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Malaria, VivaxCUREMANCT05540470

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

A study testing PART, Malakit and CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS in people with Malaria, Vivax, run by Centre Hospitalier de Cayenne at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malaria, Vivax
What is being tested?
PART, Malakit and CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,991 participants
Where
2 sitesin 2 countries
Study dates
12 Sep 2022to 25 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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
  • Be 18 years of age or older
  • Agree to participate in the research
  • Having left a garimpolocated in French Guiana since maximum one week.

Who cannot join

  • 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
Show all 10Show fewer
  • History of severe mental health disorder
  • Being positive for a malaria diagnostic test on the day of inclusion or currently taking anti-malarial treatment.
  • 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)

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Brazil1 site

  • Josiane Muller

    Oiapoque, Amapá, 68980-000

Other trials in Brazil

Suriname1 site

  • Stephen vreden

    Paramaribo, Suriname, 99437

About this study

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.
Read more

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
Being tested
PART, Malakit, CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS, QUALITATIVE STUDY
Keywords
Malaria, Plasmodium vivax, Tafenoquine, Guiana shield, Hard-to-reach populations
Medical subject headings
Malaria, Vivax, Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PARTDrug

    Also called chloroquine, primaquine, tafenoquine, module A

    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.

  • MalakitDrug

    Also called module B

    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.

  • CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYSOther

    Also called ORPAL 3 - 4

    Surveys will include the collection of a detailed questionnaire on recent malaria and mobility history, a clinical examination, and a venous blood sample

  • QUALITATIVE STUDYOther

    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

Study groups in NCT05540470
Study groupRoleWhat they receive
Module AExperimental• 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.
Receives: Drug: PART
Module BOther• 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
Receives: Drug: Malakit
Pre/post intervention surveysOtherTwo 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.
Receives: Other: CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS
QUALITATIVE STUDYOtherThe 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.
Receives: Other: QUALITATIVE STUDY

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness focus

    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

    Measured: through study completion, an average of 3 years

  2. Implementation focus

    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

    Measured: through study completion, an average of 3 years

Secondary outcomes (16)

  1. prevalence reduction - Focus on effectiveness

    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;

    Measured: through study completion, an average of 3 years

  2. contact reduction - Focus on effectiveness

    To reduce the proportion of garimpeiros with a high probability of recent P. vivax infection (and probably hypnozoite carriers);

    Measured: through study completion, an average of 3 years

  3. malaria incidence reduction - Focus on effectiveness

    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;

    Measured: through study completion, an average of 3 years

  4. Good use of antimalarial treatment - Focus on effectiveness

    To increase the proportion of garimpeiros who adequately take anti-malarial treatment when they fall ill in illegal garimpos in French Guiana;

    Measured: through study completion, an average of 3 years

  5. preventing P. vivax parasitaemia - Focus on effectiveness

    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

    Measured: through study completion, an average of 3 years

  6. increase adherence in asymptomatic - Focus on implementation

    Number of medication taken by the participants related to number of medication delivered to the participants: adherence to the primaquine posology among asymptomatic individuals;

    Measured: through study completion, an average of 3 years

  7. safety - Focus on implementation

    To assess the safety of medicines for Modules A and B on a community level;

    Measured: through study completion, an average of 3 years

  8. increase health education with specific scales on level of disease comprehension by the participants - Focus on implementation

    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;

    Measured: through study completion, an average of 3 years

  9. acceptability of digital tool - Focus on implementation

    number of participants who regularly use the smartphone application To assess the acceptability of digital tools (smartphone app):

    Measured: through study completion, an average of 3 years

  10. feasability of digital tool - Focus on implementation

    number of participants who can regularly use the smartphone application:To assess the feasibility of digital tools (smartphone app);

    Measured: through study completion, an average of 3 years

  11. effectiveness of training measured with specifics scales - Focus on implementation

    Level of comprehension of the training measured with specifics scales: to evaluate the quality and effectiveness of the training received by facilitators;

    Measured: through study completion, an average of 3 years

  12. increase inclusion process - Focus on implementation

    To assess the fidelity of the inclusion and follow-up process;

    Measured: through study completion, an average of 3 years

  13. quality of rapid serological test - Focus on implementation

    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

    Measured: through study completion, an average of 3 years

  14. intervention's costs measured in euros - Focus on implementation

    To estimate the programmatic cost of the intervention

    Measured: through study completion, an average of 3 years

  15. needs identification - Focus on implementation

    highlighting health risk factors by assessing the health situation of garimpeiros and additional health needs beyond malaria elimination

    Measured: through study completion, an average of 3 years

  16. identify facilitating factors and barriers of the intervention - Focus on implementation

    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

    Measured: through study completion, an average of 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start12 Sep 2022
  3. Primary completion31 Mar 2025
  4. Study completion25 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
1,991 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05540470
Sponsor's protocol ID
CUREMA
Acronym
CUREMA
Status last verified
Jul 2025
First submitted
2 Sep 2022
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Douine M, Lambert Y, Bardon T, Plessis L, Petit-Sinturel M, Querriou RL, Carboni C, Figueira Da Silva A, Nogueira Muller J, Basurko C, Van-Melle A, Adenis A, Nacher M, Vreden S, Suarez-Mutis M, Sanna A. Psychosocial vulnerability of people working in informal gold mines in French Guiana: a multicentric cross-sectional survey in 2024-2025. Front Public Health. 2026 Sep 11;14:1894124. doi: 10.3389/fpubh.2026.1894124. eCollection 2026.

    PubMed 42798354

  • Plessis L, Jimeno Maroto I, Lambert Y, Galindo M, Bardon T, Vreden S, Suarez-Mutis M, Figueira A, Bordalo JM, Douine M, Sanna A. Malaria incubada: a mixed methods analysis on knowledge and experiences on Plasmodium vivax and asymptomatic malaria infections in a hard-to-reach and mobile population in the Amazon. Malar J. 2025 Oct 3;24(1):316. doi: 10.1186/s12936-025-05566-5.

    PubMed 41044665

  • Douine M, Korsec V, Sanna A, Plessis L, Bardon T, Adenis A, Nacher M, Suarez-Mutis M, Vreden S, Mathieu O, Lambert Y. Prevalence of lead poisoning among artisanal gold miners in French Guiana in 2022: a multicenter cross-sectional observational survey. BMC Public Health. 2025 Aug 14;25(1):2768. doi: 10.1186/s12889-025-24109-w.

    PubMed 40814099

  • Douine M, Lambert Y, Plessis L, Jimeno I, Galindo M, Bardon T, Le Tourneau FM, Molinie P, Vie A, Adenis A, Nacher M, Figueira da Silva A, Vreden S, Suarez-Mutis MC, Sanna A. Social determinants of health among people working on informal gold mines in French Guiana: a multicentre cross-sectional survey. BMJ Glob Health. 2023 Dec 16;8(12):e012991. doi: 10.1136/bmjgh-2023-012991.

    PubMed 38103896

Questions about this trial

What is this clinical trial studying?

A study testing PART, Malakit and CROSS-SECTIONAL PRE- AND POST-INTERVENTION SURVEYS in people with Malaria, Vivax, run by Centre Hospitalier de Cayenne at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil, Suriname. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness focus (time frame: through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05540470, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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