NCT05540470

Radical CUREfor MAlaria Among Highly Mobile and Hard-to-reach Populations in the Guyanese Shield

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,991 (actual)
• Sponsor: Centre Hospitalier de Cayenne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators are proposing a new malaria control strategy to reach the group of garimpeiros not reached by the usual actions of the health services. As it is a complex strategy, several evaluation mechanisms have been designed. The main characteristics of the research are: * Access to the target population: our target population is represented by miners active and mobile in the south of the Guiana Shield, between Amapá (Brazil), French Guiana (France) and Suriname. To overcome the obstacles posed by the remoteness and clandestinity of the communities of interest, our intervention will take place in the logistical and support hubs (staging areas) of the miners, located in the border regions between the above territories. Thus, it will take advantage of their periodic mobility between these bases and the gold mining sites, and reach the target population where it can be easily accessed. * The intervention will be combined and will include a common core (malaria health education activity) and two modules that will be offered to participants. Each participant (meeting the inclusion criteria) will be able to choose between participating to one or both modules. * The common core of health education will focus on malaria: its causes, means of prevention, the main differences between P. falciparum and P. vivax disease, the importance of a complete treatment against any form of Plasmodium spp. * Module A of the intervention will be treatment targeting asymptomatic individuals at risk of carrying P. vivax. The aim of this module is to prevent relapses and reduce the number of human hosts able to transmitthe parasite. * Module B of the intervention will correspond to the provision, after appropriate training, of a Malakit self-test and self-treatment kit. The aim of this module is to provide access to quality diagnosis and treatment for episodes of symptoms consistent with malaria that occur in situations of extreme remoteness from health services. * The purpose of this study is to evaluate a strategy that, if appropriate, can be implemented by health authorities in countries with residual malaria transmission in populations with characteristics similar to our study population. The investigators will therefore use a pragmatic approach so that the conclusions drawn can be transposed as easily as possible to real life, while at the same time putting great effort into the safety of the intervention. Thus, the study field workers who will administer the intervention will have a similar profile to health workers recruited by a large number of malaria control programmes, particularly in remote areas. In addition, monitoring will be simplified and monitoring data can be collected both through face-to-face visits and remotely administered questionnaires. * The investigators chose to design many of the components of the intervention and study with a participatory approach. * In order to generate the data necessary for health authorities to potentially take ownership of the intervention in the future, the study will evaluate two aspects of the intervention: effectiveness and implementation. * First, the investigators want to evaluate the population-scale effectiveness of the intervention to reduce malaria transmission with a quasi-experimental approach. * Secondly, the investigators will analyse the implementation of the intervention, and generate valuable knowledge for further implementation within local health services. This evaluation will be carried out through the components of the CUREMA study: the intervention itself, pre/post-intervention cross-sectional surveys, the qualitative component and the modelling of epidemiological surveillance data. • The implementation of these components will have an expected duration of approximately 27 months, the start of inclusions is scheduled for September 2022.

Conditions

• Malaria, Vivax

Interventions

Type	Name	Description
DRUG	PART	Chloroquine (150mgs tablets) weight-adjusted dosage ; An 8-aminoquinoline drug 1. Primaquine (PQ) (15 mg tablets): weight-adjusted dosage. Rationale: this short-course posology has been chosen to facilitate the adherence to treatment for asymptomatic individuals participating to the Module A. Primaquine will be administered to all participants to Module A during the induction phase of the intervention. 2. OR tafenoquine (TQ) (150 mg tablets): 2 tablets as a single dose (orally), (Rationale: the posology chosen corresponds to that used in phase III trials for the radical cure of P. vivax and the therapeutic recommendation in Brazil). Tafenoquine will only be administered during the full implementation phase to participants who do not meet exclusion criteria.
DRUG	Malakit	delivery of a sturdy, lightweight, waterproof plastic involucre that contains: * 1 laminated sheet with illustrated instruction * 1 complete anti-malarial treatment targeting P. falciparum, but also effective in acute forms of P. vivax with association with artemisinin derivatives * A blister of 24 tablets of Artemether 20 mg + lumefantrine 120 mg of generic medication * Two 15 mg tablets of primaquine, to be given as a single dose (145) * 1 symptomatic treatment (analgesic, antipyretic): a blister pack of 10 paracetamol 500 mg tablets * 3 Malaria rapid diagnostic tests (RDTs) in individual packs and with easy-to-use retractable lancets. Three tests will be included, taking into account the possibility of having one or two negative or invalid tests before returning to a distribution site for further supplies.
OTHER	CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS	Surveys will include the collection of a detailed questionnaire on recent malaria and mobility history, a clinical examination, and a venous blood sample
OTHER	QUALITATIVE STUDY	Systematic mapping of stakeholders in the pre-intervention period Semi-structured interviews and focus groups. Observational techniques Participatory approach. Participatory design of a community-based adverse event surveillance system

Timeline

• Start date: 2022-09-12
• Primary completion: 2025-03-31
• Completion: 2025-04-25
• First posted: 2022-09-14
• Last updated: 2025-07-24

Locations

2 sites across 2 countries: Brazil, Suriname