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To eliminate malaria, all populations must be included. For those who are not reached by the health care system, specific interventions must be tailor-made. An innovative Malakit strategy, based on the distribution of self-diagnosis and self-treatment kits, has been evaluated in the Suriname-French Guiana- Amapá (Brazil) region. The results showed effectiveness and good acceptability. The Malakit intervention is complex and has many components. Its transferability requires adaptation to other populations and regions, while retaining the main features of the intervention. This article provides the keys to adapting, implementing and evaluating it in other contexts facing residual malaria in hard-to-reach and/or mobile populations. The process of transferring this intervention includes: diagnosis of the situation (malaria epidemiology, characteristics of the population affected) to define the relevance of the strategy; determination of the stakeholders and the framework of the intervention (research project or public health intervention); adaptation modalities (adaptation of the kit, training, distribution strategy); the role of community health workers and their need for training and supervision. Finally, evaluation needs are specified in relation to prospects for geographical or temporal extension. Malaria elimination is likely to increasingly involve marginalized people due to climate change and displacement of populations. Evaluation of the transferability and effectiveness of the Malakit strategy in new contexts will be essential to increase and refine the evidence of its value, and to decide whether it could be an additional tool in the arsenal recommended in future WHO guidelines.
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Malária , Malária/prevenção & controle , Humanos , Brasil , Suriname , Guiana Francesa , Erradicação de Doenças/métodosRESUMO
Scaling-up an experimental intervention is always a challenge. On the border between French Guiana, Brazil and Suriname, an interventional study demonstrated the effectiveness of distributing self-diagnosis and self-treatment kits (Malakits) to control malaria in mobile and hard-to-reach populations. Its integration into the Suriname's National Malaria Elimination Plan after a 2-year experiment faced numerous challenges, including human resources to cope with the additional workload of coordinators and to maintain the motivation of community health workers. The economic recession in Suriname, the Covid pandemic, and logistical issues also hampered the scale-up. Finally, thanks to the commitment of stakeholders in Suriname and French Guiana, the integration of Malakit distribution into the Surinamese national programme was proved possible.
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COVID-19 , Humanos , Guiana Francesa , Suriname , Pesquisa , BrasilRESUMO
BACKGROUND: Clandestine gold miners remain key hosts for malaria in French Guiana (FG) and contribute to imported malaria cases in Suriname and Brazil. The Malakit intervention, implemented in FG borders with Suriname and Brazil, provided gold miners with training on malaria and kits for self-diagnosis and self-treatment. Having shown a likely impact on malaria transmission, Suriname has now implemented it in routine care for cross-border moving populations. However, a decrease in malaria transmission is frequently associated with a decrease in risk perception, knowledge, and good practices regarding malaria. This study aims to describe the evolution of the perceptions, knowledge, attitudes, and practices (KAP) related to malaria among clandestine gold miners between 2015 and 2019, and to estimate the impact of Malakit on the FG/Suriname border. METHODS: The primary outcome was the overall KAP score over time and among participants and not participants in the Malakit intervention. A propensity score matching analysis and an inverse probability of treatment weighing analysis were used to estimate the Average Treatment effect on the Treated and the Average Treatment Effect of Malakit, respectively. RESULTS: Perception and knowledge scores were significantly lower in 2019 compared to 2015 (- 0.27 and - 0.23 points, respectively, p < 0.001) while attitude and practice scores were higher (+ 0.16 and + 0.47 points, respectively, p < 0.001). The overall KAP score was significantly higher among participants in Malakit with both propensity score matching (+ 0.72 points, 95%IC [0.29; 1.15]) and inverse probability of treatment weighting analysis (+ 0.70 points, 95%IC [0.34; 1.05]). CONCLUSION: A decrease in perception and knowledge about malaria but an improvement of attitudes and practices as the incidence of malaria decreased are observed. The Malakit intervention seems to have a significant positive impact on the overall KAP related to malaria. The integration of this strategy into malaria control programmes could help to improve the KAP, even in areas where malaria is nearly eliminated, through optimal training and health empowerment. Trial registration ClinicalTrials.gov registration number: NCT03695770.
