Isoniazid preventive therapy completion in children under 5 years old who are contacts of tuberculosis cases in Lima, Peru: study protocol for an open-label, cluster-randomized superiority trial.

BACKGROUND: Children < 5 years old in contact with TB cases are at high risk for developing severe and fatal forms of TB. Contact investigation, BCG vaccination, and isoniazid preventive therapy (IPT) are the most effective strategies to prevent TB among children. However, the implementation of IPT faces challenges at several stages of the cascade of care of TB infection among children, particularly those less than 5 years old. In Peru, a large proportion of children do not complete IPT, which highlights the need to design effective interventions that enhance preventive therapy adherence and completion. Although the body of evidence for such interventions has grown, interventions in medium TB incidence settings are lacking. This study aims to test the effectiveness, acceptability, and feasibility of an intervention package to increase information and motivation to complete IPT among children < 5 who have been prescribed IPT. METHODS: An open-label, cluster-randomized superiority trial will be conducted in two districts in South Lima, Peru. Thirty health facilities will be randomized as clusters, 10 to the intervention and 20 to control (standard of care). We aim to recruit 10 children from different households in each cluster. Participants will be caretakers of children aged < 5 years old who initiated IPT. The intervention consists of educational material, and short message services (SMS) reminders and motivators. The primary outcomes will be the proportion of children who picked up > 90% of the 24 weeks of IPT (22 pick-ups) and the proportion of children who picked up the 24 weeks of IPT. The standard of care is a weekly pick-up with monthly check-ups in a health facility. Feasibility and acceptability of the intervention will be assessed through an interview with the caretaker. DISCUSSION: Unfavorable outcomes of TB in young children, high effectiveness of IPT, and low rates of IPT completion highlight the need to enhance adherence and completion of IPT among children < 5 years old. Testing of a context-adapted intervention is needed to improve IPT completion rates and therefore TB prevention in young children. TRIAL REGISTRATION: ClinicalTrials.gov NCT03881228. Registered on March 19, 2019.

Usability and Effectiveness Evaluation of a Game-Based Biofeedback System to Strengthen Respiratory Muscles

The assessment and training of respiratory muscles are two essential tasks for indirect screening of status and improvement of lung function, respectively, especially in times of COVID-19. To perform both tasks, we have designed an innovative handheld mouth pressure biofeedback system for assessment and personalized game-based training of respiratory muscle strength. Thirty recovered COVID-19 patients were involved in an across-ages pilot study to evaluate their respiratory muscle strength and the system’s usability, and eight of the thirty patients were involved in a home inspiratory training program of 3 weeks to assess its effectiveness. Results revealed that participants rated the system’s overall usability as excellent (91.3 ± 6.4) and consistently performed respiratory cycles along with the game-based training program in terms of mouth pressure. Furthermore, patients involved in the home training program showed a 40% increase in their Maximal Inspiratory Pressure (Pimax). These results indicate that the proposed system stands for a proper healthcare solution for the initial diagnosis of respiratory muscle dysfunction or disease and for guiding the correct performance of tailored and consecutive threshold load breathing cycles playfully and engagingly. Furthermore, it stands for an attractive and personalized biofeedback solution to promote adherence to at-home therapy. Finally, it can be used to investigate new and effective training protocols that improve respiratory muscle performance. [ FROM AUTHOR]