This is the first study assessing availability of services for ambulatory DR-TB treatment with all-oral short regimens in Ukraine. Our data show that ambulatory facilities in Zhytomyr are not yet fully prepared to provide comprehensive treatment and care for DR-TB patients. Although basic services were present in most facilities, essential elements for patient-centred care, such as psychosocial support and integrated treatment for co-morbidities and adverse events, were found lacking.
Access to facilities was mostly possible by public transport but most facilities were not open after regular office hours. DR-TB treatment is known to lead to catastrophic costs for patients and their households, including travel-costs and due to time spent at the facility for DOT [23, 24]. Instead of enforcing DOT, patients-specific approaches on where, when and how to access treatment should be sought .
All facilities had medical staff available. TB-training was limited, especially in non-TB-units, where TB-doctors were less present. Training increases knowledge on TB and is likely to reduce stigma [26, 27]. TB-patients in Ukraine reported in interviews that they experience stigmatising behaviour more commonly from non-specialised and junior health care workers . Continuous education, including specific training on critical changes, such as introduction of new TB-regimens, should be available to all TB-care providers . Staff in newly designated outpatient DR-TB facilities should receive DR-TB training, especially non-TB-specialists in health posts and ambulatories.
Although TB-medicines were present and storage space was acceptable, ancillary medicines were rarely available outside of MSF support, even in TB-units. Stock of minimal ancillary medicines should include drugs to treat common adverse events such as gastro-intestinal disturbances, joint pains, dizziness and skin rashes . These adverse events can be debilitating if left untreated and contribute significantly to a loss of quality of life [30, 31]. ART was unavailable, and HIV-patients had to travel to an ART-centre monthly. One in five TB-patients in Ukraine is HIV-positive, yet there is lack of integration of these services . Integration of HIV/TB-services is effective and cost-effective, and specific WHO-guidance exists for patient-centred TB-services in Eastern Europe and Central Asia [32, 33]. TB-units could be the sites for referral for adverse events management and ART-refills, and they should be adequately supplied with medicines.
Basic infection control measures were unavailable in many facilities, especially health posts, but also in TB-units. Currently patients are only referred to ambulatory care once they become smear negative and are thus non-infectious. The next step in the decentralisation process is the TB-treatment initiation in ambulatory facilities. Basic measures such as ventilation, UV-equipment, and personal protective equipment will be necessary to protect other patients and health-care workers .
Laboratory and diagnostic services were available in most TB-units, but audiometry equipment was unavailable. Progressive hearing loss is an irreversible side-effect of injectables, which can be detected and limited through audiometry monitoring . While BDQ is included in national DR-TB protocols in Ukraine, audiometry remains crucial for patients already on injectable-containing regimens . Among potential side-effects of new drugs requiring regular monitoring is the prolongation of the QT-interval [35, 36]. Early safety results indicate a limited risk of cardiac toxicity from BDQ and DLM, and regular electrocardiogram monitoring might become less relevant in the future .
Psychosocial services were inconsistently available and if present, provided by external non-governmental actors. A review across 20 countries found pooled prevalence of 25% depression, 24% anxiety and 10% psychosis in DR-TB patients, with stigma, isolation, discrimination and lack of social support as main stressors . In Ukraine, high prevalence of HIV and substance use disorders in DR-TB patients contribute to additional stigma and mental stress [11, 39]. A Ukrainian study found that patient receiving social support are less likely to be lost to follow up . A health service assessment in four central European countries, concluded that tailored, patient-centred services where paramount for good DR-TB care .
Availability of ancillary medicines, psychosocial assessment, and essential ART-monitoring services like viral load at implementation sites are minimum conditions for roll-out of new DR-TB treatment according to WHO . Absence of these services hampers delivery of quality DR-TB care [3, 10]. Some benefits of TB-decentralisation are undone if patients need to travel separately to access ancillary medicines, ART or electrocardiography. Integration of services is equally necessary for diabetes, viral hepatitis, substance-use disorder and other mental health conditions . Chronic co-morbidities, as well as permanent disability from side-effects, increase the DR-TB burden and impact patients’ well-being during and after the end of treatment [30, 42]. To limit the impact of these factors in reducing quality of life after treatment, patient-centred interventions should be established during treatment . Roll-out of oral regimens is an opportunity to shift from controlling towards supporting patients to improve adherence with individualised approaches, considering patient reality.
While family doctors are set to become the main healthcare providers for patients under the healthcare reform, only two family doctors were included in this analysis. Non-TB specialists could be reluctant to recruit DR-TB patients due to TB-related stigma, which is common in Ukraine and associated with limited TB-knowledge [43, 44]. In Zhytomyr, so far only two thirds of the population have been linked to family doctors, which is in line with national numbers . A possible explanation is the fact that no clear mechanisms to link patients and doctors have been identified [14, 18]. Such mechanisms for TB, and intensive TB-training for family doctors will be necessary to provide adequate care .
Our study has several limitations. We did not assess a representative sample of ambulatory facilities in Zhytomyr, but visited facilities based on the needs of patients being discharged from the regional TB-dispensary. However, these facilities provided care for 30% of DR-TB patients in Zhytomyr, including all outpatients on BDQ/DLM-containing treatment. We used staff responses for results we could not physically verify, which could have led to overestimation of quality of services. For instance, staff might have overstated availability to provide weekend DOT-services. Recall bias might lead to an overestimation of TB-training received in the last two years. The cross-sectional design of our study did not allow tracking improvements over time, and repetition of similar surveys is necessary to evaluate progress.
As decentralisation of TB-treatment and country-wide roll-out of all-oral short regimens is imminent in Ukraine, defining needs and strengthening of ambulatory facilities is essential to ensure that quality care can be provided to DR-TB patients. In the short term, infection control equipment and ancillary medicines should be quantified and supplied to each ambulatory site. Training should be provided on integrated TB-care, including infection control, especially for staff in health posts, ambulatories and family doctors. TB-units in oblast like Zhytomyr could serve as pilot-sites for decentralisation of integrated HIV and TB-services, while including minimum standards for provision of psychosocial and psychiatric services. Similar analyses to ours could be repeated in other oblasts, should include family doctors, and identified issues should be acted upon by dedicated taskforces. A recently developed “Quality of tuberculosis services assessment tool”, including facility, provider and patient assessments could be used for more in-debt assessments in outpatient facilities .
The national TB-programme should take advantage of the health reform coinciding with all-oral DR-TB regimen roll-out to provide an integrated training package to healthcare workers, and set ambitious goals for quality DR-TB care for the country. TB patients as end-users could be engaged to monitor quality of services and given the tools to safely report gaps .