Last Updated: 30/06/2020
Operational evaluation of Mass Screening and Treatment using ultrasensitive RDTs to reduce P. falciparum incidence in a malaria elimination program in Eastern Kayin State, Myanmar
Objectives
In this project, the investigators aim at an operational research deployment of Ultrasensitive Rapid Diagnostic Test (URDT) – based Mass Screening and Treatment (MSAT) in the Malaria Elimination Task Force (METF) elimination program. This intervention will be tested in two types of setting:
- In group 1, MSAT will be used in a programmatic setting in order to decrease the reservoir of asymptomatic carriers in high incidence villages.
- In group 2, the investigators take advantage of the lighter framework of MSAT to use it as a reactive intervention in order to respond to malaria outbreaks in low to intermediate incidence villages.
The intervention will be evaluated primarily on its ability to reduce yearly cumulative incidence of clinical falciparum malaria compared to year before intervention. Additional evaluations will include: comparison of asymptomatic infection prevalence (group 1) and modifications of the shape of the incidence curve following intervention (group 2).
Shoklo Malaria Research Unit (SMRU), Thailand
University of Oxford, United Kingdom
Primary Outcome: Adjusted incidence rate ratio before/after MSAT [ 12 months ]
Secondary Outcomes:
- Prevalence of P. falciparum infection measured in the village by URDT and by reference method (group 1) [ 12 months ].
- Change in the incidence dynamics over the transmission season (group 2) [ 3 years ].
- Percentage of participant among village resident tested by URDT [ 3 years ].
- Percentage of P. falciparum positive and negative samples by reference method, which were positive by URDT and treated (group 1) [ 3 years ].
Clinical Trials identifier: NCT04093765
Study Type : Interventional (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Estimated Enrollment : 120 participants
Inclusion Criteria:
- All persons living in the village or cluster of villages, or individuals living in smaller settlements (permanent or temporary) within walking distance of a village selected for MSAT intervention.
- Large “work-related” settlements in the vicinity of a targeted village (military camps, logging camp, mining site).
Exclusion Criteria:
- Individuals who do not provide informed consent for both URDT screening and treatment in case of positive result.
- Children <1 year old.
- Individuals with a documented Pf-positive malaria RDT who received treatment during the previous 7 days.
MSAT will be conducted over a period of approximately 1 week in each hamlet, village or group of villages, and will consist in administering a P. falciparum URDT to all individuals agreeing to participate. After this intervention, the incidence of clinical falciparum episodes will be monitored by the village MP.
Asymptomatic Reservoir
Diagnostics
Impact of Interventions
Targeting Foci
Nov 2018 — Nov 2021
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