RetourEnsuring adherence to TB therapy is one of the important challenges for achieving a successful treatment outcome, particularly for patients with drug-resistant TB (DR-TB). This is because of the large number of medications, the frequent and serious adverse drug reactions, and the social and financial costs to patients related to TB treatment. Because DR-TB and extensively drug-resistant TB (XDR-TB) treatment are often the last chance for treatment for many patients, and because there are serious public health consequences if treatment fails, it is important that all patients are supported using a person-centred approach to ensure full adherence to treatment (7).
Good adherence to TB treatment (taking all the medications at the correct time) is essential to prevent the development of resistance and increase the chances of cure. Taking all the medications for TB therapy is difficult, particularly for DR-TB, because treatment regimens can sometimes be long, the daily pill burden is high, there are frequent and serious adverse drug reactions, and access to care can cause social and economic costs to patients. A person-centred approach is needed to maximize treatment adherence and enable early intervention with patients who are not responding to treatment, who are not able to take their medications or who are having adverse effects from treatment. Optimal person-centred care consists of multiple interventions, including social support (informational/educational, psychological and emotional, and material support), treatment administration options and digital adherence technologies. Staff education and support that allow health care workers to provide health education and counselling on TB disease and treatment adherence are strongly recommended. It is also recommended that all patients receive medicines under an appropriate treatment administration option and that they benefit from social support interventions that ensure full adherence to treatment, with a person-centred approach based on sound ethics and with respect for human rights.
NTPs need to improve patient access to quality treatment adherence interventions and optimal treatment administration options. Although all people with TB should receive appropriate care and support interventions, particular attention should be paid to patients being treated for DR-TB because DR-TB treatment is often the last therapeutic option for many patients and there are serious public health costs if treatment fails.
The following recommendations from the WHO guidelines on TB care and support (15, 16) continue to apply to patients with drug-susceptible (DS) and drug-resistant (DR) TB.
3.1 Social support in TB management
TB causes suffering and even death. Despite highly effective treatment, there are many psychological, social, medical and economic factors that can prevent people from accessing diagnosis, following care plans and successfully completing a course of treatment. The following is an adapted summary of how these factors may have an impact on psychological health, health-seeking behaviour and adherence (8):
- Stigma, fear of discrimination, social isolation and lack of social support can affect screening, access to care and the ability to complete a treatment plan.
- The poorest and most marginalized communities that are at high risk of TB are also most likely to experience significant health and economic inequalities which further limit their access to care and treatment.
- The diagnosis of TB may cause distress and have an impact on self-worth that may affect patients’ sense of agency.
- Financial worries and limitations on everyday activities associated with TB (e.g. time off work) and its treatment (e.g. diagnostic and treatment costs, transport costs) add to the burdens on the patients.
- Long treatment duration may cause frustration and possible side-effects may make treatment intolerable or unpleasant, leading people to interrupt treatment.
- Life situations (e.g. financial challenges, a death in the family or marital difficulties) may have a negative impact on psychological health and on patients’ ability to take their medication.
- TB often presents with comorbidities (e.g. diabetes, HIV/AIDS) which may cause further difficulties for the patient.
- People with TB may also have mental disorders – such as opioid or alcohol use disorders or depression – that may complicate their ability to adhere to treatment or tolerate medication without additional support. Similarly, some TB medications may also worsen mental health conditions.
- Poor-quality medical care without rights-based, people-centred and respectful care can also add to the psychological burden of illness and treatment.
- When treatment fails, people grieve and may suffer and feel hopeless.
- Lack of support from services, friends and family may harm the patient’s emotional health.
- TB and its long-term treatment affect families and caregivers. Their anxieties and burden of work taking care of the patient can make it difficult to support treatment adherence, infection control and the patient’s needs over time.
Several populations are particularly vulnerable to TB and at higher risk of having poor outcomes, namely: children, miners, migrant populations, people who are incarcerated, and people who suffer from opioid or alcohol use disorders. Health care providers who deal with vulnerable populations need to have skills to assess and respond to the psychological and social needs of these people when TB is detected (17).
Social support is very important to a people-centred approach to improve the well-being of people infected with TB and to support treatment plans by addressing the barriers described above. Social support must be available for people throughout TB treatment, from diagnosis to the conclusion of the treatment.
