MalariaMALAKITNCT03695770
Evaluation of a New Malaria Control Strategy Amongst Gold Miners Working Illegally in French Guiana (Malakit)
A study testing kit for self-diagnosis and self-treatment in people with Malaria and Public Health, run by Centre Hospitalier de Cayenne at 2 sites in 2 countries.
Trial summary
Illegal gold miners in French Guiana, a French overseas territory ('département') located in Amazonia, often carry malaria parasites (up to 46.8%). While the Guiana Shield Region aims at malaria elimination, the high prevalence of Plasmodiumin this hard-to-reach population in conjunction with frequent incorrect use of… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria, Public Health
- What is being tested?
- kit for self-diagnosis and self-treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,733 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Apr 2018to 30 Mar 2020
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- over 15 years-old
- working or accompanying someone working in illegal gold mining in French Guiana
- agreing to take part of the study
- to have parents authorization if age between 15 and 17 ;
- capable of performing a self-RDT during the training (validation by the facilitator);
Who cannot join
- refusing to participate in the study ;
- under 15 years old ;
- no parents authorization ;
- weighing less than 35 kg ;
- who has not been able to perform a self-RDT during the training (invalidation by the facilitator).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Suriname1 site
Foundation for Scientific Research Suriname (SWOS)
Paramaribo
About this study
Illegal gold miners in French Guiana, a French overseas territory ('département') located in Amazonia, often carry malaria parasites (up to 46.8%). While the Guiana Shield Region aims at malaria elimination, the high prevalence of Plasmodiumin this hard-to-reach population in conjunction with frequent incorrect use of artemisinin-based anti-malarials could favor the emergence of resistant parasites. Due to geographical and regulatory issues in French Guiana, usual malaria control strategies cannot be implemented in this particular context.Therefore, new strategies targeting this specific population in the forest are required.
Numerous discussions among health institutions and scientific partners from French Guiana, Brazil and Suriname have led to an innovative project based on the distribution of kits for self-diagnosis and self-treatment of Plasmodium infections. The kit-distribution will be implemented at "resting sites", which are areas across the border of French Guiana regularly frequented by gold miners. The main objective is to increase the appropriate use and complete malaria treatment after a positive malaria diagnosis with a rapid test, which will be evaluated with before-and-after cross-sectional studies. Monitoring indicators will be collected from health mediators at the time of kit distribution and during subsequent visits, and from illegal gold miners themselves, through a smartphone application. The project funding is multisource, including Ministries of Health of the three countries, WHO/PAHO, and the European Union.
Read the detailed description
Background Despite a decrease in the number of cases reported to CIRE "Cellule de l'Institut de Veille Sanitaire", an interregional epidemiological surveillance center, malaria affects many gold miners working illegally in French Guiana. The ORPAL study carried out by CIC "Centre d'Investigation Clinique" (clinical investigation center) in 2015, showed that the prevalence of Plasmodium in illegal gold miners was 22.3%, of which 84% were asymptomatic. Self-medication practices are very common (52.4%) using artemisinin derivatives.
Key issues identified:
- The mobile population of workers in illegal gold mining sites is particularly affected by malaria due to their living and working conditions and as such represents a reservoir of transmission.
- Their undocumented irregular status and difficult access to health centers makes care from health professionals rare or belated.
- The use of inadequate drugs, without prior diagnosis and with improper compliance, mainly due to the high cost of treatment on the black market, is common. These non-recommended practices contribute to the risk of emergence of ACT resistance.
- Knowledge of the disease by illegal gold miners (causes, symptoms, preventive measures and treatment) remains insufficient.
Considering the problems, the identified need is to ensure sufficient intervention coverage of appropriate and rapid care, amongst the malaria "reservoir" population, in order to reduce:
- Malaria transmission and ACT non-compliance;
- The ensuing risk of P. falciparum resistance to ACT;
- The morbidity and mortality of illegal workers in gold-mining sites;
The working hypothesis is:
The free distribution of self-diagnosis and self-treatment kits, together with appropriate training / information, at "resting sites", Brazil and Suriname, would be a strategy relevant to the specific context of French Guiana, and would respond to the identified need.
Objectives This study aims to assess a new malaria control strategy targeting gold miners working illegally in French Guiana, based on the distribution of self-diagnosis kits and self-treatment against P. falciparum in cross-border areas.
- Main objective Increase the part of illegal gold miners in French Guiana who take ACT entirely after a positive rapid diagnostic test.
- Secondary objectives
- Improve the use of anti-malarial treatments against P. falciparum appropriately and in compliance with WHO recommendations.
