Book traversal links for Annex 1. List of key messages
Messages for the ministry of health
• National governments have made a commitment at the first ever UN High Level Meeting on TB on 26th September 2018 towards “preventing tuberculosis for those most at risk of falling ill through the rapid scaling up of access to testing for tuberculosis infection, according to the domestic situation, and the provision of preventive treatment, with a focus on high-burden countries, so that at least 30 million people, including 4 million children under 5 years of age, 20 million other household contacts of people affected by tuberculosis, and 6 million people living with HIV, receive preventive treatment by 2022, and with the vision of reaching millions more, and further commit to the development of new vaccines and the provision of other tuberculosis prevention strategies, including infection prevention and control and tailored approaches, and to enacting measures to prevent tuberculosis transmission in workplaces, schools, transportation systems, incarceration systems and other congregate settings.”(11).
• In May 2014, national governments endorsed a World Health Assembly resolution for an End TB Strategy and its targets to end the global TB epidemic, with targets to reduce TB deaths by 95% and to cut new cases by 90% between 2015 and 2035. The strategy also lays down targets to provide TPT to 90% of those eligible by 2025 (8).
• TPT is a proven and effective intervention to avert the development of TB disease, reducing this risk by about 60–90% when compared to people who do not get TPT (136).
• TPT, given to people at the highest risk of progressing from TB infection to disease, remains a critical intervention worldwide to end TB. TPT is part of a larger set of actions – ranging from screening for TB disease, TB infection control, prevention and care of HIV, management of other comorbidities and health risks, better access to universal health care and social protection, to eradicate poverty.
• Large numbers of TB deaths could have been avoided if TPT had been rolled out worldwide following WHO recommendations for its programmatic use in 2008 (137). Urgent steps for nationwide implementation are therefore necessary to prevent massive suffering, catastrophic costs and deaths. If programmes start now, countries can accelerate the achievement of End TB targets.
• PMTPT is a key element of the framework for TB elimination in all settings and needs to be pursued aggressively particularly in low TB incidence settings.
• Shorter rifamycin-based TPT (4R,3HR,3HP,1HP) provides alternative options to IPT, which has historically been the main approach until of late. A shorter TPT regimen is more likely to be completed, as it is more tolerable and easier to manage programmatically, and hence may have greater potential to save lives. Demand for access to TPT should be increased by raising awareness among people at risk for TB and TB-affected communities. National programmes should be mindful that they are accountable for delivering TPT.
• Access to rapid tests and investigations to diagnose TB disease and TB infection (such as Xpert MTB/Rif, chest radiography, urine LAM, TST/IGRA) should be enhanced through investments in infrastructure, human resources and logistics in support of a nationwide scale-up of TPT.
• There is a need to establish mechanisms and invest in capacity building of nurses and health care workers in counselling People with HIV and TB patients and their family and contacts, to educate them on TPT, initiate TPT, follow-up treatment, identify and manage adverse events, as well as signals of potential toxicity and decide when it is necessary to stop TPT.
• Investing in strengthening of systematic recording and reporting using digital tools for PMTPT would enable monitoring of progress for programme management and resource allocation.
• Priority groups for TPT include household and close contacts of TB patients, People with HIV, persons with other immune-deficiency or predisposing clinical conditions (such as silicosis, dialysis, organ or blood transplant). National programmes may consider integrating TPT into an active TB casefinding component of their programme for at-risk populations.
Messages for health care workers
• TPT saves lives, cuts transmission of infection, prevents illness, and averts suffering due to TB. Some of the strongest proof comes from the TEMPRANO trial, which studied IPT among People with HIV in Cote d’Ivoire. Participants receiving IPT had a 37% reduction in mortality, independent of whether they were also on ART, with those on both IPT and ART having the greatest protection against severe disease and death (17).
• Currently recommended TPT regimens offer a durable protection following one course of TPT among People with HIV, HIV-negative contacts and other at-risk populations. The protection is shown to range between 6 to 19 years with IPT.
• There are various TPT regimens, with some of them combining two TB drugs – isoniazid and rifapentine or rifampicin – and lasting only 3 to 4 months. Evidence shows that they are as effective as older treatments in preventing progression to TB disease and are easier to complete than older treatments. While they may cost more in the short-term, they could provide a more cost-effective protection given that more people complete their treatment as prescribed. People taking shorter drug regimens are much more likely – up to three times – to complete their course of TPT than those on longer regimens, leading to better outcomes and more lives saved.
• Before starting TPT, counselling of people at risk and their families are key to: enabling an informed decision on accepting TPT, adhering to the schedule of TPT and encouraging the reporting of adverse events promptly. It is critical to educate people on TPT about signs and symptoms of serious adverse events, such as drug-induced hepatitis.
• It can be challenging and time-consuming to explain to an individual that a course of medical treatment lasting weeks to several months is needed even if she or he is not sick. It is also important to support and ensure adherence to complete the full course of TPT.
• There is no clear evidence to date showing increased TB drug resistance due to PMTPT. However, all efforts should be made to rule out TB disease using recommended procedures. If screening is negative, the likelihood of TB disease is very minimal. Withholding TPT is a missed opportunity to protect individuals and communities from avoidable disease and death and could hence be viewed as unethical.
• Concerns of harming otherwise healthy individuals need to be addressed. However, a very small proportion of people on TPT develop adverse events, and most adverse events are self-limiting and reversible. The shorter rifamycin-based regimens have a better safety profile. Having options for different populations can help in minimizing the risk.
