Objectives | Outcomes/endpoints |
---|---|
Primary | |
To compare the effectiveness of focused screening and treatment (FSAT) following current national treatment guidelines versus targeted monthly malaria prophylaxis (MMP) with DHA-piperaquine in combination with low-dose weekly primaquine (PQ) (22.5 mg) for 12 weeks | Absolute risk reduction in a cluster based on those individuals’ polymerase chain reaction (PCR)-corrected absence of parasitemia at the end of 6 months in the MMP versus FSAT clusters |
Secondary | |
Estimate the incremental benefit of insecticide-treated uniforms (ITU) over drug therapy and existing vector control interventions compared to a sham insecticide-treated uniform (sITU)a | Absolute risk reduction in a cluster based on those individuals’ PCR-corrected absence of parasitemia at the end of 6 monthsa Proportional landings of mosquitoes on treated uniform’s swatch side of cages |
Assess the effectiveness of presumptive anti-relapse and transmission-blocking therapy with weekly low-dose primaquine (22.5 mg)a | Incidence of P. vivax recurrent infection and PCR-corrected P. falciparum recrudescencea PCR-corrected absence of gametocytemiaa |
Evaluate the safety and tolerability of blood-stage antimalarials and weekly low-dose primaquine at 12 weeks versus 8 weeks in treated MMP and FSAT volunteers, respectively | Number of hemolytic events or other serious adverse events in participants over 13 years of age receiving primaquine |
Assess level of antimalarial drug resistance at the selected study sites | Number of all-species malaria recurrence, established molecular markers of drug resistance, and clinical failure rates based on WHO criteria |
Define the proportion of asymptomatic carriers of malaria in the study population | Cumulative incidence and incidence density of PCR-corrected parasitemia and submicroscopic parasitemia in each arm |
Define the epidemiology of malaria infection in volunteers developing malaria | Cumulative incidence and incidence density of parasitemia |
Compare the sensitivity and specificity of the currently recommended malaria rapid diagnostic test of choice in Cambodia with RT-PCR | Retrospective assessment of the proportion of asymptomatic carriers that would have been missed by each test and an estimate of the incremental cost-effectiveness of each test |
Compare sensitivity and specificity of two currently available rapid diagnostic tests to detect moderate to severe G6PD deficiency using quantitative G6PD testing as the reference standard | Retrospective assessment of the proportion of persons with moderate to severe deficiency who would have been missed with each screening modality, and an estimate of the cost-effectiveness of each test |
Describe population demographics to include the acceptability of FSAT, malaria prophylaxis, and use of vector control measures among participants, including willingness to participate in future malaria elimination campaigns | Descriptive analysis of participants’ responses to survey questions pre and post study regarding FSAT, malaria prophylaxis, and use of vector control measures |
Support host nation capabilities by improving the Royal Cambodian Armed Forces’ (RCAF’s) ability to diagnose, prevent, and treat malaria supported by robust data to achieve malaria elimination | A scalable military malaria elimination “unit of action” will be established at the provincial level, staffed by RCAF personnel trained during the course of the study |