Radical CUREfor MAlaria Among Highly Mobile and Hard-to-reach Populations in the Guyanese Shield
- Conditions
- Malaria, Vivax
- Interventions
- Other: CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYSOther: QUALITATIVE STUDYDrug: PARTDrug: Malakit
- Registration Number
- NCT05540470
- Lead Sponsor
- Centre Hospitalier de Cayenne
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 5000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pre/post intervention surveys CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS Two cross-sectional surveys will be conducted in the inclusion sites before and at the end of intervention implementation, during the same period of the year (preferably the last quarter of 2022 and 2024), in order to limit biases associated with seasonality. QUALITATIVE STUDY QUALITATIVE STUDY The CUREMA project includes qualitative research that will be conducted before, during and after the intervention by a trained social science researcher. The aim of this research will be to analyse the specific constraints and levers of the intervention under study and the pre-elimination context, in order to draw out lessons that are context-specific but also potentially of universal value. As described above, the study population will be broader and include not only the garimpeiros, but also the study field workers as well as other stakeholders. Module A PART • Module A - PART (Presumptive anti-relapse treatment): This is the core of the strategy for targeting the P. vivax reservoir by identifying individuals with a high probability of being asymptomatic carriers of blood forms and/or hypnozoites (by epidemiological criteria combined with a rapid serological test), and treating these individualswith chloroquine (by 150mgs tablet, according to the following posology: 600mgs on the first day, 450mgs on the second and 300mgs on the third day, or weight-adjusted dosing) and primaquine (in a short regimen of 30 mg per day for seven days, or weight-adjusted dosing) or tafenoquine (300 mg as a single observed dose), after exclusion of contraindications to these treatments. This intervention aims to reduce the likelihood of relapse of a previous infection, and subsequent transmission in forest and urban settings, ultimately helping to reduce the circulation of P. vivax. Module B Malakit • Module B - Malakit: distribution of a self-test and self-treatment kit to individuals in the target population who agree to be trained (and demonstrate understanding of the use of the kit), in order to maintain access to quality test and treatment for malaria attacks that occur in extreme isolation in illegal mining towns in French Guiana
- Primary Outcome Measures
Name Time Method Effectiveness focus through study completion, an average of 3 years To reduce overall the prevalence of symptomatic and asymptomatic infections with Plasmodium spp. as a result of reduced malaria transmission among people involved in gold mining activities in the South of the Guiana Shield
Implementation focus through study completion, an average of 3 years Evaluate the intervention's reach among the target public: reduction in the malaria burden at the collective level in the mining sites and at staging areas
- Secondary Outcome Measures
Name Time Method safety - Focus on implementation through study completion, an average of 3 years To assess the safety of medicines for Modules A and B on a community level;
increase health education with specific scales on level of disease comprehension by the participants - Focus on implementation through study completion, an average of 3 years To evaluate the effectiveness of the health education activity carried out during the intervention with specifics scales on level of disease comprehension by the participants;
effectiveness of training measured with specifics scales - Focus on implementation through study completion, an average of 3 years Level of comprehension of the training measured with specifics scales: to evaluate the quality and effectiveness of the training received by facilitators;
quality of rapid serological test - Focus on implementation through study completion, an average of 3 years To evaluate the sensitivity and specificity of the rapid serological test and to estimate the discriminatory capacity of this test to detect recent P. vivax infections in the epidemiological context of the study
prevalence reduction - Focus on effectiveness through study completion, an average of 3 years To reduce the species-specific prevalence of P. vivax and P. falciparum among people involved in gold mining activities in the South of the Guiana Shield;
contact reduction - Focus on effectiveness through study completion, an average of 3 years To reduce the proportion of garimpeiros with a high probability of recent P. vivax infection (and probably hypnozoite carriers);
malaria incidence reduction - Focus on effectiveness through study completion, an average of 3 years To reduce the incidence of malaria cases associated with gold mining activity in the southern Guyanese Shield, as detected by the epidemiological surveillance systems of the countries involved;
Good use of antimalarial treatment - Focus on effectiveness through study completion, an average of 3 years To increase the proportion of garimpeiros who adequately take anti-malarial treatment when they fall ill in illegal garimpos in French Guiana;
preventing P. vivax parasitaemia - Focus on effectiveness through study completion, an average of 3 years level of P vivax parasietaemia (percentage of red blood cells which contains P. vivax) : estimate the individual-level effectiveness of module A intervention in preventing P. vivax parasitaemia
increase adherence in asymptomatic - Focus on implementation through study completion, an average of 3 years Number of medication taken by the participants related to number of medication delivered to the participants: adherence to the primaquine posology among asymptomatic individuals;
intervention's costs measured in euros - Focus on implementation through study completion, an average of 3 years To estimate the programmatic cost of the intervention
acceptability of digital tool - Focus on implementation through study completion, an average of 3 years number of participants who regularly use the smartphone application To assess the acceptability of digital tools (smartphone app):
feasability of digital tool - Focus on implementation through study completion, an average of 3 years number of participants who can regularly use the smartphone application:To assess the feasibility of digital tools (smartphone app);
increase inclusion process - Focus on implementation through study completion, an average of 3 years To assess the fidelity of the inclusion and follow-up process;
needs identification - Focus on implementation through study completion, an average of 3 years highlighting health risk factors by assessing the health situation of garimpeiros and additional health needs beyond malaria elimination
identify facilitating factors and barriers of the intervention - Focus on implementation through study completion, an average of 3 years highlighting the obstacles and levers by assessing facilitating factors as well as barriers to delivering such an intervention in a pre-elimination setting and community involvement to be taken into account for further implementation
Trial Locations
- Locations (2)
Josiane Muller
🇧🇷Oiapoque, Amapa, Brazil
Stephen vreden
🇸🇷Paramaribo, Suriname