Barriers and facilitators of tuberculosis infection prevention and control in low- and middle-income countries from the perspective of healthcare workers: A systematic review.

Tuberculosis remains a leading cause of death worldwide. Transmission is the dominant mechanism sustaining the multidrug-resistant tuberculosis epidemic. Tuberculosis infection prevention and control (TBIPC) guidelines for healthcare facilities are poorly implemented. This systematic review aimed to explore the barriers and facilitators of implementation of TBIPC guidelines in low- and middle-income countries from the perspective of healthcare workers. Two separate reviewers carried out an electronic database search to select qualitative and quantitative studies exploring healthcare workers attitudes towards TBIPC. Eligible studies underwent thematic synthesis. Derived themes were further organised into a macro-, meso- and micro-level framework, which allows us to analyse barriers at different levels of the healthcare system. We found that most studies focused on assessing implementation within facilities in accordance with the hierarchy of TBIPC measures-administrative, environmental and respiratory protection controls. TBIPC implementation was over-estimated by self-report compared with what researchers observed within facilities, indicating a knowledge-action gap. Macro-level barriers included the lack of coordination of integrated HIV/tuberculosis care, in the context of an expanding antiretroviral therapy programme and hence increasing opportunity for nosocomial acquisition of tuberculosis; a lack of funding; and ineffective occupational health policies, such as poor systems for screening for tuberculosis amongst healthcare workers. Meso-level barriers included little staff training to implement programmes, and managers not understanding policy sufficiently to translate it into an IPC programme. Most studies reported micro-level barriers including the impact of stigma, work culture, lack of perception of risk, poor supply and use of respirators and difficulty sensitising patients to the need for IPC. Existing literature on healthcare workers' attitudes to TBIPC focusses on collecting data about poor implementation at facility level. In order to bridge the knowledge-action gap, we need to understand how best to implement policy, taking account of the context

A qualitative study of patients and healthcare workers’ experiences and perceptions to inform a better understanding of gaps in care for pre-discharged tuberculosis patients in Cape Town, South Africa

Background Many people diagnosed with Mycobacterium tuberculosis (TB) in tertiary and district hospitals in South Africa do not arrive at their primary care clinic for continued care after they are discharged from the hospital. This loss to follow up is a major, ongoing problem for public health in South Africa, and contributes to drug-resistant TB strains. The objective of this paper was to explore patients’ experiences and perceptions of diagnosis and treatment before their discharge from hospital. We use a framework known as patient-centred care to illustrate how these patient narratives point to lapses in these principles within the hospital system, and to show how such lapses may contribute to loss to follow up and inconsistent TB care. Methods We employed a qualitative study using semi-structured interviews to investigate patient and healthcare workers’ experiences and perceptions of TB care in two Western Cape hospitals. We purposefully sampled 17 patients, 10 healthcare workers, and two key informant policy makers, all of whom had relevant experiences and insights. Data collection was done between October 2015 and February 2017. Data were analysed using Miles and Huberman’s qualitative analysis framework. Results Hospitals did not achieve patient-centred care. Newly diagnosed patients were provided with inadequate TB education, diseased-focused approaches were favoured over patient-focused approaches, and there was limited engagement with patients to understand their needs and feelings during the critical period between diagnosis and discharge. Consequently, some patients felt anxious prior to their discharge from hospital. Coupled with their overwhelming socio-economic barriers and complex family situations, some patients felt hopeless and powerless as they prepared for discharge. Finally, there was a lack of patient-provider partnership due to problems including healthcare workers’ time constraints and heavy workloads, which detracted from a focus on patients’ needs and feelings. Conclusions Improving the three intersecting elements of patient-centred care (health education, engaging with patients’ needs and feelings, and shared decision-making) has the potential to positively influence patients’ continuity of care for TB in South Africa. It would be helpful to also proactively address how patients plan to stay connected to care, on treatment, and supported, in light of their family situation or socio-economic circumstances. Detailed and unique pre-discharge counselling for each patient may be valuable in this regard

Organisational Culture and Mask-Wearing Practices for Tuberculosis Infection Prevention and Control among Health Care Workers in Primary Care Facilities in the Western Cape, South Africa: A Qualitative Study

