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Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers

BACKGROUND: Elimination of mother-to-child transmission of hepatitis B virus (HBV) requires infant immunoprophylaxis and antiviral prophylaxis for pregnant women with high viral loads. Since real-time polymerase chain reaction (RT-PCR), a gold standard for assessing antiviral eligibility, is neither...

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Autores principales: Isa, Yasir Shitu, Sicsic, Jonathan, Njuguna, Henry, Ward, John, Chakroun, Mohamed, El-Kassas, Mohamed, Ramanampamonjy, Rado, Chalal, Salim, Vincent, Jeanne Perpétue, Andersson, Monique, Desalegn, Hailemichael, Fall, Fatou, Johannessen, Asgeir, Matthews, Philippa C., Ndow, Gibril, Okeke, Edith, Riches, Nicholas, Seydi, Moussa, Sinkala, Edford, Spearman, C. Wendy, Stockdale, Alexander, Vinikoor, Michael J., Wandeler, Gilles, Sombié, Roger, Lemoine, Maud, Mueller, Judith E., Shimakawa, Yusuke
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10320875/
https://www.ncbi.nlm.nih.gov/pubmed/37403107
http://dx.doi.org/10.1186/s12916-023-02939-y
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author Isa, Yasir Shitu
Sicsic, Jonathan
Njuguna, Henry
Ward, John
Chakroun, Mohamed
El-Kassas, Mohamed
Ramanampamonjy, Rado
Chalal, Salim
Vincent, Jeanne Perpétue
Andersson, Monique
Desalegn, Hailemichael
Fall, Fatou
Johannessen, Asgeir
Matthews, Philippa C.
Ndow, Gibril
Okeke, Edith
Riches, Nicholas
Seydi, Moussa
Sinkala, Edford
Spearman, C. Wendy
Stockdale, Alexander
Vinikoor, Michael J.
Wandeler, Gilles
Sombié, Roger
Lemoine, Maud
Mueller, Judith E.
Shimakawa, Yusuke
author_facet Isa, Yasir Shitu
Sicsic, Jonathan
Njuguna, Henry
Ward, John
Chakroun, Mohamed
El-Kassas, Mohamed
Ramanampamonjy, Rado
Chalal, Salim
Vincent, Jeanne Perpétue
Andersson, Monique
Desalegn, Hailemichael
Fall, Fatou
Johannessen, Asgeir
Matthews, Philippa C.
Ndow, Gibril
Okeke, Edith
Riches, Nicholas
Seydi, Moussa
Sinkala, Edford
Spearman, C. Wendy
Stockdale, Alexander
Vinikoor, Michael J.
Wandeler, Gilles
Sombié, Roger
Lemoine, Maud
Mueller, Judith E.
Shimakawa, Yusuke
author_sort Isa, Yasir Shitu
collection PubMed
description BACKGROUND: Elimination of mother-to-child transmission of hepatitis B virus (HBV) requires infant immunoprophylaxis and antiviral prophylaxis for pregnant women with high viral loads. Since real-time polymerase chain reaction (RT-PCR), a gold standard for assessing antiviral eligibility, is neither accessible nor affordable for women living in low-income and middle-income countries (LMICs), rapid diagnostic tests (RDTs) detecting alternative HBV markers may be needed. To inform future development of the target product profile (TPP) for RDTs to identify highly viremic women, we used a discrete choice experiment (DCE) and elicited preference and trade-off of healthcare workers (HCW) in Africa between the following four attributes of fictional RDTs: price, time-to-result, diagnostic sensitivity, and specificity. METHODS: Through an online questionnaire survey, we asked participants to indicate their preferred test from a set of two RDTs in seven choice tasks with varying levels of the four attributes. We used mixed multinomial logit models to quantify the utility gain or loss generated by each attribute. We attempted to define minimal and optimal criteria for test attributes that can satisfy ≥ 70% and ≥ 90% of HCWs, respectively, as an alternative to RT-PCR. RESULTS: A total of 555 HCWs from 41 African countries participated. Increases in sensitivity and specificity generated significant utility and increases in cost and time-to-result generated significant disutility. The size of the coefficients for the highest attribute levels relative to the reference levels were in the following order: sensitivity (β = 3.749), cost (β = -2.550), specificity (β = 1.134), and time-to-result (β = -0.284). Doctors cared most about test sensitivity, while public health practitioners cared about cost and midwives about time-to-result. For an RDT with 95% specificity, costing 1 US$, and yielding results in 20 min, the minimally acceptable test sensitivity would be 82.5% and the optimally acceptable sensitivity would be 87.5%. CONCLUSIONS: African HCWs would prefer an RDT with the following order of priority: higher sensitivity, lower cost, higher specificity, and shorter time-to-result. The development and optimization of RDTs that can meet the criteria are urgently needed to scale up the prevention of HBV mother-to-child transmission in LMICs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-02939-y.
