Implementation of an Integrated Care Strategy for Children Contacts of Patients With Tuberculosis

NCT04331262 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 163

Last updated 2023-08-30

No results posted yet for this study

Summary

Introduction: childhood tuberculosis continues to be a major public health problem, despite the fact that the visibility of the epidemic in this population group has increased, studies are still lacking that can resolve the gaps that persist.

Objective: To design, implement and evaluate an integrated care strategy for children under five years old household contacts of patients with smear positive pulmonary tuberculosis in Medellín and the Metropolitan Area.

Methodology: quasi-experimental study, in which around 300 children household contacts of patients with smear positive pulmonary tuberculosis from Medellín and the Metropolitan Area will be evaluated, who will be recruited in a period of one year. A subgroup of these children, estimated at 85, who require treatment for latent tuberculosis, will be offered to receive treatment for latent tuberculosis under a integrated care strategy that includes some modifications to the currently standardized scheme in Colombia, with rifampicin treatment daily oral route for four months, follow-up under the project scheme with the availability of a nurse, general practitioner, specialists, care by professionals from other disciplines such as social work, psychology, and nutritionist, and the provision of incentives (transport and food assistance). This strategy will be compared with isoniazid treatment according to the standardized scheme in the country, which was received by a cohort of children between 2015 and 2018. The study has the CIB Research Ethics Committee approval.

Expected results: this project is expected to contribute with greater local evidence of integrated care strategies that allow greater compliance with treatment for latent tuberculosis in children, so that there is a real impact in the control of childhood tuberculosis and in the reduction of tuberculosis reservoirs in order to achieve the goals proposed by the World Health Organization's End TB Strategy.

Conditions

  • Latent Tuberculosis

Sponsors & Collaborators

  • Universidad Pontificia Bolivariana

    collaborator OTHER
  • Universidad de Antioquia

    collaborator OTHER
  • Secretaría de Salud de Medellín

    collaborator UNKNOWN
  • Secretaría Seccional de Salud y Protección Social de Antioquia

    collaborator UNKNOWN
  • Hospital Pablo Tobón Uribe

    collaborator OTHER
  • Corporacion para Investigaciones Biologicas

    lead OTHER

Principal Investigators

  • Jaime Robledo, Dr · Corporacion para Investigaciones Biologicas

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-26
Primary Completion
2022-12-30
Completion
2023-07-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04331262 on ClinicalTrials.gov