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Ouro , Malária , Humanos , Estudos Transversais , Guiana Francesa/epidemiologia , Conhecimentos, Atitudes e Prática em Saúde , Malária/prevenção & controle , Malária/epidemiologiaRESUMO
BACKGROUND: A novel strategy to combat malaria was tested using a methodology adapted to a complex setting in the Amazon region and a hard-to-reach, mobile community. The intervention strategy tested was the distribution, after training, of malaria self-management kits to gold miners who cross the Surinamese and Brazilian borders with French Guiana to work illegally in the remote mining sites in the forest of this French overseas entity. MAIN TEXT: This article aims at presenting all process and implementation outcomes following the Conceptual Framework of Implementation Fidelity i.e. adherence, including content and exposure, and moderators, comprising participant responsiveness, quality of delivery, facilitation strategies, and context. The information sources are the post-intervention survey, data collected longitudinally during the intervention, a qualitative study, data collected during an outreach mission to a remote gold mining site, supervisory visit reports, in-depth feedback from the project implementers, and videos self-recorded by facilitators based on opened ended questions. As expected, being part of or close to the study community was an essential condition to enable deliverers, referred to as "facilitators", to overcome the usual wariness of this gold mining population. Overall, the content of the intervention was in line with what was planned. With an estimated one third of the population reached, exposure was satisfactory considering the challenging context, but improvable by increasing ad hoc off-site distribution according to needs. Participant responsiveness was the main strength of the intervention, but could be enhanced by reducing the duration of the process to get a kit, which could be disincentive in some places. Regarding the quality of delivery, the main issue was the excess of information provided to participants rather than a lack of information, but this was corrected over time. The expected decrease in malaria incidence became a source of reduced interest in the kit. Expanding the scope of facilitators' responsibilities could be a suitable response. Better articulation with existing malaria management services is recommended to ensure sustainability. CONCLUSIONS: These findings supplement the evaluation outcomes for assessing the relevance of the strategy and provide useful information to perpetuate and transfer it in comparable contexts. TRIAL REGISTRATION: ClinicalTrials.gov. NCT03695770 . 10/02/2018 "Retrospectively registered".
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Malária , Mineradores , Ouro , Humanos , Malária/diagnóstico , Malária/prevenção & controle , Motivação , AutotesteRESUMO
Malaria is endemic in French Guiana, in particular, where illegal gold mining activities take place. Gold miners travel from Brazil to remote camps in the Guiana forest to carry out mining activities, exposing themselves to the presumed contamination area. This article presents the results of a qualitative case study of the Malakit project, an intervention where health facilitators offer appropriate training and distribution of self-diagnosis and self-treatment kits to manage an episode of malaria at resting sites on the French Guiana borders. The objectives were: (i) Determine the contextual elements influencing the use of Malakit; (ii) Understand the way gold miners perceive Malakit; (iii) Identify the elements that are favorable and unfavorable to the use of Malakit; (iv4) Identify what can be improved in the project. The data were collected using three methods: on-site observation, semi-structured individual interviews (n = 26), and group interviews (n = 2). The results indicate that Malakit responds to the need for treatment and facilitates access to care. Gold miners say they trust the facilitators and receive accurate explanations, the kit is easy to use and carry, and explanations given are sufficient. Nonetheless, the results lead us to believe that contextual elements influence exposure to numerous risk factors and that malaria among gold miners working illegally in French Guiana is a question of social inequalities in health. Thus, malaria intervention practices such as Malakit cannot be carried out without considering the complexity generated by social inequalities in health.
