Arresting Vertical Transmission of Hepatitis B Virus

NCT03567382 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: 17-2090IGHID 11720
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; Vertical Transmission of Infectious Disease

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Drug: Tenofovir Disoproxil Fumarate; Biological: Monovalent HBV vaccine

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.

Biological: Monovalent HBV vaccine

Interventions

Tenofovir Disoproxil Fumarate DRUG

300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.

Also known as: Viread

High-risk HBV dyads

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.

Also known as: Engerix-B

High-risk HBV dyads; Low-risk HBV dyads

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women receiving care at Binza and Kingasani maternity centers presenting prior to 24 weeks gestation
• Infants born to HBV-positive women

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Kinshasa School of Public Health: collaborator
• Ohio State University: collaborator

Study Sites (1)

Kinshasa School of Public Health

Kinshasa, Democratic Republic of the Congo

Location

Related Publications (1)

• 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.

  PMID: 34416175 DERIVED

MeSH Terms

Conditions

Hepatitis B

Interventions

Tenofovir; Engerix-B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Peyton Thompson, MD, MSCR
• Organization: University of North Carolina at Chapel Hill

peyton_thompson@med.unc.edu

919-445-0854

Study Officials

• Steven Meshnick, MD

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

• Peyton Thompson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: June 25, 2018
• Study Start: September 24, 2018
• Primary Completion: March 6, 2020
• Study Completion: August 15, 2020
• Last Updated: February 24, 2021
• Results First Posted: February 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)