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
L. Otero,
N. Zetola,
M. Campos,
J. Zunt,
A. Bayer,
M. Curisinche,
T. Ochoa,
M. Reyes,
V. Vega,
P. Van der Stuyft,
TR. Sterling
Affiliations
L. Otero
Facultad de Medicina, Universidad Peruana Cayetano Heredia
N. Zetola
Division of Pulmonary and Critical Care, Augusta University
M. Campos
Facultad de Medicina, Universidad Peruana Cayetano Heredia
J. Zunt
Department of Neurology, University of Washington School of Medicine
A. Bayer
Facultad de Salud Pública, Universidad Peruana Cayetano Heredia
M. Curisinche
Dirección de Prevención Y Control de Tuberculosis, Ministerio de Salud
T. Ochoa
Facultad de Medicina, Universidad Peruana Cayetano Heredia
M. Reyes
Instituto de Medicina Tropical Alexander Von Humboldt, Universidad Peruana Cayetano Heredia
V. Vega
Instituto de Medicina Tropical Alexander Von Humboldt, Universidad Peruana Cayetano Heredia
P. Van der Stuyft
Department of Public Health, Faculty of Medicine, Ghent University
Abstract Background Children 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.