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Malária , Mineradores , Ouro , Humanos , Malária/epidemiologia , Malária/prevenção & controle , Mineração , Pesquisa QualitativaRESUMO
BACKGROUND: In French Guiana, gold miners working illegally represents a major reservoir of malaria. This mobile population, mainly of Brazilian descent, enters the French Guianese forest from neighbouring countries, Suriname and Brazil. A complex and innovative intervention was piloted as a cooperation with the three involved countries involved to control malaria in this specific population. The principle was that health workers called "facilitators" provide the participants with a self-diagnosis and self-treatment kit along with adequate training and material to rapidly manage an episode of malaria symptoms on their own, when they find themselves isolated from health care services. METHODS: This paper describes the design, development, content of the intervention and players' organization of this multi-country project, the opportunities and constraints encountered, and the lessons learnt at this stage. RESULTS: The choice not to implement the usual "Test and Treat" approach within the community is mainly driven by regulatory reasons. The content of medical messages tends to balance the tension between thoroughness, accuracy and efficacy. The wide range of tools developed through a participatory approach was intended to cope with the challenges of the literacy level of the target population. Despite the difficulties encountered due to language, regulation differences and distance between partners, cooperation was fruitful, due to the complementary of stakeholders, their involvement at all important stages and regular face-to-face meetings. DISCUSSION AND CONCLUSION: This experience shows the feasibility of an ambitious project of action-research in a border malaria context, involving several countries and with a mobile and undocumented population. It reveals some factors of success which may be transferable in analogous settings.
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Controle de Doenças Transmissíveis/métodos , Malária Falciparum/prevenção & controle , Malária Vivax/prevenção & controle , Adulto , Brasil , Feminino , Guiana Francesa , Pesquisa sobre Serviços de Saúde , Humanos , Cooperação Internacional , Masculino , Pessoa de Meia-Idade , SurinameRESUMO
BACKGROUND: 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 Plasmodium in this hard-to-reach population in conjunction with frequent incorrect use of artemisinin-based anti-malarials could favour 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. METHODS: 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. RESULTS: This project will start in April 2018 as a 18 month pilot study led by the Clinical Investigation Centre of Cayenne. Results should be available at the end of 2019. DISCUSSION: This innovative approach may have several limitations which should be taken into account, as potential side effects, kit misuse or resale, declarative main criteria, or no Plasmodium vivax curative treatment. Close monitoring is thus needed. CONCLUSIONS: This project may be the best available solution to a specific and important public health challenge in the Guiana Shield. If the use of self-diagnosis and self-treatment approach is effective, this strategy could be sustained by health institutions in the region.
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Testes Diagnósticos de Rotina/métodos , Malária Falciparum/diagnóstico , Malária Falciparum/prevenção & controle , Mineradores , Testes Diagnósticos de Rotina/instrumentação , Guiana Francesa , Humanos , Projetos PilotoRESUMO
INTRODUCTION: Social determinants of health, such as living and working conditions, economical and environmental context and access to care, combine to impact the health of individuals and communities. In French Guiana (FG), the persons working in informal artisanal and small-scale gold mining in the rainforest are a particularly vulnerable population which lives in precarious conditions and far from the health system. Previous studies have demonstrated their high morbidity due to infectious diseases. This study aims to describe the social determinants of health in this specific population. METHODS: This international multicentre cross-sectional survey included people working on the informal FG gold mines at the crossing points located at both borders with Suriname and Brazil. After collecting written informed consent, a structured questionnaire was administered. RESULTS: From September to December 2022, 539 gold miners were included. These poorly educated migrants, mainly from Brazil (99.1%) did not have access to drinkable water (95.4%), lived in close contact with wild fauna by hunting, eating bushmeat or being bitten and were exposed to mercury by inhalation (58.8%) or ingestion (80.5%). They report frequent accidents (13.5%) and chronic treatment interruptions (26.6% of the 11.9% reporting chronic treatment). Half of them considered themselves in good health (56.4%). CONCLUSION: This study shows a singular combination of adverse exposures of gold miners working in FG such as zoonoses, heavy metal poisoning, aggression of wild fauna. For ethical as well as public health reasons, actions towards health equity must be considered at different levels: individual, community, environmental, systemic and global level. As end users of minerals, we must assume our responsibilities for the well-being of the extractors by including health in political decisions to engage together in global health. TRIAL REGISTRATION NUMBER: NCT05540470.
