The COMBAT HBV Feasibility Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2025-12-31

Brief Summary

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This is a double-blind, randomized placebo-controlled trial (RCT) of a prophylaxis-for-all approach to prevention of mother-to-child transmission (PMTCT) of hepatitis B virus (HBV) in the Democratic Republic of Congo (DRC). HBV-infected pregnant women will be randomized to either receive tenofovir or placebo beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Women will be followed every 4-6 weeks throughout the prenatal and postpartum period to evaluate for side effects related to the medication. Infants will receive a birth-dose of HBV vaccine, ideally within 24 hours. Participants will be followed longitudinally through 6 months' postpartum.

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Detailed Description

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The overall study design is a randomized, double-blind, placebo-controlled trial among two groups of mother-infant dyads: women who receive TDF vs placebo in late pregnancy and the postpartum period (beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum). While official World Health Organization (WHO) recommendations are to continue TDF at least through delivery, a range from delivery through 12 weeks' postpartum is possible; the investigators will continue therapy through 4 weeks' postpartum in this study. This feasibility trial will evaluate the acceptability, safety and preliminary effectiveness of a TDF-for-all approach to prevent MTCT of HBV in low-resource settings. HBsAg-positive pregnant women will be enrolled at 28-32 weeks' gestation, and will present for regular medication checks, with a study closeout visit at 24 weeks' postpartum. Study activities at monthly medication checks will include medication refills, assessment of adherence (via pill counts and verbal surveys), and evaluation for side effects. All infants will receive a birth-dose of HBV vaccine within 24 hours of life. MTCT of HBV will be defined as the proportion of infants with positive HBsAg testing at 6 months. This pilot study will provide preliminary data for sample size calculations, including safety and effectiveness data, to prepare for larger RCTs to determine the effectiveness of a tenofovir-for-all approach, as well as the added benefit of tenofovir over birth-dose vaccination.

Conditions

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Hepatitis B Vertical Transmission of Infectious Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pregnant women will be randomized at the time of enrollment (at 28-32 weeks' gestation) in a 1:1 ratio to receive tenofovir disoproxil fumarate (TDF) vs placebo, with an expected 140 women in the TDF arm and 140 in the placebo arm. A permuted block randomization technique will be employed to ensure equal distribution between the two arms at the two maternity centers. A biostatistician from the University of North Carolina (UNC) will design the randomization scheme, which will utilize the randomization-and-concealment feature within the REDCap database; the biostatistician will not be directly involved in study enrollment activities. REDCap personnel at UNC will ensure proper design and use of the randomization-and-concealment feature, and study personnel will receive training on the randomization process prior to study roll-out.

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The trial will be double-blinded, with study staff and participants blinded to allocation to the TDF vs placebo arm. Blinding to medication type will be achieved via use of over-encapsulation of TDF and placebo pills. Laboratory technicians who perform point-of-care hepatitis B core related antigen testing, HBV viral load testing and hepatitis B e antigen testing will be blinded to study arm.

Study Groups

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Tenofovir disoproxil fumarate (TDF) arm

140 pregnant women in the experimental arm will receive tenofovir disoproxil fumarate (TDF) 300 milligrams (mg) daily, beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Infants born to these women will be included in this arm and will receive a birth-dose of hepatitis B vaccine.

Group Type EXPERIMENTAL

Tenofovir Disoproxil Fumarate 300 MG

Intervention Type DRUG

Pregnant women in the experimental arm will receive TDF daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.

Hepatitis B monovalent vaccine

Intervention Type BIOLOGICAL

All infants born to women in the study will receive a birth-dose hepatitis B vaccine.

Placebo arm

140 pregnant women in the placebo arm will receive a placebo pill daily, beginning at 28-32 weeks' gestation and continuing through 4 weeks' postpartum. Infants born to these women will be included in this arm and will receive a birth-dose of hepatitis B vaccine.

Group Type PLACEBO_COMPARATOR

Hepatitis B monovalent vaccine

Intervention Type BIOLOGICAL

All infants born to women in the study will receive a birth-dose hepatitis B vaccine.

Placebo

Intervention Type DRUG

Pregnant women in the placebo arm will receive a placebo pill daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.

Interventions

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Tenofovir Disoproxil Fumarate 300 MG

Pregnant women in the experimental arm will receive TDF daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.

Intervention Type DRUG

Hepatitis B monovalent vaccine

All infants born to women in the study will receive a birth-dose hepatitis B vaccine.

Intervention Type BIOLOGICAL

Placebo

Pregnant women in the placebo arm will receive a placebo pill daily beginning in the 3rd trimester of pregnancy and continuing through 1 month postpartum.

Intervention Type DRUG

Other Intervention Names

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Viread Hepatitis B birth-dose vaccine Engerix-B

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No