STS: TB Infection treatment and care

TB Infection

Content

TB Infection (or previously known as Latent TB infection) is a stage in between uninfected and having active TB. In this stage the person has no symptoms and can only be identified using laboratory tests.
The vast majority of infected people may never develop TB disease. However, to achieve TB elimination, it is important to treat TB infection in people at risk of developing active TB disease.
It is a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifested active TB.
There is no single acceptable/reliable test for direct identification of Mycobacterium tuberculosis infection in humans. Tuberculin Skin Test (TST) and Interferon-gamma release assay (IGRA) are commonly used tests for identifying TB infection.

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Testing for TB Infection

Content

For TB infection, there are two recommended tests which can be used to identify such patients.

Tuberculin Skin Test (TST)

The skin test is done by injecting a small amount (0.5 ml) of TB antigens into the top layer of skin on your inner forearm. If one has ever been exposed to TB bacteria (Mycobacterium tuberculosis), there will be a reaction indicated by the development of a firm red bump (induration) >= 10 mm at the site within 2 days.

Figure: Tuberculin Skin Test

Interferon-gamma release assay (IGRA)

IGRA is a Blood test. If one has been exposed to TB bacteria, the white blood cell in the blood will release a substance called gamma interferon when the cells are exposed to specific TB antigens.

Figure: Interferon-gamma release assay (IGRA)

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Target groups for TPT

Content

The NTEP has prioritized the target population for TPT based on elevated risk of progression from infection to TB disease or increased likelihood of exposure to TB disease.

The target populations have been divided into two groups:

Household contacts of bacteriologically confirmed pulmonary TB patients notified in Nikshay from public and private sector.

Target Population	Strategy
People living with HIV (+ ART) Adults and children >12 months Infants <12 months with HIV in contact with active TB HHC below 5 years of pulmonary* TB patients	TPT to all after ruling out active TB disease
HHC 5 years and above of pulmonary* TB patients#	TPT among TBI positive# after ruling out TB disease

#Chest X Ray (CXR) and TBI testing would be offered wherever available, but TPT must not be deferred in their absence

*Bacteriologically confirmed pulmonary TB patients to be prioritized for enumeration of the target population for TPT

Expanded to other risk groups

Target Population	Strategy
Individuals who are: on immunosuppressive therapy having silicosis on anti-TNF treatment on dialysis preparing for organ or hematologic transplantation	TPT after ruling out TB disease among TBI positive

Target Population

Strategy

Individuals who are:

on immunosuppressive therapy
having silicosis
on anti-TNF treatment
on dialysis
preparing for organ or hematologic transplantation

TPT after ruling out TB disease among TBI positive

Cascade of Care for TPT

Content

In the cascade of care approach, all target populations (People Living with HIV (PLHIV), Household Contacts (HHCs) and other such groups) who are at risk of developing TB disease are systematically reached out, screened for TB disease and after ruling out active TB disease, provided TB Preventive Treatment (TPT) as a part of the continuum of care.

The cascade of care approach among TPT target populations is shown in Figure 1.

Figure 1: Cascade of TB Preventive Treatment; Source: Guidelines for Programmatic Management of Tuberculosis Preventive Treatment, p3.

Resources:

Guidelines for Programmatic Management of Tuberculosis Preventive Treatment in India.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which of the following is the correct TPT cascade of care?	Offer upfront CBNAAT to all at-risk populations, then offer TPT based on the results.	Identify at-risk populations, then offer TPT to all the people that have been identified.	Identify target populations at risk of developing TB, screen them, rule-out active TB disease, and provide TPT to eligible populations.	None of the above	3	The TPT cascade of care is: Identify target populations at risk of developing TB disease, screen them for TB disease, rule-out active TB disease, and provide TPT to eligible populations.

Approaches for TPT implementation

Content

There are two programmatic approaches for Tuberculosis Preventive Therapy (TPT) implementation:

1. Test-and-treat approach – This approach aims to detect TB infection among key groups for implementing TPT.

After ruling out active TB, the beneficiary is tested for TB infection.
TPT is offered only to those with a positive test (Interferon Gamma Release Assay (IGRA)/ Tuberculin Skin Test (TST)/ Cutaneous TB (C-TB))

2. Treat-only approach – For certain groups, like People Living with HIV (PLHIV) and House Hold Contacts (HHC) < 5 years old, detecting TB infection is not required. Hence, this approach is given.

After ruling out active TB, TPT is offered without testing for TB infection.

Test and treat approach*	HHC of sputum positive Pulmonary TB >/= 5 years old Individuals on: Immunosuppressive therapy Having silicosis On anti-TumourTNF treatment On dialysis Preparing for solid organ or haematopoietic stem cell transplantation
Treat-only approach	HHC of sputum positive Pulmonary TB (PTB) < 5 years old PLHIV^#

*All efforts should be made to make IGRA available. However, TPT should not be withheld in case of non-availability of IGRA.

