Clinical trial NCT05540470: Radical CUREfor MAlaria Among Highly Mobile and Hard-to-reach Populations in the Guyanese Shield
Official title: Radical CUREfor MAlaria Among Highly Mobile and Hard-to-reach Populations in the Guyanese Shield
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malaria, Vivax
Lead sponsor: Centre Hospitalier de Cayenne
Sponsor class: OTHER
Collaborators: name: Oswaldo Cruz Foundation
name: Foundation for Scientific Research Suriname (SWOS) Paramaribo, Suriname
First posted: 2022-09-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is an intervention study, multicentre and international using mixed methods and quasi-experimental design that associates an effectiveness evaluation and an implementation research approach, thus characterising a hybrid design.

We intend to combine several components that will contribute to achieve the primary and secondary objectives:

* The intervention per se, which is the core of the study, and combines delivery of the intervention (Module A, Module B or Module A and B) with data collection at inclusion and during a 14-day follow-up.
* Pre- and post-intervention research (cross-sectional studies), being preponderant for the evaluation of primary objectives (with a quasi-experimental design).
* A qualitative evaluation of the implementation of the intervention at multiple levels (target population, professionals involved in the study, stakeholders).
* The modelling study of surveillance data from national malaria programmes.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Effectiveness focus
timeFrame: through study completion, an average of 3 years
measure: Implementation focus
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
measure: prevalence reduction - Focus on effectiveness
timeFrame: through study completion, an average of 3 years
measure: contact reduction - Focus on effectiveness
timeFrame: through study completion, an average of 3 years
measure: malaria incidence reduction - Focus on effectiveness
timeFrame: through study completion, an average of 3 years
measure: Good use of antimalarial treatment - Focus on effectiveness
timeFrame: through study completion, an average of 3 years
measure: preventing P. vivax parasitaemia - Focus on effectiveness
timeFrame: through study completion, an average of 3 years
measure: increase adherence in asymptomatic - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: safety - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: increase health education with specific scales on level of disease comprehension by the participants - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: acceptability of digital tool - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: feasability of digital tool - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: effectiveness of training measured with specifics scales - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: increase inclusion process - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: quality of rapid serological test - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: intervention's costs measured in euros - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: needs identification - Focus on implementation
timeFrame: through study completion, an average of 3 years
measure: identify facilitating factors and barriers of the intervention - Focus on implementation
timeFrame: through study completion, an average of 3 years
Other outcomes:
Locations:
city: Oiapoque
country: Brazil
facility: Josiane Muller
state: Amapa
city: Paramaribo
country: Suriname
facility: Stephen vreden
Study officials:
affiliation: Foundation for the Advancement of Scientific Research in Suriname
name: Stephen Vreden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Oswaldo Cruz /IOC /FIOCRUZ
name: Martha Suaréz-Mutis, PhD
role: PRINCIPAL_INVESTIGATOR
References: