within 24 hours after birth |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 2 |
| 10 |
| EG001 | Low-risk Mothers | 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. Monovalent HBV vaccine: Infants born to HBsAg-positive mothers will be given a single dose of monovalent HBV vaccine within 24 hours of life. | 0 | 81 | 0 | 81 | 0 | 81 |
| EG002 | Infants Born to High-risk Mothers | Infants born to mothers with high-risk HBV | 0 | 9 | 0 | 9 | 0 | 9 |
| EG003 | Infants Born to Low-risk Mothers | Infants born to mothers with low-risk HBV | 1 | 79 | 0 | 79 | 0 | 79 |
|
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Separated |
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| Never Married |
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| Missing |
|
| Higher education |
|
| Missing |
|