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

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ClinicalTrials.gov Identifier: NCT03074799
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : September 18, 2019
Sponsor:
Collaborator:
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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).

Condition or disease Intervention/treatment Phase
Tuberculosis Other: Symptom -based Screening(Child Contacts) Other: Clinical based Decisions Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4054 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: We propose a cluster randomized trial to be conducted in 16 decentralized care clinics with existing TB services that will measure the implementation of symptom-based, nurse-led initiation of IPT compared to the current standard of care with TST-based referral to a pediatricians at the district hospital. A baseline assessment of clinic records and procedures will inform clinic stratification prior to randomization. Clinics will be stratified by size (number of patients seen per month) and TB case notifications. The clinics will then be randomized in a 1:1 ratio to receive either the intervention or the current standard of care. Given the intervention will be carried out by a clinic in its entirety, neither the provider nor the patient will be blinded to the study procedure. No additional staff will be provided to the clinics to assist in this process as we wish to evaluate the implementation of IPT for child contacts under 5 years old in a real world, resource-limited setting.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : September 15, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Active Comparator: TST-based Screening (Child contacts)
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.
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.


Experimental: Symptom -based Screening(Child Contacts)
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.
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




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074799


Locations
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South Africa
PHRU
Klerksdorp, Matlosana, South Africa
Sponsors and Collaborators
Johns Hopkins University
United States Agency for International Development (USAID)
Investigators
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Principal Investigator: Richard Chaisson, MD Director, Center for Tuberculosis Research

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03074799    
Other Study ID Numbers: IRB00055079
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study is ongoing; plans for data sharing are in process

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections