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Table of Contents
SHORT RESEARCH COMMUNICATION
Year : 2020  |  Volume : 57  |  Issue : 2  |  Page : 182-186

Malaria radical cure opportunity assessment in India: Discussing opportunities through stakeholder convening workshop and recommendation for improved access to malaria treatment


1 PATH, New Delhi, India
2 PATH, Seattle, Washington, USA
3 Medicines for Malaria Venture, Geneva, Switzerland
4 GSK GlaxoSmithKline, GSK House, United Kingdom

Date of Submission04-Jun-2019
Date of Acceptance10-Oct-2019
Date of Web Publication14-Jul-2021

Correspondence Address:
Abhijit Sharma
PATH, New Delhi
India
Dr Rajiv Tandon
Health Director, Research Triangle Institute International
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0972-9062.310865

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  Abstract 

India contributes to over 40% of the global Plasmodium vivax disease burden, and P. vivax contributes to approximately one-third of all malaria in India. Government of India has set goals to eliminate malaria by 2030. Doing so will require scaling up existing and new strategies, treatments and diagnostic tools. Access to appropriate diagnosis and treatment for P. vivax malaria is currently limited, and it is unclear how new tools will be rolled out. To support the government in its malaria elimination efforts, the current challenges associated with access to best clinical management of vivax malaria must be understood and mitigated to effectively deploy new tools and scale up existing solutions. The recent Food and Drug Administration (US-FDA) as well as Therapeutics Goods Administration (Australian TGA) approval of tafenoquine, developed by GSK GlaxoSmithKline and Medicines for Malaria Venture (MMV) as a new single-dose radical cure treatment for P. vivax malaria, and the commercial availability of new point-of-care glucose-6-phosphate dehydrogenase (G6PD) tests provide new opportunities to improve clinical management of vivax malaria in India. This report discusses the background, objectives, implementation strategies, and next steps that came out of the Stakeholder Workshop on Malaria Radical Cure in New Delhi, India on 4 February 2019. The focus was to understand the risks and opportunities associated with access to best clinical practices for managing vivax malaria in India. A key outcome was to propose a framework for articulating and segmenting important investment opportunities for improving access to best clinical practices for P. vivax radical cure in India.

Keywords: Plasmodium vivax, malaria radical cure, malaria treatment, G6PD


How to cite this article:
Tandon R, Spark-DePass E, Sharma A, Gerth-Guyette E, Slutsker L, Daumerie PG, Domingo GJ, Bird P, Agarwal N. Malaria radical cure opportunity assessment in India: Discussing opportunities through stakeholder convening workshop and recommendation for improved access to malaria treatment. J Vector Borne Dis 2020;57:182-6

How to cite this URL:
Tandon R, Spark-DePass E, Sharma A, Gerth-Guyette E, Slutsker L, Daumerie PG, Domingo GJ, Bird P, Agarwal N. Malaria radical cure opportunity assessment in India: Discussing opportunities through stakeholder convening workshop and recommendation for improved access to malaria treatment. J Vector Borne Dis [serial online] 2020 [cited 2021 Aug 5];57:182-6. Available from: https://www.jvbd.org/text.asp?2020/57/2/182/310865

Dr. Rajiv Tandon, Current affiliation: Health Director, Research Triangle Institute International, India


Goals of the workshop

The Stakeholder Workshop on Malaria Radical Cure in India was conducted to discuss opportunities for improved access to malaria radical cure. The workshop, held on 4 February 2019 in New Delhi, brought together national and state-level leaders of vector borne disease (VBD) programs including the Director of NVBDCP (National Vector Borne Disease Control Programme) and state VBD officials. Other notable policymakers included representatives from the Directorate General of Health Services (Ministry of Health and Family Welfare), malaria research specialists from the National Institute of Malaria Research (NIMR) and National Academy of Vector Borne Diseases (NAVBD), and a pharmacovigilance expert from the Post Graduate Institute of Medical Education and Research, Chandigarh. Other participants were from the World Health Organization (WHO), Medicines for Malaria Venture (MMV), Public Health Foundation of India, GlaxoSmithkline, the Bill & Melinda Gates Foundation and other donors, and academic partners from Kolkata Medical College and Hospital (KMCH) and Jawaharlal Nehru University (JNU), Delhi. The workshop was cohosted by the Indian Council of Medical Research (ICMR) and PATH.

