Tuberculosis Infections and Infestations Tuberculosis
Conditions
Interventions
Randomization will be at the household level and will be simple randomization. At enrolment, TB index patients and their household and community contacts will be randomized into either ‘standard TB sc
investigation of symptomatic patients with Xpert Ultra and referral of TB positive patients for TB treatment at their chosen or nearest health facility. Those that don’t have symptoms or test negative
Sponsors
Aurum Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Fulfilling definition for an index patient: diagnosed with new or recurrent TB disease 2. Diagnosed =2 weeks at enrolment 3. Microbiologically confirmed TB disease (drug-sensitive or drug-resistant) 4. Adult aged 18 years and above 5. Have at least one household contact 6. Willing and able to provide written informed consent 7. Willingness to be randomized 8. Patients living within the study catchment area and willing to inform the study team of any change of address during the treatment and follow-up period
Exclusion criteria
Exclusion criteria: 1. Not willing to give written informed consent 2. Not fluent in any language in which informed consent is provided, or in which researchers are able to communicate 3. Participating in other investigational product/device trials related to TB and/or lung diseases 4. Having another member of the household enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TB yield among household contacts (defined as the proportion of new microbiologically-confirmed contacts with TB) measured using the Xpert Ultra test at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The prevalence of latent TB infection (LTBI) in TB contacts measured using QuantiFERON-TB Gold Plus test at baseline 2. The proportion of household contacts (adults or children) started on TB preventive therapy in accordance with national guidelines, measured using a questionnaire and medical records within 1 month of the household visit 3. The proportion of household contacts (adults or children) diagnosed with TB started on TB treatment in accordance with national guidelines, measured using a questionnaire and medical records within 1 month of the household visit 4. Cost-effectiveness in terms of incremental cost per additional case detected through a universal test and treat strategy using GeneXpert ultra vs the standard TB screening using symptom screen at baseline 5. TB transmission dynamics measured using Next-Generation Whole Genome Sequencing (NG-WGS) at baseline | — |
Countries
Lesotho, South Africa, Tanzania
Contacts
Public ContactKavindhran;Thobani Velen;Ntshiqa
;
Outcome results
None listed