Toward a conceptual framework of the acceptability of tuberculosis treatment in children using a theory generative approach



Tuberculosis (TB) treatment for drug-susceptible (DS) and drug-resistant (DR)-TB and TB prevention in children and adolescents includes regimens comprising multiple drugs given daily, either as fixed-dose combinations or single-drug formulations. These may be challenging to prepare, administer and ingest [1, 2]. The predominant definition of treatment acceptability is “the overall ability of the patient and caregiver (defined as ‘user’) to use a medicinal product as intended (or authorised)” [3]. However, globally recognised criteria to define and standard methods to assess overall treatment acceptability have not been established [4]. Improving TB treatment acceptability for children and adolescents is increasingly recognised as a global health priority, as poor acceptability of treatment for prevention and treatment along the TB care cascade, may increase the risk of loss-to-follow-up (LTFU) and adversely affect treatment outcomes [5, 6]. Research suggests losses along the TB treatment continuum of 10.8–20.0% among children and unfavourable outcomes of 10–17% [711]. No research to date, describes the associations between treatment acceptability and LTFU and children’s health outcomes.

Broadly, ‘acceptability’ research has included evaluations of behaviour change interventions, health care access, marketing research, perceptions of new technologies and treatment [1218]. Acceptability of drug treatment in children has typically been limited to assessing palatability (which includes the smell, taste, aftertaste, and mouthfeel of drugs) and ease of administration, often using adherence as a proximal indication of acceptability [1921]. However, individual patient-related factors including co-morbidities, treatment adverse effects, and psychological responses may also impact treatment uptake and adherence thus overall acceptability [2226]. Additional broader socio-environmental factors that may contribute to TB treatment acceptability, such as stigmatisation, social determinants of health, poverty and poor functioning health systems, have not been considered [24, 27].

Increased focus on TB in children and adolescents over the past two decades has led to breakthroughs in treatment and care [28, 29]. Among the available TB treatment formulations, the dispersible, taste-masked, fixed-dose combination (FDC) drug formulations for DS-TB regimens in children have been hailed as a marked improvement [30]. Similar development of more child-friendly formulations of second-line TB medications, such as levofloxacin, moxifloxacin, linezolid, bedaquiline and delamanid, have followed [6, 31, 32]. These child-friendly formulations are reportedly more palatable, and are therefore supposedly more acceptable to children and their caregivers [3335]. However, much work remains to be done to design shorter, less complicated regimens for TB prevention and treatment of disease which are easier to complete, with fewer adverse effects to further improve acceptability of regimens [28, 33, 36].

In this manuscript we employed a broader conceptualisation of treatment acceptability and interrogated the acceptability of TB treatment for children along the TB care cascade including prevention and treatment of disease. The more holistic evaluation of the acceptability of TB treatment regimens and care processes could identify opportunities for intervention and improved treatment experiences, thus potentially improving outcomes. A more comprehensive understanding of the acceptability of TB treatment among children and their caregivers is especially important in high TB-burden settings, where social determinants of health influence TB risk, access to care and treatment processes [3739]. A single framework that proposes a holistic conceptual model of TB treatment acceptability in children that includes psychosocial factors has not yet been described [4, 20, 40]. Translating and defining the many aspects of acceptability which can be practicably measured to help establish a more standardised model for the evaluation of TB treatment acceptability is challenging [41, 42]. We aim to fill this gap by proposing an initial conceptual framework to guide the evaluation of acceptability of TB treatment among children and their caregivers.

Materials and methods

Iterative process of generating domains and dimensions for conceptual framework

We first explored existing definitions and operationalisations of acceptability, as previously described, and measured at different points along the TB care cascade (Table 1). We then looked for commonalities and unique components across those definitions and operationalisations. Thereafter we grouped and re-organised these, including suggesting superordinate domains with subordinate dimensions, through several iterations between four of the authors (DTW, RR, LJR and GH). In this process, we renamed, combined, and collapsed, some domains or dimensions to ensure greatest clarity, with consideration of mutually exclusive dimensions and definitional precision. For example, definitions of ‘accommodation’, ‘approachability’, and ‘cultural sensitivity’ overlap substantially, and conversations between co-authors involved identifying that these definitions had to do with (1) receptivity of treatment and care, and (2) health systems interactions. Additional conversations involved excluding some concepts thought to be beyond the scope of the definition of acceptability (e.g., accessibility which involves standardised measures of engagement with the health system) and introduced additional dimensions to cover perceived gaps in the conceptual model, like stigma which, though well-known to impact TB treatment experiences, has not been included in measures of acceptability.

