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

NCT03074799 | Completed

• 1 other identifier: IRB00055079
• Study Type: interventional
• Target: 4,054
• Locations: 1 country
• Sites: 1

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).

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Percent of child contacts placed on IPT

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

  2 years

Study Arms (2)

TST-based Screening (Child contacts)

ACTIVE COMPARATOR

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)

Symptom -based Screening(Child Contacts)

EXPERIMENTAL

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

Interventions

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.

TST-based Screening (Child contacts)

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

Symptom -based Screening(Child Contacts)

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

PHRU

Klerksdorp, Matlosana, South Africa

Location

Related Publications (2)

• Salazar-Austin N, Milovanovic M, West NS, Tladi M, Barnes GL, Variava E, Martinson N, Chaisson RE, Kerrigan D. Post-trial perceptions of a symptom-based TB screening intervention in South Africa: implementation insights and future directions for TB preventive healthcare services. BMC Nurs. 2021 Feb 8;20(1):29. doi: 10.1186/s12912-021-00544-z.

  PMID: 33557831 DERIVED

• Salazar-Austin N, Cohn S, Barnes GL, Tladi M, Motlhaoleng K, Swanepoel C, Motala Z, Variava E, Martinson N, Chaisson RE. Improving Tuberculosis Preventive Therapy Uptake: A Cluster-randomized Trial of Symptom-based Versus Tuberculin Skin Test-based Screening of Household Tuberculosis Contacts Less Than 5 Years of Age. Clin Infect Dis. 2020 Apr 10;70(8):1725-1732. doi: 10.1093/cid/ciz436.

  PMID: 31127284 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard Chaisson, MD

  Director, Center for Tuberculosis Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 9, 2017
• Study Start: October 1, 2015
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)