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

Primary Outcome: Adjusted incidence rate ratio before/after MSAT [ 12 months ]

Secondary Outcomes:

1. Prevalence of P. falciparum infection measured in the village by URDT and by reference method (group 1) [ 12 months ].
2. Change in the incidence dynamics over the transmission season (group 2) [ 3 years ].
3. Percentage of participant among village resident tested by URDT [ 3 years ].
4. 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.

ClinicalTrials.gov - Project details

Asymptomatic Reservoir
Diagnostics
Impact of Interventions
Targeting Foci

Nov 2018 — Nov 2021

Myanmar

Malaria Elimination Task Force II

Mass Test and Treat (MTaT) strategies