In parallel, we explored data from three qualitative studies of the experiences of children and their caregivers on standard TB treatment regimens for prevention and treatment (see Table 2). We used those data to identify real-world, illustrative examples of the suggested dimensions which we then discussed to refine our definitional clarity and mutual understanding. We also considered whether any aspects of the children and their caregivers’ experiences of their TB treatment were being missed in our iteratively developing conceptual model and refined as needed. We shared a draft conceptual model with illustrative examples with co-authors to further refine the dimensions, domains, and ensure clarity of illustrative examples. Once we had reasonable consensus, we created a diagram to depict the conceptual model. This diagram (Fig 1) and its components were further refined through four iterations of internal author review. We present this conceptual model with illustrative examples as a preliminary framework through which acceptability of TB treatment could be evaluated in future.

Illustrative examples of TB treatment acceptability

The data are drawn from qualitative acceptability studies of three complementary TB treatment trials in children: SHINE (treatment of DS-TB disease), TB-CHAMP (prevention of drug-resistant disease), and MDR-PK2 (treatment of drug-resistant disease) [2, 56, 57]. In each, the aim was to better understand which factors contribute to, or influenced TB treatment acceptability among caregivers and children. SHINE was a randomised trial which compared the safety and efficacy of 4 versus 6 months of daily WHO-recommended FDCs of first-line TB drugs in HIV-positive and HIV-negative children with non-severe DS-TB in four countries [55]. These FDCs were intended to be child-friendly dispersible formulations that had undergone substantial taste-masking. TB-CHAMP is a randomized clinical trial comparing levofloxacin to a placebo as TB preventive therapy (TPT) for child MDR-TB contacts under 5 years of age [56]. The examples were drawn from an exploratory qualitative study within the TB-CHAMP lead-in study, during which a novel dispersible, taste-masked levofloxacin formulation was evaluated [35]. MDR-PK2 was an observational study of the pharmacokinetics and safety of MDR-TB treatment in HIV-positive and HIV-negative children routinely treated as per local standard of care for MDR-TB [2]. All data were collected as in-depth, semi-structured interviews (transcribed and translated verbatim) between September 2016 and July 2018. Separate acceptability studies for SHINE, TB-CHAMP, and MDRPK2 have been reported elsewhere [3335]. The diversity in clinical research samples (prevention, treatment, drug-resistant, drug susceptible, observational and interventional), provided a broad context through which to establish a conceptual understanding of TB treatment acceptability among children and caregivers.


We suggest a novel conceptualisation of overall treatment acceptability, informed by Tables 1 and 3, comprising three broad domains and eight dimensions within these domains (Fig 1). Domain one (usability) refers to the properties of the TB treatment itself and includes dimensions of palatability, administration processes, and appeal. Domain two (receptivity) is the alignment between the treatment and end-users’ perceptions and includes dimensions on adverse consequences, conceptions of health and illness, and prior experiences of treatment and care. Domain three (integration) is the relationship between the treatment and its implementation in the systems/environments where it is intended to be used and includes dimensions of socioeconomic circumstances and health system delivery. Below, we describe each domain and dimension in turn, and in Table 3 provide further illustrative examples using participant quotes from the three qualitative sub-studies.

Domain 1: User-drug interface or ‘usability’

Usability is the alignment between the requirements of daily administration and caregivers’ and children’s ability to incorporate TB treatment into their daily routine. Challenges in usability interfere with integrating TB treatment into everyday routine. We suggest that usability includes treatment palatability, administration considerations, and appeal.