^#PLHIV < 1 year old are offered TPT only if they are a household contact of an active TB case.

Resources

Guidelines for Programmatic Management of TB Preventive Treatment in India, 2021.

Assessment

Question

Answer 1

Answer 2

Answer 3

Answer 4

Correct answer

Correct explanation

Page id

Part of Pre-test

Part of Post-test

Which of the following category of TPT beneficiaries is offered TPT without IGRA testing?

Household contacts of sputum positive PTB >/= 5 years old

PLHIV

Patient on dialysis

Silicosis patient

2

PLHIV and HHC of sputum positive PTB < 5 years old are offered TPT without testing for IGRA. This is called Treat-only approach.

Yes

Counselling for IGRA/TST

Content

Interferon Gamma Release Assay (IGRA) and Tuberculin Skin Tests (TST) are performed on individuals who are ruled out for active TB disease.

However, positive and negative tests in IGRA and TST do not necessarily mean the patient does or does not have Tuberculosis Infection (TBI) as the possibility of false positives and false negatives cannot be ruled out in these tests.

Importance of Counselling in IGRA/ TST

All patients who undergo IGRA/ TST are already aware that they do not have an active TB disease and hence counselling is important to help them make informed decisions about undergoing IGRA/ TST for detecting TBI.
Additionally, at the time of receiving positive IGRA/ TST results, they may be symptom-free or otherwise healthy. In such cases, resistance/denial to receive a prophylactic treatment like TB Preventive Therapy (TPT) is higher as its treatment course duration also is relatively longer.
Counselling in IGRA/ TST is of utmost importance when the respective person belongs to the high-risk population and needs to be necessarily initiated on TPT and thus needs to be counselled for the same.

Components of Counselling in IGRA/ TST

Information on TBI
Need for undergoing IGRA/ TST
Importance of initiating TPT post-IGRA/ TST tests
If initiated on treatment, then schedule of medication
Medication adherence support
Follow-up
Importance of completing the TPT course, adverse events

Resources

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Counselling for IGRA/ TST should necessarily include which of the following?	Counselling on DR-TB	Counselling on TB Infection (TBI)	Counselling on DBT	None of the above	2	Counselling for IGRA/ TST should necessarily include ‘Counselling on TB infection (TBI)’.		Yes	Yes

Counselling for TPT

Content

Counselling is of paramount importance for TB Preventive Treatment (TPT) initiation and completion as most of the target population screened and found eligible would know that they do not have TB disease, would be symptom-free or otherwise healthy and would not feel the need to take any treatment, especially Household Contacts (HHC).

Stakeholders Involved in Counselling for TPT (Figure below)

Figure: Stakeholders involved in counselling for TPT

Abbr: HWCs: Health and Wellness Centres; PHC: Primary Health Centre; ICTC: Integrated Counselling and Testing Centres; ART: Anti-retroviral Therapy; PLHIV: People Living with HIV

Components of Counselling for TPT

While counselling the person and family members, the treating doctors/ staff must follow the steps outlined in the table below for an effective counselling session.

Component	Actions to be taken
Confidentiality	Ensure confidentiality when seeking a person’s commitment to complete the course before initiating TPT.
Information	Provide information on: TB infection Need for TPT and protective benefits to the individual, household and wider community TPT is available free of charge under National Tuberculosis Elimination Programme (NTEP) TPT regimen prescribed, including duration, schedule of medication collection, and directions on how to take the medications Potential side-effects and adverse events involved and what to do in the event of various side-effects. People treated with rifamycins should be alerted in advance about the pink discolouration of secretions due to this medicine Importance of completing the full course of TPT Reasons and schedule of regular clinical and laboratory follow-up for treatment and monitoring Signs and symptoms of TB and advise on steps if they develop them
Medication adherence support	Agree on the best way to support treatment adherence, including the most suitable location for drug intake and the need for a treatment supporter, if required.
Family support	Involve family members and caregivers in health education when possible.
Openness	Invite clarification questions and provide clear and simple answers.
Information, Education and Communication materials	Provide information materials in the local language and at the appropriate literacy level of the person concerned. Reinforce supportive educational messages at each contact during treatment.
Call support (in case of emergencies)	Provide a telephone number of the HCW staff/ TB Health Visitors and Senior Treatment Supervisors concerned to call for other queries or a need to contact health services for advice.

The National TB Elimination Programme (NTEP) national call centre (NIKSHAY SAMPARK – Toll-free number 1800116666) may be provided to index TB patients, those initiated on TPT and family members to serve as a resource for information, counselling and troubleshooting as required to enable TPT initiation, follow-up monitoring and completion.

Resources:

Guidelines for Programmatic Management of Tuberculosis Preventive Treatment in India.

Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which of the following people are involved when counselling for TPT?	Index TB patients	Caregivers	Family members	All of the above	4	When counselling persons eligible for TPT, it is best to involve the index TB patients, their families and caregivers.		Yes	Yes

Monitoring adherence to TPT

Content

To achieve high treatment completion rates and the desired epidemiological impact of the TB Preventive Treatment (TPT), monitoring TPT treatment adherence, including management of missed doses and Adverse Drug Reactions (ADRs), is of paramount importance under the National TB Elimination Programme (NTEP).

Significance of Monitoring Adherence to TPT

Adherence to the TPT course and treatment completion are important determinants of clinical benefit, both at the individual and population levels as:

Irregular or inadequate treatment reduces the protective efficacy of the TPT regimen.
Poor adherence or early cessation of TPT can potentially increase the risk of the individual developing TB, including drug-resistant TB.
Efficacy of TPT is greatest if at least 80% of the doses are taken within the duration of the regimen. The total number of doses taken is also a key determinant of the extent of TB prevention.

Figure: Strategies to Promote Adherence

Prevent TB India App and Integration with Nikshay as a Monitoring Tool

Currently, under the NTEP, the person’s lifecycle approach and TB treatment episode level are recorded in Nikshay.
TPT information management is integrated with this existing Nikshay approach. This includes information on screening, testing, eligibility assessment, TPT initiation, adherence monitoring and follow-up till treatment completion.
The NTEP has adapted the World Health Organisation (WHO) Prevent TB India app and hosted it on Nikshay as an interim solution till the Nikshay TPT module is developed and fully functional.
Health workers or treatment supporters will make entries directly into the app.
The TPT monitoring dashboard can be accessed by various levels of supervisors using their respective Nikshay login ids using a link provided in the Nikshay Reports section on TPT Reports.
A web-based comprehensive dashboard for Prevent TB initiative is also available at https://ltbi.nikshay.in/ltbi-generic-new/#/

Table: Roles of Stakeholders in Monitoring Adherence to TPT
Role	Stakeholder
Treatment support and adherence monitoring including entry of daily doses taken in the Prevent TB India app/ Nikshay TPT module.	Community volunteers (TB survivors/ champions, Accredited Social Health Activists (ASHAs) and Anganwadi Workers)
Regularly undertake home visits or tele/ video calls to monitor TPT adherence. Identify treatment interruptions at the earliest (Dashboards of Prevent TB India app/ Nikshay TPT module may be checked every week along with pill counting).	HWCs/ sub-centre/ urban health posts (Community Health Officers (CHOs), Auxillary Nurse Midwives (ANMs), multipurpose workers and other field staff) Primary Health Centres (PHCs)/ Urban PHCs/ Private clinic (Medical Officers (MO), staff nurse)
Adherence support and clinical monitoring through the concerned PHC/ sub-centre. Supportive supervision and handholding support to field level facilities and frontline workers, ASHAs and community volunteers on digital recording, using Prevent TB India app and monitoring TPT and follow-up examinations.	TB Unit (MO, Laboratory Technicians (LTs), staff nurse, pharmacist, counsellor (if available), Senior Treatment Supervisors (STS), Senior TB Laboroary Supervisors (STLS), TB Health Visitors (TBHV))
Ensuring adherence support for People Living with HIV (PLHIV) on TPT through mechanisms such as outreach workers, PLHIV networks, peer support groups, etc.	Anti Retroviral Therapy (ART) centre/ Link ART centre (MO, pharmacist, (institutional) staff nurse, counsellor, care coordinator)
Monitor and support adherence to TPT.	Tertiary care/ Medical colleges/ Corporate hospitals/ District hospitals/ Dialysis/ Cancer facilities (doctors, staff nurses)
Review data updating in Prevent TB India app/ Nikshay TPT module wherever available, check the quality of data regularly and provide feedback to TPT treatment supporters and for retrieval of TPT interrupters.	Supervisory staff at all health facilities including the State/ District TB cell (State TB Officers (STO), District TB Officers (DTO), State/ District Programme Coordinators)

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Assessment

Question	Answer 1	Answer 2	Answer 3	Answer 4	Correct answer	Correct explanation	Page id	Part of Pre-test	Part of Post-test
Which tools are used to monitor TPT adherence under the NTEP?	Video calls	Counting empty blisters	Directly asking the patient	Options 1 and 2	4	TPT adherence monitoring tools include direct observation of drug intake, 99DOTS/ MERM, counting empty blisters, tele/ video calls and refill monitoring.
Which of the following apps are currently used by NTEP to monitor TPT adherence?	TB Aarogya Sathi	Prevent TB India App	TPT app for NTEP	None of the above	2	NTEP has adapted the WHO Prevent TB India app and hosted it on Nikshay to monitor the entire TPT care cascade, including TPT adherence.