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).
Highlights
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
Proactive case detection can be conducted at the community scale (mass screen and treat (MSAT) or mass test and treat (MTAT)) or in small geographic areas (focal screen and treat (FSAT) or focal test and treat (FTAT))
It is hypothesized that Focal test and treat (FTAT) and mass test and treat with HS-Rapid diagnostic test (RDT) (MTAT) when combined in a single interventional area will be associated with an overall 50% reduction of P. falciparum prevalence as measured by Polymerase chain reaction (PCR)
Summary
The SPIRIT guidelines for randomized trials[15] have been followed throughout the design and reporting of this study protocol; the completed checklist has been archived see (reporting guidelines[16]). After being trained in data and sample collection, the primary role of PNs throughout the study will be to actively seek non-village based HRPs in forested areas, rice fields and plantations, and any other non-permanent settlements within target HCCAs, and conduct FTAT among all consenting individuals. Secondary analyses will include adjustment for age, sex, health center-catchment and village-level baseline prevalence of P. falciparum parasitemia by PCR, and other potential confounders, and a per-protocol analysis of the primary effect estimate. Time-series Poisson or negative binomial model with random intercepts at the health center catchment and village levels These analyses will include a fixed effect for each study arm, an interaction term for the combination of MTAT and FTAT, and a fixed effect for time period (pre- and post-intervention).
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