Mass Screening and Treatment for Reduction of Falciparum Malaria

Summary

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 (following the same principles and objective as previously deployed MDA interventions). 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 MSAT intervention will be preceded with community-level consent and community engagement (CE) activities. 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. A limited subgroup (expected 5-25%) will be found positive and receive supervised treatment over 3 days for the standard regimen (DP to cure asexual stage infection + single low-dose primaquine to destroy gametocytes). After this intervention, the incidence of clinical falciparum episodes will be monitored by the village MP. In group 1, a comparison of the prevalence at baseline and 12 months after MSAT intervention will be performed through a second URDT survey, in addition to which both baseline and 12-month surveys will include the collection of a 200µL capillary blood sample for reference detection in the laboratory.

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 of the impact of MSAT will include: in group 1, comparison of asymptomatic infection prevalence; and in group 2, modifications of the shape of the incidence curve following intervention.

Funder: Wellcome Trust grant reference 106698/B/14/Z

Conditions

• Plasmodium Falciparum Malaria

Interventions

DIAGNOSTIC_TEST

Ultrasensitive Rapid Diagnostic Test (URDT)

Investigation will consist in 1 URDT. For P. falciparum URDT positive: * collection of 3x1cm dried blood spots on filter paper * administration of a supervised antimalarial treatment course to individuals for which a P. falciparum will have been detected by URDT. Specifically in group 1, a population list will be collected in each village prior to MSAT campaign and all participants will undergo: * collection of a 200 µL-aliquot of capillary blood for each participant to the screening during the MSAT intervention. * 1 URDT + collection of a 200µL-aliquot of capillary blood for each participant to the follow-up survey at M12.

DRUG

Antimalarials

A safe, recommended treatment of P. falciparum malaria will be administered to URDT positive individuals based on participant's characteristics: * The standard regimen for participants without known antimalarial allergy, not pregnant and not breastfeeding, will be a 3-day supervised weight-adjusted DP course and a single low dose PMQ. The single low dose PMQ will be administered on the first day. * Pregnant women and in their 2nd or 3rd trimester, and breastfeeding mothers, will receive a DP course but no PMQ. * Pregnant women in their first trimester will receive an oral course of quinine+clindamycin (7 days). * Individuals with known drug allergy to piperaquine will be treated with AL (+/- sld PMQ as per their pregnancy/breastfeeding status) * Specific/complex cases will be assessed by a medic and referred to a health facility for treatment if necessary.

Sponsors & Collaborators

• University of Oxford

  lead OTHER

Principal Investigators

• francois Nosten, PhD · Shoklo Malaria Research Unit

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

1 Year

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-01

Primary Completion

2019-12-31

Completion

2020-12-31

Countries

• Thailand

Study Locations