Background: Although many healthcare workers (HCWs) are aware of the protective role that mask-wearing has in reducing transmission of tuberculosis (TB) and other airborne diseases, studies on infection prevention and control (IPC) for TB in South Africa indicate that mask-wearing is often poorly implemented. Mask-wearing practices are influenced by aspects of the environment and organisational culture within which HCWs work. Methods: We draw on 23 interviews and four focus group discussions conducted with 44 HCWs in six primary care facilities in the Western Cape Province of South Africa. Three key dimensions of organisational culture were used to guide a thematic analysis of HCWs’ perceptions of masks and mask-wearing practices in the context of TB infection prevention and control. Results: First, HCW accounts address both the physical experience of wearing masks, as well as how mask-wearing is perceived in social interactions, reflecting visual manifestations of organisational culture in clinics. Second, HCWs expressed shared ways of thinking in their normalisation of TB as an inevitable risk that is inherent to their work and their localization of TB risk in specific areas of the clinic. Third, deeper assumptions about mask-wearing as an individual choice rather than a collective responsibility were embedded in power and accountability relationships among HCWs and clinic managers. These features of organisational culture are underpinned by broader systemic shortcomings, including limited availability of masks, poorly enforced protocols, and a general lack of role modelling around mask-wearing. HCW mask-wearing was thus shaped not only by individual knowledge and motivation but also by the embodied social dimensions of mask-wearing, the perceptions that TB risk was normal and localizable, and a shared underlying tendency to assume that mask-wearing, ultimately, was a matter of individual choice and responsibility. Conclusions: Organisational culture has an important, and under-researched, impact on HCW mask-wearing and other PPE and IPC practices. Consistent mask-wearing might become a more routine feature of IPC in health facilities if facility managers more actively promote engagement with TB-IPC guidelines and develop a sense of collective involvement and ownership of TB-IPC in facilities

Waiting times, patient flow, and occupancy density in South African primary health care clinics: implications for infection prevention and control

AbstractBackgroundTransmission of respiratory pathogens, such as Mycobacterium tuberculosis and severe acute respiratory syndrome coronavirus 2, is more likely during close, prolonged contact and when sharing a poorly ventilated space. In clinics in KwaZulu-Natal (KZN) and Western Cape (WC), South Africa, we estimated clinic visit duration, time spent indoors and outdoors, and occupancy density of waiting rooms.MethodsWe used unique barcodes to track attendees’ movements in 11 clinics in two provinces, multiple imputation to estimate missing arrival and departure times, and mixed-effects linear regression to examine associations with visit duration.Results2,903 attendees were included. Median visit duration was 2 hours 36 minutes (interquartile range [IQR] 01:36–3:43). Longer mean visit times were associated with being female (13.5 minutes longer than males; p&lt;0.001) and attending with a baby (18.8 minutes longer than those without; p&lt;0.01), and shorter mean times with later arrival (14.9 minutes shorter per hour after 0700; p&lt;0.001) and attendance for tuberculosis or ante/postnatal care (24.8 and 32.6 minutes shorter, respectively, than HIV/acute care; p&lt;0.01).Overall, attendees spent more of their time indoors (median 95.6% [IQR 46–100]) than outdoors (2.5% [IQR 0–35]). Attendees at clinics with outdoor waiting areas spent a greater proportion (median 13.7% [IQR 1– 75]) of their time outdoors.In two clinics in KZN (no appointment system), occupancy densities of ∼2.0 persons/m2 were observed in smaller waiting rooms during busy periods. In one clinic in WC (appointment system), occupancy density did not exceed 1.0 persons/m2 despite higher overall attendance.ConclusionsLonger waiting times were associated with early arrival, being female, and attending with a young child. Attendees generally waited where they were asked to. Regular estimation of occupancy density (as patient flow proxy) may help staff assess for risk of infection transmission and guide intervention to reduce time spent in risky spaces.</jats:sec

Estimating waiting times, patient flow, and waiting room occupancy density as part of tuberculosis infection prevention and control research in South African primary health care clinics

