GXT - GeneXpert or Chest-X-ray or Tuberculin Skin Testing for Household Contact Assessment

Launched by MCGILL UNIVERSITY HEALTH CENTRE/RESEARCH INSTITUTE OF THE MCGILL UNIVERSITY HEALTH CENTRE · Aug 24, 2020

Keywords

ClinConnect Summary

Background:

At a recent United Nations high level conference on TB a target was set that more than 30 million individuals should be treated for LTBI over the next 5 years. This ambitious goal will require massive scaling up of LTBI diagnosis and treatment - which will be challenging, if not impossible, with current approaches to diagnosis and treatment of latent TB. Two aspects of management of LTBI - need for CXR and need for TST - are controversial, as both can create important barriers to LTBI initiation, thereby reducing the individual as well as public health benefits of treatment. Fo...

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Eligibility criteria

• Inclusion Criteria:
• * Index TB patients:
• • 1. New diagnosis of pulmonary microbiologically confirmed (smear, GX or culture) active TB within 30 days of treatment initiation.
• • For Brazil: a new diagnosis of clinically pulmonary active is eligible.
• • 2. Must have at least one identified household contact, and HHC investigation has not been started already.
• • 3. Must agree to allow research team to access their medical history and approach their household contacts.
• * Household contacts:
• • 1. Age 5-50 years for Benin and Age 0-50 for Brazil
• • 2. On average in the past 3 months - slept in the same house, at least one night per week, or spent at least one hour per day for 5 days per week.
• • 3. Pregnant woman can be included.
• • 4. People with prior active TB or latent TB therapy will be included. These participants will be assessed for prevalent active TB, although they will not be treated for LTBI. Hence they will be included in the analyses of yield of active case finding, but excluded from analyses of numbers diagnosed and treated for LTBI.
• Exclusion Criteria:
• * Index TB patients:
• • 1. Known drug-resistant TB (INH resistant, multidrug resistance or rifampin resistance) may be excluded - after discussion in each country with TB program officials. If the TB programme's policy is to screen contacts of MDR cases for active TB only and not provide any LTBI therapy, then index TB patients with MDR will be excluded as well as their HHCs. However, if the national TB program policy is to treat such individuals with standard LTBI therapy (since some HHCs of MDR patients will develop TB with drug-sensitive isolates later), then these index TB patients and their HHCs will be eligible. Hence, this will be a country-specific exclusion criterion.
• • 2. Index TB patient with previous history of active TB (because their HHC may have undergone investigation before - which may change their need for study interventions, and also potentially change their perceptions and behaviours in the study).
• • 3. Only has extra-pulmonary TB.
• • 4. No identified household contacts.
• * Household contacts:
• • 1. Members of the household, but do not meet the minimum time definitions for HH contacts.
• • 2. Had TST/IGRA within 3 months.
• • 3. Had a CXR on the same day or after the date of diagnosis of the index TB patient.
• • 4. People living with HIV. (In most TB programs, HH contacts have unknown HIV status; HIV testing is recommended by WHO only if the index TB patient is known to have HIV co-infection). Contacts will be asked if they have been previously diagnosed to have HIV infection, and also asked if they are taking anti-retroviral therapy (if patients are receiving any medications, these will be checked carefully to verify what these are, and in particular if they are on anti-retroviral therapy). Both questions will be asked because some patients may be on therapy, but are not aware of the indication, or they may not wish to divulge their HIV status. If HHC are on anti-retroviral therapy and/or provide a history of previous HIV diagnosis, then they will be excluded, because the WHO recommended algorithm for investigation of household contacts who are HIV infected is different from that followed in the study arms. All index TB patients should undergo HIV testing based on national algorithm. If the index TB patient is found to be HIV positive, partner notification services will be recommended to the person living with HIV. The children of women who are HIV-infected should also undergo HIV testing. HIV testing will be offered to all household contacts who have not been HIV-tested within the last 6 months. If any household contact is found to be HIV-infected, they will be excluded pre-randomization. If there is a significant delay between identification of the household contacts and obtaining the HIV result, the HHCs can be randomized and then excluded post-randomization. These HHCs will be excluded from the modified intention to treat analysis, which will be the primary analysis. All HHCs identified to have HIV-infection will undergo investigations and treatment following WHO guidelines for HIV-infected household contacts.
• • 5. If one member family refuses to participate to the study and has no objection to have the other HH members to participate in the study, then we can proceed with the consent process with the other HHC. But if one household contact refuses to participate and objects to other HH members to take part of the study, then none of the HHC in this family can participate in the study. It is not necessary that all of the HHC signed consent but simply that no one objects. At any time a participant can refuse any test, or have other investigations - as ordered by their doctor/nurse or if they prefer).