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 | |
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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 |
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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 |
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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 |
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Reported adverse events • notification detailed in Suppl. Mat. 2 |
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Impact on malaria epidemiology in the region • modeling based on data from passive surveillance systems of Brazil and Suriname |
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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.