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Gates Open Res. 2019 Dec 17;3:1730. doi: 10.12688/gatesopenres.13088.1. eCollection 2019.

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).

Author information

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
Center for Global Health/ DPDM Malaria Branch/ US President's Malaria Initiative, US Center for Disease Control & 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.

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).

KEYWORDS:

community-randomized study; disease elimination; high-risk populations; malaria

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