Protocol for EVOLVE-HBV, a study to determine the prevalence and characteristics of chronic hepatitis B virus infection in KwaZulu-Natal, South Africa, to inform interventions for diagnosis, treatment and prevention
Motswedi Anderson, Tongai G. Maponga, Janine Upton, Gloria Sukali, Lusanda Mazibuko, Kathy Baisley, Theresa Smit, Elizabeth Waddilove, Marion Delphin, Dickman Gareta, Nikiwe Mbatha, Landiwe Ndimande, Njabulo Dayi, Gregory Ording-Jespersen, Njabulo Myeni, Busangani Ngwenya, Nondumiso Mpanza, Katya Govender, Ngcebo Mhlongo, Guy Harling, Alasdair Leslie, Nomathamsanqa Majozi, Dumisani Siwela, Xanthe Hunt, Bongiwe Ndlovu, Lulama Mthethwa, Nokukhanya Msomi, M. Azim Ansari, Resign Gunda, Vasudevan G. Naidoo, Shaun R. G. Temmers, Thumbi Ndung’u, Maryam Shahmanesh, Mark Siedner, Emily B. Wong, Janet Seeley, Thandeka Khoza, Collins Iwuji, Philippa C. MatthewsBackground:
Hepatitis B virus (HBV) infection is endemic in many African populations, but has been neglected by funding, education, clinical infrastructure and research. High-profile international targets have been set for HBV elimination by 2030.
Objectives:
We here present the protocol for EVOLVE-HBV, an interdisciplinary study based at the Africa Health Research Institute aiming to quantify and characterize HBV infection in the KwaZulu-Natal (KZN) province, South Africa. The study aims to develop insights into HBV by assessing population knowledge, epidemiology, clinical features and laboratory characteristics, with the overall aim of enhancing local care pathways.
Design:
Study phase I is a retrospective, observational cross-sectional assessment of HBV sero-epidemiology. Phase II incorporates the prospective recruitment of adults living with HBV and HBV-negative controls from the same community. Study dates are 1 August 2023 to 31 July 2027.
Methods:
The study is supported by an active programme of community engagement. Phase I: banked samples are tested for HBV serum markers in a clinical diagnostic laboratory and analysed to generate weighted estimates of HBV infection, exposure and immunity. Phase II: data are collected through questionnaire, clinical assessment, biometric data, imaging using Fibroscan™ and laboratory assays including measurement of biomarkers, antiviral drug concentrations and HBV whole genome sequencing. Social scientists collect qualitative data regarding beliefs, experiences and needs of the community. Data across all themes inform a detailed picture of the sociodemographic, clinical and molecular characteristics of HBV infection.
Ethics:
EVOLVE-HBV is approved by the University of KZN Biomedical Research Ethics Committee in South Africa (ref. 00004495/2022), and University College London (UCL) ethics committee in the United Kingdom (ref. 23221/001).
Discussion:
This protocol describes a study that will inform insights into local HBV epidemiology, determine the need for scale-up of vaccination, screening and treatment, inform local policy, education and service-development and provide an evidence-based foundation for future clinical practice and translational research. Collectively, this work aims to inform improvements in clinical and public health strategies to support progress towards 2030 targets.