• All people prescribed TPT should be informed clearly of the schedule of treatment, possible adverse events (“side-effects”), and health alerts to look out for, to contact their health care provider or to stop TPT.
• Systematic recording and reporting are important both to inform about individual care as well as to monitor the indicators of programme performance.
• With appropriate training in knowledge and skills, nurses and other frontline health care workers in the periphery can undertake most of the clinical duties required of PMTPT. This includes decisions on testing for TB infection and active disease, interpretation of results, eligibility for TPT, starting TPT and monitoring adherence to it, making decisions about whether TPT should be suspended or changed (e.g. in the case of adverse events) or restarted (e.g. after an interruption by the person on treatment). In most instances there is no need to solicit the opinion of a medical doctor or a specialist for these decisions on TPT although provision for this should be available in case it becomes necessary.
Messages for People with HIV and individuals offered TPT
• You (your family members) do NOT have TB disease. You (your family members) may have an infection that could become active TB. TB is a serious disease and could threaten your life and it could spread to your family/neighbours/coworkers.
• Your doctor/provider has determined that you would benefit from TPT (for you or your family members) despite you (your family members) being healthy at present. TPT can reduce your risk of getting TB by 60–90%. In most individuals TPT will not cause any discomfort or adverse events (“side-effects”). However, if adverse events develop, your caregiver will follow up with you regularly and provide care to overcome them. Your health care provider will inform you of the common adverse events of TPT you are offered. Even so you are free to take TPT or opt out or stop it after starting.
• Protection offered by TPT is optimal only when the prescribed course of TPT is completed as expected. If you decide to take TPT please remember to take it as indicated by your health care giver.
• If you (your family members) notice any adverse event, consult your health care worker at the earliest. If danger signs are noted (such as signs of jaundice – yellowing of the skin and whites of the eyes) stop TPT and seek care and support in a health facility.
• If you (your family members) are on rifamycin-based TPT and wish to avoid pregnancy it is important to note that rifapentine (and other rifamycins) decreases the effectiveness of hormonal contraceptives (138). You (your family members) should consider using a different, or barrier form of contraception when taking rifapentine or a rifampicin-based TPT.
• Parents or legal guardians: giving your children TPT will protect them from getting TB which can be difficult to diagnose and could have long lasting negative effects. Child-friendly medicines that dissolve in water and have a nice taste are now available and make it easier for your child to take treatment regularly.
Messages for the community
• TB is a contagious disease that is transmitted through air when a person with infectious TB coughs. Having TB is associated with considerable morbidity and mortality even when treated. Even if people with TB successfully complete treatment, some are left with considerable damage to the lung or to other organs which can seriously affect quality of life.
• However, TB is preventable, and prevention is much better than cure. There are a number of options available to prevent TB and reduce the burden of TB in the community. These include early detection and treatment of people with TB disease, BCG vaccination to infants and providing TPT to individuals who are currently well but have been exposed to TB or are at a higher risk of developing TB disease.
• In an effort to reduce the number of individuals who develop TB each year, countries have committed to provide TPT to people who have been exposed or those who already have TB infection in their bodies even if this has not yet progressed to TB disease, such as among People with HIV, children and family members of TB patients. Providing treatment to these individuals will prevent TB disease in them and result in a healthier community.
• TB infection is extremely common. People in the community who require TPT are not sick, are not coughing and are at no risk of transmitting TB to anyone else. TPT is prescribed to minimize future risk of developing TB disease in an individual. This also protects the community because TB is a contagious disease.
• The drugs used for TPT are generally very safe. Shorter TPT regimens that combine two TB drugs – isoniazid with rifapentine or rifampicin – are now available. Evidence shows that these are effective treatments to prevent progression to TB disease. These TPT regimens have fewer side-effects and are easier for people to take. It can still be challenging for people with TB infection who do not show symptoms to understand that they need to take a medication to treat the infection.
• Unlike the treatment of TB disease, which lasts 6 months or more, shorter TPT regimens that can be completed in 4 to 12 weeks are now available. All TPT needs to be completed as prescribed in order to be effective.
• It may be challenging for an individual to complete a full course of TPT. There are ways to support people who are taking TPT to finish it by working with community health workers, affected communities,TB survivors, civil society organizations and nongovernmental organizations.
• By keeping adults free from TB, children will be able to avoid being exposed to TB and live healthier lives growing up. At the same time, keeping People with HIV free from TB reduces their suffering and help them live healthier and longer TB-free lives.
• People with HIV who are responding well to ART may still get TB. Their TB infection may go unnoticed and untreated for long, until it is too late. Taking TPT will ensure that People with HIV will be protected from TB disease. Not taking TPT is a missed opportunity to prevent unnecessary sickness or even death.
• Most children who become infected with TB have been infected by an adult – whether a parent or another person in the household. They are also at a higher risk of developing TB in the following years and would benefit from TPT. It is important that when someone within the family has been identified to have a TB disease, family members, including children, should be evaluated and encouraged to take TPT.
• There is a need to create demand by sharing information to communities to access TPT and promote TPT among people who need to be protected from TB infection and disease.
• The People with HIV community, people affected by TB, TB survivors, civil society organizations working with children, and civil society organizations and NGOs working on TB are in a unique position to advocate strongly for TPT. Their role is important for symptom screening of household and community contacts, encouraging and referring people to access TPT, lobbying and advocating with the local and national health ministries for allocation of resources and increasing demand to access TPT in their countries and localities.