Background
Each year, approximately 700,000 people globally are treated for recurrent tuberculosis (TB) and a further 125,000 are treated for multi-drug resistant tuberculosis [
1]. People presenting with recurrent or multidrug-resistant disease require extended courses of treatment which include daily injections of anti-tuberculous medications, often for many months [
2]. If the treatment of recurrent and drug resistant TB is to be successful, it is essential that models for the delivery of long-term injectables are feasible and affordable for health systems; but crucially that they are also acceptable to health system users.
There are various options for the delivery of long-term daily injectables as part of TB treatment, but each has major disadvantages. Prolonged admission to hospital is associated with hospital-acquired infections [
3]; social and economic consequences for patients and their households [
4]; and a disproportionate burden on health systems [
5]. A number of community-based approaches to care have been implemented, but once again these often face barriers to success [
6]. A system which involves healthcare workers travelling daily to patients at home in order to administer injections incurs additional expense and healthcare worker hours. The alternative is for patients to travel daily to a health facility, but this model simply transfers the time and financial burdens onto already vulnerable health system users.
The TB-RROC (TB Retreatment Regimen Outcomes and Care) Trial (ISRCTN05815615) aimed to assess a novel method of community-based management for patients with recurrent TB. These patients are prescribed a number of oral anti-tuberculous drugs plus the injectable drug
streptomycin daily during the first two months of TB treatment [
2]. Participants in the TB-RROC Trial received hospital or community-based care during the two-month period that they were receiving streptomycin injections. Community-based care involved training patient-nominated lay people (‘guardians’) to administer streptomycin injections to patients in their own homes. In many Sub-Saharan African countries, if a patient is admitted to hospital they are accompanied by a ‘guardian’ – a lay person, usually a family member or friend, who looks after them and provides much of their basic care including washing, dressing, feeding and even giving oral medications [
7]. In the TB-RROC trial, adult patients were recruited after admission to the TB ward for treatment of recurrent TB. Two hundred and four participants were individually randomised to receive hospital or community-based care after the patient was medically fit for discharge and their self-appointed guardian had successfully been trained to deliver injections.
The aim of this qualitative study was to evaluate the experiences of the participants in the TB-RROC trial. This is the first study which specifically addresses user experiences of different models of care for patients who require long-term injections as part of TB treatment.
Discussion
Evaluation of the lived experiences of patients and their guardians during the injections for TB retreatment produced three main categories of description: medical issues, the physical environment and trust. Experiences were often influenced by context of the patients’ and guardians’ prior roles within their communities and households, and resulted in a range of emotional responses such as sadness, fear, anger, happiness and acceptance. Community-based management affected experiences in all three categories of description, and again these experiences were impacted by previous roles and backgrounds.
A striking finding is the disastrous effect that admission to hospital has on peoples’ ability to continue normal daily life, and in particular the catastrophic consequences of this on their livelihoods. Once discharged, those in the community were relieved of many of their expenses and more easily able to return to their usual routines, thus relieving some of the economic pressures and associated emotional stress. Reducing catastrophic costs associated with TB is a key element of the post 2015 Global TB strategy [
9], as catastrophic costs push households further into poverty, which is associated with the development of TB [
10], delayed diagnosis [
11], poor adherence and worse clinical outcomes [
12].
Socially, the advantages of a community-based model were also evident. Patients, guardians, family members and local communities were all affected by having to look after those in hospital. Social capital is widely recognised to be a crucial component of peoples’ ability to access care, engage with health systems and remain in treatment. Although solidarity from social networks or ‘the clanship system’ [
13] have traditionally been seen as fundamental to the structure of many African societies, it has also been reported that the main source of assistance (and therefore duty) lies within the household rather than with the wider community [
14]. In line with this, those with strong social networks admitted to hospital in this study were able to rely on both families and broader social groups to help with the practicalities of being sick, whereas those with weaker social networks suffered. ‘Social networks’ were most often informal, but also included networks based around a workplace or religious community.
The commitment and sacrifice shown by guardians was often enormous. The motivations for people to volunteer as community health workers have previously been well described and include both financial and non-financial reward [
15,
16]. However, the factors that influence how a family member or friend volunteers to take on a guardian role, are less well understood, and this study goes some way to describing those factors.
Reciprocity is a key concept defining social interactions. It includes motivation for looking after the sick, and is particularly relevant in Africa [
17]. The importance of reciprocity is once again demonstrated by this study in multiple situations, including the motivation for taking on the role of guardian in hospital and at home; community responsibility for the sick; and patients looking after other unwell people on the ward.
