Preventing hepatitis B transmission from mothers to infants in the Democratic Republic of Congo
Simplifying Hepatitis B Care in Pregnancy by Combining Birth-dose Vaccine and Tenofovir: The COMBAT HBV Feasibility Trial
This study is testing if giving a medication to pregnant women with hepatitis B can help prevent passing the virus to their babies at birth in the Democratic Republic of Congo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 560 (estimated) |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Kinshasa) |
| Trial ID | NCT05705427 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a prophylaxis-for-all approach to prevent mother-to-child transmission of hepatitis B virus (HBV) among pregnant women in the Democratic Republic of Congo. HBV-positive pregnant women will be randomly assigned to receive either tenofovir or a placebo starting at 28-32 weeks of gestation and continuing through 4 weeks postpartum. The study will monitor the safety and effectiveness of this intervention, with infants receiving a birth-dose of HBV vaccine within 24 hours of birth. Participants will be followed for side effects and adherence to the medication throughout the prenatal and postpartum periods.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older who are HBV-positive and seeking maternity care in Kinshasa.
Not a fit: Patients who are HIV-positive or plan to relocate outside of Kinshasa during the study will not benefit from this trial.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the transmission of hepatitis B from mothers to their infants, improving health outcomes for both.
How similar studies have performed: Previous studies have shown promise in using tenofovir for preventing mother-to-child transmission of HBV, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women ≥18 years of age who present for routine prenatal care between 28-32 weeks' gestation and who test HBV-positive by point-of-care hepatitis B surface antigen test. Women must intend to seek maternity and postpartum care exclusively at one of the Kinshasa-based study maternity centers. * Infants born to enrolled women will be included in the study Exclusion Criteria: * Individuals with abnormal creatinine by point-of-care testing * Any woman who plans to move outside of Kinshasa Province during the study period. * Any HIV-positive individual, determined by routine point-of-care screening at antenatal care visits
Where this trial is running
Kinshasa
- Université Protestant au Congo — Kinshasa, Congo, The Democratic Republic of the (Recruiting)
Study contacts
- Principal investigator: Peyton Thompson, MD, MSCR — University of North Carolina, Chapel Hill
- Study coordinator: Peyton J Thompson, MD, MSCR
- Email: peyton_thompson@med.unc.edu
- Phone: 919-445-0854
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.