Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya
Chronic hepatitis B infection (CHB) is a significant problem worldwide with around 300 million people infected. Ambitious goals have been set towards its elimination as a public health threat by 2030. However, accurate seroprevalence estimates in many countries are lacking or fail to provide represe...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-12-01
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| Series: | Journal of Virus Eradication |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2055664023000419 |
| _version_ | 1827400970348265472 |
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| author | Louise O. Downs Cori Campbell Michael Abouyannis Mark Otiende Melissa Kapulu Christina W. Obiero Mainga Hamaluba Caroline Ngetsa Monique I. Andersson George Githinji George Warimwe Kathy Baisley J. Anthony G. Scott Philippa C. Matthews Anthony Etyang |
| author_facet | Louise O. Downs Cori Campbell Michael Abouyannis Mark Otiende Melissa Kapulu Christina W. Obiero Mainga Hamaluba Caroline Ngetsa Monique I. Andersson George Githinji George Warimwe Kathy Baisley J. Anthony G. Scott Philippa C. Matthews Anthony Etyang |
| author_sort | Louise O. Downs |
| collection | DOAJ |
| description | Chronic hepatitis B infection (CHB) is a significant problem worldwide with around 300 million people infected. Ambitious goals have been set towards its elimination as a public health threat by 2030. However, accurate seroprevalence estimates in many countries are lacking or fail to provide representative population estimates, particularly in the WHO African Region (AFRO). This means the full extent of HBV infection is not well described, leading to a lack of investment in diagnostics, treatment and disease prevention. Clinical trials in the WHO AFRO region have been increasing over time and many test for infectious diseases including hepatitis B virus (HBV) to determine baseline eligibility for participants, however these screening data are not reported. Here we review data from six clinical trials completed at the KEMRI-Wellcome Trust Research Programme between 2016 and 2023 that screened for HBV using hepatitis B surface antigen (HBsAg) as part of the trial exclusion criteria. 1727 people had HBsAg results available, of which 60 tested positive. We generated a crude period HBV prevalence estimate of 3.5% (95% CI 2.6–4.5%), and after standardisation for sex and age to account for the population structure of the Kilifi Health Demographics Surveillance System (KHDSS), the prevalence estimate increased to 5.0% (95% CI 3.4–6.6%). The underrepresentation of women in these trials was striking with 1263/1641 (77%) of participants being male. Alanine aminotransferase (ALT) was significantly higher in the HBsAg positive group but was not outside the normal range. We argue that routine collation and publishing of data from clinical trials could increase precision and geographical representation of global HBV prevalence estimates, enabling evidence-based provision of clinical care pathways and public health interventions to support progress towards global elimination targets. We do acknowledge when using clinical trials data for seroprevalence estimates, that local population structure data is necessary to allow standardisation of results, and the point of care tests used here are limited in sensitivity and specificity. |
| first_indexed | 2024-03-08T20:12:24Z |
| format | Article |
| id | doaj.art-bfc7985470f84c3ba518a325115374c0 |
| institution | Directory Open Access Journal |
| issn | 2055-6640 |
| language | English |
| last_indexed | 2024-03-08T20:12:24Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Journal of Virus Eradication |
| spelling | doaj.art-bfc7985470f84c3ba518a325115374c02023-12-23T05:20:29ZengElsevierJournal of Virus Eradication2055-66402023-12-0194100355Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, KenyaLouise O. Downs0Cori Campbell1Michael Abouyannis2Mark Otiende3Melissa Kapulu4Christina W. Obiero5Mainga Hamaluba6Caroline Ngetsa7Monique I. Andersson8George Githinji9George Warimwe10Kathy Baisley11J. Anthony G. Scott12Philippa C. Matthews13Anthony Etyang14Nuffield Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UK; KEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, Kenya; Corresponding author. Nuffield Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UK.Nuffield Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UKKEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, Kenya; Liverpool School of Tropical Medicine, Pembroke Pl, Liverpool, L3 