Barriers that prevent adults living with HBV infection from participating in clinical research: experience from South Africa

Nombuyiselo Mofokeng; Tongai G Maponga; Marije van Schalkwyk; Susan Hugo; Molefi Daniel Morobadi; Sabeehah Vawda; Leane Badenhorst; Cloete van Vuuren; Christo van Rensburg; Wolfgang Preiser; Jantjie Taljaard; Su Wang; Veronica Miller; Dan Wu; Joseph D Tucker; Janet Seeley; Dominique Goedhals; Philippa C Matthews

doi:10.1016/j.jve.2023.100317

Barriers that prevent adults living with HBV infection from participating in clinical research: experience from South Africa

J Virus Erad. 2023 Feb 23;9(1):100317. doi: 10.1016/j.jve.2023.100317. eCollection 2023 Mar.

Authors

Nombuyiselo Mofokeng¹, Tongai G Maponga², Marije van Schalkwyk³, Susan Hugo³, Molefi Daniel Morobadi^{1

4}, Sabeehah Vawda¹, Leane Badenhorst¹, Cloete van Vuuren¹, Christo van Rensburg⁵, Wolfgang Preiser², Jantjie Taljaard³, Su Wang^{6

7}, Veronica Miller⁸, Dan Wu⁹, Joseph D Tucker⁹, Janet Seeley^{10

11}, Dominique Goedhals^{1

12}, Philippa C Matthews^{13

14

15

16}

Affiliations

¹ University of the Free State, Nelson Mandela Drive, Bloemfontein, 9300, South Africa.
² Division of Medical Virology, University of Stellenbosch, Tygerberg Hospital, Francie Van Zijl Drive, Cape Town, 7505, South Africa.
³ Division of Infectious Diseases, Department of Medicine, Stellenbosch University / Tygerberg Academic Hospital, Cape Town, South Africa.
⁴ Ampath Laboratories, Pretoria, South Africa.
⁵ Division of Gastroenterology, Department of Medicine, Stellenbosch University / Tygerberg Academic Hospital, Cape Town, South Africa.
⁶ Cooperman Barnabas Medical Center, Florham Park, NJ, USA.
⁷ World Hepatitis Alliance, London, UK.
⁸ University of California Berkeley School of Public Health, 2121 Berkeley Way, Berkeley, CA, 94704, USA.
⁹ Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel St, London, WC1E 7HT, UK.
¹⁰ Department of Global Health and Development, Faculty of Public Health and Policy, School of Hygiene and Tropical Medicine, 15-17 Tavistock Place, London, WC1H 9SH, UK.
¹¹ Africa Health Research Institute (AHRI), 719 Umbilo Rd, Umbilo, Durban, 4001, South Africa.
¹² PathCare Vermaak, Pretoria, South Africa.
¹³ Nuffield Department of Medicine, University of Oxford, OX1 3SY, UK.
¹⁴ The Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK.
¹⁵ University College London, Gower Street, London, WC1E 6BT, UK.
¹⁶ University College London Hospitals, 235 Euston Rd, London, NW1 2BU, UK.

Abstract

High profile international goals have been set for the elimination of hepatitis B virus (HBV) infection as a public health threat by the year 2030. Developing and expanding equitable, accessible translational HBV research programmes that represent real-world populations are therefore an urgent priority for clinical and academic communities. We present experiences and insights by an expert interdisciplinary group focusing on barriers that impede adults living with HBV infection from participating in clinical studies. Our viewpoint describes barriers we have identified through working in a variety of settings across South Africa, including lack of education and awareness, experiences of stigma and discrimination, challenges for governance and data management, and a burden of complex morbidity. Through identifying these challenges, we propose solutions and interventions, highlight new approaches, and provide a framework for future research.

Keywords: Barriers; Clinical research; Elimination; Equity; Ethics; HBV; HBV, Hepatitis B Virus; HCV, Hepatitis C Virus; HCW, Healthcare Workers; HIV, Human Immunodeficiency Virus; Hepatitis B virus; LMIC; South Africa; TB, Tuberculosis; Trials; WHO, World Health Organization; eHealth, Electronic Health.

Associated data

figshare/10.6084/m9.figshare.16685047.v1