Reducing Vertical Transmission of Hepatitis B in Africa (NCT04704024) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Reducing Vertical Transmission of Hepatitis B in Africa
United States450 participantsStarted 2021-09-03
Plain-language summary
Hepatitis B virus is an infection that can be easily transmitted from women to newborns at the time of delivery. Our objective is to identify novel options that are effective and safe in preventing perinatal transmission of hepatitis B in Africa. The REVERT-B study (Reducing Vertical Transmission of Hepatitis B in Africa) is a clinical trial designed to test a new strategy of using antiviral medication in high-risk pregnant women and newborns to reduce the risk of hepatitis B transmission. The study will measure efficacy, safety, tolerability and adherence to medication.
Who can participate
Age range
16 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* prenatal clinic patient,
* age ≥16 years,
* 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound,
* active hepatitis B with risk of vertical transmission (HBsAg+ AND HBeAg+ or HBV DNA \>1000 IU/ML),
* plan to receive follow up care and deliver at study facility,
* capable of providing informed consent.
Exclusion Criteria:
* HIV positive (according to HIV antibody testing performed at the initial prenatal visit)
* known liver cirrhosis or end-stage liver disease,
* elevated liver enzymes (ALT \>5x upper limit of normal),
* elevated serum creatinine (\>1.4 mg/dl)
* currently taking tenofovir medication
* allergy or intolerance to tenofovir study medication,
* known fetal anomaly in the current pregnancy,
* clinical illness requiring hospitalization at the time of enrollment
* evidence of early labor at the time of enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.