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Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases

NCT03074799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4054

Last updated 2020-03-04

No results posted yet for this study

Summary

To assess implementation of a nurse-led, symptom-based screening program in local, decentralized clinics for tuberculosis (TB) screening of child contacts less than 5 years old who were exposed to tuberculosis in the home. This will allow nurses in decentralized clinics to either start IPT for those asymptomatic patients and refer symptomatic patients for evaluation of TB disease and possible antituberculous therapy (ATT).

Conditions

Interventions

OTHER

Symptom -based Screening(Child Contacts)

Aim 1: Determine the number of child contacts per adult index case of tuberculosis to assess quality of contact tracing. Aim 2: Determine the percentage of child contacts initiated on IPT or antituberculous therapy (ATT) and compare between intervention (symptom-based, nurse-led initiation of IPT) vs control clinics (TST-based screening with referral to hospital, current standard of care). Aim 3: Compare outcomes of children initiated on IPT between both groups including: completion of therapy, discontinuation due to side effects, lost to follow up, and adherence while on therapy.

OTHER

Clinical based Decisions

the child is symptomatic, they will be referred to the hospital for further evaluation of TB disease including both chest X-ray and testing of either sputum or swallowed sputum. If the child is asymptomatic, the TB nurse at the local clinic will initiate them on weight-appropriate dosing of IPT

Sponsors & Collaborators

Principal Investigators

  • Richard Chaisson, MD · Director, Center for Tuberculosis Research

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-01
Primary Completion
2018-09-15
Completion
2018-09-15

Countries

  • South Africa

Study Locations

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Entities

Diseases
Companies

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 NCT03074799 on ClinicalTrials.gov