Study protocol for development of an options assessment toolkit (OAT) for National Malaria Programs in Asia Pacific to determine best combinations of vivax radical cure for their given contexts
Authors: Shrestha Manash , Neukom Josselyn , Acharya Sanjaya , Habib Muhammad Naeem , Wini Lyndes , Duong Tran Thanh , Thang Ngo Duc , Lhazeen Karma , Thriemer Kamala , Lynch Caroline A. 
Published: July 2022

Introduction

Recent advances in G6PD deficiency screening and treatment are rapidly changing the landscape of radical cure of vivax malaria available for National Malaria Programs (NMPs). While NMPs await the WHO’s global policy guidance on these advances, they will also need to consider different contextual factors related to the vivax burden, health system capacity, and resources available to support changes to their policies and practices. Therefore, we aim to develop an Options Assessment Toolkit (OAT) that enables NMPs to systematically determine optimal radical cure options for their given environments and potentially reduce decision-making delays. This protocol outlines the OAT development process.

Methods

Utilizing participatory research methods, the OAT will be developed in four phases where the NMPs and experts will have active roles in designing the research process and the toolkit. In the first phase, an essential list of epidemiological, health system, and political & economic factors will be identified. In the second phase, 2-3 NMPs will be consulted to determine the relative priority and measurability of these factors. These factors and their threshold criteria will be validated with experts using a modified e-Delphi approach. In addition, 4-5 scenarios representing country contexts in the Asia Pacific region will be developed to obtain the expert-recommended radical cure options for each scenario. In the third phase, additional components of OAT, such as policy evaluation criteria, latest information on new radical cure options, and others, will be finalized. The OAT will be pilot-tested with other Asia Pacific NMPs in the final phase.

Ethics and Dissemination

Human Research Ethics Committee approval has been received from the Northern Territory, Department of Health, and Menzies School of Health Research (HREC Reference Number: 2022-4245). The OAT will be made available for the NMPs, introduced at the APMEN Vivax Working Group annual meeting, and reported in international journals.

Strengths and limitations of the study

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We will systematically develop the OAT in collaboration with select NMPs who represent the intended end-users of the toolkit, thus ensuring this research project is relevant to NMP decision-making on vivax radical cure treatment and approaches.

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This study will obtain expert consensus on radical cure options for particular scenarios and threshold criteria for baseline factors.

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While 4-5 scenarios will be developed in the OAT, it is possible that some individual country contexts of the Asia Pacific region may not be fully represented in those scenarios.

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Some larger malaria endemic countries in the Asia Pacific have a wide diversity of contexts at the sub-national level when it comes to vivax malaria. However, as the policies are made at the national level, the OAT will not be designed to facilitate analysis of separate radical cure options for the sub-national level.

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The toolkit may be subject to change/revision as new data on the radical cure tools become available and as additional countries use the OAT post the APMEN Vivax Working Group annual meeting.