Table 1.
Outcomes
| 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 |
aPilot study objective and endpoint added to assess operational feasibility given ongoing community concerns regarding these interventions. These endpoints are statistically underpowered and this data will be used to inform larger studies in the future