Ethics & Engagement across the Wellcome Trust Major Overseas Programmes

Ethical Challenges Related to Short Course Tenofovir to Prevent Mother to Child Transmission of Hepatitis B in Myanmar

Htet Htet Aung is a 2018 GHBN Bursary Fellow.


Htet Htet Aung has a BA Degree in English Literature (2016) and has been working as a clinical research assistant in the Myanmar Oxford Clinical Research Unit (MOCRU) since May 2017. She works as a monitor for multi-centre trials as well as in-house studies conducted by MOCRU. She also handles the OxTREC and local Ethics Committee Submissions and provides GCP Trainings. Her special interest is in bioethics and at present she is studying the ethical paradox of conducting clinical research in vulnerable populations such as pregnant women.

Project Description: Ethical Challenges Related to Short Course Tenofovir to Prevent Mother to Child Transmission of Hepatitis B in Myanmar

Viral hepatitis kills over 1.3 million people annually. Myanmar is one of 28 high burden countries. The most common route of infection is mother to child transmission (MTCT) as the immunization coverage is low and Hepatitis B immunoglobulin is expensive and not widely available.

The use of antivirals (Tenofovir disoproxil fumarate or TDF) during pregnancy to prevent MTCT is mentioned as a new intervention in the recent WHO Global Hepatitis Report. A multi-centre, randomised, placebo-controlled trial of TDF in pregnancy to reduce vertical transmission of hepatitis B is planned in Southeast Asia in 2019 and Myanmar is a potential site. The proposed design of the study using placebo presents additional ethical challenges, since some women whose child could benefit will not receive the active drug.

We aim to explore the ethical and practical challenges related to the use of placebo through In-depth Interviews and Focus Group Discussions among pregnant women and health care providers. This study will provide valuable information about the potential ethical challenges, knowledge and attitude of the pregnant women for the researchers conducting placebo-controlled trials with vulnerable populations and policy makers who are considering implementing TDF-short course for MTCT.

Update - July 2020

The study is still waiting for valid MOU to submit to the local IRB, University of Public Health (UoPH).
Unfortunately, the MOU process can take longer than usual as a result of delays caused by COVID-19.
Therefore, we are writing a new proposal with the same purpose of the study and submitting it to another IRB from the military side. With respect to the military IRB, the process is easier, faster and we also have an existing network with them from previous malaria studies.
We are not going to withdraw the current study from the local IRB. We plan to do the study in parallel if we can obtain approval from both IRBs.

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