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Ouro , Determinantes Sociais da Saúde , Humanos , Estudos Transversais , Guiana Francesa/epidemiologia , MineraçãoRESUMO
Introduction: An innovative and community-based intervention is implemented in the Guiana Shield to eliminate malaria among people involved in artisanal and small-scale gold mining. The intervention consists of the distribution of malaria self-management kits to goldminers and the presumptive treatment for individuals at risk of carrying Plasmodium vivax hypnozoites. The intervention is possible owing to community health workers (CHWs) who are previously trained to master all intervention procedures, including health education activities and goldmining training. This study aimed to evaluate the training program provided to CHWs in terms of quality and effectiveness. Methods: A training-of-trainers program for CHWs has been developed based on the CDC framework. A mixed-method case study was implemented in two steps between February and March 2023. The evaluation was based on a knowledge survey, satisfaction test, observations, and semi-structured interviews. Quantitative and qualitative data were analyzed and triangulated. Results: A total of 20 CHWs participated in the training and the first-step evaluation. For the second step, four semi-structured interviews were conducted. The Qualitative data showed that group dynamics and adaptations were central elements of a high-quality training program. Quantitative analysis found that CHWs' satisfaction was elevated (> 4/5 overall), especially regarding format and learning results. Improvements in knowledge level demonstrated good effectiveness (pre-training vs. post-training, p < 0.05). Nevertheless, some difficulties persisted regarding tasks of the intervention procedure, such as informed consent and smartphone application procedures (with an inaccuracy rate of 29.2% and 16.7%, respectively). Further on-the-job training permitted to address these issues. The project team's previous experience and the Guiana Shield countries' commitment to the WHO-E-2025-initiative were identified as levers for the quality of the training, while the complexity of the project context was a challenge. Discussion: High-quality, effective, and appropriate training programs are required for effective and sustainable interventions involving CHW profiles. Training design is a crucial point to address to accomplish quality and effectiveness. The training-of-trainers model has been shown to allow a high level of satisfaction, good learning results, and satisfactory implementation in the field. Initial and continuing training is an indispensable continuum to sustain good practices in the field and CHWs' motivation. Training evaluation permits standardizing methods and facilitates transferability.
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Agentes Comunitários de Saúde , Malária , Humanos , Educação em Saúde , Aprendizagem , Confiabilidade dos Dados , Malária/prevenção & controleRESUMO
BACKGROUND: An interventional study named Malakit was implemented between April 2018 and March 2020 to address malaria in gold mining areas in French Guiana, in collaboration with Suriname and Brazil. This innovative intervention relied on the distribution of kits for self-diagnosis and self-treatment to gold miners after training by health mediators, referred to in the project as facilitators. OBJECTIVE: This paper aims to describe the process by which the information system was designed, developed, and implemented to achieve the monitoring and evaluation of the Malakit intervention. METHODS: The intervention was implemented in challenging conditions at five cross-border distribution sites, which imposed strong logistical constraints for the design of the information system: isolation in the Amazon rainforest, tropical climate, and lack of reliable electricity supply and internet connection. Additional constraints originated from the interaction of the multicultural players involved in the study. The Malakit information system was developed as a patchwork of existing open-source software, commercial services, and tools developed in-house. Facilitators collected data from participants using Android tablets with ODK (Open Data Kit) Collect. A custom R package and a dashboard web app were developed to retrieve, decrypt, aggregate, monitor, and clean data according to feedback from facilitators and supervision visits on the field. RESULTS: Between April 2018 and March 2020, nine facilitators generated a total of 4863 form records, corresponding to an average of 202 records per month. Facilitators' feedback was essential for adapting and improving mobile data collection and monitoring. Few technical issues were reported. The median duration of data capture was 5 (IQR 3-7) minutes, suggesting that electronic data capture was not taking more time from participants, and it decreased over the course of the study as facilitators become more experienced. The quality of data collected by facilitators was satisfactory, with only 3.03% (147/4849) of form records requiring correction. CONCLUSIONS: The development of the information system for the Malakit project was a source of innovation that mirrored the inventiveness of the intervention itself. Our experience confirms that even in a challenging environment, it is possible to produce good-quality data and evaluate a complex health intervention by carefully adapting tools to field constraints and health mediators' experience. TRIAL REGISTRATION: ClinicalTrials.gov NCT03695770; https://clinicaltrials.gov/ct2/show/NCT03695770.