Palatability describes children’s responses to the physical characteristics of the TB treatment (defined as smell, taste, aftertaste and mouth feel, and sight and sound) [4]. For example, a sixteen-year-old adolescent boy said the treatment tastes horrible, making him gag. He tried to neutralise the poor palatability by ingesting the treatment with a lot of water, immediately followed by eating something sweet. Poor palatability negatively impacts usability, and therefore overall acceptability. Additionally, when children dislike the taste of the treatment, it adds to caregivers’ burden of care as they must overcome their children’s resistance to ensure treatment adherence. The caregiver of an eight-month-old girl said the bitter taste of treatment amplified her daughter’s resistance to treatment administration. The caregiver had to improvise new ways to administer treatment to her daughter every day, adding to the emotional and physical labour of care.

Domain 2: User-treatment interface ‘receptivity’

Receptivity refers to the association between end users’ (caregivers’ and children’s) expectations about treatment, and the actual experience of treatment. For example, if the end users hold a health belief that the worse a drug tastes the more effective it must be, then child-friendly formulations of TB treatment that have high palatability may still have poor acceptability because of a poor match to expectations. We suggest three dimensions important to this relationship: (1) balance between TB prevention or treatment benefits against adverse consequences, (2) coherence with conceptions of health and illness, and (3) coherence with prior experiences of TB treatment and other treatments.

Adverse consequences.

Adverse consequences include any detrimental physiological and/or psychosocial consequences children and/or caregivers experience following their child’s treatment initiation. Adverse physiological consequences of TB treatment (including but not limited to, nausea and vomiting, pain, itching and changes in skin colour or texture) negatively impact treatment acceptability. For example, a fourteen-year-old girl on treatment for MDR-TB reported feeling disoriented and lethargic after ingesting treatment, disrupting her ability to contribute to household activities and normal everyday functioning. Her physiological inability to contribute to household chores, also negatively impacted her psychosocial wellbeing. Disruptions to caregivers’ and children’s normal social functioning negatively impacted their experience of TB treatment and therefore its acceptability.

Other adverse psychosocial consequences of TB disease and treatment include withdrawal of social and financial support, isolation, interpersonal conflict, depression, and stigmatisation. The caregiver of a thirteen-year-old-girl on MDR-TB treatment, described how she felt guilty for exposing her daughter (and others) to MDR-TB. Family members and health workers subsequently treated her and her child with apprehension. The internal psychological strain of exposing her child to MDR-TB was exacerbated by others’ negative behaviour towards her and her child. The experience of feeling ostracised by people in their social network adversely affects TB treatment acceptability, as people may be deterred from returning to the clinic and/or adhering to treatment.

Prior and current experiences of treatment and care.

Prior experiences of treatment include experiences of TB treatment and other treatment experiences that may negatively or positively influence caregivers’ and children’s willingness to engage with TB treatment. Caregivers with prior experience of TB disease may access care earlier for their children, as they are more aware of the signs and symptoms of TB and are better able to navigate the health system’s processes to secure a diagnosis. The caregiver of a ten-year-old-boy said she helped enable her child’s diagnosis by identifying signs and symptoms and navigating the health system’s processes after having had TB herself.

Children and caregivers with negative prior experiences of TB treatment (or other treatment) may be less willing and able to administer treatment to their children. For instance, the caregiver of a nine-month-old-boy living with HIV said her son immediately knew when she was going to administer his TB treatment or antiretroviral treatment (ART) and cried during every administration episode. Her child’s experience of ART biased his acceptance of TB treatment. Concurrently administering TB treatment alongside other chronic medications can add to the burden of care and negatively impact overall acceptability among children and caregivers. Conversely, being in long term care and having experienced adherence support services either for a chronic illness (e.g., for HIV) or prior TB episode may also improve understanding and uptake.

Domain 3: User-health system interface ‘integration’

We use user-health system interface to describe the degree of fit between the health systems delivery of TB treatment and care, and the end user’s capacity to utilise that care. We suggest that TB treatment-health system interface, or ‘integration,’ includes socio-economic circumstances and health systems processes like level of care offered, as well as the accessibility and availability of TB treatment related services.


