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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)

  • Lover, Andrew A.1
  • Dantzer, Emily2
  • Hocini, Sophia3
  • Estera, Ronaldo4
  • Rerolle, Francois2
  • Smith, Jennifer L.2
  • Hwang, Jimee2, 5
  • Gosling, Roly2
  • Yukich, Joshua6
  • Greenhouse, Bryan7
  • Jacobson, Jerry8
  • Phetsouvanh, Rattanaxay9
  • Hongvanthong, Bouasy10
  • Bennett, Adam2
  • 1 Department of Biostatistics and Epidemiology; School of Public Health and Health Sciences, University of Massachusetts- Amherst, Amherst, Massachusetts, 01003-9304, USA
  • 2 Malaria Elimination Initiative, Global Health Group, University of California, San Francisco, San Francisco, CA, 94158, USA
  • 3 Department of Anesthesiology and Perioperative Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
  • 4 Health Poverty Action, Vientiane, Lao People's Democratic Republic
  • 5 & Prevention, Atlanta, GA, 30333, USA
  • 6 School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, 70118, USA
  • 7 Department of Medicine, Division of Infectious Diseases, University of California, San Francisco, San Francisco, CA, 94158, USA
  • 8 Independent Consultant, Los Angeles, CA, 90031, USA
  • 9 Department of Communicable Disease Control, Ministry of Health, Lao PDR, Vientiane, Lao People's Democratic Republic
  • 10 Center for Malariology, Parasitology and Entomology, Ministry of Health, Lao PDR, Vientiane, Lao People's Democratic Republic
Published Article
Gates Open Research
F1000 Research Limited
Publication Date
Dec 17, 2019
DOI: 10.12688/gatesopenres.13088.1
PMID: 32118199
PMCID: PMC7019195
PubMed Central


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, 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: NCT03783299 (21/12/2018)

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