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spelling pubmed-103208752023-07-06 Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers Isa, Yasir Shitu Sicsic, Jonathan Njuguna, Henry Ward, John Chakroun, Mohamed El-Kassas, Mohamed Ramanampamonjy, Rado Chalal, Salim Vincent, Jeanne Perpétue Andersson, Monique Desalegn, Hailemichael Fall, Fatou Johannessen, Asgeir Matthews, Philippa C. Ndow, Gibril Okeke, Edith Riches, Nicholas Seydi, Moussa Sinkala, Edford Spearman, C. Wendy Stockdale, Alexander Vinikoor, Michael J. Wandeler, Gilles Sombié, Roger Lemoine, Maud Mueller, Judith E. Shimakawa, Yusuke BMC Med Research Article BACKGROUND: Elimination of mother-to-child transmission of hepatitis B virus (HBV) requires infant immunoprophylaxis and antiviral prophylaxis for pregnant women with high viral loads. Since real-time polymerase chain reaction (RT-PCR), a gold standard for assessing antiviral eligibility, is neither accessible nor affordable for women living in low-income and middle-income countries (LMICs), rapid diagnostic tests (RDTs) detecting alternative HBV markers may be needed. To inform future development of the target product profile (TPP) for RDTs to identify highly viremic women, we used a discrete choice experiment (DCE) and elicited preference and trade-off of healthcare workers (HCW) in Africa between the following four attributes of fictional RDTs: price, time-to-result, diagnostic sensitivity, and specificity. METHODS: Through an online questionnaire survey, we asked participants to indicate their preferred test from a set of two RDTs in seven choice tasks with varying levels of the four attributes. We used mixed multinomial logit models to quantify the utility gain or loss generated by each attribute. We attempted to define minimal and optimal criteria for test attributes that can satisfy ≥ 70% and ≥ 90% of HCWs, respectively, as an alternative to RT-PCR. RESULTS: A total of 555 HCWs from 41 African countries participated. Increases in sensitivity and specificity generated significant utility and increases in cost and time-to-result generated significant disutility. The size of the coefficients for the highest attribute levels relative to the reference levels were in the following order: sensitivity (β = 3.749), cost (β = -2.550), specificity (β = 1.134), and time-to-result (β = -0.284). Doctors cared most about test sensitivity, while public health practitioners cared about cost and midwives about time-to-result. For an RDT with 95% specificity, costing 1 US$, and yielding results in 20 min, the minimally acceptable test sensitivity would be 82.5% and the optimally acceptable sensitivity would be 87.5%. CONCLUSIONS: African HCWs would prefer an RDT with the following order of priority: higher sensitivity, lower cost, higher specificity, and shorter time-to-result. The development and optimization of RDTs that can meet the criteria are urgently needed to scale up the prevention of HBV mother-to-child transmission in LMICs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-023-02939-y. BioMed Central 2023-07-04 /pmc/articles/PMC10320875/ /pubmed/37403107 http://dx.doi.org/10.1186/s12916-023-02939-y Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Isa, Yasir Shitu
Sicsic, Jonathan
Njuguna, Henry
Ward, John
Chakroun, Mohamed
El-Kassas, Mohamed
Ramanampamonjy, Rado
Chalal, Salim
Vincent, Jeanne Perpétue
Andersson, Monique
Desalegn, Hailemichael
Fall, Fatou
Johannessen, Asgeir
Matthews, Philippa C.
Ndow, Gibril
Okeke, Edith
Riches, Nicholas
Seydi, Moussa
Sinkala, Edford
Spearman, C. Wendy
Stockdale, Alexander
Vinikoor, Michael J.
Wandeler, Gilles
Sombié, Roger
Lemoine, Maud
Mueller, Judith E.
Shimakawa, Yusuke
Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers
title Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers
title_full Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers
title_fullStr Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers
title_full_unstemmed Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers
title_short Informing a target product profile for rapid tests to identify HBV-infected pregnant women with high viral loads: a discrete choice experiment with African healthcare workers
title_sort informing a target product profile for rapid tests to identify hbv-infected pregnant women with high viral loads: a discrete choice experiment with african healthcare workers
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10320875/
https://www.ncbi.nlm.nih.gov/pubmed/37403107
http://dx.doi.org/10.1186/s12916-023-02939-y
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