Vivax Elimination With Tafenoquine (VET) Study
NCT Number: NCT06575647
Acronym: VET
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Malaria|Malaria, Vivax|Plasmodium Vivax|Plasmodium Vivax Malaria
Interventions: DRUG: Tafenoquine
Sponsor: Shoklo Malaria Research Unit
Collaborators: Mahidol Oxford Tropical Medicine Research Unit
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 1000
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-09-30
Locations: Shoklo Malaria Research Unit (SMRU), Myawady, Karen State, Myanmar

Summary:
Theoretically, so long as there is a sink-source for malaria, transmission could be sustained at very low level (even at sub-microscopic oscillation) and reintroduce malaria either as sporadic cases or as resurgent outbreak. Uncertainty or shortage in financing has typically limited the malaria control or elimination projects to go further beyond the "Pre-elimination phase". Since malaria is no longer a top scoring mortality in national statistics in South East Asia, the governments/stakeholders are less willing to allocate from the austerity budget. There are proven evidence of resurgences after cessation of intervention programs where over 90% of all resurgence events were attributed to the interruption of malaria control programmes. In Karen state Myanmar-Thailand border, multiple factors including a cascade of political, financial, and logistical fiascos have compounded on the ongoing malaria elimination activities. Deleterious impacts after military coup since 2021 February including cessation of foreign investment, humanitarian aids, Civil Dis-obedience Movement of government staff and resuming armed-conflicts have strained the nearly failed health infrastructure of the country to a collapse stage. Interruption of the National Malaria Control activities due to the health system failure and accelerating combats countrywide could inevitably lead to the overturn in recently achieved malaria pre-elimination status especially in Karen state.

The disruption in health services within Myanmar is already resulting in an increase in malaria. Supply of the first line antimalarial drug artemether-lumefantrine, and other essential malaria control interventions, has been interrupted. The study is proposed to evaluate the impact of Mass Drug Administration (MDA) in 3 villages in Karen state with consistently high incidence of P. vivax and spatially clustered within 5 km radius. This proposal outlines a study to assess the feasibility and the safety of tafenoquine MDA.

Primary Outcome Measures: Incidence of Serious Adverse Events (SAEs) to assess safety and tolerability of Tafenoquine MDA, Number of (serious) adverse events reported, Baseline survey to end of Month-1 survey
Secondary Outcome Measures: To compare the incidence by Rapid Diagnostic Test (RDT) of P. vivax before and 1-3-6 months after providing the single round of MDA with Tafenoquine radical cure treatment, Malaria Incidence by RDT reported from malaria post at month 1, 3 and 6, Month 1, 3 and 6|To evaluate the adherence of healthcare workers to the SOP for implementing MDA of Tafenoquine., Proportion of village health workers adhere to the SOP for G6PD testing \& documentation, tafenoquine administration and adverse event recording \& reporting., Baseline survey and Month-1 survey|To compare the prevalence by PCR of P. vivax before and a month after providing the single round of MDA., Difference in proportion positive to PCR positive before and a month after providing the single round of MDA., Baseline survey and Month-1 survey