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. 2021 Sep 4;4:100047. doi: 10.1016/j.lana.2021.100047

Table 1.

Design, main outcomes and inclusion criteria of Malakit intervention and pre/post intervention surveys, French Guiana –Brazil-Suriname, 2015-2020

Pre intervention survey Post intervention survey Malakit intervention
Aim To evaluate the effectiveness of the Malakit intervention strategy To assess the use of the kits by the study participants

Inclusion sites Gold miners staging areas* located along the Brazilian and Surinamese border of French Guiana Five distributions sites located in the gold miners staging areas along the two borders and in Paramaribo (capital of Suriname)

Investigating center • Surinamese border: Centre d'Investigation Clinique (CIC) Antilles-Guyane, Inserm 1424, CH Cayenne, FG
• Brazilian border: Foundation Oswaldo Cruz (Fiocruz), Rio de Janeiro, Brazil
Sponsor: CIC Inserm 1424, CH Cayenne
Principal Investigator (PI) in FG: Dr Douine (CIC)
PI in Suriname: Dr Vreden (SWOS Foundation)
PI in Brazil: Dr Suarez-Mutis (Fiocruz)

Data collectors One physician, one nurse and one facilitator Nine Malakit facilitators

Roll-out • Surinamese border: January to June 2015
• Brazilian border: May-June and October-November 2018
October-December 2019 • Surinamese border: April 2018-March 2020
• Brazilian border: October 2018- March 2020

Population People that work on the illegal gold mining sites in French Guiana

Inclusion criteria • Be 18 years old or more (16 on the Brazilian border)
• Work or accompany someone on a clandestine gold mining site in French Guiana
• Be out of the forest for less than 7 days
• Give a written consent
• Be 15 years old or more
• Intend to work or accompany someone on a clandestine gold mining site in French Guiana

Types of data Cross-sectional data
Longitudinal data
Initial data to estimate the indicators before Malakit Final data to estimate the indicators after Malakit Data collected at inclusion and follow-up visits as part of the monitoring of the intervention

Data collection Questionnaires were administered by the facilitators for socio-economic data and behavior during the last malaria episode. They were collected on paper or with the help of tablets that transferred the anonymized data to a secure online database, Clinsight. A venous blood sample was taken for each participant to perform a PCR-Plasmodium at the Pasteur Institute of FG. A RDT was performed on site and participants who tested positive were referred to the nearest health facility for confirmation by microscopy, notification and treatment. During each visit, facilitators administered a questionnaire and filled out the electronic form with the open-source ODK Collect application on Android tablets. Each completed questionnaire generated a record that was immediately encrypted and sent to a server managed by Ona when an Internet connection was available. Data retrieval, decryption, and aggregation were performed using a specifically developed R package. The data collected by the facilitators was subjected to a real-time validation process by the sponsor's supervisory team to verify its quality.

Main outcome Difference between the proportion of participants who reported appropriate behavior (i.e., using a certified ACT after a positive malaria test by using a kit or turning to the health system) before/after the Malakit intervention.

Secondary outcomes Coverage of the study population by the intervention
• proportion of participants in the post intervention survey who were included in the Malakit
intervention

Number of kits distributed
Difference of treatment adherence before/after the intervention and according to the behavior
• proportion of good treatment adherence in the pre/post intervention surveys assessed by
questionnaire
Proportion of the kit users included in the Malakit intervention, who used their kit correctly during the first episode of malaria symptoms reported on the last follow-up visit
• defined as having taken the whole medication
(Artemether-lumefantrine) in three days after
a positive RDT or no antimalarial after a
negative RDT
Ability to perform self-RDT and knowledge about malaria treatment for participants included in the Malakit intervention
• realization of a RDT themselves in front of the facilitator
• questionnaire about malaria treatment
Modification of Plasmodium-PCR prevalence pre/post the Malakit intervention
• assessed by multiplex real-time PCR derived from Shokoples et al. [14]
Proportion of Malakit participants who acquired a kit before inclusion
• assessed by questionnaire
Reported adverse events
• notification detailed in Suppl. Mat. 2
Impact on malaria epidemiology in the region
• modeling based on data from passive surveillance systems of Brazil and Suriname

Ethics and regulation • in Brazil: Approval from the Fiocruz Ethics Committee (Opinion Number 2.560.415)
• in Suriname: Approval from the CMWO (Commissie voor Mensgebonden Wetenschappelijk Onderzoek) (Opinion Number VG10-14)
• in France: Approval from INSERM Ethics Evaluation Committee (No. 14-187 of 09.12.2014)
• in Brazil: Approval from the Fiocruz Ethics Committee (Opinion Number 2.560.415)
• in Suriname: Approval from the CMWO (Opinion Number DVG-738)
• in Brazil: Approval from the Fiocruz Ethics Committee (Opinion Number 2.831.534)
• in Suriname: Approval from the CMWO (Opinion Number VG 25-17)

* staging areas are specific neighborhoods in border towns or small informal settlements located on border rivers where gold miners come to rest, buy supplies or sell their gold.