- Reduce the prevalence of malaria among illegal gold miners in French Guiana.
- Increase the part of illegal gold miners in French Guiana who:
- Know malaria, its causes, the symptoms and protection measures.
- Have a positive attitude towards recommended prevention measures, the use of adequate anti-malarial treatment, and adherence to treatment.
- Report applying good preventive practices.
Project implementation:
This project will be carried out in cooperation with Brazil, Suriname and France. It is divided into 2 sections:
- Part 1: Implementation and monitoring of the intervention Distribution of self-diagnosis and self-treatment kits to people working illegally at gold-mining sites in French Guiana, along with the provision of training. This distribution will take place at resting sites by trained facilitators. Proactive digital collection of data will be conducted by these facilitators and via gold miners themselves through a mobile application.
- Part 2: Evaluation of the intervention The final evaluation of the project will be carried out in a cross-sectional study "Orpal bis", with a questionnaire on knowledge, attitudes and practices and blood sampling to measure the prevalence of Plasmodium carriers before / after the intervention. The same study (Orpal) was carried out in 2015 along the Surinamese border, and will be carried out before implementation along the Brazilian border.
Therefore, it will be a pre-post evaluation. Depending on the results, the sustainability of the action will be determined by the Health Authorities.
Duration As a pilot project, the inclusion period for which the data will be processed in the view of determining the potential sustainability is 12 months. The length of the results capitalizing is estimated to be 6 months, during which the intervention will be maintained, in order to avoid any useless gap. Therefore, the total duration of the pilot phase is 18 months.
- Conditions
- Malaria, Public Health
- Being tested
- kit for self-diagnosis and self-treatment
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kit for self-diagnosis and self-treatmentOther
distribution of kits for malaria self-diagnosis and self-treatment after a training by health facilitators
| Study group | Role | What they receive |
|---|---|---|
| target population | Experimental | All the target population should be included in the experimental arm Receives: Other: kit for self-diagnosis and self-treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
KAP Questionnaire
change the part of illegal gold miners in French Guiana who take a correct antimalarial treatment (with artemisinin-combined therapy) with a good adherence and after a positive rapid diagnostic test.
Measured: 12 months
Secondary outcomes (2)
malaria prevalence
change PCR-Plasmodium prevalence amongst gold miners working illegally in French Guiana
Measured: 12 months
KAP questionnaire
change the use of protection measures against mosquitoes
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start16 Apr 2018
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before/after study design
- Masking
- None (open label)
- Enrolment
- 3,733 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Stephen Vreden (Foundation for Scientific Research Suriname : SWOS), Oswaldo Cruz Foundation, Dr Maylis Douine (Centre Hospitalier de Cayenne)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695770
- Sponsor's protocol ID
- MALAKIT
- Acronym
- MALAKIT
- Status last verified
- May 2021
- First submitted
- 28 Sep 2018
- Last updated
- 20 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Douine M, Sanna A, Galindo M, Musset L, Pommier de Santi V, Marchesini P, Magalhaes ED, Suarez-Mutis M, Hiwat H, Nacher M, Vreden S, Garancher L. Malakit: an innovative pilot project to self-diagnose and self-treat malaria among illegal gold miners in the Guiana Shield. Malar J. 2018 Apr 10;17(1):158. doi: 10.1186/s12936-018-2306-5.
PubMed 29631588Douine M, Lazrek Y, Blanchet D, Pelleau S, Chanlin R, Corlin F, Hureau L, Volney B, Hiwat H, Vreden S, Djossou F, Demar M, Nacher M, Musset L. Predictors of antimalarial self-medication in illegal gold miners in French Guiana: a pathway towards artemisinin resistance. J Antimicrob Chemother. 2018 Jan 1;73(1):231-239. doi: 10.1093/jac/dkx343.
PubMed 29045645Douine M, Musset L, Corlin F, Pelleau S, Pasquier J, Mutricy L, Adenis A, Djossou F, Brousse P, Perotti F, Hiwat H, Vreden S, Demar M, Nacher M. Prevalence of Plasmodium spp. in illegal gold miners in French Guiana in 2015: a hidden but critical malaria reservoir. Malar J. 2016 Jun 9;15:315. doi: 10.1186/s12936-016-1367-6.
PubMed 27277831Pommier de Santi V, Djossou F, Barthes N, Bogreau H, Hyvert G, Nguyen C, Pelleau S, Legrand E, Musset L, Nacher M, Briolant S. Malaria Hyperendemicity and Risk for Artemisinin Resistance among Illegal Gold Miners, French Guiana. Emerg Infect Dis. 2016 May;22(5):903-6. doi: 10.3201/eid2205.151957.
