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.


Journal

BMC medicine
ISSN: 1741-7015
Titre abrégé: BMC Med
Pays: England
ID NLM: 101190723

Informations de publication

Date de publication:
04 07 2023
Historique:
received: 06 01 2023
accepted: 13 06 2023
medline: 6 7 2023
pubmed: 5 7 2023
entrez: 4 7 2023
Statut: epublish

Résumé

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. 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. 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%. 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.

Sections du résumé

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.

Identifiants

pubmed: 37403107
doi: 10.1186/s12916-023-02939-y
pii: 10.1186/s12916-023-02939-y
pmc: PMC10320875
doi:

Substances chimiques

Antiviral Agents 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

243

Subventions

Organisme : Wellcome Trust
Pays : United Kingdom
Organisme : Wellcome Trust
ID : 110110/Z/15/Z
Pays : United Kingdom
Organisme : Department of Health
Pays : United Kingdom

Informations de copyright

© 2023. The Author(s).

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Auteurs

Yasir Shitu Isa (YS)

Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie Des Maladies Émergentes, 25-28 Rue du Dr Roux, 75015, Paris, France.
EHESP French School of Public Health, Rennes, France.

Jonathan Sicsic (J)

Université Paris Cité, LIRAES F-75006, Paris, France.

Henry Njuguna (H)

Coalition for Global Hepatitis Elimination, Decatur, GA, USA.

John Ward (J)

Coalition for Global Hepatitis Elimination, Decatur, GA, USA.

Mohamed Chakroun (M)

Infectious Disease Department, Fattouma Bourguiba Hospital, Monastir, Tunisia.

Mohamed El-Kassas (M)

Endemic Medicine Department, Faculty of Medicine, Helwan University, Cairo, Egypt.

Rado Ramanampamonjy (R)

Unité de Gastro-Entérologie, Hôpital Joseph Raseta Befelatanana, Antananarivo, Madagascar.

Salim Chalal (S)

Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie Des Maladies Émergentes, 25-28 Rue du Dr Roux, 75015, Paris, France.
Plateforme de Data Management, Institut Pasteur, Paris, France.

Jeanne Perpétue Vincent (JP)

Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie Des Maladies Émergentes, 25-28 Rue du Dr Roux, 75015, Paris, France.

Monique Andersson (M)

Division of Medical Virology, Stellenbosch University, Faculty of Medicine and Health Sciences, Cape Town, South Africa.
Nuffield Division of Clinical Laboratory Science, Radcliffe Department of Medicine, University of Oxford, Oxford, UK.

Hailemichael Desalegn (H)

Medical Department, St. Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia.

Fatou Fall (F)

Department of Hepatology and Gastroenterology, Hopital Principal de Dakar, Dakar, Senegal.

Asgeir Johannessen (A)

Department of Infectious Diseases, Vestfold Hospital, Tønsberg, Norway.
Institute of Clinical Medicine, University of Oslo, Oslo, Norway.

Philippa C Matthews (PC)

The Francis Crick Institute, London, UK.
Division of Infection and Immunity, University College London, London, UK.
Department of Infectious Diseases, University College London Hospital, London, UK.

Gibril Ndow (G)

Medical Research Council Unit The Gambia, London School of Hygiene & Tropical Medicine, Fajara, The Gambia.
Department of Metabolism, Digestion & Reproduction, Imperial College London, London, UK.

Edith Okeke (E)

Faculty of Medical Sciences, University of Jos, Jos, Nigeria.

Nicholas Riches (N)

Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, UK.

Moussa Seydi (M)

Service de Maladies Infectieuses Et Tropicales, Centre Hospitalier National Universitaire de Fann, Dakar, Senegal.

Edford Sinkala (E)

Department of Internal Medicine, University of Zambia, Lusaka, Zambia.

C Wendy Spearman (CW)

Division of Hepatology, Department of Medicine, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.

Alexander Stockdale (A)

Department of Clinical Infection, Microbiology and Immunology, Institute of Infection, University of Liverpool, Liverpool, UK.
Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.

Michael J Vinikoor (MJ)

Department of Internal Medicine, University of Zambia, Lusaka, Zambia.
Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.

Gilles Wandeler (G)

Department of Infectious Diseases, Bern University Hospital, University of Bern, Bern, Switzerland.

Roger Sombié (R)

Service d'Hépato-Gastroentérologie, Centre Hospitalier Universitaire Yalgado Ouédraogo, Ouagadougou, Burkina Faso.

Maud Lemoine (M)

Medical Research Council Unit The Gambia, London School of Hygiene & Tropical Medicine, Fajara, The Gambia.
Department of Metabolism, Digestion & Reproduction, Imperial College London, London, UK.

Judith E Mueller (JE)

Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie Des Maladies Émergentes, 25-28 Rue du Dr Roux, 75015, Paris, France.
EHESP French School of Public Health, Rennes, France.

Yusuke Shimakawa (Y)

Institut Pasteur, Université Paris Cité, Unité d'Épidémiologie Des Maladies Émergentes, 25-28 Rue du Dr Roux, 75015, Paris, France. yusuke.shimakawa@gmail.com.

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