Mass Screening and Treatment for Reduction of Falciparum Malaria

NCT04093765 | Completed

• 1 other identifier: MAL17011
• Study Type: interventional
• Target: 5,542
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Ultrasensitive Rapid Diagnostic Test; Mass Screening and Treatment; Greater Mekong Subregion; Malaria Elimination Task Force

Outcome Measures

Primary Outcomes (1)

• Adjusted incidence rate ratio before/after MSAT

  12 month

Secondary Outcomes (4)

• 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

• The percentage of participant among village resident tested by URDT.

  3 years

• % of P. falciparum positive samples by reference method which were positive by URDT and treated; % of P. falciparum negative samples by reference method which were positive by URDT and treated (group 1)

  3 years

Other Outcomes (1)

• Cumulative incidence of falciparum malaria episodes before and after MDA/MSAT; prevalence of falciparum infection before and after MDA/MSAT

  3 years

Study Arms (2)

Sustained high incidence villages

EXPERIMENTAL

Villages classified as high incidence, low probability of elimination (P. falciparum cumulative incidence \>84 cases/1000/year, in spite of \>1 year of functioning malaria post) will be eligible to be included in group 1. Villages in this group will be addressed by MSAT waves of 10-15 villages. Interventions will consist of 1 Ultrasensitive Rapid Diagnostic Test (URDT) and antimalarials drugs.

Diagnostic Test: Ultrasensitive Rapid Diagnostic Test (URDT); Drug: Antimalarials

Seasonal focal transmission villages/locations

EXPERIMENTAL

This group will follow the NMCP case/and foci investigation guidelines, but use URDT instead of standard RDT for screening. MSAT group 2 locations will be cluster of houses, villages or clusters of villages selected based on the results of case or foci/outbreak investigation. Interventions will consist of 1 Ultrasensitive Rapid Diagnostic Test (URDT) and antimalarials drugs. * Village inclusion after case investigation * Village inclusion after outbreak investigation

Diagnostic Test: Ultrasensitive Rapid Diagnostic Test (URDT); Drug: Antimalarials

Interventions

Ultrasensitive Rapid Diagnostic Test (URDT) DIAGNOSTIC_TEST

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.

Seasonal focal transmission villages/locations; Sustained high incidence villages

Antimalarials DRUG

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.

Seasonal focal transmission villages/locations; Sustained high incidence villages

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All persons living in the village or cluster of villages will be eligible for MSAT intervention.
• Individuals living in smaller settlements (permanent or temporary) within walking distance of a selected intervention village will also be eligible.
• Large "work-related" settlements in the vicinity of a targeted village (military camps, logging camp, mining site) will be approached by the team to be included in the screening and treatment activity. They will be included in the analysis as a unit within a cluster of villages if all the study information can be collected (including follow-up survey for Group 1).

You may not qualify if:

• Individuals who do not provide informed consent for both URDT screening and treatment in case of positive result. Individuals will be given the possibility to refuse the collection of the 200µL reference sample or the DBS collection but participate to URDT screening and treatment.
• Children \<1 year old
• Individuals with a documented Pf-positive malaria RDT who received treatment (AL+sld PMQ) during the previous 7 days.
• NB: Individuals who were diagnosed infected with PF and received a treatment between 7 and 30 days before the intervention are still likely to be URDT positive due to the persistence of HRP2, and this will result in treatment of individuals who are likely uninfected. However, in a high prevalence area or in an outbreak context, previous infection signals exposure, and DP will provide a protection against a likely re-infection.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Antimalarials

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• francois Nosten, PhD

  Shoklo Malaria Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 18, 2019
• Study Start: November 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: March 27, 2024

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)