An interventional study of kit for self-diagnosis and self-treatment in Malaria and Public Health, sponsored by Centre Hospitalier de Cayenne. Completed at 2 sites in 2 countries. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-20.
Sponsored by Centre Hospitalier de Cayenne · Not applicable, Interventional, and Other
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.
Background Despite a decrease in the number of cases reported to CIRE "Cellule de l'Institut de Veille Sanitaire", an interregional epidemiological surveillance center, malaria affects many gold miners working illegally in French Guiana. The ORPAL study carried out by CIC "Centre d'Investigation Clinique" (clinical investigation center) in 2015, showed that the prevalence of Plasmodium in illegal gold miners was 22.3%, of which 84% were asymptomatic. Self-medication practices are very common (52.4%) using artemisinin derivatives.
Key issues identified:
Considering the problems, the identified need is to ensure sufficient intervention coverage of appropriate and rapid care, amongst the malaria "reservoir" population, in order to reduce:
The working hypothesis is:
The free distribution of self-diagnosis and self-treatment kits, together with appropriate training / information, at "resting sites", Brazil and Suriname, would be a strategy relevant to the specific context of French Guiana, and would respond to the identified need.
Objectives This study aims to assess a new malaria control strategy targeting gold miners working illegally in French Guiana, based on the distribution of self-diagnosis kits and self-treatment against P. falciparum in cross-border areas.
Secondary objectives
Increase the part of illegal gold miners in French Guiana who:
Project implementation:
This project will be carried out in cooperation with Brazil, Suriname and France. It is divided into 2 sections:
Therefore, it will be a pre-post evaluation. Depending on the results, the sustainability of the action will be determined by the Health Authorities.
Duration As a pilot project, the inclusion period for which the data will be processed in the view of determining the potential sustainability is 12 months. The length of the results capitalizing is estimated to be 6 months, during which the intervention will be maintained, in order to avoid any useless gap. Therefore, the total duration of the pilot phase is 18 months.
1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.
This study's enrollment of 3,733 is above the median of 220 across 1,027 interventional studies indexed under Malaria.
Browse Malaria studies →Centre Hospitalier de Cayenne is the lead sponsor of 47 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
All the target population should be included in the experimental arm
Other: kit for self-diagnosis and self-treatment
distribution of kits for malaria self-diagnosis and self-treatment after a training by health facilitators
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.
Time frame: 12 months
malaria prevalence
change PCR-Plasmodium prevalence amongst gold miners working illegally in French Guiana
Time frame: 12 months
KAP questionnaire
change the use of protection measures against mosquitoes
Time frame: 12 months
Plan to share: No
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Cayenne