Tailoring Mobile Data Collection for Intervention Research in a Challenging Context: Development and Implementation in the Malakit Study.

BACKGROUND: An interventional study named Malakit was implemented between April 2018 and March 2020 to address malaria in gold mining areas in French Guiana, in collaboration with Suriname and Brazil. This innovative intervention relied on the distribution of kits for self-diagnosis and self-treatment to gold miners after training by health mediators, referred to in the project as facilitators. OBJECTIVE: This paper aims to describe the process by which the information system was designed, developed, and implemented to achieve the monitoring and evaluation of the Malakit intervention. METHODS: The intervention was implemented in challenging conditions at five cross-border distribution sites, which imposed strong logistical constraints for the design of the information system: isolation in the Amazon rainforest, tropical climate, and lack of reliable electricity supply and internet connection. Additional constraints originated from the interaction of the multicultural players involved in the study. The Malakit information system was developed as a patchwork of existing open-source software, commercial services, and tools developed in-house. Facilitators collected data from participants using Android tablets with ODK (Open Data Kit) Collect. A custom R package and a dashboard web app were developed to retrieve, decrypt, aggregate, monitor, and clean data according to feedback from facilitators and supervision visits on the field. RESULTS: Between April 2018 and March 2020, nine facilitators generated a total of 4863 form records, corresponding to an average of 202 records per month. Facilitators' feedback was essential for adapting and improving mobile data collection and monitoring. Few technical issues were reported. The median duration of data capture was 5 (IQR 3-7) minutes, suggesting that electronic data capture was not taking more time from participants, and it decreased over the course of the study as facilitators become more experienced. The quality of data collected by facilitators was satisfactory, with only 3.03% (147/4849) of form records requiring correction. CONCLUSIONS: The development of the information system for the Malakit project was a source of innovation that mirrored the inventiveness of the intervention itself. Our experience confirms that even in a challenging environment, it is possible to produce good-quality data and evaluate a complex health intervention by carefully adapting tools to field constraints and health mediators' experience. TRIAL REGISTRATION: ClinicalTrials.gov NCT03695770; https://clinicaltrials.gov/ct2/show/NCT03695770.

Setting-up a cross-border action-research project to control malaria in remote areas of the Amazon: describing the birth and milestones of a complex international project (Malakit).

BACKGROUND: In French Guiana, gold miners working illegally represents a major reservoir of malaria. This mobile population, mainly of Brazilian descent, enters the French Guianese forest from neighbouring countries, Suriname and Brazil. A complex and innovative intervention was piloted as a cooperation with the three involved countries involved to control malaria in this specific population. The principle was that health workers called "facilitators" provide the participants with a self-diagnosis and self-treatment kit along with adequate training and material to rapidly manage an episode of malaria symptoms on their own, when they find themselves isolated from health care services. METHODS: This paper describes the design, development, content of the intervention and players' organization of this multi-country project, the opportunities and constraints encountered, and the lessons learnt at this stage. RESULTS: The choice not to implement the usual "Test and Treat" approach within the community is mainly driven by regulatory reasons. The content of medical messages tends to balance the tension between thoroughness, accuracy and efficacy. The wide range of tools developed through a participatory approach was intended to cope with the challenges of the literacy level of the target population. Despite the difficulties encountered due to language, regulation differences and distance between partners, cooperation was fruitful, due to the complementary of stakeholders, their involvement at all important stages and regular face-to-face meetings. DISCUSSION AND CONCLUSION: This experience shows the feasibility of an ambitious project of action-research in a border malaria context, involving several countries and with a mobile and undocumented population. It reveals some factors of success which may be transferable in analogous settings.

Self-diagnosis and self-treatment of malaria in hard-to-reach and mobile populations of the Amazon: results of Malakit, an international multicentric intervention research project.

