NCT04411836.

Study name	Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine (EFFORT)
Methods	Health care facility based, randomized, controlled, open label, superiority trial with 3 arms
Participants	Inclusion criteria P vivax peripheral parasitaemia (mono‐infection) as determined by microscopy G6PD normal status (G6PD activity ≥ 70% of the adjusted male median as determined by the Biosensor™ (SD Bioline, ROK)) Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours Age ≥18 years Written informed consent Living in the study area and willing to be followed for six months Exclusion criteria Danger signs or symptoms of severe malaria Anaemia (defined as Hb <8g/dl) Pregnant or lactating females Known hypersensitivity to any of the study drugs
Interventions	Schizontocidal treatment plus low dose PQ (total dose 3.5mg/kg) unsupervised over 14 days Schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days Schizontocidal treatment plus a single dose of Tafenoquine (TQ) 300mg
Outcomes	Primary outcome: the incidence risk (time to first event) of symptomatic P vivax parasitaemia during the 6‐month follow up period as determined by microscopy
Starting date	January 2021
Contact information	Sophie Weston (sophie.weston@menzies.edu.au), Menzies School of Health research
Notes	Location: Not provided Sponsor: Menzies School of Health Research

ALT: alanine aminotransferase; DHA‐PQP: dihydroartemisinin‐piperaquine; G6PD: glucose‐6‐phosphate dehydrogenase; PQ: primaquine; TQ: tafenoquine.