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Table 1 Outcomes

From: Cluster-randomized trial of monthly malaria prophylaxis versus focused screening and treatment: a study protocol to define malaria elimination strategies in Cambodia

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

  1. 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