Background: Illegal gold miners are currently key hosts for malaria in French Guiana (FG), with a risk of emergence of resistance linked to improper use of artemisinin-based combination therapy (ACT). The remoteness of the mines and regulatory issues hinder their access to health care. Methods: A quasi-experimental researched project (Malakit) implemented in FG borders with Brazil and Suriname aimed at determining the effectiveness of distributed kits for self-diagnosis and self-treatment to illegal gold miners, after training, at strategic border staging areas. Evaluation relied on questionnaires at inclusion and follow-up visits, and pre/post intervention surveys. The primary outcome was the proportion of persons reporting a use of certified ACT after a positive malaria diagnosis. The secondary outcomes assessed antimalarial adherence, kit use and impact on malaria epidemiology. Findings: The proportion of patients reporting a use of certified ACT after a positive diagnosis increased after the intervention (OR 1.8, 95%CI [1.1-3.0]). From April 2018 to March 2020, 3,733 persons participated in the intervention. The kit was used correctly by 71.7% [65.8-77.7] of the 223 persons reporting having used a malakit during the follow-up visits. No serious adverse events related to the misuse of malakit have been reported. The intervention appears to have accelerated the decline in malaria incidence in the region by 42.9%. Interpretation: This innovative international project showed that people with low education can correctly self-manage their malaria symptoms. This strategy could be integrated in the malaria control programs of the countries involved and considered in other regions with residual malaria in remote areas. Funding: This project was funded by the European Union, the Global Fund, Brazil MoH, Cayenne Hospital and FG Health Regional Agency. Editor's note: This translation in French was submitted by the authors and we reproduce it as supplied. It has not been peer reviewed. Our editorial processes have only been applied to the original abstract in English, which should serve as reference for this manuscript. The Lancet Group takes a neutral position with respect to territorial claims in published maps and institutional affiliations. Contexte: Les chercheurs d'or illégaux sont actuellement un réservoir clé du paludisme en Guyane, avec un risque d'émergence de résistance lié à une mauvaise utilisation des combinaisons thérapeutiques à base d'artémisinine (ACT). L'isolement de ces sites miniers clandestins et des contraintes règlementaires entravent leur accès aux soins. Méthodes: Un projet de recherche opérationnelle quasi-expérimental (Malakit) a été mis en œuvre aux frontières de la Guyane avec le Brésil et le Suriname. Il visait à déterminer l'efficacité de la distribution de kits d'autodiagnostic et d'autotraitement à des orpailleurs illégaux, après une formation adaptée, dans des zones stratégiques transfrontalières. L'évaluation s'est appuyée sur des questionnaires lors des visites d'inclusion et de suivi, et sur des enquêtes pré/post intervention. L'indicateur principal était la proportion de personnes déclarant avoir utilisé une ACT certifiée après un diagnostic positif de paludisme. Les indicateurs secondaires reposaient sur l'adhérence aux traitements antipaludiques, l'utilisation des kits et l'impact sur l'épidémiologie du paludisme. Résultats: La proportion de patients déclarant une utilisation d'ACT certifiée après un diagnostic positif a augmenté après l'intervention (OR 1,8, 95%CI [1,1-3,0]). D'avril 2018 à mars 2020, 3 733 personnes ont participé à l'intervention. Le kit a été utilisé correctement par 71,7% [65,8-77,7] des 223 personnes revues en visites de suivi ayant déclaré avoir utilisé un malakit. Aucun événement indésirable grave lié à une mauvaise utilisation du malakit n'a été signalé. L'intervention semble avoir accéléré la diminution de l'incidence du paludisme dans la région de 42,9%. Interprétation: Ce projet international innovant a montré que les personnes ayant un faible niveau d'éducation peuvent se prendre en charge par eux-mêmes pour des symptômes de paludisme. Cette stratégie pourrait être intégrée dans les programmes de lutte contre le paludisme des pays impliqués et envisagée dans d'autres régions où du paludisme résiduel persiste dans des zones isolées. Financement: Ce projet a été financé par l'Union Européenne, le Fonds Mondial, le Ministère de la santé du Brésil, le Centre Hospitalier de Cayenne et l'Agence Régionale de Santé de Guyane.