PubMed 27089004van Eer ED, Bretas G, Hiwat H. Decreased endemic malaria in Suriname: moving towards elimination. Malar J. 2018 Jan 30;17(1):56. doi: 10.1186/s12936-018-2204-x.
PubMed 29378594Musset L, Pelleau S, Girod R, Ardillon V, Carvalho L, Dusfour I, Gomes MS, Djossou F, Legrand E. Malaria on the Guiana Shield: a review of the situation in French Guiana. Mem Inst Oswaldo Cruz. 2014 Aug;109(5):525-33. doi: 10.1590/0074-0276140031. Epub 2014 Aug 13.
PubMed 25184998Terrentroy GA, Lambert Y, Hureau-Mutricy L, Galindo M, Adenis A, Nacher M, Vreden S, Douine M. A multicentric cross-sectional survey to assess cardiovascular risk factors among persons working in informal gold mines in French-Guiana. BMC Public Health. 2026 Mar 12;26(1):1293. doi: 10.1186/s12889-026-26723-8.
PubMed 41820970Longchamps C, Galindo MS, Lambert Y, Sanna A, Mutricy L, Garancher L, Adenis A, Nacher M, Suarez-Mutis M, Cairo H, Hiwat H, Vreden S, Douine M. Impact of Malakit intervention on perceptions, knowledge, attitudes, and practices related to malaria among workers in clandestine gold mines in French Guiana: results of multicentric cross-sectional surveys over time. Malar J. 2022 Dec 28;21(1):397. doi: 10.1186/s12936-022-04391-4.
PubMed 36577968Lambert Y, Galindo M, Suarez-Mutis M, Mutricy L, Sanna A, Garancher L, Cairo H, Hiwat H, Bordalo Miller J, Gomes JH, Marchesini P, Adenis A, Nacher M, Vreden S, Douine M. Tailoring Mobile Data Collection for Intervention Research in a Challenging Context: Development and Implementation in the Malakit Study. JMIR Form Res. 2022 Jun 16;6(6):e29856. doi: 10.2196/29856.
PubMed 35708763Galindo MS, Lambert Y, Mutricy L, Garancher L, Miller JB, Gomes JH, Sanna A, Peterka C, Cairo H, Hiwat H, Adenis A, Nacher M, Suarez-Mutis MC, Vreden S, Douine M. Implementation of a novel malaria management strategy based on self-testing and self-treatment in remote areas in the Amazon (Malakit): confronting a-priori assumptions with reality. BMC Public Health. 2022 Apr 15;22(1):770. doi: 10.1186/s12889-022-12801-0.
PubMed 35428230
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a New Malaria Control Strategy Amongst Gold Miners Working Illegally in French Guiana (Malakit)
- ClinicalTrials.gov ID
- NCT03695770
- Acronym / sponsor ID
- MALAKIT / MALAKIT
- Conditions
- Malaria, Public Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,733 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Collaborators
- Dr Stephen Vreden (Foundation for Scientific Research Suriname : SWOS), Oswaldo Cruz Foundation, Dr Maylis Douine (Centre Hospitalier de Cayenne)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 4 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Illegal gold miners in French Guiana, a French overseas territory ('département') located in Amazonia, often carry malaria parasites (up to 46.8%). While the Guiana Shield Region aims at malaria elimination, the high prevalence of Plasmodiumin this hard-to-reach population in conjunction with frequent incorrect use of artemisinin-based anti-malarials could favor the emergence of resistant parasites. Due to geographical and regulatory issues in French Guiana, usual malaria control strategies cannot be implemented in this particular context.Therefore, new strategies targeting this specific population in the forest are required.
Numerous discussions among health institutions and scientific partners from French Guiana, Brazil and Suriname have led to an innovative project based on the distribution of kits for self-diagnosis and self-treatment of Plasmodium infections. The kit-distribution will be implemented at "resting sites", which are areas across the border of French Guiana regularly frequented by gold miners. The main objective is to increase the appropriate use and complete malaria treatment after a positive malaria diagnosis with a rapid test, which will be evaluated with before-and-after cross-sectional studies. Monitoring indicators will be collected from health mediators at the time of kit distribution and during subsequent visits, and from illegal gold miners themselves, through a smartphone application. The project funding is multisource, including Ministries of Health of the three countries, WHO/PAHO, and the European Union.
Detailed description
Background Despite a decrease in the number of cases reported to CIRE "Cellule de l'Institut de Veille Sanitaire", an interregional epidemiological surveillance center, malaria affects many gold miners working illegally in French Guiana. The ORPAL study carried out by CIC "Centre d'Investigation Clinique" (clinical investigation center) in 2015, showed that the prevalence of Plasmodium in illegal gold miners was 22.3%, of which 84% were asymptomatic. Self-medication practices are very common (52.4%) using artemisinin derivatives.
