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
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Other: Symptom -based Screening(Child Contacts) Other: Clinical based Decisions||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4054 participants|
|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)|
|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|
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
- 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
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
|Klerksdorp, Matlosana, South Africa|
|Principal Investigator:||Richard Chaisson, MD||Director, Center for Tuberculosis Research|