Table 2.

Table of times and events for adults and children over 12 years of age

Event	Screen/enroll day 1	Day 33	Day 307	Day 607	Day 907	Day 1207	Day 1507	Day 1807	Malaria diagnosis/ recurrence2
a. Informed consent	X
b. Medical history	X
c. Physical exam	X								X
d. Brief clinical evaluation and vital signs1			X	X	X	X	X	X	X
e. Malaria RDT, DBS, smear and PCR genotyping6	2 mL		1.5	1.5	1.5	1.5	1.5	1.5	1.5 mL
i. CBC	1 mL	1 mL3
k. Molecular resistance markers2									6 mL
l. G6PD RDT, fluorescent spot, quantitative testing	1.5 mL
m. Gametocyte PCR	2.5 mL		2.5	2.5	2.5	2.5	2.5	2.5	2.5 mL
n. Urine pregnancy test (women of child-bearing age)	X		X	X					X
o. Malaria treatment4,5	X		X	X					X
Daily phlebotomy (mL)	7	13	4	4	4	4	4	4	10
Cumulative phlebotomy (approximately mL)	7		11	15	19	23	27	31	41

¹Brief clinical evaluation includes an interval medical history, vital signs and a directed physical exam as indicated

²Performed only for volunteers with smear-positive malaria. Those with PCR-positive malaria will be treated following national guidelines but will not have blood drawn for molecular markers of resistance

³To be drawn for G6PD-deficient volunteers only. All G6PD-deficient volunteers with > 10% of Hgb or HTC drop on D3 will have CBC on day 7

⁴Patients screening positive on microscopy and/or PCR for P. falciparum malaria in the FSAT arm will receive currently recommended blood-stage antimalarials under published national treatment guidelines as well as single, low-dose primaquine (15 mg). Volunteers with P. vivax will be treated with the currently recommended blood-stage agent (DHA-PIP), as well as primaquine – G6PD-normal volunteers will receive 15 mg daily for 14 days, while G6PD-deficient volunteer will receive 45 mg × 8 weeks. All volunteers in the MMP arm will receive a fixed-dose 3-day course of DHA-piperaquine at 0, 24 and 48 h starting on days 1, 30, and 60, and a weekly 22.5-mg dose of primaquine for 12 weeks. All therapy will be directly observed

⁵For all volunteers with recurrent malaria, rescue therapy will be with the recommended agent(s) per national guidelines

⁶May be repeated as medically indicated (e.g., if patient is malaria-positive or otherwise ill on enrollment). An additional 0.5 mL will be collected on the day of enrollment for baseline G6PD genotyping

⁷Time window of ± 7 days

CBC complete blood count, DBS dried blood spot, DHA-PIP dihydroartemisinin-piperaquine, G6PD glucose-6-phosphatase dehydrogenase, Hgb hemoglobin, PCR polymerase chain reaction, RDT rapid diagnostic test