Hepatitis BPhase 4AVERT-HBVNCT03567382

Arresting Vertical Transmission of Hepatitis B Virus

A Phase 4 study testing Tenofovir Disoproxil Fumarate and Monovalent HBV vaccine in people with Hepatitis B and Vertical Transmission of Infectious Disease, run by University of North Carolina, Chapel Hill at 1 site in Democratic Republic of the Congo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hepatitis B, Vertical Transmission of Infectious Disease
What is being tested?: Tenofovir Disoproxil Fumarate and Monovalent HBV vaccine
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 179 participants
Where: 1 siteDemocratic Republic of the Congo
Study dates: 24 Sep 2018to 15 Aug 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Democratic Republic of the Congo1 site

Kinshasa School of Public Health
Kinshasa

Other trials in Democratic Republic of the Congo

About this study

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

Read the 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.

Conditions: Hepatitis B, Vertical Transmission of Infectious Disease
Being tested: Tenofovir Disoproxil Fumarate, Monovalent HBV vaccine
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tenofovir Disoproxil FumarateDrug
Also called Viread
300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.
Monovalent HBV vaccineBiological
Also called Engerix-B
Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.

Study groups in NCT03567382
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Monovalent HBV vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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%.
Measured: 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%.
Measured: 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
Mother-to-child transmission of HBV is defined as HBsAg positivity in the infant at 6 months of life.
Measured: Measured at 6 months after birth
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
Measured: 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
Measured: Within 24 hours after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 201815 Aug 2020

First posted25 Jun 2018
Study start24 Sep 2018
Primary completion6 Mar 2020
Study completion15 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hepatitis BStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03567382
Sponsor's protocol ID: 17-2090
Other IDs: IGHID 11720
Acronym: AVERT-HBV
Status last verified: Jan 2021
First submitted: 13 Sep 2017
Last updated: 24 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 34416175

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study
ClinicalTrials.gov ID: NCT03567382
Acronym / sponsor ID: AVERT-HBV / 17-2090
Conditions: Hepatitis B, Vertical Transmission of Infectious Disease
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 179 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Kinshasa School of Public Health, Ohio State University
Study start: 24 Sep 2018 (actual)
Primary completion: 6 Mar 2020 (actual)
Study completion: 15 Aug 2020 (actual)
First posted: 25 Jun 2018 (actual)
Results: Posted 5 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
High-risk HBV dyads	Experimental	Drug: Tenofovir Disoproxil Fumarate, Biological: Monovalent HBV vaccineMothers 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	Biological: Monovalent HBV vaccineMothers 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tenofovir Disoproxil FumarateAlso: Viread300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.	Drug	High-risk HBV dyads
Monovalent HBV vaccineAlso: Engerix-BInfants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.	Biological	High-risk HBV dyads, Low-risk HBV dyads

Primary outcome

Number of Participants With Lab Testing Acceptability Survey Scores >80%
Time frame: 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%
Time frame: 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%.

3 secondary outcomes

Number of Infants With HBV Positivity at 6 Months of Life to Indicate Mother-to-Child Transmission of HBV
Time frame: Measured at 6 months after birth
Number of Mothers With High-risk HBV Demonstrating Adherence to Tenofovir Therapy
Time frame: Pill counts to be measured monthly. Total adherence averaged over 6-month treatment period.
Number of Infants Receiving Timely Birth Dose Vaccination
Time frame: Within 24 hours after birth

Results and safety

Results posted to the registry on 5 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High-risk Mothers	10	7
Low-risk Mothers	81	46
Infants Born to High-risk Mothers	9	7
Infants Born to Low-risk Mothers	79	46

Primary outcome: Number of Participants With Lab Testing Acceptability Survey Scores >80%

Time frame: Upon completion of the exit survey, or up to 12 months. Count of participants. Unit: Participants

Measure	High-risk Mothers n = 7	Low-risk Mothers n = 46
Testing for Mothers	7	41
Testing for Infants	7	40

Population analysed: 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.

Primary outcome: Number of Mothers With Infant Vaccination Acceptability Survey Scores >80%

Time frame: Upon completion of the exit survey, or up to 12 months. Count of participants. Unit: Participants

Measure	High-risk Mothers n = 7	Low-risk Mothers n = 46
Value	7	42

Population analysed: 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.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High-risk Mothers	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Low-risk Mothers	0 of 81 (0%)	0 of 81 (0%)	0 of 81
Infants Born to High-risk Mothers	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Infants Born to Low-risk Mothers	0 of 79 (0%)	0 of 79 (0%)	1 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34416175Thompson 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Meshnick, MD study director

University of North Carolina, Chapel Hill

Peyton Thompson, MD principal investigator

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Lab Testing Acceptability Survey Scores >80% (time frame: Upon completion of the exit survey, or up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03567382, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.