Social support refers to the amount of perceived and practical care received from family, friends and/or the community (18). It aims to provide care to patients to show that they are part of a social network that cares for them. Social support improves health outcomes and reduces death. Adding social support to the medication treatment regimens can improve treatment outcomes for people suffering from TB (15, 16).
Social support is made up of four resources, namely (11):
- Informational support is information or education that helps a person to solve problems and reduce stress; it includes training and education on the medications a person is taking, their possible side-effects, how treatment is monitored, and how the success of treatment is determined.
- Psychological (emotional) support refers to all types of care that strengthen self-esteem through understanding, trust, encouragement and care, and that help to deal with the psychological challenges in life.
- Material support includes financial support which could be money (e.g. grants from the government), food support, travel support or anything that helps the patient with the financial costs of TB disease and its treatment.
- Companionship support is help that makes a person feel that he or she belongs to the social system, and that he or she can rely on it for certain needs.
Creating a way for the TB programme to deliver these four social support resources to patients, taking into consideration any specific age- or gender-sensitive concerns, is necessary for a person-centred approach that makes sure patients are doing well and can complete their TB treatment. The principles of social support described here should be ensured for vulnerable populations, including older persons, people who are incarcerated, internally displaced persons or refugees, people with substance use disorders, indigenous communities and ethnic minorities.
Many programmes use a multidisciplinary “support to adherence” team (social workers, nurses, health educators, community treatment supporters and doctors). Support may focus on problems related to different stages of treatment, social stigma of the illness, treatment adherence, side-effects, financial and social difficulties, other comorbidities or special situations and death.
The type of support should be selected on the basis of an assessment of the patient’s needs, the health provider’s resources and conditions in the community. A single type of support or a combination of different types of social support can be chosen for each patient according to the individual needs. Social support should be available to people in inpatient or outpatient care, including home- or community-based treatment and care, peer support and community TB support programmes.
3.1.1 Informational and educational support
This support includes all information necessary to help patients and their caregivers understand TB, including the biological and social determinants of the disease, and agree on the steps for following the treatment plan and participating in local activities to engage communities in the response to TB. As an example, the guide on the standardized package of community-based support services to improve TB outcomes describes many of the possible services for adherence support in detail (19). Provision of information and education should begin as soon as diagnosis is made and should continue throughout the course of treatment. Patient information and education take place over several visits with different health care providers, including physicians, nurses and community health workers. Materials should be appropriate to the literacy levels of the patient, available in local languages and should be gender-, age- and culturally sensitive. Information and educational pamphlets with reminders of the main points, in the local language, are helpful. For patients with literacy limitations, efforts should be made to use e-health tools based on audio or visual support.
Patients should also be provided with material to help them understand their rights in their local language (9, 10). The Patients’ Charter for Tuberculosis Care also describes the responsibilities of patients and will help the provider to educate the patient about the disease, the treatment and the overall response of the government and civil society to the TB epidemic.
The NTP and all health care providers should use methods of “communicating with” (and not “talking at”) patients and their caregivers in a way that builds a positive partnership towards successful improved quality of life and treatment completion. For patients with literacy limitations, e-health tools based on audio or visual support should be used.
Although implementing patient-centred high-quality TB care as outlined in the International standards for tuberculosis care (1) will often require additional time to be spent by health care workers, a lot can be achieved with simple changes in the attitudes and language used by health care providers and by communicating key information about the disease.
The ethical and person-centred approach of the End TB Strategy is to be reflected as well in the language used by all TB stakeholders, including health care providers. Language is a well-known method of exerting power and control. Words such as “defaulter”, “suspect” and “control” contribute to disempowering TB patients despite the good intentions of the health care providers. It is still not uncommon to find expressions such as “patient failed treatment”, which puts the blame only on the patient as if he or she were the only person responsible for failure of treatment. WHO has recommended replacing such language with words that are more respectful of patients and reflect better the values of the patient-centred approach to care that is now widely accepted in the TB community. Some examples include replacing “defaulter” with “person lost to follow-up”, “TB suspect” with “person with suspected TB” or “person to be evaluated for TB”; and “control” with ‘prevention and care’. This handbook and future TB documents of WHO are taking note of this suggestion to prevent derogatory and judgemental tones in the language used with patients and within TB prevention, diagnosis, treatment and care (20). For further details, see Section 4.2 on Effective communication skills and Section 4.3 on Counselling to provide information.
