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.

BACKGROUND: A novel strategy to combat malaria was tested using a methodology adapted to a complex setting in the Amazon region and a hard-to-reach, mobile community. The intervention strategy tested was the distribution, after training, of malaria self-management kits to gold miners who cross the Surinamese and Brazilian borders with French Guiana to work illegally in the remote mining sites in the forest of this French overseas entity. MAIN TEXT: This article aims at presenting all process and implementation outcomes following the Conceptual Framework of Implementation Fidelity i.e. adherence, including content and exposure, and moderators, comprising participant responsiveness, quality of delivery, facilitation strategies, and context. The information sources are the post-intervention survey, data collected longitudinally during the intervention, a qualitative study, data collected during an outreach mission to a remote gold mining site, supervisory visit reports, in-depth feedback from the project implementers, and videos self-recorded by facilitators based on opened ended questions. As expected, being part of or close to the study community was an essential condition to enable deliverers, referred to as "facilitators", to overcome the usual wariness of this gold mining population. Overall, the content of the intervention was in line with what was planned. With an estimated one third of the population reached, exposure was satisfactory considering the challenging context, but improvable by increasing ad hoc off-site distribution according to needs. Participant responsiveness was the main strength of the intervention, but could be enhanced by reducing the duration of the process to get a kit, which could be disincentive in some places. Regarding the quality of delivery, the main issue was the excess of information provided to participants rather than a lack of information, but this was corrected over time. The expected decrease in malaria incidence became a source of reduced interest in the kit. Expanding the scope of facilitators' responsibilities could be a suitable response. Better articulation with existing malaria management services is recommended to ensure sustainability. CONCLUSIONS: These findings supplement the evaluation outcomes for assessing the relevance of the strategy and provide useful information to perpetuate and transfer it in comparable contexts. TRIAL REGISTRATION: ClinicalTrials.gov.  NCT03695770 . 10/02/2018 "Retrospectively registered".

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.

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.