5QA, UKKEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, KenyaNuffield Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UK; KEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, KenyaKEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, KenyaNuffield Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UK; KEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, KenyaKEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, KenyaOxford University Hospitals, Headley Way, Oxford, OX3 9DU, UK; Radcliffe Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UKKEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, Kenya; Department of Biochemistry and Biotechnology, Pwani University, KenyaNuffield Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UK; KEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, KenyaDepartment of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, WC1F 7HT, UKKEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, Kenya; Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, WC1F 7HT, UKThe Francis Crick Institute, 1 Midland Road, London, NW1 1AT, UK; Division of Infection and Immunity, University College London, London, UK; University College London Hospital, 235 Euston Road, London, NW1 2BU, UKNuffield Department of Medicine, University of Oxford, Oxford, OX1 3AZ, UK; KEMRI-Wellcome Trust Research Programme, PO Box 230, Hospital Road, 80108, Kilifi, KenyaChronic hepatitis B infection (CHB) is a significant problem worldwide with around 300 million people infected. Ambitious goals have been set towards its elimination as a public health threat by 2030. However, accurate seroprevalence estimates in many countries are lacking or fail to provide representative population estimates, particularly in the WHO African Region (AFRO). This means the full extent of HBV infection is not well described, leading to a lack of investment in diagnostics, treatment and disease prevention. Clinical trials in the WHO AFRO region have been increasing over time and many test for infectious diseases including hepatitis B virus (HBV) to determine baseline eligibility for participants, however these screening data are not reported. Here we review data from six clinical trials completed at the KEMRI-Wellcome Trust Research Programme between 2016 and 2023 that screened for HBV using hepatitis B surface antigen (HBsAg) as part of the trial exclusion criteria. 1727 people had HBsAg results available, of which 60 tested positive. We generated a crude period HBV prevalence estimate of 3.5% (95% CI 2.6–4.5%), and after standardisation for sex and age to account for the population structure of the Kilifi Health Demographics Surveillance System (KHDSS), the prevalence estimate increased to 5.0% (95% CI 3.4–6.6%). The underrepresentation of women in these trials was striking with 1263/1641 (77%) of participants being male. Alanine aminotransferase (ALT) was significantly higher in the HBsAg positive group but was not outside the normal range. We argue that routine collation and publishing of data from clinical trials could increase precision and geographical representation of global HBV prevalence estimates, enabling evidence-based provision of clinical care pathways and public health interventions to support progress towards global elimination targets. We do acknowledge when using clinical trials data for seroprevalence estimates, that local population structure data is necessary to allow standardisation of results, and the point of care tests used here are limited in sensitivity and specificity.http://www.sciencedirect.com/science/article/pii/S2055664023000419Chronic hepatitis BClinical trialsSeroprevalenceElimination goalsClinical care |
| spellingShingle | Louise O. Downs Cori Campbell Michael Abouyannis Mark Otiende Melissa Kapulu Christina W. Obiero Mainga Hamaluba Caroline Ngetsa Monique I. Andersson George Githinji George Warimwe Kathy Baisley J. Anthony G. Scott Philippa C. Matthews Anthony Etyang Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya Journal of Virus Eradication Chronic hepatitis B Clinical trials Seroprevalence Elimination goals Clinical care |
| title | Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya |
| title_full | Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya |
| title_fullStr | Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya |
| title_full_unstemmed | Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya |
| title_short | Where do those data go? Reuse of screening results from clinical trials to estimate population prevalence of HBV infection in adults in Kilifi, Kenya |
| title_sort | where do those data go reuse of screening results from clinical trials to estimate population prevalence of hbv infection in adults in kilifi kenya |
| topic | Chronic hepatitis B Clinical trials Seroprevalence Elimination goals Clinical care |
| url | http://www.sciencedirect.com/science/article/pii/S2055664023000419 |
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