Formative research to inform development of a new diagnostic for soil-transmitted helminths: Going beyond the laboratory to ensure access to a needed product

Soil-transmitted helminths (STHs) affect more than 1.5 billion people. The global strategy to control STH infections requires periodic mass drug administration (MDA) based on prevalence among populations at risk determined by diagnostic testing. Widely used copromicroscopy methods to detect infection, however, have low sensitivity as the prevalence and intensity of STH infections decline with repeated MDA. More sensitive diagnostic tools are needed to inform program decision-making. Using an integrated product development process, PATH conducted qualitative and quantitative formative research to inform the design and development of a more sensitive test for STH infections. The research, grounded in a conceptual framework for ensuring access to health products, involved stakeholder analysis, key opinion leader interviews, observational site visits of ongoing STH surveillance programs, and market research including market sizing, costing and willingness-to-pay analyses. Stakeholder analysis identified key groups and proposed strategic engagement of stakeholders during product development. Interviews highlighted features, motivations and concerns that are important for guiding design and implementation of new STH diagnostics. Process mapping outlined current STH surveillance workflows in Kenya and the Philippines. Market sizing in 2016 was estimated around half a million tests for lower STH burden countries, and 1–2 million tests for higher STH burden countries. The cost of commodities per patient for a molecular STH diagnostic may be around $10, 3–4 times higher than copromicroscopy methods, though savings may be possible in time and staffing requirements. The market is highly price sensitive as even at $5 per test, only 27% of respondents thought the test would be used by surveillance programs. A largely subsidized STH control strategy and a semi-functional Kato-Katz test may have created few incentives for manufacturers to innovate in STH diagnostics. Diverse partnerships, as well as balancing needs and expectations for new STH diagnostics are necessary to ensure access to needed products.

土壤传播蠕虫（Soil-transmitted helminths，STHs）已造成全球超过15亿人感染。目前控制STHs感染的全球防控策略要求，基于诊断检测确定的高危人群感染率，开展周期性大规模药物给药（Mass Drug Administration，MDA）。然而，当前广泛使用的粪便显微镜检查法（copromicroscopy）检测感染的灵敏度较低：随着反复MDA实施，STHs感染的流行率与感染强度均会下降，此类方法的检测局限性愈发凸显，亟需灵敏度更高的诊断工具为项目决策提供科学依据。
PATH通过整合式产品开发流程，开展定性与定量形成性研究（formative research），以指导STHs感染高灵敏度检测方法的设计与开发。本研究以保障卫生产品可及性的概念框架为基础，涵盖利益相关者分析（stakeholder analysis）、关键意见领袖访谈（key opinion leader interviews）、对正在实施的STHs监测项目的现场观察走访（observational site visits），以及包含市场规模测算（market sizing）、成本核算（costing）与支付意愿分析（willingness-to-pay analyses）在内的市场调研。
利益相关者分析明确了核心参与群体，并提出了产品开发阶段的利益相关者战略参与方案。访谈结果提炼出指导新型STHs诊断工具设计与落地实施的关键特征、相关动机与顾虑。流程图谱梳理了肯尼亚与菲律宾当前的STHs监测工作流程。2016年的市场规模测算显示，STHs感染负担较低的国家年检测需求约为50万次，高负担国家则为100万至200万次。
分子类STHs诊断检测的单份患者试剂成本约为10美元，是粪便显微镜检查法的3至4倍，但在检测耗时与人力需求上或可实现成本节约。该市场对价格高度敏感：即便检测单价降至5美元，仍仅有27%的受访者认为监测项目会采用该检测方法。长期以来的大幅补贴STHs防控策略，以及加藤-Katz厚涂片法（Kato-Katz test）的现有应用局限，或导致制造商缺乏研发新型STHs诊断工具的动力。因此，需构建多元化合作伙伴关系，并平衡新型STHs诊断工具的各方需求与预期，才能保障所需产品的可及性。