3.1.2 Psychological and emotional support
Dealing with TB and its treatment can be emotionally devastating for patients and their families. As a result, there is immense distress that affects the quality of life of patients and that may also interfere with the way they follow their treatment.
Emotional support usually refers to having close relationships with family and friends, with whom one can talk and feel loved and cared for. Psychological support is based on a skill set whereby trained personal can help alleviate distress. Psychological support tries to help with thought, emotional and behavioural concerns that may arise because of the stress of being diagnosed with TB, because of the treatment, or because of other life situations or stresses caused by TB. Informal psychological support can be provided by physicians, nurses, treatment supporters, family or community members by building a relationship with patients based on understanding and compassion to help them deal with psychological challenges in life, solve problems and lessen sources of stress. This kind of support may also help patients to follow their treatment plans and gain the skills needed to deal with stigma and discrimination. Details of techniques to provide psychological support are further discussed in Section 4.5.
For formal psychological support – particularly if informal support is not successful, the impact of the challenges is severe or mental health problems are suspected (e.g. depression, substance and alcohol misuse, and persons experiencing post-traumatic stress disorder) – some TB patients may need to be referred to mental health services. There is also a close association between common mental disorders, including substance use disorders, which is described in Section 4.5. Therefore, it is essential to have a comprehensive assessment and referral system between TB, mental health services and community support.
Formal methods of providing psychological support can be one-to-one counselling sessions or support groups assisted by counsellors. Support groups may allow patients with TB to meet and socialize with other patients, including those who have recovered from TB, and provide support to each other as well. Further details are discussed in Section 4.5 on Counselling to provide psychological support.
3.1.3 Material support
Socioeconomic problems should be addressed to enable patients and their families to be able to complete TB treatment and reduce the impact that the disease and treatment have on their quality of life. These challenges can be successfully tackled through socioeconomic interventions, such as food baskets or transportation vouchers, that enable patients to complete the treatment and which usually work best when they are adapted to a patient’s specific needs. Some NTPs and health care providers have used these as enablers – i.e. as a means to help patients to address hurdles in taking medication and completing therapy. While enablers may improve outcomes, it is most important to use material support to overcome barriers that otherwise would be impossible for patients to overcome without some form of support.
Material support can be services or commodities – e.g. financial support, food baskets, food supplements, food vouchers, transport subsidies, living allowance, housing enablers or cash transfer. This support helps patients or caregivers with the costs they face in order to obtain health services and tries to lessen the stress of income loss related to TB. At the beginning of treatment, the financial resources of the patient should be evaluated in order to support those in need of assistance using material support. The most support should be given to patients with the most need. Health care workers, treatment supporters, social workers or other professionals can help evaluate needs and make sure the material support reaches the patient. Cash transfers and microfinance support can improve household food security, which has been shown to increase access to health care. When prolonged hospitalization is necessary, supporting the patient and their family financially with a minimum “living-allowance” would be a helpful step under the patient-centred care approach.
Nutritional support is particularly important and can be part of material support. Not only does nutritional support help to lessen the financial stress of TB disease, but malnutrition/undernutrition can make TB disease worse, and TB can cause malnutrition. People who are malnourished/undernourished and who have TB disease are more likely to have worse outcomes and are more likely to die of TB than others. Children and pregnant/breastfeeding women are at particular risk from malnutrition. Treatment of malnutrition/undernutrition through material support should be considered just as important as other TB medications when managing patients with TB. Indeed, nutritional support should be included as part of a standard treatment and care plan for TB. Further details on nutritional care and support can be found in the Guideline: nutritional care and support for patients with tuberculosis (21) and WHO framework for collaborative action on tuberculosis and comorbidities (22).
The involvement of civil society – such as patient support groups and nongovernmental organizations, as well as community- or faith-based organizations – is necessary to provide social support services. A more long-term way to provide material support to TB patients is to include all patients who qualify in the social protection programmes (such as unemployment benefits if the patient cannot work) that many countries have for vulnerable populations.
