Évaluation de la fidélité des interventions en santé publique dans le cadre des essais randomisés en grappes dans les pays du Sud : revue systématique et étude de cas

Evidence-based public health should be based on the best available evidence to make informed decisions and to implement interventions aimed at maintaining and improving the health and well-being of all people. Randomized controlled trials (RCTs) are often used in clinical research to test the effects of a drug, therapy, or intervention on an experimental group that may benefit from the intervention, comparing it to a control group that received either a placebo or no intervention treatment. Although the debate persists, randomized controlled trials are an important and objectively high quality method for evaluating the effectiveness of health interventions. Due to multiple factors, cluster randomized trials (CRTs) are widely used to assess the delivery of health services and public health interventions. In this type of trial, it is no longer individuals who are randomized, but groups of individuals such as families, doctors, and village communities who receive the intervention. These interventions may differ during implementation as a result of various factors related to the complexity of the intervention design, context, participants, and stakeholders involved. These factors should be considered at the time of assessment and before replication in other contexts. Implementation fidelity assessment, a key tool in process evaluation, examines study processes to assess the extent to which the intervention was carried out as originally intended. The fidelity of implementation is an essential part of the scale-up process.  This thesis aimed to examine the fidelity of implementation of public health interventions in the context of cluster randomized trials, to determine whether the interventions implemented under a controlled model should consider this type of evaluation to strengthen their results and facilitate their replication on a large scale. This thesis has two parts: a systematic review and a single case study with three units of analysis using a mixed triangulated approach. The first article assessed the implementation fidelity of public health interventions in the context of cluster randomized trials. The systematic review highlighted the finding that public health interventions implemented under this model did not systematically consider this type of evaluation, that the way of doing it was very heterogeneous, and that the evaluation was not adequately documented. The second and third articles were the research findings of the evaluation of an intervention, using a case study as the research method, that was conducted to first examine the plausibility of the intervention theory and to better understand the design and context of the intervention being evaluated, and second, to evaluate implementation fidelity and its acceptability among the participants with the aim of making improvements (if necessary) before large-scale replication. The evaluation of the case study highlighted several key findings. First, the results of the evaluation reflected that the underlying theory and model of the public health intervention were well designed to achieve the desired results. The evaluation provided key points and actions to consider during intervention development to serve hard-to-reach communities and improve health outcomes. Further, it was shown that the results demonstrated a high degree of implementation fidelity. The clarity of the theory of the intervention, the motivation and commitment of the stakeholders as well as the periodic meetings of supervisors with the field team largely explained the high level of fidelity obtained. Contextual factors such as geographical distance to the intervention, access to a mobile phone, level of education, and gender norms contributed to the heterogeneity of the participation of the intervention target group. Finally, this evaluation underlined the finding that the mobile platform coupled with community mobilization, both key components of the intervention, were well received by the participants and may be an effective means of improving health knowledge and changing health-related behaviors.  This thesis contributes to the development of methodological knowledge concerning the evaluation of the fidelity of implementation of public health interventions by identifying gaps in this field, and by suggesting a tool that facilitates advancing this evaluation practice. This thesis also contributes to the strengthening of research in implementation sciences, and empirically provides key elements essential to assess the fidelity of the implementation of this type of intervention using CRT studies and evaluation of this fidelity, which is the subject of this doctoral research.

Keyphrases: Public health intervention, Cluster randomized trials, Systematic review, Fidelity assessment, Process evaluation, Global health, Developing countries