In contrast to previous studies [
18,
19], the role of guardian was not particularly gendered with men and women taking equal responsibility for all aspects of care. It may have been that the task of administering injections was seen as more important (and therefore more appropriate for men to take on) than other traditional roles played by guardians such as washing and cleaning. However, by and large, male guardians enrolled into the trial continued in their guardian roles even after being randomised to hospital-based care.
There were a few instances where people encountered discrimination, but this was not a central theme and the examples were all related to fears around TB being associated with HIV, which have been well illustrated in previous studies [
20‐
22]. It was acknowledged that admission to hospital often disclosed HIV as well as TB status, particularly if the admission was long. The research was conducted in two urban areas with high burdens of HIV and TB, therefore the understanding and assumptions which people were able to make may apply less in settings where the prevalence of HIV is lower. Importantly, there was only perceived, but not realised, stigma around guardians delivering injections in the community; and no concerns were expressed about transmission of TB from patients receiving injections at home.
Emotionally, there was a broad range of experiences, which arose from medical, practical and social factors. Experiences of people on the ward were often distressing, with issues around overcrowding, lack of space, and hygiene being paramount. Other common feelings were the sadness and anxiety around financial issues and the neglect of children at home, which is consistent with previous literature [
23].
The concept of ‘the sick role’ acknowledges illness as a social and cultural phenomenon, in which the sick person adheres to a specific role within society, which brings with it certain rights and responsibilities. Data from this study clearly demonstrate patients taking on a sick role, as the nature of their position in society and relationships with others are completely changed by their illness. In this study, it is clear that patients in the community feel able to break free from the sick role whereas patients in hospital maintain the role. Moreover, one of the aspects of community-based care which contributed most to patients’ emotional well-being (and, according to some, physical well-being) was the ability to practically and psychologically move away from this role.
Experience of medical care varied. Participants described well known barriers and facilitators to accessing care such as previous experience of TB [
24], costs [
25], accessing informal providers [
26], stigma [
27], and HIV [
28].
For both hospital and community-based care, trust in the health system is crucial. The importance of trust in the health system is that it increases a patient’s willingness to seek care, enhances ability to engage with treatment, improves relationships between patient and clinician, facilitates disclosure, and may grant patients more autonomy in decision-making [
29]. Theories of trust can be framed around both trust in the individual and in the system. In the current study we see that indeed trust in the healthcare system was primarily determined by interactions with healthcare workers, and that failure of these representatives to earn the respect of trial participants, impaired the relationship between the two. Conversely, the feeling of security generated by being in hospital represented the trust that people had in the ability of clinicians and nurses to provide help if a patient was unwell.
One of the major advantages of community-based care was the opportunity to escape the overcrowded and often unclean conditions on the ward. The distress that this caused to patients and guardians is in keeping with previous literature in which patients with MDR-TB have expressed a preference for home-based care, citing transmission of infection and lack of psychosocial support as problems with hospital-based care [
30].
Study limitations
The study had some limitations. Data were collected almost exclusively at a single time point, just after completion of injections. It may have been that experiences changed during the period of the intervention and also that both community-based management and hospital-based management may have longer term effects on participants beyond the completion of injections. Additionally, although every attempt was made to sample participants who experienced adverse events during the trial, only two participants (one patient and his guardian) were interviewed who had complications whilst in the community. The impact of urban or rural residence was not specifically examined in this study, with only three of the interviewees from rural areas.
Stakeholder concerns addressed and implications for policy
There had been a number of concerns raised by those consulted at the start of the TB-RROC trial, which this evaluation have helped address. Firstly, there was a fear that guardians simply would not deliver the injections at home. Not only did trial participants report excellent adherence, this was made more convincing by the (often in-depth) explanations they were able to provide as to why they would not miss doses.
Secondly, there had been a worry that guardians would not be competent to deliver injections. Although many were also initially apprehensive, all of those who took part were able to overcome these concerns and embrace the responsibility.
Thirdly, the issue of access to medical care during treatment at home had been raised. Very few participants described needing to access care whilst in the community but those who did were able to contact the study team, and in the one situation where admission was necessary, this was easily arranged and the ultimate outcome was positive.
Finally, it had been suggested that training people to do injections might create a cadre within society of ‘lay injectors’ who would be expected to provide injections for people within their communities. The data from this study strongly suggest that the risk of that happening would be very low.
These data were used to provide the Malawi National TB Programme with additional information which could be used to modify and improve the model of community-based care for patients requiring injections as part of TB treatment. Recommendations included: developing more concrete clinical guidelines for selecting patients to be managed in the community; setting out suggestions for choosing guardians to do injections; and ensuring clear pathways to access care from the community if patients become unwell.