3.1.4 Companionship support
On-site social support for patients, their families and friends through peer counselling can improve the effectiveness of TB programmes. TB programmes can develop support activities that identify patients who have been cured (“community champion” or “ex-patient”) and provide them with training to be a peer supporter. This worker engages in support, treatment literacy and communication with other patients under treatment. These community champions or ex-patients should follow each patient from diagnosis through to cure, and they should act as both friend and educator. From the patient’s perspective, having this companion available reduces the psychological burden of the long duration of treatment and provides them with skills to cope with TB stigma and discrimination.
Peer support groups, community champions or ex-patients and trained health workers can offer information-sharing sessions to educate patients, help with better detection of risk factors for default (e.g. understanding adverse effects of medication) and identify other warning signs that can affect treatment outcome.
Companionship support provides the basis for developing a social network within the care facility, which can play an essential role in improving rates of treatment completion. Working together, a health worker, a peer supporter and the patient can build a spirit of collaboration and innovation aimed at reducing stigma and can reaffirm that TB can be successfully treated within an environment of mutual respect among all involved.
3.2 Treatment administration and digital adherence technologies
3.2.1 Treatment support
Treatment administration options that are effective and suitable should be considered for each patient at the start of the patient’s treatment. Treatment support (an updated adaptation of directly observed treatment) is defined as another person (either a health care worker or a lay person) helping a patient with TB take his/her TB medications, providing emotional support and medically intervention (or recognizing when medical intervention is necessary) in the case of non-response to therapy or adverse effects from treatment. However, some subgroups of patients with factors affecting treatment adherence are more likely or less likely to benefit from certain forms of treatment support than other patients are; or certain types of delivery of treatment support (e.g. location of treatment support or type of treatment support provider) are likely to work better than others. Consequently, an assessment is required at the start of treatment in order to choose the most appropriate treatment administration option for each patient. Treatment provided closer to the patient normally offers convenience for the patient and, therefore, achieves better outcomes. Treatment support delivered at home or in the community, near the patient’s home or workplace, should be considered as the preferred options as they have shown better outcomes than treatment support provided at a health care facility, which is normally further away from the patient than the other options (15, 23).
The TB treatment supporter should maintain strict confidentiality regarding the patient’s disease and treatment. In some cases, this may require working out a system whereby the patient can receive medication without the knowledge of others. The TB treatment supporter should be someone whom the patient is comfortable with. The TB treatment supporter should have the appropriate training and skills. Although evidence shows that treatment support by a health care worker, trained lay provider and family member displays advantages compared to unsupervised treatment, treatment support provided by trained lay providers and health care workers are the preferred options and the least preferred treatment support provider is a family member (15).
In some settings and circumstances treatment support may be provided by health workers and in others by community members trained to deliver treatment for all forms of TB. While family-based treatment support has shown effectiveness in several settings, health care workers should be aware that family relationships can be complicated for the TB patient, and as a result either the patient or the family TB treatment supporter may encounter subtle manipulation or abuse that can jeopardize adherence to treatment, management of adverse drug reactions and access to social support services. Training and education for health care workers and treatment support providers are necessary to ensure the quality of treatment administration. Training and education can be done through many types of educational sessions, charts or visual reminders, educational tools and desktop aids for decision-making and reminders.
When in-person treatment support is not possible for the patient and treatment provider, digital adherence technologies, such as video-supported treatment (VST), short message service (SMS), telephone calls or other means of communication can be considered when they are available and can be used by both health care providers and patients.
3.2.2 Digital adherence technologies
Various digital health products are being used to support different elements of TB programmes, such as electronic health records, direct data transfer from diagnostic systems and e-Learning modules on mobile applications (24). Digital adherence technologies fit into the larger landscape of information technologies and are intended to help improve communication between patients and health care workers (25). Three technologies have been studied in TB patients and are used to support treatment on a large scale, namely SMS or mobile text, event monitoring devices for medication support (EMMs) and VST for TB (26, 27).
