Study protocol for a cluster-randomized split-plot design trial to assess the effectiveness of targeted active malaria case detection among high-risk populations in Southern Lao PDR (the AcME-Lao study)

Abstract

Introduction: Novel interventions are needed to accelerate malaria elimination, especially in areas where asymptomatic parasitemia is common, and where transmission generally occurs outside of village-based settings. Testing of community members linked to a person with clinical illness (reactive case detection, RACD) has not shown effectiveness in prior studies due to the limited sensitivity of current point-of-care tests. This study aims to assess the effectiveness of active case finding in village-based and forested-based settings using novel high-sensitivity rapid diagnostic tests in Lao People’s Democratic Republic (Lao PDR). Methods and analysis: This study is a cluster-randomized split-plot design trial. The interventions include village-based mass test and treat (MTAT), focal test and treat in high-risk populations (FTAT), and the combination of these approaches, using high-sensitivity rapid diagnostic tests (HS-RDTs) to asses P. falciparum infection status. Within four districts in Champasak province, Lao PDR fourteen health center-catchment areas will be randomized to either FTAT or control; and within these HCCAs, 56 villages will be randomized to either MTAT or control. In intervention areas, FTAT will be conducted by community-based peer navigators on a routine basis, and three separate rounds of MTAT are planned. The primary study outcome will be PCR-based Plasmodium falciparum prevalence after one year of implementation. Secondary outcomes include malaria incidence; interventional coverage; operational feasibility and acceptability; and cost and cost- effectiveness. Ethics and dissemination: Findings will be reported on clinicaltrials.gov, in peer-reviewed publications and through stakeholder meetings with Ministry of Health and community leaders in Lao PDR and throughout the Greater Mekong Subregion. Trial registration: clinicaltrials.gov NCT03783299 (21/12/2018)

Spatio-temporal associations between deforestation and malaria incidence in Lao PDR

“…The 4 districts in the south were selected within a larger cluster randomized controlled trial (RCT) study designed to assess the e ectiveness of high-risk group targeted active case detection in southern Lao PDR [40], where more than 95% of the country malaria burden is concentrated [2].…”

Spatio-temporal associations between deforestation and malaria incidence in Lao PDR

“…Engaging in forest activities, such as logging, hunting or spending the night in the forest, has been reported as a major risk factor by many studies in the region [17, 20, 39, 22, 61]. As countries of the GMS work towards malaria elimination, the literature stresses the key role of forest-going populations [30, 45,11, 68, 56], although research programs highlight the challenges of accessing them [14, 40] as well as their diversity [45,11]. To our knowledge, no previous study has leveraged geo-spatial statistical analyses to characterize the importance of forest-going populations in the GMS.…”

“…The 4 districts in the south were selected within a larger cluster randomized controlled trial (RCT) study designed to assess the effectiveness of high-risk group targeted active case detection in southern Lao PDR [40], where more than 95% of the country malaria burden is concentrated [2]. This region is characterized by a moderately hilly and forested terrain and a workforce primarily engaged in forest-based and agricultural activities [14].…”

Population Size Estimation of Seasonal Forest-going Populations in Southern Lao PDR.

“…This study was conducted in Champasak Province, one of the ve southernmost provinces in Lao PDR, together accounting for 95% of the country's malaria burden 29 . As part of a randomized controlled trial, surveys were conducted between December 2017 and November 2018 to assess the effectiveness of active case detection in village-based and forested-based settings 30 . Across four districts, 56 villages in 14 health center catchment areas (HCCA) were randomized to one of four arms: no intervention, Focal Test-And-Treat (FTAT), an intervention speci cally targeting forest-goers, Mass Test-And-Treat (MTAT), where everyone was tested for malaria using rapid diagnostics tests (RDTs) and treated if positive or both interventions.…”