Key issues identified:
- The mobile population of workers in illegal gold mining sites is particularly affected by malaria due to their living and working conditions and as such represents a reservoir of transmission.
- Their undocumented irregular status and difficult access to health centers makes care from health professionals rare or belated.
- The use of inadequate drugs, without prior diagnosis and with improper compliance, mainly due to the high cost of treatment on the black market, is common. These non-recommended practices contribute to the risk of emergence of ACT resistance.
- Knowledge of the disease by illegal gold miners (causes, symptoms, preventive measures and treatment) remains insufficient.
Considering the problems, the identified need is to ensure sufficient intervention coverage of appropriate and rapid care, amongst the malaria "reservoir" population, in order to reduce:
- Malaria transmission and ACT non-compliance;
- The ensuing risk of P. falciparum resistance to ACT;
- The morbidity and mortality of illegal workers in gold-mining sites;
The working hypothesis is:
The free distribution of self-diagnosis and self-treatment kits, together with appropriate training / information, at "resting sites", Brazil and Suriname, would be a strategy relevant to the specific context of French Guiana, and would respond to the identified need.
Objectives This study aims to assess a new malaria control strategy targeting gold miners working illegally in French Guiana, based on the distribution of self-diagnosis kits and self-treatment against P. falciparum in cross-border areas.
- Main objective Increase the part of illegal gold miners in French Guiana who take ACT entirely after a positive rapid diagnostic test.
- Secondary objectives
- Improve the use of anti-malarial treatments against P. falciparum appropriately and in compliance with WHO recommendations.
- Reduce the prevalence of malaria among illegal gold miners in French Guiana.
- Increase the part of illegal gold miners in French Guiana who:
- Know malaria, its causes, the symptoms and protection measures.
- Have a positive attitude towards recommended prevention measures, the use of adequate anti-malarial treatment, and adherence to treatment.
- Report applying good preventive practices.
Project implementation:
This project will be carried out in cooperation with Brazil, Suriname and France. It is divided into 2 sections:
- Part 1: Implementation and monitoring of the intervention Distribution of self-diagnosis and self-treatment kits to people working illegally at gold-mining sites in French Guiana, along with the provision of training. This distribution will take place at resting sites by trained facilitators. Proactive digital collection of data will be conducted by these facilitators and via gold miners themselves through a mobile application.
- Part 2: Evaluation of the intervention The final evaluation of the project will be carried out in a cross-sectional study "Orpal bis", with a questionnaire on knowledge, attitudes and practices and blood sampling to measure the prevalence of Plasmodium carriers before / after the intervention. The same study (Orpal) was carried out in 2015 along the Surinamese border, and will be carried out before implementation along the Brazilian border.
Therefore, it will be a pre-post evaluation. Depending on the results, the sustainability of the action will be determined by the Health Authorities.
Duration As a pilot project, the inclusion period for which the data will be processed in the view of determining the potential sustainability is 12 months. The length of the results capitalizing is estimated to be 6 months, during which the intervention will be maintained, in order to avoid any useless gap. Therefore, the total duration of the pilot phase is 18 months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before/after study design
| Arm | Type | Receives |
|---|---|---|
| target population | Experimental | Other: kit for self-diagnosis and self-treatmentAll the target population should be included in the experimental arm |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- over 15 years-old
- working or accompanying someone working in illegal gold mining in French Guiana
- agreing to take part of the study
- to have parents authorization if age between 15 and 17 ;
- capable of performing a self-RDT during the training (validation by the facilitator);
Key exclusion criteria (5 listed)
- refusing to participate in the study ;
- under 15 years old ;
- no parents authorization ;
- weighing less than 35 kg ;
- who has not been able to perform a self-RDT during the training (invalidation by the facilitator).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kit for self-diagnosis and self-treatmentdistribution of kits for malaria self-diagnosis and self-treatment after a training by health facilitators | Other | target population |
Primary outcome
KAP Questionnaire
Time frame: 12 months
change the part of illegal gold miners in French Guiana who take a correct antimalarial treatment (with artemisinin-combined therapy) with a good adherence and after a positive rapid diagnostic test.
2 secondary outcomes
malaria prevalence
Time frame: 12 months
KAP questionnaire
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2021.