SMS is a standard, built-in function found in all types of mobile telephones worldwide and is generally inexpensive and easy to use. It is thus widely applied for communicating with outpatients. SMS can provide regular, automated message reminders to patients to take their medications, can provide information related to their health or condition (unidirectional) or provide opportunities to interact as well (bidirectional). Most RCTs of SMS reminders in TB care in different geographical settings failed to show improved patient outcomes when compared with standard care. However, the control groups in these trials achieved high levels of adherence through varying scales of in-person support. The results also suggest that SMS could, to some degree, support adherence at times during treatment when in-person treatment support by a health care provider is not possible, thus increasing efficiency if not effectiveness. SMS could also be used when there is less necessity to see the patient face to face but there is still a need to keep in contact with the patient in case any concerns arise, such as during the continuation phase of treatment or when a patient has been on stable treatment for a long time without any problems. Research has yet to look more creatively at how SMS can influence adherence behaviour other than just by reminding people to take their pills, such as by channelling cash transfers when treatment milestones are achieved, by combining SMS reminders with other digital solutions and by targeting other points along the patient pathway. The popularity and affordability of SMS present a compelling case for further studies to investigate its potential more exhaustively. Instant messaging via installed mobile software may be used instead of SMS.
EMMs aim to provide more patient flexibility when following up treatment; to support patients with dosing and refill reminders and instructions; and to compile patient-specific dosing histories to enable counselling and differentiated care. EMM boxes consist of automated electronic devices that record and inform the health care provider about the regularity with which a medicine container is opened. Older devices recorded usage on the container itself, but mobile telephones now allow patient reminders and alerts to be sent to the caregiver when medicine boxes remain unopened for a day or more. A large cluster-randomized trial showed a statistically significant effect of EMM boxes on adherence relative to the SoC; however, the effect on successful treatment completion was less clear (28). Various technological advances with EMMs, such as requiring patients to dial in (to toll-free numbers) codes revealed when daily blister packs of medications are opened can be used to verify adherence. Under trial, a prototype brand of this technology – 99DOTS (29) – showed similar treatment completion rates when compared to the traditional adherence monitoring and support used by the sites, suggesting that this EMM could be a viable alternative to more labour-intensive forms of medication adherence monitoring (30). Nonetheless, more evaluation is needed of the feasibility and utility of this technology (31).
VST is the form of digital adherence technology that most closely replicates human interaction. The increasing availability of Internet-enabled smartphones and tablet computers equipped with free or customized video communication software has increased options for both real-time (synchronous) and recorded (asynchronous) interactions. Observational studies and trials of VST for TB treatment from different settings suggest that the technique can produce similar outcomes to those produced by in-person monitoring and can improve efficiency (32–35). Given the potential benefits of VST, studies are needed to evaluate it against different standards of care, including self-administered treatment, and to evaluate the acceptability of VST in different population subgroups and in more resource-limited geographical settings.
The advantages of using VST are its potential to provide treatment support from a distance – and even when people travel and cannot visit or be visited by a TB treatment supporter. VST could help achieve better levels of patient interaction at a much lower cost and less inconvenience when compared with in-person treatment support. VST can be used in addition to, or interchangeably with, in-person treatment support or other treatment administration options.
Another option for providing care to patients when face-to-face visits are difficult is to schedule appointments to talk with them by telephone. Questions regarding treatment can be answered, symptoms can be monitored and counselling can be provided. Care should be taken to make sure that patients are able to find a place to talk where they have privacy. Also, if airtime is expensive, the length of time needed for these discussions may be too costly for the patient.
The performance of digital adherence technology under study conditions needs to be translated into programmatic realities. Health care practitioners and patients require practical aids that can adapt to a patient’s treatment course across a wide variety of different treatment conditions and at distinct time points when treatment interruption is more likely to happen. Technologies for treatment adherence support should be part of an integrated approach that complements the delivery of quality care. For instance, it is unrealistic and undesirable for patients on a longer DR-TB regimen to be placed on exclusive VST for 18–20 months. The risk of interruption is not uniform between patients or even during the treatment of the same patient. Treatment support therefore needs to be flexible throughout a patient’s course of treatment. Special attention is needed when there is a change in the treatment regimen which increases the risk of developing adverse medication reactions when: 1) the patient questions the need to continue the prescribed treatment as symptoms disappear and when she or he feels better; 2) conversely, when the patient may not be feeling better and may feel that treatment is hopeless; 3) when the patient travels far away from the usual treatment centre; or 4) when other events affect a patient’s daily routine and make daily treatment more difficult.
