Serological Screen and Treat trial for P. vivax: a Proof-of-concept trial in Eastern Indonesia

Study Type: Interventional (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)

A total of 800 schoolchildren living in Malaka regency, West Timor, Indonesia, will be individually randomized into the intervention (SSAT) or control (routine care) group:

• Serological diagnosis arm: Screened for the presence of antibodies to a previously validated panel of malaria antigens, and screened by microscopy. If positive by either test, they will be treated.
• Control arm: Screened by microscopic examination and treated when they show or have history of fever in the last 3 days.

After initial screening, all children will be actively followed for 9 months with qPCR assessment every 4 weeks. Anytime a child becomes acutely ill will, they will be tested by microscopy and referred to Primary Health Center to receive treatment when positive. Furthermore, household members of these infected children will also be screened for malaria by microscopy and post-hoc qPCR (treatment given to any microscopy-positive individual, regardless of symptoms).

NOTE: The study start date had to be postponed due to COVID-19 pandemic.

ClinicalTrials.gov - Project detailsClinicalTrials.gov - Study protocol

Diagnostics
Impact of Interventions
P. vivax

Feb 2022 — Jun 2023

Indonesia

Targeted Test and Treat (TTaT) strategies
Reactive strategies
Malaria Molecular Surveillance (MMS)