We initially highlight the incongruencies between the broad definition of acceptability, “the overall ability of the patient and caregiver (defined as ‘user’) to use a medicinal product as intended (or authorised)” [3], and existing measures of acceptability of TB treatment in children which primarily focus on palatability and ease of use, particularly among children. We therefore attempted to develop a more holistic conceptual model of acceptability of TB treatment among children and caregivers. Following a theory-generative and iterative process, we propose three domains that encompasses most factors relevant to the overall acceptability of TB treatment: usability, receptivity, and integration. Usability encompasses the alignment between the characteristics most immediately related to the preparation, administration, and use of TB treatment, including the ability to incorporate TB treatment into daily routine. Receptivity involves the relationship between end users’ expectations of the TB treatment and the lived experience of taking TB treatment. Integration involves the association between the health system’s delivery of TB treatment and the end user’s capacity to access and make use of the TB treatment within their context.

Other research on the acceptability of a digital health technology intervention for diagnosing and treating childhood pneumonia in resource-limited settings included understanding the impact of patients’ and caregivers’ economic condition and perceptions of the device’s efficacy [53]. Sekhon et al., argue that the concept of ‘acceptability’ remains “ill-defined, under-theorized, and poorly assessed” [57]. Among the recent conceptual frameworks of treatment acceptability, however, none have been developed that focus on TB treatment in children [4]. Our conceptual model builds on other work that has advocated for drug developers, health services and healthcare workers to collaborate and respond to the myriad pragmatic, financial and social determinations that caregivers and children experience during their TB treatment journeys [33, 50, 58, 59]. Similar to others, we found that the domains/dimensions may overlap [13]. Furthermore, challenges experienced in one domain or dimension may have implications for other domains/dimensions. For example, stigmatisation which falls within the receptivity domain is linked to the appeal of treatment packaging which falls within our ‘usability’ domain. The interrelatedness of each domain resembles the biopsychosocial health model which describes how biological, psychological, and social systems impact individuals’ health possibilities and outcomes [60, 61]. More research is needed to better explore and understand how the domains and correlating dimensions of TB treatment acceptability intersect with and/or influence one another.

Strengths of our theory-generative process include the grounding of our suggested domains within data from three studies with caregivers and children across a wide age spectrum, with and without HIV, and receiving different treatment regimens for prevention and treatment. Additionally, the data were drawn from a diverse group of people from different cultural and ethnic backgrounds. Importantly we included both children and caregivers’ perceptions and experiences of TB treatment in this study. Furthermore, we used multiple iterations of engagement with the published literature and an interdisciplinary team of authors to ensure coherence and applied relevance. Limitations for extrapolation of our conceptual model include that it is based on an inductive process rather than on empirical research. The illustrative examples were all from South Africa, although the clinical context varied substantially, and acceptability may differ by context. More research must be done to determine whether the acceptability of treatment from health workers’ perspectives may influence treatment management processes. Furthermore, this conceptual model requires further empirical research to determine its utility and applicability in different settings including in routine care. Additional investigation of each conceptual domain and related dimensions is necessary to generate a standardised and itemised scale to measure overall acceptability among children and caregivers. Although our framework is informed by the acceptability of TB treatment in children and their caregivers in South Africa, it may have application across different age groups and settings.

Our proposed conceptual framework presents an opportunity to identify key obstacles within households, communities, and healthcare systems to optimise the degree of fit between patients’ needs and available treatment for children with TB. It provides the first steps towards a global standard against which novel treatment strategies could be measured to determine overall TB treatment acceptability. Previously, research on the acceptability of TB treatment in children was scattered and unsystematic. This framework focuses future research on TB treatment acceptability by providing three defined and described domains which can be investigated collectively or separately. Furthermore, this conceptual framework provides a common language through which the acceptability of treatment regimens, strategies, and related health system processes can be studied and compared. Lastly, the framework provides the field with a model with which to determine the acceptability of novel TB treatment strategies in children in the context of family-centred care.


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