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.
Creators: name: Isa, Yasir Shitu
name: Sicsic, Jonathan
name: Njuguna, Henry
name: Ward, John
name: Chakroun, Mohamed
name: El-Kassas, Mohamed
name: Ramanampamonjy, Rado
name: Chalal, Salim
name: Vincent, Jeanne Perpétue
name: Andersson, Monique
name: Desalegn, Hailemichael
name: Fall, Fatou
name: Johannessen, Asgeir
name: Matthews, Philippa C
name: Ndow, Gibril
name: Okeke, Edith
name: Riches, Nicholas
name: Seydi, Moussa
name: Sinkala, Edford
name: Spearman, C Wendy
name: Stockdale, Alexander
name: Vinikoor, Michael J
name: Wandeler, Gilles
name: Sombié, Roger
name: Lemoine, Maud
name: Mueller, Judith E
name: Shimakawa, Yusuke
Publisher: name: The Francis Crick Institute
Year: 2023
Subjects: subject: Genetics &amp; Genomics
subject: Infectious Disease
subject: Immunology
subject: FOS: Clinical medicine

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.