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

Johns Hopkins University

Status: Completed

Conditions: Tuberculosis

Treatments: Other: Symptom -based Screening(Child Contacts); Other: Clinical based Decisions

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03074799

IRB00055079

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 4,054 patients

Sex: All

Ages: 1 day to 5 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,054 participants in 2 patient groups

TST-based Screening (Child contacts)

Active Comparator group

Description:

In the control clinics, decision regarding IPT will be made based on TST results, as is now the standard of care in this South African health district. In this setting, all TST negative children are initiated on IPT by the nurse at the local clinic. TST positive children are all referred to the district hospital for further evaluation of TB disease regardless of clinical symptoms. Again, clinical outcome data will be obtained from patient records and the same longitudinal child contact register.

Treatment:

Other: Symptom -based Screening(Child Contacts)

Symptom -based Screening(Child Contacts)

Experimental group

Description:

In the intervention clinics, decisions regarding IPT will be made on a clinical basis. If 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. Children will be followed at least monthly for the duration of the six month course of isoniazid, as is standard of care in South Africa at this time. Clinical outcome data will be obtained from patient records and implementation of a contact register aimed at improving longitudinal care of children on isoniazid preventive therapy.

Treatment:

Other: Clinical based Decisions