National Guidelines on the Treatment of Tuberculosis Infection

Objectives

South Africa’s tuberculosis (TB) preventive treatment (TPT) guideline aims to reduce progression to TB disease and the overall TB burden by preventing disease among people with significant TB exposure, people living with HIV, and other immunocompromised or high-risk groups. It aligns TPT with the National Strategic Plan for HIV, TB and Sexually Transmitted Infections 2017–2022, the World Health Organization End TB Strategy and Sustainable Development Goals, and contributes to the target of reducing TB incidence by 50% and TB mortality by 75% by 2025.[1][2][3]

• Prevent new TB infections and disease, identify disease earlier, reduce loss to follow-up and improve treatment outcomes through interventions implemented at scale.[1]
• Offer TPT after TB disease has been excluded to people with significant exposure and to immunocompromised people, including after each new exposure or period of immunocompromise.[2][3]
• Prioritise contacts of people with pulmonary TB, people living with HIV, children, exposed newborns, pregnant and breastfeeding women, people with confirmed silicosis, people receiving dialysis or anti-tumour necrosis factor treatment, and people preparing for organ or haematological transplantation.[3][4][5]
• Expand TPT coverage among groups inadequately reached by prior isoniazid preventive treatment, particularly people living with HIV and child contacts.[1]
• Use shorter, patient-friendly regimens where feasible to improve completion, safety and tolerability and lessen burdens on individuals, households and health services.[6][7]
• Apply a family-centred or household-centred approach where feasible, including use of similar regimens within a household or group when clinically appropriate, to reduce complexity and stigma and strengthen adherence support.[7][3]

Implementation

The guideline uses a test-and-treat model: assess eligible people for active TB disease before starting TPT, provide TB treatment if disease is found, and offer preventive treatment when disease is excluded. It applies across public and private services for clinicians, pharmacists and healthcare managers, with implementation coordinated by the Department of Health and partner organisations including the National TB Think Tank and its TB Prevention Task Team, the World Health Organization, the United States President’s Emergency Plan for AIDS Relief, and the Global Fund to Fight AIDS, Tuberculosis and Malaria.[1][8]

• Conduct contact investigation and document significant exposure, defined as sharing an enclosed space overnight or frequently or extensively during daytime in the three months before the index patient started treatment.[9]
• Assess people through symptom screening, physical examination and diagnostic testing, using sputum Xpert testing where sputum can be obtained, relevant alternative samples for children where appropriate, chest radiography where available, and urine lipoarabinomannan testing for eligible people where available.[8][10][11]
• Do not require a tuberculin skin test or interferon-gamma release assay to initiate TPT, and do not allow unavailable chest radiography or TB-infection testing to block TPT for well eligible people after clinical assessment.[8][12]
• Initiate TPT for all contacts after exclusion of disease regardless of age or HIV status, including well young children for whom sputum testing or chest radiography is unavailable, with continuing clinical follow-up.[9][13]
• Provide TPT to all people living with HIV after TB disease is excluded, including newly diagnosed people who should start antiretroviral therapy immediately and TPT within two weeks; screen people already in HIV care for TB symptoms at every visit.[14][11]
• Provide TPT during pregnancy and breastfeeding rather than deferring treatment where indicated, with TB assessment at initial antenatal care, subsequent antenatal visits and postpartum follow-up.[15][16]
• Select regimens according to age, weight, HIV status, antiretroviral therapy, viral suppression, drug interactions, household circumstances and formulation availability. Options include three months of weekly isoniazid and rifapentine, three months of daily rifampicin and isoniazid, six months of isoniazid and 12 months of isoniazid.[7][14]
• Provide pyridoxine throughout TPT where indicated, including for pregnant and breastfeeding women and children, without allowing supply shortages to delay treatment.[17][18][16]
• Defer or withhold TPT for people with TB disease, active liver disease, severe peripheral neuropathy, relevant previous medicine reactions, or excessive alcohol use that cannot be reduced.[9][16]
• Deliver monthly clinical follow-up during shorter treatment courses, aligning visits with chronic disease or antiretroviral therapy appointments where appropriate, and assess TB symptoms, adherence, missed appointments, social-support needs, weight, dose requirements and adverse effects.[19][20]
• Support adherence through counselling, treatment literacy, individual plans, household and community health-worker support, reminders and management of side effects; offer counselling and reassessment at later opportunities to people who initially decline treatment.[19][13][21]
• Use multi-month dispensing and repeat prescription collection strategies for clinically stable people where appropriate, including facility, community, private pharmacy, private general practitioner and community-venue collection points.[20][21]
• Train care providers on updated guidance, especially to expand access for groups previously neglected by TPT services.[19]
• Record patient information and outcomes through patient folders, primary healthcare tick registers, the TB identification register and TIER.Net, and report through District Health Management Information System processes.[22][23]
• Monitor the TPT care cascade, including eligibility, initiation, completion, loss to follow-up and deaths, and use dashboards and quality-improvement plans to identify and address underperforming facilities, districts and provinces.[23]
• Report adverse events using the standard form associated with National Pharmacovigilance Centre Guidelines and classify outcomes as completed, lost to follow-up, stopped treatment or died.[24][20]

Monitoring & Evaluation

Monitoring and evaluation combines patient-level clinical follow-up, routine facility reporting and care-cascade analysis to track tuberculosis preventive treatment (TPT) delivery, safety, adherence and outcomes. It uses standardised registers, electronic systems and upward data verification, while national tuberculosis targets include reducing incidence by 50 per cent and mortality by 75 per cent by 2025.[1][22][23]

• Monitor individuals before and throughout TPT through symptom screening, physical examination and diagnostic testing for tuberculosis disease, with chest radiography, Xpert testing, culture or urine lipoarabinomannan testing used according to clinical circumstances and local availability.[6][25][11]
• Reassess people after significant new tuberculosis exposure, during pregnancy and antenatal care where applicable, after tuberculosis treatment in specified circumstances, and when symptoms develop.[25][14][15][11]
• Conduct monthly clinical follow-up for adherence and adverse effects, monitor weight and adjust doses where required, particularly for children, and provide counselling and social-support assessment at follow-up visits.[19][17][20]
• Record patient categorisation as new or previously treated and classify TPT outcomes as treatment completed, lost to follow-up, treatment stopped or died.[26][24]
• Report adverse events through the standard form associated with National Pharmacovigilance Centre Guidelines, alongside clinical management and referral of serious reactions.[20][27]
• Register and notify TPT provision and relevant outcomes, using patient record folders as source documents, primary healthcare tick registers for monthly statistics, the tuberculosis identification register for presumptive tuberculosis cases, and TIER.Net for treatment initiation and outcomes.[8][22]
• Report data through District Health Management Information System processes, with facilities, districts and provinces responsible for data flow and managers at each level checking and signing off data before upward reporting.[22][23]
• Analyse the care cascade at facility, district, provincial and national levels, tracking TPT eligibility, initiation, completion, loss to follow-up and deaths during treatment; use dashboards to identify underperforming areas and develop intensive-support plans.[23]
• Use programme monitoring to assess whether activities proceed as planned and inform service-delivery decisions and resource use, and conduct periodic, time-bound evaluations of performance, impact and the contribution of inputs and activities to results.[28][22]
• Apply illustrated cascade targets of 90 per cent for testing, 100 per cent for the relevant subsequent testing or initiation step, and 90 per cent for treatment completion; further indicator definitions are not provided in the supplied material.[23]
• Maintain patient-level follow-up within repeat prescription collection strategies through assessment before enrolment, a clinical review one month after TPT initiation, symptom and side-effect screening at collection visits, a six-month review and completion assessment at the next annual comprehensive consultation.[29]

Although the guidance refers to programme assessments, indicators, registers, notification and outcome monitoring, the supplied extracts do not set out a complete national indicator framework, disaggregated targets, evaluation timetable, surveillance architecture or formal accountability sanctions.[19][8][3]

Costing & Financing

The supplied material contains no explicit budget, costing estimate, allocation, funding gap, resource-mobilisation target or economic assumption for TPT implementation. It nevertheless identifies resource-dependent delivery requirements, including medicines and formulations, diagnostic capacity, health infrastructure, trained providers, routine monitoring systems and multi-month dispensing arrangements.[7][3][23]

• Recognise support from the United States President’s Emergency Plan for AIDS Relief and the Global Fund to Fight AIDS, Tuberculosis and Malaria among partner organisations involved in the guideline context, without specifying the value, scope or duration of that support.[1]
• Address deficiencies in tuberculosis disease-testing availability urgently, while ensuring that unavailable chest radiography or tests for tuberculosis infection do not prevent eligible people from starting TPT after clinical assessment.[25][12]
• Provide routine access to TPT regimens and child-friendly formulations where available, including routinely available dispersible, scored fixed-dose combinations for three months of daily rifampicin and isoniazid in South Africa.[30]
• Supply pyridoxine throughout TPT for relevant patient groups, without delaying treatment where supply is unavailable.[17][18][16]
• Support delivery through family-centred care, community health workers, electronic registers, facility digitisation, pharmacovigilance reporting and repeat prescription collection arrangements, but without costed implementation plans.[19][20][23][21]

No explicit financial values or machine-readable cost items are available in the supplied extracts.[31][2][29]