Hepatitis B Clinical Trial
— AVERT-HBVOfficial title:
Arresting Vertical Transmission of Hepatitis B Virus in the Democratic Republic of the Congo: The AVERT-HBV Study
Verified date | January 2021 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 179 |
Est. completion date | August 15, 2020 |
Est. primary completion date | March 6, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion criteria: - Pregnant women receiving care at Binza and Kingasani maternity centers presenting prior to 24 weeks gestation - Infants born to HBV-positive women Exclusion criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Congo, The Democratic Republic of the | Kinshasa School of Public Health | Kinshasa |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Kinshasa School of Public Health, Ohio State University |
Congo, The Democratic Republic of the,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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%. | Upon completion of the exit survey, or up to 12 months | |
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%. | 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. | 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 | 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 | Within 24 hours after birth |
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