From PLOS via Jisc Publications RouterHistory: received 2021-09-01, collection 2022, accepted 2022-06-13, epub 2022-07-20Publication status: PublishedFunder: Economic and Social Research Council; funder-id: http://dx.doi.org/10.13039/501100000269; Grant(s): ES/P008011/1Funder: The Bloomsbury SET; Grant(s): CCF17-7779Transmission of respiratory pathogens, such as Mycobacterium tuberculosis and severe acute respiratory syndrome coronavirus 2, is more likely during close, prolonged contact and when sharing a poorly ventilated space. Reducing overcrowding of health facilities is a recognised infection prevention and control (IPC) strategy; reliable estimates of waiting times and ‘patient flow’ would help guide implementation. As part of the Umoya omuhle study, we aimed to estimate clinic visit duration, time spent indoors versus outdoors, and occupancy density of waiting rooms in clinics in KwaZulu-Natal (KZN) and Western Cape (WC), South Africa. We used unique barcodes to track attendees’ movements in 11 clinics, multiple imputation to estimate missing arrival and departure times, and mixed-effects linear regression to examine associations with visit duration. 2,903 attendees were included. Median visit duration was 2 hours 36 minutes (interquartile range [IQR] 01:36–3:43). Longer mean visit times were associated with being female (13.5 minutes longer than males; p<0.001) and attending with a baby (18.8 minutes longer than those without; p<0.01), and shorter mean times with later arrival (14.9 minutes shorter per hour after 0700; p<0.001). Overall, attendees spent more of their time indoors (median 95.6% [IQR 46–100]) than outdoors (2.5% [IQR 0–35]). Attendees at clinics with outdoor waiting areas spent a greater proportion (median 13.7% [IQR 1–75]) of their time outdoors. In two clinics in KZN (no appointment system), occupancy densities of ~2.0 persons/m2 were observed in smaller waiting rooms during busy periods. In one clinic in WC (appointment system, larger waiting areas), occupancy density did not exceed 1.0 persons/m2 despite higher overall attendance. In this study, longer waiting times were associated with early arrival, being female, and attending with a young child. Occupancy of waiting rooms varied substantially between rooms and over the clinic day. Light-touch estimation of occupancy density may help guide interventions to improve patient flow

Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial

Background—Children account for a substantial proportion of cases and deaths from Ebola virus disease. We aimed to assess the safety and immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vectorbased vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a paediatric population in Sierra Leone. Methods—This randomised, double-blind, controlled trial was done at three clinics in Kambia district, Sierra Leone. Healthy children and adolescents aged 1–17 years were enrolled in three age cohorts (12–17 years, 4–11 years, and 1–3 years) and randomly assigned (3:1), via computer-generated block randomisation (block size of eight), to receive an intramuscular injection of either Ad26.ZEBOV (5 × 1010 viral particles; first dose) followed by MVA-BN-Filo (1 × 108 infectious units; second dose) on day 57 (Ebola vaccine group), or a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo (second dose) on day 57 (control group). Study team personnel (except for those with primary responsibility for study vaccine preparation), participants, and their parents or guardians were masked to study vaccine allocation. The primary outcome was safety, measured as the occurrence of solicited local and systemic adverse symptoms during 7 days after each vaccination, unsolicited systemic adverse events during 28 days after each vaccination, abnormal laboratory results during the study period, and serious adverse events or immediate reportable events throughout the study period. The secondary outcome was immunogenicity (humoral immune response), measured as the concentration of Ebola virus glycoprotein-specific binding antibodies at 21 days after the second dose. The primary outcome was assessed in all participants who had received at least one dose of study vaccine and had available reactogenicity data, and immunogenicity was assessed in all participants who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response. This study is registered at ClinicalTrials.gov, NCT02509494. Findings—From April 4, 2017, to July 5, 2018, 576 eligible children or adolescents (192 in each of the three age cohorts) were enrolled and randomly assigned. The most common solicited local adverse event during the 7 days after the first and second dose was injection-site pain in all age groups, with frequencies ranging from 0% (none of 48) of children aged 1–3 years after placebo injection to 21% (30 of 144) of children aged 4–11 years after Ad26.ZEBOV vaccination. The most frequently observed solicited systemic adverse event during the 7 days was headache in the 12–17 years and 4–11 years age cohorts after the first and second dose, and pyrexia in the 1–3 years age cohort after the first and second dose. The most frequent unsolicited adverse event after the first and second dose vaccinations was malaria in all age cohorts, irrespective of the vaccine types. Following vaccination with MenACWY, severe thrombocytopaenia was observed in one participant aged 3 years. No other clinically significant laboratory abnormalities were observed in other study participants, and no serious adverse events related to the Ebola vaccine regimen were reported. There were no treatment-related deaths. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine regimen were observed in 131 (98%) of 134 children aged 12–17 years (9929 ELISA units [EU]/mL [95% CI 8172–12 064]), in 119 (99%) of 120 aged 4–11 years (10 212 EU/mL [8419–12 388]), and in 118 (98%) of 121 aged 1–3 years (22 568 EU/mL [18 426–27 642]). Interpretation—The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen was well tolerated with no safety concerns in children aged 1–17 years, and induced robust humoral immune responses, suggesting suitability of this regimen for Ebola virus disease prophylaxis in children

Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial

Background The Ebola epidemics in west Africa and the Democratic Republic of the Congo highlight an urgent need for safe and effective vaccines to prevent Ebola virus disease. We aimed to assess the safety and long-term immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in Sierra Leone, a country previously affected by Ebola. Methods The trial comprised two stages: an open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2. The study was done at three clinics in Kambia district, Sierra Leone. In stage 1, healthy adults (aged ≥18 years) residing in or near Kambia district, received an intramuscular injection of Ad26.ZEBOV (5×1010 viral particles) on day 1 (first dose) followed by an intramuscular injection of MVA-BN-Filo (1×108 infectious units) on day 57 (second dose). An Ad26.ZEBOV booster vaccination was offered at 2 years after the first dose to stage 1 participants. The eligibility criteria for adult participants in stage 2 were consistent with stage 1 eligibility criteria. Stage 2 participants were randomly assigned (3:1), by computer-generated block randomisation (block size of eight) via an interactive web-response system, to receive either the Ebola vaccine regimen (Ad26.ZEBOV followed by MVA-BN-Filo) or an intramuscular injection of a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo on day 57 (second dose; control group). Study team personnel, except those with primary responsibility for study vaccine preparation, and participants were masked to study vaccine allocation. The primary outcome was the safety of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen, which was assessed in all participants who had received at least one dose of study vaccine. Safety was assessed as solicited local and systemic adverse events occurring in the first 7 days after each vaccination, unsolicited adverse events occurring in the first 28 days after each vaccination, and serious adverse events or immediate reportable events occurring up to each participant’s last study visit. Secondary outcomes were to assess Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second vaccine in a per-protocol set of participants (ie, those who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response) and to assess the safety and tolerability of the Ad26.ZEBOV booster vaccination in stage 1 participants who had received the booster dose. This study is registered at ClinicalTrials.gov, NCT02509494. Findings Between Sept 30, 2015, and Oct 19, 2016, 443 participants (43 in stage 1 and 400 in stage 2) were enrolled; 341 participants assigned to receive the Ad26.ZEBOV and MVA-BN-Filo regimen and 102 participants assigned to receive the MenACWY and placebo regimen received at least one dose of study vaccine. Both regimens were well tolerated with no safety concerns. In stage 1, solicited local adverse events (mostly mild or moderate injection-site pain) were reported in 12 (28%) of 43 participants after Ad26.ZEBOV vaccination and in six (14%) participants after MVA-BN-Filo vaccination. In stage 2, solicited local adverse events were reported in 51 (17%) of 298 participants after Ad26.ZEBOV vaccination, in 58 (24%) of 246 after MVA-BN-Filo vaccination, in 17 (17%) of 102 after MenACWY vaccination, and in eight (9%) of 86 after placebo injection. In stage 1, solicited systemic adverse events were reported in 18 (42%) of 43 participants after Ad26.ZEBOV vaccination and in 17 (40%) after MVA-BN-Filo vaccination. In stage 2, solicited systemic adverse events were reported in 161 (54%) of 298 participants after Ad26.ZEBOV vaccination, in 107 (43%) of 246 after MVA-BN-Filo vaccination, in 51 (50%) of 102 after MenACWY vaccination, and in 39 (45%) of 86 after placebo injection. Solicited systemic adverse events in both stage 1 and 2 participants included mostly mild or moderate headache, myalgia, fatigue, and arthralgia. The most frequent unsolicited adverse event after the first dose was headache in stage 1 and malaria in stage 2. Malaria was the most frequent unsolicited adverse event after the second dose in both stage 1 and 2. No serious adverse event was considered related to the study vaccine, and no immediate reportable events were observed. In stage 1, the safety profile after the booster vaccination was not notably different to that observed after the first dose. Vaccine-induced humoral immune responses were observed in 41 (98%) of 42 stage 1 participants (geometric mean binding antibody concentration 4784 ELISA units [EU]/mL [95% CI 3736–6125]) and in 176 (98%) of 179 stage 2 participants (3810 EU/mL [3312–4383]) at 21 days after the second vaccination. Interpretation The Ad26.ZEBOV and MVA-BN-Filo vaccine regimen was well tolerated and immunogenic, with persistent humoral immune responses. These data support the use of this vaccine regimen for Ebola virus disease prophylaxis in adults