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

NCT04331262 | Completed

• 1 other identifier: 68722
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Latent tuberculosis; Integrated care; Rifampin

Outcome Measures

Primary Outcomes (1)

• Treatment Compliance

  Proportion of treatment compliance

  4 months

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Universe: the study universe are children under five years old household contacts of patients with smear positive confirmed pulmonary TB from Medellín and the Metropolitan Area, in whom treatment for latent TB is indicated. Sample: the sample will be children under five years of age household contacts of patients with smear positive confirmed pulmonary TB from Medellín and the Metropolitan Area notified to the surveillance system during 2020, in whom treatment for latent TB is indicated. Sampling type: it will correspond to an Incidental Sampling, since the children of the study will be recruited as new cases (incidents) of smear positive confirmed pulmonary TB appear in Medellín and the Metropolitan Area.

You may qualify if:

• Child under five years of age.
• Household contact of smear positive confirmed pulmonary tuberculosis patient.
• That the parents or legal guardian sign the informed consent.
• To live in Medellín or the Metropolitan Area of the Aburrá Valley.
• Diagnostic criteria for latent tuberculosis
• Asymptomatic child.
• Normal clinical assessment, without clinical signs of active TB.
• Normal chest x-ray.
• Response to the tuberculin skin test (TST) ≥5 mm and / IGRA (QuantiFERON®-TB Gold Plus - QFT Plus) positive.
• Having a diagnosis of latent tuberculosis or
• Being in immunological window period.

You may not qualify if:

• Having symptoms or signs of active TB and that the disease has not been ruled out.
• Having basic liver disorder.
• Having severe asthma.

Sponsors & Collaborators

• Corporacion para Investigaciones Biologicas: lead
• Universidad Pontificia Bolivariana: collaborator
• Universidad de Antioquia: collaborator
• Secretaría de Salud de Medellín: collaborator
• Secretaría Seccional de Salud y Protección Social de Antioquia: collaborator
• Hospital Pablo Tobón Uribe: collaborator

Study Sites (1)

Corporación para Investigaciones Biológicas

Medellín, Colombia

Location

Related Publications (1)

• Benjumea-Bedoya D, Villegas Arbelaez E, Martinez-Penaloza D, Beltran-Arroyave CP, Restrepo Gouzy AV, Marin D, Cadavid Alvarez LM, Molinares B, Montes Zuluaga FN, Pulido Duarte H, Suarez Parra PM, Alzate Angel JC, Velez-Parra G, Realpe T, Vasquez Villa M, Rios Buitrago SY, Puerta Zapata J, Arango Garcia LM, Perea Torres Y, Perez Doncel N, Arbelaez Montoya MP, Robledo J. Implementation of an integrated care strategy for child contacts of tuberculosis patients: a quasi-experimental study protocol. BMC Pediatr. 2023 Jan 19;23(1):28. doi: 10.1186/s12887-022-03798-x.

  PMID: 36653768 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

sputum samples, gastric juice, blood, urine, stools,

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Jaime Robledo, Dr

  Corporacion para Investigaciones Biologicas

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 2, 2020
• Study Start: July 26, 2021
• Primary Completion: December 30, 2022
• Study Completion: July 31, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)