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Completed

NCT Number: NCT03074799

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

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).

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

1 day–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PHRU

Klerksdorp, Matlosana, South Africa

About this study

Retrospective review of routine program data for child contacts less than five years of adult TB index cases who are receiving TB care at local, decentralized clinics in the Matlosana district of Northwest Province will be assessed. 16 clinics will be stratified and randomized in 1:1 fashion to either TST-based screening, the current standard of care, or symptom-based screening, the newly recommended standard of care in South Africa. Those who are TST positive in the TST-based group and those who are symptomatic in the symptom-based group will be referred to Klerkdorp Hospital for further evaluation of tuberculosis. Nurses in the decentralized clinics will initiate those who are TST negative or asymptomatic on IPT. Their clinical course will be monitored throughout treatment and adherence to therapy measured. The investigators will compare clinic-level outcomes including percentage of patients initiated on, adherent to, and completing IPT.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Child less than five years old
  • Household contact of a drug-sensitive pulmonary or extrapulmonary TB index case (drug sensitivity is define as culture-confirmed OR absence of rifampin resistance on gene Xpert) admitted to one of the public clinics in the Matlosana sub-district on or after October 1, 2015.

Exclusion criteria

  • Household contact of a drug-resistant TB index case. (Drug resistance defined either by culture or by presence of rifampin resistance on gene Xpert).

Treatment and study plan

Symptom -based Screening(Child Contacts)

Other

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.

Clinical based Decisions

Other

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

Primary outcomes

  1. Percent of child contacts placed on IPT

    Time frame: 2 years

    The primary outcome is the mean percentage of identified contacts initiated on IPT or ATT

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • United States Agency for International Development (USAID)

Registry information

Acronym: SOAR

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 9, 2017
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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