The national, regional and global experts in the workshop provided critical observations and recommendations on the opportunities to improve safe and radical cure treatment of malaria in India. The objectives of this one-day workshop were to:

  1. Review an information package assembled by PATH including an analysis of risks and opportunities with current vivax malaria case management in India.
  2. Provide inputs on strategies for mitigating risks and leveraging opportunities identified by the research.
  3. Make recommendations on prioritizing activities for future work.


Background

Plasmodium vivax cases in India have been declining since 2002[1],[2],[3]. In spite of this, India still contributes 49 percent of the global P. vivax burden. The Ministry of Health in India has recently launched the National Framework for Malaria Elimination with the goal of eliminating malaria by 2030. Meeting this goal will require innovative efforts to reduce India’s malaria burden, caused primarily by Plasmodium falciparum, the most common cause of malaria worldwide, and P. vivax, a species largely found in Asia, Latin America and the Horn of Africa. The recent establishment of the Malaria Elimination Research Alliance (MERA) India is an important step towards meeting this goal[2]. Unlike P. falciparum malaria, patients with P. vivax require two types of antimalarial drugs: one to kill the blood stage of the parasite and another to target a latent liver stage of the parasite (the hypnozoite); both are required to completely cure the patient (radical cure). Currently, primaquine, an 8-aminoquinoline, remains the only licensed antimalarial in malaria endemic countries with the proven ability to eliminate the hypnozoites. However, primaquine’s 14-day dosing requirement is associated with poor compliance, with several studies reporting compliance rates under 50 percent.

To address this challenge, GSK has collaborated with Medicines for Malaria Venture (MMV) to develop single-dose tafenoquine, a long-acting 8-aminoquinoline[4],[5]. The long half-life of tafenoquine enables a convenient single-dose course of therapy, which is expected to dramatically increase treatment adherence. However, tafenoquine, an 8-aminoquinoline like primaquine, can cause acute hemolysis of red blood cells leading to severe anemia in patients who have deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD). To safely administer primaquine and tafenoquine, G6PD deficiency testing must be conducted prior to treatment. PATH and its donors are advancing a portfolio of point-of-care diagnostic tests for G6PD deficiency, the first of which (manufactured by SD Biosensor, South Korea) became commercially available in India in 2018[6],[7].

Malaria radical cure opportunity assessment objectives

Given the impending commercial availability of both tafenoquine and the G6PD diagnostic, PATH, GSK and partners have sponsored the Malaria Radical Cure Opportunity Assessment (MRCOA) study in India, in consultation with national-level leadership. This new scope of work assessed the opportunities and challenges to incorporate of G6PD testing to support and inform P. vivax malaria case management and radical cure. The aim of the assessment was:

  1. To understand opportunities and challenges related to adoption of best clinical practices for management of P. vivax malaria in India.
  2. To propose a framework for assessing and prioritizing investment opportunities for improving access to the best clinical practices for P. vivax radical cure in India.


To support these aims, the first phase of the assessment focused on the following activities:

  1. Determine appropriate, India-specific use cases for radical cure therapy and G6PD testing.
  2. Assess the opportunities and challenges associated with each use case.
  3. Define the health benefit of the safe implementation of radical cure and G6PD testing based on the project findings.


The interim findings from these activities were provided as an information package and pre-read to the workshop participants to inform the discussions during the workshop.

