DOI: 10.1186/s13063-022-07062-6
OpenAccess: Gold
This work has “Gold” OA status. This means it is published in an Open Access journal that is indexed by the DOAJ.

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

Larissa Otero,N. Zetola,M. Campos,J. Zunt,A. Bayer,M. Curisinche,T. Ochoa,M. Reyes,V. Vega,P. Van der Stuyft,TR. Sterling

Medicine
Psychological intervention
Randomized controlled trial
Abstract 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.
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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” is a paper by Larissa Otero N. Zetola M. Campos J. Zunt A. Bayer M. Curisinche T. Ochoa M. Reyes V. Vega P. Van der Stuyft TR. Sterling published in the journal Trials (Volume 24, Issue 1) in 2023. It was published by Springer Science+Business Media. It is a paper about Medicine, Psychological intervention, Randomized controlled trial, Tuberculosis, Pediatrics, Cluster (spacecraft), Cluster randomised controlled trial, Intervention (counseling), Family medicine, Vaccination, Psychiatry, Surgery, Immunology, Pathology, Computer science, and Programming language. It has an Open Access status of “ gold”. You can read and download a PDF Full Text of this paper here.