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

Centre Hospitalier de Cayenne

Status: Completed

Conditions: Malaria, Vivax

Treatments: Other: QUALITATIVE STUDY; Drug: PART; Drug: Malakit; Other: CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS

Study type: Interventional

Funder types: Other

Identifiers

NCT05540470

CUREMA

Details and patient eligibility

About

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.

Enrollment: 1,991 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for PART and Malakit:

• Be 18 years of age or older
• Agree to participate in the study
• Have an actual involvement in gold mining activities (having been to the garimpo in the last year or planning to enter the garimpo in the following month), regardless of country
• No symptoms of malaria at the time of the inclusion visit
• Weigh over 35 Kg

Eligibility Criteria for PART - Module A -- Wish to take part in module A

• Epidemiological and/or biological criteria in favour of a current asymptomatic carriage of P. vivax (blood stage or liver stage). At least one of the following conditions:

• have a history of clinical malaria during the past 12 months
• OR having a life-long malaria history AND have stayed for at least 1 week during the last 12 months in an area with extensive P. vivax transmission
• OR have a positive P.vivax rapid serological test (if available)

Eligibility Criteria for Malakit - Module B:

• Wish to take part in module B
• Plan to enter agarimpo located in French Guiana the following month

Exclusion Criteria for PART - Module A:

• Refuse to participate in an active follow-up during the 14 days following the start of treatment
• Current pregnancy (declared or rapid urine test positive) or breastfeeding
• Haemoglobinemia below 9 g/dL
• G6PD activity below 70% (for simplicity G6PD activity of 6 UI/dL or below).
• Have received a full course of tafenoquine within the last 3 months or a full course of primaquine in the last month.
• Hypersensitivity or known contraindication to primaquine or tafenoquine or chloroquine
• History of severe mental health disorder
• Being positive for a malaria diagnostic test on the day of inclusion or currently taking anti-malarial treatment.

Exclusion Criteria for Malakit - Module B:

• Inability to self-test (perform and interpret an RDT) during training
• Inability to understand and explain correctly what to do in case of malaria symptoms (tests and ACT posology)

Inclusion criteria for Pre/post intervention surveys

• Be 18 years of age or older
• Agree to participate in the research
• Having left a garimpolocated in French Guiana since maximum one week.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,991 participants in 4 patient groups

Module A

Experimental group

Description:

• 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.

Treatment:

Drug: PART

Module B

Other group

Description:

• 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

Treatment:

Drug: Malakit

Pre/post intervention surveys

Other group

Description:

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.

Treatment:

Other: CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS

QUALITATIVE STUDY

Other group

Description:

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.

Treatment:

Other: QUALITATIVE STUDY