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

Tuberculosis Clinical Trial

— SOAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074799
• Other study ID #: IRB00055079
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: September 15, 2018

Study information

• Verified date: March 2020
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4054
• Est. completion date: September 15, 2018
• Est. primary completion date: September 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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).

Related Conditions & MeSH terms

• Tuberculosis

Intervention

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.
• 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

Locations

Country	Name	City	State
South Africa	PHRU	Klerksdorp	Matlosana

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	United States Agency for International Development (USAID)

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of child contacts placed on IPT	The primary outcome is the mean percentage of identified contacts initiated on IPT or ATT	2 years