Clinical trial NCT03074799: Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases
Official title: Nurse-Led, Symptom-Based Screening of Household Child Contacts of Tuberculosis Index Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2017-03-09
Enrollment: 4054
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).

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.

Eligibility 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).

Primary outcomes:
measure: Percent of child contacts placed on IPT
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Klerksdorp
country: South Africa
facility: PHRU
state: Matlosana
Study officials:
affiliation: Director, Center for Tuberculosis Research
name: Richard Chaisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.