Data sources for the information package

PATH’s approach to the MRCOA included five key components [Figure 1]. First, the project team identified nine use cases based on three focal distinguishing characteristics: state, level of urbanization (urban or rural), and health sector (public or private). The team then conducted secondary research with a review of relevant literature and policy documents, followed by primary research, which included interviews with more than 100 key informants at state and community levels. Key resources included the National Strategic Plan for Malaria Elimination in India 2017–2022 and the Malaria Elimination Scenario Planning (Clinton Health Access Initiative) report as well as other references[1],[8],[9]. Geospatial modeling was conducted to map key aspects of risk and opportunity, such as prevalence of G6PD deficiency and access to health services. The project team then used the research findings and modeling results to inform the development of a framework for identifying and evaluating potential investments to improve management of P. vivax malaria in India.
Figure 1: Key components of the Malaria Radical Cure Opportunity Assessment.

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Use case selection

Use cases were created based on three focus market segments: state, level of urbanization (urban or rural), and health sector (public or private). Use cases [Table 1] were selected based on the following:
Table 1: Use cases selected for primary research. Elimination categories are defined as per the National Framework for Malaria Elimination in India, where by Category 1 represents a setting in elimination, Category 2 a setting in pre-elimination and Category 3 a setting in intensified control

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  • Representative of India’s malaria-specific context, including states spanning all elimination contexts as defined by the National Framework for Malaria Elimination in India 2016–2030.
  • Inclusive of special populations relevant for P. vivax malaria (e.g., tribal, migrant workers).
  • Inclusive of urban and rural populations.
  • Inclusive of public and private health facilities.


Workshop proceedings

At the February 2019 workshop on Malaria Radical Cure Opportunity Assessment, moderated panel discussions were held on the following topics:

  1. Malaria priorities in India and review of elimination efforts.
  2. P. vivax malaria opportunities, challenges, and investments required at state level.


MMV and PATH presented the progress toward the availability of tafenoquine and point-of-care tests for G6PD deficiency, followed by a presentation of the workshop pre-read information package. The second half of the workshop was dedicated to articulating challenges to access radical cure and prioritize opportunities to address these challenges and accelerate access to best clinical practices for P. vivax malaria case management. This was achieved through small group discussions followed by presentations to the broader workshop participants. Each breakout group was provided a framework to categorize the opportunities by level of investment required and to make a qualitative assessment of the impact of the investment on access to radical cure [Figure 2]. The opportunities can originate from all use cases, and the positioning on the framework is independent of the use case.
Figure 2: Framework for categorizing opportunities to increase access to safe radical cure. Each subgroup of workshop participants was asked to identify opportunities to address current challenges and barriers to wide access to glucose-6-phosphate dehydrogenase (G6PD) testing and radical cure, by a qualitative assessment of the investment required to execute on the opportunity (x-axis) and the health impact (y-axis).

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Principal findings and analysis

The key challenges and opportunities identified through this research have been organized into four cross-cutting themes: epidemiology and demographics, value proposition for G6PD testing and radical cure, political environment and financing, and malaria case management.

Based on the principal findings from primary and secondary research, the MRCOA team generated investment options to mitigate challenges and capitalize on opportunities. The team prioritized interventions with a focus on improving access to best clinical practices for vivax malaria. Several investment options were generic interventions likely to address more than one challenge or opportunity.

Investment options identified prior to the stakeholder workshop

  1. Conduct operational research for high-risk/special vivax malaria populations.
  2. Develop and evaluate specific guidelines and standard operating procedures for safe vivax malaria management, including management of anemic patients.
  3. Partner with city governments and construction companies to offer targeted interventions for migrant workers in urban areas.
  4. Conduct pediatric studies to expand tafenoquine indication (currently underway).
  5. Create and disseminate a data package pertaining to the value proposition for safe radical cure and G6PD testing.
  6. Convene an expert review panel to assess risk-based implementation of G6PD testing and radical cure scale-up; update guidelines based on the assessment.
  7. Engage the private sector via public-private partnerships, medical colleges, or innovative incentives.
  8. Conduct education, training and advocacy campaigns pertaining to the challenges and benefits of radical cure.
  9. Replicate successful models of care (e.g., Odisha and Punjab).
  10. Explore the feasibility of leveraging technology solutions, such as mobile health (mHealth) platforms, to support case reporting, patient monitoring, and follow-up.
  11. Create P. vivax pilot sites, leveraging learnings and data systems from the visceral leishmaniasis program.


