PAVE PNG - Partnership for Vivax Elimination

The primary objective of the study is to determine the operational feasibility and cost-effectiveness of introducing this revised case management for patients with vivax malaria to inform national antimalarial policy and practice. The same study will be performed at 6 sites in Indonesia under a joint Short Course Primaquine for the radical cure of P. vivax (SCOPE) Master Protocol in partnership with Menzies School of Health Research with a shared Statistical Analysis Plan and patient recruitment target.

The work is part of a new UNITAID-funded PArtnership for Vivax Elimination (PAVE), working with Menzies School of Health Research, MMV and PATH to advance the development of treatments for relapse prevention and support malaria-endemic countries in developing and implementing new strategies to eliminate P. vivax malaria.

2021–2025

In this multicentre, implementation, before-and-after longitudinal study, we will determine the feasibility and cost-effectiveness of introducing a revised case management package to facilitate a well-tolerated and effective radical cure of patients with vivax malaria at 4 selected public health care facilities across PNG. These facilities include Mugil Health Centre, Baro clinic, Wirui clinic and Napapar Health Centre in Madang, West Sepik, East Sepik and East New Britain provinces respectively.

The revised case management package has been prioritised and endorsed by the National Department of Health and will include:

• Semi-quantitative point-of-care glucose-6-phosphate dehydrogenase (G6PD) activity assessment prior to treatment with primaquine
• Prescription high dose (7 mg/kg total) primaquine over 7 (PQ7) or 14 (PQ14) days, to all eligible patients presenting with P. vivax malaria
• Patient education and counselling prior to treatment and supervision of the first dose of primaquine at the health care clinic
• Community-based clinical review at day 3 of primaquine treatment to encourage treatment adherence and facilitate detection and management of adverse events to treatment
• Improved malaria surveillance and pharmacovigilance.

Nearly 40 per cent of the world’s population remains at risk of P. vivax, which is now the most common cause of malaria outside of sub-Saharan Africa and widely considered a major obstacle to achieving malaria elimination. Despite considerable achievements in reducing the overall burden of malaria in Papua New Guinea (PNG), the prevalence of P. vivax remains unacceptably high (20 to 30 per cent prevalence in community surveys) and is a key barrier in progressing towards elimination. In the 2020–2025 PNG National Malaria Control Program (NMCP) Strategy, strengthening P. vivax case management was a highlighted as a key priority for the program.

Over the last few years, new tools and treatment strategies have been developed for better tolerated and more effective radical cure treatment regimens. In areas with high risk of relapse, short-course (7 days), high daily-dose (1mg/kg body weight) primaquine has been shown to have similar efficacy compared with the same WHO-recommended total dose of 7 mg/kg body weight administered over 14 days (0.5mg/kg body weight daily dose). However, the higher daily dose in the 7 day regimen (1 mg/kg) was associated with more adverse events, particularly an increased risk of haemolysis and gastrointestinal events. A point-of-care quantitative G6PD test (SD Biosensor, ROK) has been developed and if feasible to use as part of vivax case management in PNG, has the potential to allow for safer and more efficacious treatment with primaquine to reduce the burden of vivax.