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BACKGROUND: Most emerging pathogens are zoonoses and have a wildlife origin. Anthropization and disruption of ecosystems favor the crossing of inter-species barriers. We hypothesize that the marginalized population of undocumented goldminers in the Amazon is at risk of acquiring zoonoses. METHOD: A multicentric cross-sectional study included consenting gold-mining adult workers in 2019. A clinical examination recorded dermatological signs of leishmaniosis and past history of yellow fever vaccination. Biological tests were performed for yellow fever, Q fever and leptospirosis serologies. Additional blood samples from a previous study in 2015 were also tested for leptospirosis. RESULTS: In 2019, 380 individuals were included in the study, along with 407 samples from the 2015 biological collection. The seroprevalence of leptospirosis was 31.0% [95%CI = 26.4-35.5] in 2015 and 28.1% [23.5-32.7] in 2019. The seroprevalence of Q fever was 2.9% [1.2-4.6]. The majority of participants reported being vaccinated against yellow fever (93.6%) and 97.9% had seroneutralizing antibodies. The prevalence of suspected active mucocutaneous leishmaniasis was 2.4% [0.8-3.9]. DISCUSSION: These unique data shed new light on the transmission cycles of zoonoses still poorly understood in the region. They support the existence of a wild cycle of leptospirosis but not of Q fever. Leishmaniasis prevalence was high because of life conditions and tree felling. High yellow fever vaccine coverage was reassuring in this endemic area. In the era of global health, special attention must be paid to these vulnerable populations in direct contact with the tropical ecosystem and away from the health care system.
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Leishmaniose , Leptospirose , Febre Q , Febre Amarela , Adulto , Animais , Estudos Transversais , Ecossistema , Guiana Francesa/epidemiologia , Ouro , Humanos , Leptospirose/epidemiologia , Mineração , Febre Q/epidemiologia , Estudos Soroepidemiológicos , Vacinação , Febre Amarela/epidemiologia , Febre Amarela/prevenção & controle , Zoonoses/epidemiologiaRESUMO
OBJECTIVES: Common representations of the world of gold mining-especially illegal-are usually negative: the activity conjures up images of drug trafficking, human exploitation, the sex trade, environmental destruction, and infectious diseases, in particular sexually transmitted infections (STIs). The aim of the present article is to describe the levels of risk behaviors such as transactional sex, multiple sexual partners, and the frequency of condom use, addictive substance consumption, and the prevalence of STIs among the population of illegal gold miners in French Guiana (FG), a French overseas entity in Amazonia, in order to guide potential interventions. METHODS: An observational multicenter cross-sectional study was carried out from October to December 2019 along the two borders of FG with Suriname and Brazil at rest sites used by the miners. RESULTS: Among the 499 participants, transactional sex was very prevalent, declared by 33.5% of men and 8.4% of women. Condoms were more frequently used for transactional sex than with a non-commercial partner (93.4% versus 42.1%). More women were tested for HIV than men (91.1% versus 55.2%). Excessive alcohol consumption (57.3%%) and tobacco use (41.2%) were very frequent, but cocaine or crack consumption was low (1.2%), which refuted our initial assumption. Consumers of alcohol had more sexual partners and reported condom use more frequently. Prevalence of HIV, HCV, HBV, and syphilis was respectively 0.5% (95% CI: 0.1-2.1), 2.1% (95% CI: 0.7-3.6), 1.6% (95% CI: 0.3-2.8), and 12.4% (95% CI: 9.0-15.7), which was higher than in the local population, especially for syphilis. CONCLUSION: This study documents for the first time the risk behaviors of gold miners in FG. Although the level of condom use was high, the prevalence of STIs combined with the high rate of transactional sex should encourage an increase in prevention and screening, in particular through rapid tests, given the mobility of the population concerned.