Stakeholder feedback from the workshop

The workshop prioritization exercise largely validated the investment options the MRCOA team had selected. Most investments prioritized by stakeholders overlapped with the team’s list of investment options, many of which were considered high impact. Stakeholders generally categorized investments that would require a high level of partnership, such as capacity-building and training, in the major projects category. Investments that could be carried out independently, such as creating and disseminating data packages, were placed in the immediate opportunity category.

The investments prioritized most frequently in the workshop were further articulated to include the following topics:

  • Engaging the non-government sector. Stakeholders agreed that engaging this sector will be critical to scaling access to safe radical cure. This was seen as a major investment that will require significant resources.
  • Creating and disseminating data packages. Raising awareness of the value of safe radical cure through dissemination of evidence was viewed as a high-impact, low-resource investment option.
  • Leveraging technology. One theme throughout the workshop was the need for better data, improved surveillance and patient follow-up. Many stakeholders agreed that adopting mHealth platforms would enable progress on these fronts, leading to significant health impact. However, groups were divided as to the level of investment required.
  • Operational research/pilot studies/pharmacovigilance. There was a consensus that models of testing and treating P. vivax malaria with safe radical cure need to be field-tested through pilot studies that focus on operational factors, with particular regard for pharmacovigilance.
  • Training and capacity-building. Increasing the capabilities of health workers to safely administer radical cure was viewed as an impactful and investment-intensive option to improve access.


New investments prioritized by stakeholders

Workshop participants also advanced several investments that were not included in the set of options initially presented. The most popular options included activities to improve malaria surveillance, as well as behavioral change activities to improve care-seeking behaviors and adherence to radical cure [Table 2]. Although each investment option may be a discrete intervention, many stakeholders outlined potential solutions that would incorporate multiple investments simultaneously. For example, an investment in operational research could engage nongovernment actors while testing models for pharmacovigilance and mHealth platforms. In addition, participants voiced strong support for the creation of a technical advisory group, which could sustain momentum for safe radical cure at the national level.
Table 2: Number of workshop groups prioritizing each of five new investment options

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Next steps

The next steps of this project will seek to capitalize on the momentum generated through the stakeholder workshop and the relationships developed during primary research. Improving access to best clinical practices for vivax malaria will require innovative tools, new evidence as to the operational and contextual factors that will determine successful uptake of these tools, and sustained coordination and advocacy efforts at the national, state and local levels.


  Conclusion Top


This project sought to understand opportunities and challenges related to adoption of the best clinical practices for management of P. vivax malaria in India and to propose a framework for assessing and prioritizing investment opportunities for improving access. There is a richly diverse and dynamic landscape of malaria policy, epidemiology, and case management across India. Within this landscape, myriad opportunities and current and future challenges are evident, and equally evident are market segments ready to adopt and expand access to new tools.

In this complex landscape, the investment framework offers a transparent methodology to prioritize and gain consensus on next steps. The stakeholders convening described above served to catalyze this consensus-building and spur the discussions and partnerships that will be required to realize the health impact of expanded access to best clinical practices and new tools for vivax malaria. These recommendations for next steps offer concrete ways to build on the foundation of this project and sustain the drive towards greater coordination, new evidence, and the creative application of innovative tools for vivax malaria diagnosis and treatment. These are all in alignment and supportive of the MERA India initiative[2].


  Acknowledgments Top


The Stakeholder Workshop on Malaria Radical Cure in India conducted on February 4 2019 was funded by the UK Department for International Development (DFID), grant number 204139. The primary and secondary research in preparation for the workshop was funded by a GSK grant to PATH to support adoption of best clinical practices for radical cure of Plasmodium vivax in India. The findings and conclusions contained within are those of the authors and do not necessarily reflect positions of the DFID or GSK.