The three digital approaches discussed have specific strengths and weaknesses, which may make them work better in some circumstances rather than in others, as well as differing preferences of the patient and health care workers. On the basis of the different characteristics of each of the adherence support technologies and the patient’s individual situation, multiple options might be suitable. Two additional issues to consider are access to smartphones and to broadband Internet via mobile subscriptions. Smartphones and tablet computers, given their computing power and storage space, could be a valuable resource for multiple aspects of TB care. These can be useful even when broadband Internet is unavailable or erratic (e.g. recording of asynchronous VST, storage of patient medical records and e-Learning applications). SMS and EMM – which can operate without mobile broadband Internet coverage – are currently the most accessible, affordable and easily expandable treatment support approaches in resource-limited settings. Where mobile Internet is reliable and computer hardware available, solutions with more connectivity requirements can be considered as options.
The increasing range of technologies available for treatment support helps improve person-centred care. Nonetheless, digital technologies are still to be regarded as tools and should not replace face-to-face interactions when these are more appropriate. Another important consideration is that digital adherence technologies depend on the regular observation of a person’s behaviour in order to follow up adherence. This poses a number of ethical issues (7). Some technologies may affect a patient’s privacy more than others – such as receiving a daily SMS text message that asks for a reply, the automated monitoring of the opening of a medicine box, or a video recording of a medicine being swallowed. The benefits of having recordings of patients taking their medications and the ability to text or speak with patients have to be balanced against potential downsides – such as patients feeling they are being controlled, a sense of being tracked and distrusted, loss of empowerment and concerns about confidentiality. These issues need to be discussed at length with the patients (see Section 4.1 on Guiding principles for health education and counselling). Further issues to consider when determining which treatment support technology may be best for a patient include the ability and willingness to learn to use the technology. Visual impairment and literacy may make it difficult for patients to use mobile telephones correctly. Another concern is that the cost of airtime or data may be too expensive for patients to use some of these technologies. Acceptability and preferences should be explored with each patient as part of her or his adherence plan.
3.3 Selecting a suitable package of care and support for a patient
To support people with TB during their treatment, health policy-makers and practitioners must appreciate that TB affects all aspects of patients’ lives. A focus on caring for each patient as an individual should underlie all aspects of treatment and care. Overall, the principles for person-centred care and support (described in Section 2) should be followed.
The evidence reviewed and WHO recommendations suggested that a combination of appropriate care and support interventions improves outcomes for patients (15, 23). Selecting appropriate interventions for each patient is very important and requires proper assessments and consultation with each patient to identify her or his needs and preferences. This should be done both prior to the start of the TB treatment and during the treatment. All the recommended interventions should be considered as part of this process – including social support, treatment administration options, digital adherence technologies and the model of TB care.
Box 1 describes the use of the 5 A’s (Assess, Advise, Agree, Assist and Arrange) that help to facilitate a process for identifying the best treatment plan together with the most appropriate package of care and support interventions that best suits the patient.
33 Treatment adherence interventions include social support such as: patient education and counselling; material support (e.g. food, financial incentives, transport fees); psychological support; tracers such as home visits or digital health communications (e.g. SMS, telephone calls); medication monitor; and staff education. The interventions should be selected based on the assessment of the individual patient’s needs, provider’s resources and conditions for implementation.
34 Suitable treatment administration options include various forms of treatment support, such as video-supported treatment and regular community or home-based treatment support.
35 Tracers refer to the communication with the patient – including via SMS, telephone (voice) calls or home visits.
36 A digital medication monitor is a device that can measure the time between openings of the pill box. The medication monitor may have audio reminders or may send an SMS to remind the patient to take the medications, along with recording when the pill box is opened.
37 Material support can be food or financial support: meals, food baskets, food supplements, food vouchers, transport subsidies, living allowance, housing incentives or financial bonus. This support addresses indirect costs incurred by patients or their attendants in accessing health services and, possibly, tries to mitigate the consequences of income loss related to the disease.
38 Psychological support can be counselling sessions or peer-group support.
39 Staff education can be adherence education, charts or visual reminders, educational tools and desktop aids for decision-making and reminder.