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Cocaína , Infecções por HIV , Infecções Sexualmente Transmissíveis , Sífilis , Estudos Transversais , Feminino , Guiana Francesa/epidemiologia , Ouro , Infecções por HIV/epidemiologia , Humanos , Masculino , Assunção de Riscos , Infecções Sexualmente Transmissíveis/epidemiologia , Sífilis/epidemiologiaRESUMO
Background: Illegal gold miners are currently key hosts for malaria in French Guiana (FG), with a risk of emergence of resistance linked to improper use of artemisinin-based combination therapy (ACT). The remoteness of the mines and regulatory issues hinder their access to health care. Methods: A quasi-experimental researched project (Malakit) implemented in FG borders with Brazil and Suriname aimed at determining the effectiveness of distributed kits for self-diagnosis and self-treatment to illegal gold miners, after training, at strategic border staging areas. Evaluation relied on questionnaires at inclusion and follow-up visits, and pre/post intervention surveys. The primary outcome was the proportion of persons reporting a use of certified ACT after a positive malaria diagnosis. The secondary outcomes assessed antimalarial adherence, kit use and impact on malaria epidemiology. Findings: The proportion of patients reporting a use of certified ACT after a positive diagnosis increased after the intervention (OR 1.8, 95%CI [1.1-3.0]). From April 2018 to March 2020, 3,733 persons participated in the intervention. The kit was used correctly by 71.7% [65.8-77.7] of the 223 persons reporting having used a malakit during the follow-up visits. No serious adverse events related to the misuse of malakit have been reported. The intervention appears to have accelerated the decline in malaria incidence in the region by 42.9%. Interpretation: This innovative international project showed that people with low education can correctly self-manage their malaria symptoms. This strategy could be integrated in the malaria control programs of the countries involved and considered in other regions with residual malaria in remote areas. Funding: This project was funded by the European Union, the Global Fund, Brazil MoH, Cayenne Hospital and FG Health Regional Agency. Editor's note: This translation in French was submitted by the authors and we reproduce it as supplied. It has not been peer reviewed. Our editorial processes have only been applied to the original abstract in English, which should serve as reference for this manuscript. The Lancet Group takes a neutral position with respect to territorial claims in published maps and institutional affiliations. Contexte: Les chercheurs d'or illégaux sont actuellement un réservoir clé du paludisme en Guyane, avec un risque d'émergence de résistance lié à une mauvaise utilisation des combinaisons thérapeutiques à base d'artémisinine (ACT). L'isolement de ces sites miniers clandestins et des contraintes règlementaires entravent leur accès aux soins. Méthodes: Un projet de recherche opérationnelle quasi-expérimental (Malakit) a été mis en Åuvre aux frontières de la Guyane avec le Brésil et le Suriname. Il visait à déterminer l'efficacité de la distribution de kits d'autodiagnostic et d'autotraitement à des orpailleurs illégaux, après une formation adaptée, dans des zones stratégiques transfrontalières. L'évaluation s'est appuyée sur des questionnaires lors des visites d'inclusion et de suivi, et sur des enquêtes pré/post intervention. L'indicateur principal était la proportion de personnes déclarant avoir utilisé une ACT certifiée après un diagnostic positif de paludisme. Les indicateurs secondaires reposaient sur l'adhérence aux traitements antipaludiques, l'utilisation des kits et l'impact sur l'épidémiologie du paludisme. Résultats: La proportion de patients déclarant une utilisation d'ACT certifiée après un diagnostic positif a augmenté après l'intervention (OR 1,8, 95%CI [1,1-3,0]). D'avril 2018 à mars 2020, 3 733 personnes ont participé à l'intervention. Le kit a été utilisé correctement par 71,7% [65,8-77,7] des 223 personnes revues en visites de suivi ayant déclaré avoir utilisé un malakit. Aucun événement indésirable grave lié à une mauvaise utilisation du malakit n'a été signalé. L'intervention semble avoir accéléré la diminution de l'incidence du paludisme dans la région de 42,9%. Interprétation: Ce projet international innovant a montré que les personnes ayant un faible niveau d'éducation peuvent se prendre en charge par eux-mêmes pour des symptômes de paludisme. Cette stratégie pourrait être intégrée dans les programmes de lutte contre le paludisme des pays impliqués et envisagée dans d'autres régions où du paludisme résiduel persiste dans des zones isolées. Financement: Ce projet a été financé par l'Union Européenne, le Fonds Mondial, le Ministère de la santé du Brésil, le Centre Hospitalier de Cayenne et l'Agence Régionale de Santé de Guyane.