- Background: PubMed 29631588Douine M, Sanna A, Galindo M, Musset L, Pommier de Santi V, Marchesini P, Magalhaes ED, Suarez-Mutis M, Hiwat H, Nacher M, Vreden S, Garancher L. Malakit: an innovative pilot project to self-diagnose and self-treat malaria among illegal gold miners in the Guiana Shield. Malar J. 2018 Apr 10;17(1):158. doi: 10.1186/s12936-018-2306-5.
- Background: PubMed 29045645Douine M, Lazrek Y, Blanchet D, Pelleau S, Chanlin R, Corlin F, Hureau L, Volney B, Hiwat H, Vreden S, Djossou F, Demar M, Nacher M, Musset L. Predictors of antimalarial self-medication in illegal gold miners in French Guiana: a pathway towards artemisinin resistance. J Antimicrob Chemother. 2018 Jan 1;73(1):231-239. doi: 10.1093/jac/dkx343.
- Background: PubMed 27277831Douine M, Musset L, Corlin F, Pelleau S, Pasquier J, Mutricy L, Adenis A, Djossou F, Brousse P, Perotti F, Hiwat H, Vreden S, Demar M, Nacher M. Prevalence of Plasmodium spp. in illegal gold miners in French Guiana in 2015: a hidden but critical malaria reservoir. Malar J. 2016 Jun 9;15:315. doi: 10.1186/s12936-016-1367-6.
- Background: PubMed 27089004Pommier de Santi V, Djossou F, Barthes N, Bogreau H, Hyvert G, Nguyen C, Pelleau S, Legrand E, Musset L, Nacher M, Briolant S. Malaria Hyperendemicity and Risk for Artemisinin Resistance among Illegal Gold Miners, French Guiana. Emerg Infect Dis. 2016 May;22(5):903-6. doi: 10.3201/eid2205.151957.
- Background: PubMed 29378594van Eer ED, Bretas G, Hiwat H. Decreased endemic malaria in Suriname: moving towards elimination. Malar J. 2018 Jan 30;17(1):56. doi: 10.1186/s12936-018-2204-x.
- Background: PubMed 25184998Musset L, Pelleau S, Girod R, Ardillon V, Carvalho L, Dusfour I, Gomes MS, Djossou F, Legrand E. Malaria on the Guiana Shield: a review of the situation in French Guiana. Mem Inst Oswaldo Cruz. 2014 Aug;109(5):525-33. doi: 10.1590/0074-0276140031. Epub 2014 Aug 13.
- Derived from this study: PubMed 41820970Terrentroy GA, Lambert Y, Hureau-Mutricy L, Galindo M, Adenis A, Nacher M, Vreden S, Douine M. A multicentric cross-sectional survey to assess cardiovascular risk factors among persons working in informal gold mines in French-Guiana. BMC Public Health. 2026 Mar 12;26(1):1293. doi: 10.1186/s12889-026-26723-8.
- Derived from this study: PubMed 36577968Longchamps C, Galindo MS, Lambert Y, Sanna A, Mutricy L, Garancher L, Adenis A, Nacher M, Suarez-Mutis M, Cairo H, Hiwat H, Vreden S, Douine M. Impact of Malakit intervention on perceptions, knowledge, attitudes, and practices related to malaria among workers in clandestine gold mines in French Guiana: results of multicentric cross-sectional surveys over time. Malar J. 2022 Dec 28;21(1):397. doi: 10.1186/s12936-022-04391-4.
- Derived from this study: PubMed 35708763Lambert Y, Galindo M, Suarez-Mutis M, Mutricy L, Sanna A, Garancher L, Cairo H, Hiwat H, Bordalo Miller J, Gomes JH, Marchesini P, Adenis A, Nacher M, Vreden S, Douine M. Tailoring Mobile Data Collection for Intervention Research in a Challenging Context: Development and Implementation in the Malakit Study. JMIR Form Res. 2022 Jun 16;6(6):e29856. doi: 10.2196/29856.
- Derived from this study: PubMed 35428230Galindo MS, Lambert Y, Mutricy L, Garancher L, Miller JB, Gomes JH, Sanna A, Peterka C, Cairo H, Hiwat H, Adenis A, Nacher M, Suarez-Mutis MC, Vreden S, Douine M. Implementation of a novel malaria management strategy based on self-testing and self-treatment in remote areas in the Amazon (Malakit): confronting a-priori assumptions with reality. BMC Public Health. 2022 Apr 15;22(1):770. doi: 10.1186/s12889-022-12801-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing kit for self-diagnosis and self-treatment in people with Malaria and Public Health, 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 5 inclusion and 5 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 20 May 2021. 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?
KAP Questionnaire (time frame: 12 months). 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 NCT03695770, which also lists 10 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 20 May 2021.