  Participating Organizations and Institutions Top


ICMR, WHO, NIMR, MoHFW, NVBDCP, Health Services Odisha, Punjab state VBD, DMO Sohnbhadra, DGHS (Public Health), PHFI, Directorate General of Health Services, MMV, GSK, PATH Seattle, PATH India, National Centre for Communicable Disease Control, DCGI/CDSCO, BIRAC, DBT, MNM, BMGF, NAVBD, Caritas, IMA, PGIMER Pharmacovigilance Centre and School of Public Health, JNU, FICCI, Godrej, Hillman Labs, Tata Trusts, Government of Jharkhand, Heritage Institute of Medical Sciences, Varanasi, ex Health Commissioner Government of Gujarat and ex Joint Secretary Ministry of Health and family Welfare, Government of India, Roll Back Malaria, Pharmacovigilance Program of India, Regional Medical Research Center, Bhubaneshwar, UNICEF, Medical College and Hospital (Kolkata) and USAID.

 
  References Top

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Anvikar AR, Shah N, Dhariwal AC, Sonal GS, Pradhan MM, Ghosh SK et al. Epidemiology of Plasmodium vivax Malaria in India. Am J Trop Med Hyg 2016; 95(6 Suppl): 108–20. (Accessed on 3 May 2019)  Back to cited text no. 1
    
2.
Rahi M, et al, MERA India: Malaria elimination research alliance India. J Vector Borne Dis2019; 56(1): 1–3. (Accessed on 3 May 2019)  Back to cited text no. 2
    
3.
World Malaria Report 2017. Geneva: World Health Organisation 2017. (Accessed on 3 May 2019)  Back to cited text no. 3
    
4.
Lacerda MVG, Llanos-Cuentas A, Krudsood S, Lon C, Saunders DL, Mohammed R, et al. Single-dose tafenoquine to prevent relapse of Plasmodium vivax malaria. N Engl J Med 2019; 380(3): pp. 215–28. (Accessed on 3 May 2019)  Back to cited text no. 4
    
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Llanos-Cuentas A, Lacerda Marcus VG, Hien Tran T, Vélez Iván D, Namaik-larp C, Chu CS, et al. Tafenoquine versus primaquine to prevent relapse of Plasmodium vivax malaria. N Engl J Med 2019; 380(3): 229–41. (Accessed on 3 May 2019)  Back to cited text no. 5
    
6.
Alam MS, Kibria MG, Jahan N, Thriemer K, Hossain MD S, Douglas Nicholas M, et al. Field evaluation of quantitative point of care diagnostics to measure glucose-6-phosphate dehydrogenase activity. PLoS One 2018; 13(11): p. e0206331. (Accessed on 3 May 2019)  Back to cited text no. 6
    
7.
Pal S, Bansal P, Bancone G, Hrutkay S, Kahn M, Gornsawun G, et al. Evaluation of a novel quantitative test for glucose-6-phosphate dehydrogenase Deficiency: Bringing quantitative testing for glucose-6-phosphate dehydrogenase deficiency closer to the patient. Am J Trop Med Hyg 2019; 100(1): 213–21. (Accessed on 3 May 2019)  Back to cited text no. 7
    
8.
CHAI, Malaria Elimination Scenario Planning. 2017. (Accessed on 3 May 2019)  Back to cited text no. 8
    
9.
National Vector Borne Disease Control Programme (NVBDCP), D.G.o.H.S., Ministry of Health and Family Welfare, Government of India., National Strategic Plan for Malaria Elimination in India (2017-22). Delhi: NVBDCP, 2017. Available from: http://www.indiaenvironmentportal.org.in/content/445149/ national-strategic-plan-for-malaria-elimination-2017-22/. (Accessed on 9 June 2021)  Back to cited text no. 9
    


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