Evaluation of a New Malaria Control Strategy Amongst Gold Miners Working Illegally in French Guiana (Malakit)

NCT03695770 | Completed DMC

• 1 other identifier: MALAKIT
• Study Type: interventional
• Target: 3,733
• Locations: 2 countries
• Sites: 2

Brief Summary

Illegal gold miners in French Guiana, a French overseas territory ('département') located in Amazonia, often carry malaria parasites (up to 46.8%). While the Guiana Shield Region aims at malaria elimination, the high prevalence of Plasmodiumin this hard-to-reach population in conjunction with frequent incorrect use of artemisinin-based anti-malarials could favor the emergence of resistant parasites. Due to geographical and regulatory issues in French Guiana, usual malaria control strategies cannot be implemented in this particular context.Therefore, new strategies targeting this specific population in the forest are required. Numerous discussions among health institutions and scientific partners from French Guiana, Brazil and Suriname have led to an innovative project based on the distribution of kits for self-diagnosis and self-treatment of Plasmodium infections. The kit-distribution will be implemented at "resting sites", which are areas across the border of French Guiana regularly frequented by gold miners. The main objective is to increase the appropriate use and complete malaria treatment after a positive malaria diagnosis with a rapid test, which will be evaluated with before-and-after cross-sectional studies. Monitoring indicators will be collected from health mediators at the time of kit distribution and during subsequent visits, and from illegal gold miners themselves, through a smartphone application. The project funding is multisource, including Ministries of Health of the three countries, WHO/PAHO, and the European Union.

Conditions

Malaria; Public Health

Outcome Measures

Primary Outcomes (1)

• KAP Questionnaire

  change the part of illegal gold miners in French Guiana who take a correct antimalarial treatment (with artemisinin-combined therapy) with a good adherence and after a positive rapid diagnostic test.

  12 months

Secondary Outcomes (2)

• malaria prevalence

  12 months

• KAP questionnaire

  12 months

Study Arms (1)

target population

EXPERIMENTAL

All the target population should be included in the experimental arm

Other: kit for self-diagnosis and self-treatment

Interventions

kit for self-diagnosis and self-treatment OTHER

distribution of kits for malaria self-diagnosis and self-treatment after a training by health facilitators

target population

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• over 15 years-old
• working or accompanying someone working in illegal gold mining in French Guiana
• agreing to take part of the study
• to have parents authorization if age between 15 and 17 ;
• capable of performing a self-RDT during the training (validation by the facilitator);

You may not qualify if:

• refusing to participate in the study ;
• under 15 years old ;
• no parents authorization ;
• weighing less than 35 kg ;
• who has not been able to perform a self-RDT during the training (invalidation by the facilitator).

Sponsors & Collaborators

• Centre Hospitalier de Cayenne: lead
• Dr Stephen Vreden (Foundation for Scientific Research Suriname : SWOS): collaborator
• Oswaldo Cruz Foundation: collaborator
• Dr Maylis Douine (Centre Hospitalier de Cayenne): collaborator

Study Sites (2)

Fondation Oswaldo Cruz

Rio de Janeiro, Brazil

Location

Foundation for Scientific Research Suriname (SWOS)

Paramaribo, Suriname

Location

Related Publications (9)

• Douine M, Sanna A, Galindo M, Musset L, Pommier de Santi V, Marchesini P, Magalhaes ED, Suarez-Mutis M, Hiwat H, Nacher M, Vreden S, Garancher L. Malakit: an innovative pilot project to self-diagnose and self-treat malaria among illegal gold miners in the Guiana Shield. Malar J. 2018 Apr 10;17(1):158. doi: 10.1186/s12936-018-2306-5.

  PMID: 29631588 BACKGROUND

• Douine M, Lazrek Y, Blanchet D, Pelleau S, Chanlin R, Corlin F, Hureau L, Volney B, Hiwat H, Vreden S, Djossou F, Demar M, Nacher M, Musset L. Predictors of antimalarial self-medication in illegal gold miners in French Guiana: a pathway towards artemisinin resistance. J Antimicrob Chemother. 2018 Jan 1;73(1):231-239. doi: 10.1093/jac/dkx343.

  PMID: 29045645 BACKGROUND

• Douine M, Musset L, Corlin F, Pelleau S, Pasquier J, Mutricy L, Adenis A, Djossou F, Brousse P, Perotti F, Hiwat H, Vreden S, Demar M, Nacher M. Prevalence of Plasmodium spp. in illegal gold miners in French Guiana in 2015: a hidden but critical malaria reservoir. Malar J. 2016 Jun 9;15:315. doi: 10.1186/s12936-016-1367-6.

  PMID: 27277831 BACKGROUND

• Pommier de Santi V, Djossou F, Barthes N, Bogreau H, Hyvert G, Nguyen C, Pelleau S, Legrand E, Musset L, Nacher M, Briolant S. Malaria Hyperendemicity and Risk for Artemisinin Resistance among Illegal Gold Miners, French Guiana. Emerg Infect Dis. 2016 May;22(5):903-6. doi: 10.3201/eid2205.151957.

  PMID: 27089004 BACKGROUND

• van Eer ED, Bretas G, Hiwat H. Decreased endemic malaria in Suriname: moving towards elimination. Malar J. 2018 Jan 30;17(1):56. doi: 10.1186/s12936-018-2204-x.

  PMID: 29378594 BACKGROUND

• Musset L, Pelleau S, Girod R, Ardillon V, Carvalho L, Dusfour I, Gomes MS, Djossou F, Legrand E. Malaria on the Guiana Shield: a review of the situation in French Guiana. Mem Inst Oswaldo Cruz. 2014 Aug;109(5):525-33. doi: 10.1590/0074-0276140031. Epub 2014 Aug 13.

  PMID: 25184998 BACKGROUND

• Longchamps C, Galindo MS, Lambert Y, Sanna A, Mutricy L, Garancher L, Adenis A, Nacher M, Suarez-Mutis M, Cairo H, Hiwat H, Vreden S, Douine M. Impact of Malakit intervention on perceptions, knowledge, attitudes, and practices related to malaria among workers in clandestine gold mines in French Guiana: results of multicentric cross-sectional surveys over time. Malar J. 2022 Dec 28;21(1):397. doi: 10.1186/s12936-022-04391-4.

  PMID: 36577968 DERIVED

• Lambert Y, Galindo M, Suarez-Mutis M, Mutricy L, Sanna A, Garancher L, Cairo H, Hiwat H, Bordalo Miller J, Gomes JH, Marchesini P, Adenis A, Nacher M, Vreden S, Douine M. Tailoring Mobile Data Collection for Intervention Research in a Challenging Context: Development and Implementation in the Malakit Study. JMIR Form Res. 2022 Jun 16;6(6):e29856. doi: 10.2196/29856.

  PMID: 35708763 DERIVED

• Galindo MS, Lambert Y, Mutricy L, Garancher L, Miller JB, Gomes JH, Sanna A, Peterka C, Cairo H, Hiwat H, Adenis A, Nacher M, Suarez-Mutis MC, Vreden S, Douine M. Implementation of a novel malaria management strategy based on self-testing and self-treatment in remote areas in the Amazon (Malakit): confronting a-priori assumptions with reality. BMC Public Health. 2022 Apr 15;22(1):770. doi: 10.1186/s12889-022-12801-0.

  PMID: 35428230 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Receptor Protein-Tyrosine Kinases

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: before/after study design

Study Record Dates

• First Submitted: September 28, 2018
• First Posted: October 4, 2018
• Study Start: April 16, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); SU (1)