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A prospective study was conducted among different intra and extra-hospital populations of French Guiana to evaluate the performance of saliva testing compared to nasopharyngeal swabs. Persons aged 3 years and older with mild symptoms suggestive of COVID-19 and asymptomatic persons with a testing indication were prospectively enrolled. Nasopharyngeal and salivary samples were stored at 4°C before analysis. Both samples were analyzed with the same Real-time PCR amplification of E gene, N gene, and RdRp gene. Between July 22th and October 28th, 1159 persons were included, of which 1028 were analyzed. When only considering as positives those with 2 target genes with Ct values <35, the sensitivity of RT-PCR on saliva samples was 100% relative to nasopharyngeal samples. Specificity positive and negative predictive values were above 90%. Across a variety of cultures and socioeconomic conditions, saliva tests were generally much preferred to nasopharyngeal tests and persons seemed largely confident that they could self-sample. For positive patients defined as those with the amplification of 2 specific target genes with Ct values below 35, the sensitivity and specificity of RT-PCR on saliva samples was similar to nasopharyngeal samples despite the broad range of challenging circumstances in a tropical environment.
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Teste de Ácido Nucleico para COVID-19/métodos , Saliva/virologia , Adolescente , Adulto , Idoso , Teste de Ácido Nucleico para COVID-19/normas , Criança , Pré-Escolar , Feminino , Guiana Francesa , Hospitais/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Nasofaringe/virologia , Aceitação pelo Paciente de Cuidados de Saúde , Sensibilidade e Especificidade , Clima TropicalRESUMO
Current testing for COVID-19 relies on reverse-transcriptase polymerase chain reaction from a nasopharyngeal swab specimen. Saliva samples have advantages regarding ease and painlessness of collection, which does not require trained staff and may allow self-sampling. We enrolled 776 persons at various field-testing sites and collected nasopharyngeal and pooled saliva samples. One hundred sixty two had a positive COVID-19 RT-PCR, 61% were mildly symptomatic and 39% asymptomatic. The sensitivity of RT-PCR on saliva samples vs. nasopharygeal swabs varied depending on the patient groups considered or on Ct thresholds. There were 10 (6.2%) patients with a positive saliva sample and a negative nasopharyngeal swab, all of whom had Ct values <25 for three genes. For symptomatic patients for whom the interval between symptoms onset and sampling was <10 days sensitivity was 77% but when excluding persons with isolated N gene positivity (54/162), sensitivity was 90%. In asymptomatic patients, the sensitivity was only 24%. When we looked at patients with Cts <30, sensitivity was 83 or 88.9% when considering two genes. The relatively good performance for patients with low Cts suggests that Saliva testing could be a useful and acceptable tool to identify infectious persons in mass screening contexts, a strategically important task for contact tracing and isolation in the community.