AVERT-HBV
Sponsor study identifier
Secondary identifiers
OTHER · UNC Institute for Global Health and Infectious Diseases
interventional
179
1 country
1
Study Start
September 24, 2018
Actual (reported)Primary Completion
March 6, 2020
Actual (reported)Study Completion
August 15, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 15, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2017
Actual (reported)June 25, 2018
Actual (reported)September 24, 2018
Actual (reported)March 6, 2020
Actual (reported)August 15, 2020
Actual (reported)February 5, 2021
Actual (reported)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
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
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.
Number of Infants Receiving Timely Birth Dose Vaccination
Within 24 hours after birth
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.
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.
300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.
Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.
Kinshasa School of Public Health
Kinshasa, Democratic Republic of the Congo
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.
Steven Meshnick, MD
University of North Carolina, Chapel Hill
Peyton Thompson, MD
University of North Carolina, Chapel Hill
179 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2017
First Posted
June 25, 2018
Study Start
September 24, 2018
Actual (reported)Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 6, 2020
Actual (reported)Study Completion
August 15, 2020
Actual (reported)Last Updated
February 24, 2021
Results First Posted
February 5, 2021
Record last verified: 2021-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: