Predictors of SARS-CoV-2 transmission in congregate living settings: a multicenter prospective study.

BACKGROUND: Older adults residing in congregate living settings (CLS) such as nursing homes and independent living facilities remain at increased risk of morbidity and mortality from coronavirus disease 2019. We performed a prospective multicenter study of consecutive severe acute respiratory coronavirus virus 2 (SARS-CoV-2) exposures to identify predictors of transmission in this setting. METHODS: Consecutive resident SARS-CoV-2 exposures across 17 CLS were prospectively characterized from 1 September 2022 to 1 March 2023, including factors related to environment, source, and exposed resident. Room size, humidity, and ventilation were measured in locations where exposures occurred. Predictors were incorporated in a generalized estimating equation model adjusting for the correlation within CLS. RESULTS: Among 670 consecutive exposures to SARS-CoV-2 across 17 CLS, transmission occurred among 328 (49.0%). Increased risk was associated with nursing homes (odds ratio (OR) = 90.8; 95% CI, 7.8-1047.4), Jack and Jill rooms (OR = 2.2; 95% CI, 1.3-3.6), from source who was pre-symptomatic (OR = 11.2; 95% CI, 4.1-30.9), symptomatic (OR = 6.5; 95% CI, 1.4-29.9), or rapid antigen test positive (OR = 35.6; 95% CI, 5.6-225.6), and in the presence of secondary exposure (OR = 6.3; 95% CI, 1.6-24.0). Exposure in dining room was associated with reduced risk (OR = 0.02; 95% CI, 0.005-0.08) as was medium room size (OR = 0.3; 95% CI, 0.2-0.6). Recent vaccination of exposed resident (OR = 0.5; 95% CI, 0.3-1.0) and increased ventilation of room (OR = 0.9; 95% CI, 0.8-1.0) were marginally associated with reduced risk. CONCLUSION: Prospective assessment of SARS-CoV-2 exposures in CLS suggests that source characteristics and location of exposure are most predictive of resident transmission. These findings can inform risk assessment and further opportunities to prevent transmission in CLS.

Influenza outbreak management tabletop exercise for congregate living settings.

We conducted a tabletop exercise on influenza outbreak preparedness that engaged a large group of congregate living settings (CLS), with improvements in self-reported knowledge and readiness. This proactive approach to responding to communicable disease threats has potential to build infection prevention and control capacity beyond COVID-19 in the CLS sector.

Integration of hospital with congregate care homes in response to the COVID-19 pandemic.

Background: The coronavirus disease 2019 (COVID-19) pandemic has highlighted the need to improve the safety of the environments where we care for older adults in Canada. After providing assistance during the first wave, many Ontario hospitals formally partnered with local congregate care homes in a "hub and spoke" model during second pandemic wave onward. The objective of this article is to describe the implementation and longitudinal outcomes of residents in one hub and spoke model composed of a hospital partnered with 18 congregate care homes including four long-term care and 14 retirement or other congregate care homes. Intervention: Homes were provided continuous seven-day per week access to hospital support, including infection prevention and control (IPAC), testing, vaccine delivery and clinical support as needed. Any COVID-19 exposure or transmission triggered a same-day meeting to implement initial control measures. A minimum of weekly on-site visits occurred for long-term care homes and biweekly for other congregate care homes, with up to daily on-site presence during outbreaks. Outcomes: Case detection among residents increased following implementation in context of increased testing, then decreased post-immunization until the Omicron wave when it peaked. After adjusting for the correlation within homes, COVID-related mortality decreased following implementation (OR=0.51, 95% CI, 0.30-0.88; p=0.01). In secondary analysis, homes without pre-existing IPAC programs had higher baseline COVID-related mortality rate (OR=19.19, 95% CI, 4.66-79.02; p<0.001) and saw a larger overall decrease during implementation (3.76% to 0.37%-0.98%) as compared to homes with pre-existing IPAC programs (0.21% to 0.57%-0.90%). Conclusion: The outcomes for older adults residing in congregate care homes improved steadily throughout the COVID-19 pandemic. While this finding is multifactorial, integration with a local hospital partner supported key interventions known to protect residents.

An ethical framework adapted for infection prevention and control.

OBJECTIVE: The ethical implications of infection prevention and control (IPAC) are recognized, yet a framework to guide the application of ethical principles is lacking. We adapted an ethical framework to provide a systematic approach for fair and transparent IPAC decision making. METHODS: We conducted a literature search for existing ethical frameworks in IPAC. Working with practicing healthcare ethicists, an existing ethical framework was adapted for use in IPAC. Indications were developed for application to practice, with integration of ethical principles and process conditions specifically relevant to IPAC. Practical refinements were made to the framework based on end-user feedback and application to 2 real-world situations. RESULTS: In total, 7 articles were identified that discussed ethical principles within IPAC, but none proposed a systematic framework to guide ethical decision making. The adapted framework, named the Ethical Infection Prevention and Control (EIPAC) framework, takes the user through 4 intuitive and actionable steps, centering key ethical principles that facilitate reasoned and just decision making. In applying the EIPAC framework to practice, weighing the predefined ethical principles in different scenarios was a challenge. Although no hierarchy of principles can apply to all contexts in IPAC, our experience highlighted that the equitable distribution of benefits and burdens, and the proportional impacts of options under review, are particularly important considerations for IPAC. CONCLUSIONS: The EIPAC framework can serve as an actionable ethical principles-based decision-making tool for use by IPAC professionals encountering complex situations in any healthcare context.

Evaluating the impact of a virtual outpatient care programme in preventing hospitalizations, emergency department visits and mortality for patients with COVID-19: a matched cohort study.

OBJECTIVES: To evaluate the impact of virtual care in preventing unnecessary healthcare visits for patients with SARS-CoV-2. METHODS: We conducted a retrospective matched cohort study, evaluating the COVID-19 Expansion to Outpatients (COVIDEO) programme involving virtual assessments for all positive patients in the Sunnybrook assessment centre from January 2020 to June 2021, followed by risk-stratified routine follow-up, couriering of oxygen saturation devices, and 24 hour/day direct-to-physician pager for urgent questions. We linked COVIDEO data to province-wide datasets, matching each eligible COVIDEO patient to ≤10 other Ontario SARS-CoV-2 patients on age, sex, neighbourhood, and date. The primary outcome was emergency department (ED) visit, hospitalization or death within 30 days. Multivariable regression accounted for comorbidities, vaccination, and pre-pandemic healthcare utilization. RESULTS: Among 6508 eligible COVIDEO patients, 4763 (73.1%) were matched to ≥1 non-COVIDEO patient. COVIDEO care was protective against the primary composite outcome (adjusted odds ratio [aOR] 0.91, 95% CI, 0.82-1.02), with a reduction in ED visits (7.8% vs. 9.6%; aOR 0.79, 95% CI, 0.70-0.89), but increase in hospitalizations (3.8% vs. 2.7%, aOR 1.37, 95% CI, 1.14-1.63) reflecting more direct-to-ward admissions (1.3% vs. 0.2%, p < 0.0001). Results were similar when matched comparators were limited to patients who had not received virtual care elsewhere with a decrease in ED visits (7.8 vs. 8.6%, aOR 0.86, 95% CI, 0.75-0.99) and an increase in hospitalizations (3.7 vs. 2.4%, aOR 1.45, 95% CI, 1.17-1.80). DISCUSSION: An intensive remote care programme can prevent unnecessary ED visits and facilitate direct-to-ward hospitalizations and thereby mitigate the impact of COVID-19 on the healthcare system.

Which Curve Are We Flattening? The Disproportionate Impact of COVID-19 Among Economically Marginalized Communities in Ontario, Canada, Was Unchanged From Wild-Type to Omicron.

Person-level surveillance (N = 14 million) and neighborhood-level income data were used to explore magnitude of inequalities in COVID-19 hospitalizations and deaths over 5 waves in Ontario, Canada. Despite attempts at equity-informed policies alongside fluctuating levels of public health measures, the magnitude of inequalities in hospitalizations and deaths remained unchanged across waves.

Impact of universal admission testing for severe acute respiratory coronavirus 2 (SARS-CoV-2) in era of the omicron variant.

In this prospective study, universal admission testing for severe acute respiratory coronavirus virus 2 (SARS-CoV-2) averted transmission in shared patient rooms especially since the emergence of the SARS-CoV-2 omicron variant when the yield in identifying infectious asymptomatic cases more than doubled. This change may be due to the higher rate of asymptomatic infection with the omicron variant, the broader community prevalence during the omicron era, or both.

Differential Patterns by Area-Level Social Determinants of Health in Coronavirus Disease 2019 (COVID-19)-Related Mortality and Non-COVID-19 Mortality: A Population-Based Study of 11.8 Million People in Ontario, Canada.

BACKGROUND: Social determinants of health (SDOH) have been associated with coronavirus disease 2019 (COVID-19) outcomes. We examined patterns in COVID-19-related mortality by SDOH and compared these patterns to those for non-COVID-19 mortality. METHODS: Residents of Ontario, Canada, aged ≥20 years were followed from 1 March 2020 to 2 March 2021. COVID-19-related death was defined as death within 30 days following or 7 days prior to a positive COVID-19 test. Area-level SDOH from the 2016 census included median household income; proportion with diploma or higher educational attainment; proportion essential workers, racially minoritized groups, recent immigrants, apartment buildings, and high-density housing; and average household size. We examined associations between SDOH and COVID-19-related mortality, and non-COVID-19 mortality using cause-specific hazard models. RESULTS: Of 11 810 255 individuals, we observed 3880 COVID-19-related deaths and 88 107 non-COVID-19 deaths. After accounting for demographics, baseline health, and other area-level SDOH, the following were associated with increased hazards of COVID-19-related death (hazard ratio [95% confidence interval]: lower income (1.30 [1.04-1.62]), lower educational attainment (1.27 [1.07-1.52]), higher proportions essential workers (1.28 [1.05-1.57]), racially minoritized groups (1.42 [1.08-1.87]), apartment buildings (1.25 [1.07-1.46]), and large vs medium household size (1.30 [1.12-1.50]). Areas with higher proportion racially minoritized groups were associated with a lower hazard of non-COVID-19 mortality (0.88 [0.84-0.92]). CONCLUSIONS: Area-level SDOH are associated with COVID-19-related mortality after accounting for demographic and clinical factors. COVID-19 has reversed patterns of lower non-COVID-19 mortality among racially minoritized groups. Pandemic responses should include strategies to address disproportionate risks and inequitable coverage of preventive interventions associated with SDOH.

Prevalence and predictors of persistent post-COVID-19 symptoms.

BACKGROUND: The pandemic has affected hundreds of millions of people; early reports suggesting high rates of prolonged symptoms may be prone to selection bias. METHODS: In a program caring for all SARS-CoV-2 positive inpatients and outpatients between March to October 2020, and offering universal 90-day follow-up, we compared those who died prior to 90 days, not responding to follow-up, declining, or accepting follow-up. Among those seen or declining follow-up, we determined the prevalence and predictors of persistent symptoms. RESULTS: Among 993 patients, 21 (2.1%) died prior to 90 days, 506 (50.9%) did not respond, 260 (26.1%) declined follow-up because they were well, and 206 (20.7%) were fully assessed. Of 466 who responded to follow-up inquiry, 133 (28.5%) reported ≥1 persistent symptom, including constitutional (15.5%), psychiatric (14.2%), rheumatologic (13.1%), neurologic (13.1%), cardiorespiratory (12.0%), and gastrointestinal (1.7%). Predictors differed for each symptom type. Any persistent symptom was more common in older patients (adjusted odds ratio [aOR] 1.11, 95% CI 1.04 to 1.18/5 years), those diagnosed in hospital (aOR 2.03, 95% CI 1.24 to 3.33) and those with initial constitutional and rheumatologic symptoms. Patients not responding to follow-up were younger and healthier at baseline. CONCLUSION: Persistent symptoms are common and diverse 3 months post-COVID-19 but are likely over-estimated by most reports.

HISTORIQUE: La pandémie touche des centaines de millions de gens. Les rapports précoces laissant croire à des symptômes prolongés pourraient être assujettis à un biais de sélection. MÉTHODOLOGIE: Dans un programme de soins auprès de tous les patients ambulatoires et hospitalisés ayant reçu un résultat positif au SRAS-CoV-2 entre mars et octobre 2020, assorti d'un suivi universel de 90 jours, les chercheurs ont comparé les personnes qui ont succombé avant 90 jours, n'ont pas répondu au suivi ou ont décliné ou accepté le suivi. Chez celles qui ont été vues ou ont décliné le suivi, ils ont déterminé la prévalence et les prédicteurs de symptômes persistants. RÉSULTATS: Chez les 993 patients, 21 (2,1 %) sont décédés avant les 90 jours, 506 (50,9 %) n'ont pas répondu, 260 (26,1 %) ont décliné le suivi parce qu'ils se sentaient bien et 206 (20,7 %) se sont soumis à une évaluation complète. Des 466 qui ont répondu à l'offre de suivi, 133 (28,5 %) ont signalé ressentir au moins un symptôme persistant, y compris d'ordre constitutionnel (15,5 %), psychiatrique (14,2 %), rhumatologique (13,1 %), neurologique (13,1 %), cardiorespiratoire (12,0 %) et gastro-intestinal (1,7 %). Les prédicteurs différaient en fonction de chaque type de symptômes. Les symptômes persistants étaient courants chez les personnes âgées (rapport de cotes corrigé [RCc] 1,11, IC à 95 %, 1,04 à 1,18/cinq ans), les personnes diagnostiquées à l'hôpital (RCc 2,03, IC à 95 %, 1,24 à 3,33) et celles dont les manifestations initiales comportaient des symptômes constitutionnels et rhumatologiques. Les patients qui ne répondaient pas au suivi étaient plus jeunes et en meilleure santé au départ. CONCLUSION: Les symptômes persistants sont courants et diversifiés trois mois après la COVID-19, mais sont probablement surestimés dans la plupart des rapports.

COVID-19 Cases Among Congregate Care Facility Staff by Neighborhood of Residence and Social and Structural Determinants: Observational Study.

BACKGROUND: Disproportionate risks of COVID-19 in congregate care facilities including long-term care homes, retirement homes, and shelters both affect and are affected by SARS-CoV-2 infections among facility staff. In cities across Canada, there has been a consistent trend of geographic clustering of COVID-19 cases. However, there is limited information on how COVID-19 among facility staff reflects urban neighborhood disparities, particularly when stratified by the social and structural determinants of community-level transmission. OBJECTIVE: This study aimed to compare the concentration of cumulative cases by geography and social and structural determinants across 3 mutually exclusive subgroups in the Greater Toronto Area (population: 7.1 million): community, facility staff, and health care workers (HCWs) in other settings. METHODS: We conducted a retrospective, observational study using surveillance data on laboratory-confirmed COVID-19 cases (January 23 to December 13, 2020; prior to vaccination rollout). We derived neighborhood-level social and structural determinants from census data and generated Lorenz curves, Gini coefficients, and the Hoover index to visualize and quantify inequalities in cases. RESULTS: The hardest-hit neighborhoods (comprising 20% of the population) accounted for 53.87% (44,937/83,419) of community cases, 48.59% (2356/4849) of facility staff cases, and 42.34% (1669/3942) of other HCW cases. Compared with other HCWs, cases among facility staff reflected the distribution of community cases more closely. Cases among facility staff reflected greater social and structural inequalities (larger Gini coefficients) than those of other HCWs across all determinants. Facility staff cases were also more likely than community cases to be concentrated in lower-income neighborhoods (Gini 0.24, 95% CI 0.15-0.38 vs 0.14, 95% CI 0.08-0.21) with a higher household density (Gini 0.23, 95% CI 0.17-0.29 vs 0.17, 95% CI 0.12-0.22) and with a greater proportion working in other essential services (Gini 0.29, 95% CI 0.21-0.40 vs 0.22, 95% CI 0.17-0.28). CONCLUSIONS: COVID-19 cases among facility staff largely reflect neighborhood-level heterogeneity and disparities, even more so than cases among other HCWs. The findings signal the importance of interventions prioritized and tailored to the home geographies of facility staff in addition to workplace measures, including prioritization and reach of vaccination at home (neighborhood level) and at work.

Using Virtual Care to Facilitate Direct Hospital Admissions in Outpatients with Worsening COVID-19 Infection.

Recognizing emergency department overcrowding during the COVID-19 pandemic, a pathway to facilitate direct admissions for outpatients with worsening COVID-19 infection was created using the COVID-19 expansion to outpatients (COVIDEO) virtual care program. Outpatients appropriate for direct admission had oxygen saturations consistently <92% without severe respiratory distress. Pulse oximeters were proactively delivered to high-risk patients, and patients contacted the program in the event of worsening symptoms or desaturation persistently <92%. Over a 15-month period, 9,116 outpatients were managed by the program, 164 of whom were hospitalized, and 83 of those hospitalized (50.6%) were directly admitted through this pathway. Of those directly admitted, 10 (12.0%) patients required ICU admission, occurring a median of 4 days from hospital admission. The mortality rate among directly admitted patients was 3.6% (3/83). Implementation of a virtual care program to facilitate direct admissions in outpatients with COVID-19 created a safe, efficient, and patient-centered pathway of care.

Streptococcus pyogenes secondary impetigo due to loofah sponge use.

Loofah sponges have been implicated in skin and soft tissue infections due to their ability to harbor bacteria and cause microtrauma to the skin. In this case report, we describe a case of impetigo and cellulitis due to Streptococcus pyogenes complicated by secondary spread through loofah sponge use. The same organism was cultured from the infected body sites and loofah sponge, and a comparative genomic analysis confirmed that the isolates were identical.

Increasing concentration of COVID-19 by socioeconomic determinants and geography in Toronto, Canada: an observational study.

BACKGROUND: Inequities in the burden of COVID-19 were observed early in Canada and around the world, suggesting economically marginalized communities faced disproportionate risks. However, there has been limited systematic assessment of how heterogeneity in risks has evolved in large urban centers over time. PURPOSE: To address this gap, we quantified the magnitude of risk heterogeneity in Toronto, Ontario from January to November 2020 using a retrospective, population-based observational study using surveillance data. METHODS: We generated epidemic curves by social determinants of health (SDOH) and crude Lorenz curves by neighbourhoods to visualize inequities in the distribution of COVID-19 and estimated Gini coefficients. We examined the correlation between SDOH using Pearson-correlation coefficients. RESULTS: Gini coefficient of cumulative cases by population size was 0.41 (95% confidence interval [CI]:0.36-0.47) and estimated for: household income (0.20, 95%CI: 0.14-0.28); visible minority (0.21, 95%CI:0.16-0.28); recent immigration (0.12, 95%CI:0.09-0.16); suitable housing (0.21, 95%CI:0.14-0.30); multigenerational households (0.19, 95%CI:0.15-0.23); and essential workers (0.28, 95%CI:0.23-0.34). CONCLUSIONS: There was rapid epidemiologic transition from higher- to lower-income neighborhoods with Lorenz curve transitioning from below to above the line of equality across SDOH. Moving forward necessitates integrating programs and policies addressing socioeconomic inequities and structural racism into COVID-19 prevention and vaccination programs.

Short-term Mortality Outcomes of HIV-Associated Cryptococcal Meningitis in Antiretroviral Therapy-Naïve and -Experienced Patients in Sub-Saharan Africa.

BACKGROUND: An increasing proportion of patients with HIV-associated cryptococcal meningitis have received antiretroviral therapy (ART) before presentation. There is some evidence suggesting an increased 2-week mortality in those receiving ART for <14 days compared with those on ART for >14 days. However, presentation and outcomes for cryptococcal meningitis patients who have recently initiated ART, and those with virologic failure and/or nonadherence, are not well described. METHODS: Six hundred seventy-eight adults with a first episode of cryptococcal meningitis recruited into a randomized, noninferiority, multicenter phase 3 trial in 4 Sub-Saharan countries were analyzed to compare clinical presentation and 2- and 10-week mortality outcomes between ART-naïve and -experienced patients and between patients receiving ART for varying durations before presentation. RESULTS: Over half (56%; 381/678) the study participants diagnosed with a first episode of cryptococcal meningitis were ART-experienced. All-cause mortality was similar at 2 weeks (17% vs 20%; hazard ratio [HR], 0.85; 95% CI, 0.6-1.2; P = .35) and 10 weeks (38% vs 36%; HR, 1.03; 95% CI, 0.8-1.32; P = .82) for ART-experienced and ART-naïve patients. Among ART-experienced patients, using different cutoff points for ART duration, there were no significant differences in 2- and 10-week mortality based on duration of ART. CONCLUSIONS: In this study, there were no significant differences in mortality at 2 and 10 weeks between ART-naïve and -experienced patients and between ART-experienced patients according to duration on ART.

Risk of SARS-CoV-2 transmission from universally masked healthcare workers to patients or residents: A prospective cohort study.

In a multifacility prospective cohort study, we identified 116 acute care, 26 long-term care, and 67 rehabilitation patients who received direct care from a universally masked healthcare worker while communicable with COVID-19. Among 133(64%) patients with at least 14-day follow-up, 3 (2.3%, 95% CI, 0.77-6.4) became positive for SARS-CoV-2. Universal masking, embedded with other infection control practices, is associated with low risk of transmission of SARS-CoV-2 from healthcare workers to patients and residents.

Déterminants individuels et sociaux du test de dépistage du SRAS-CoV-2 et de l'obtention d'un résultat positif en Ontario, au Canada: une étude populationnelle.

CONTEXTE: Optimiser la réponse de la santé publique pour diminuer le fardeau de la COVID-19 nécessite la caractérisation de l'hétérogénéité du risque posé par la maladie à l'échelle de la population. Cependant, l'hétérogénéité du dépistage du SRAS-CoV-2 peut fausser les estimations selon le modèle d'étude analytique utilisé. Notre objectif était d'explorer les biais collisionneurs dans le cadre d'une vaste étude portant sur les déterminants de la maladie et d'évaluer les déterminants individuels, environnementaux et sociaux du dépistage et du diagnostic du SRAS-CoV-2 parmi les résidents de l'Ontario, au Canada. MÉTHODES: Nous avons exploré la présence potentielle de biais collisionneurs et caractérisé les déterminants individuels, environnementaux et sociaux de l'obtention d'un test de dépistage et d'un résultat positif à la présence de l'infection au SRAS-CoV-2 à l'aide d'analyses transversales parmi les 14,7 millions de personnes vivant dans la collectivité en Ontario, au Canada. Parmi les personnes ayant obtenu un diagnostic, nous avons utilisé des études analytiques distinctes afin de comparer les prédicteurs pour les personnes d'obtenir un résultat de test de dépistage positif plutôt que négatif, pour les personnes symptomatiques d'obtenir un résultat de test de dépistage positif plutôt que négatif et pour les personnes d'obtenir un résultat de test de dépistage positif plutôt que de ne pas obtenir un résultat positif (c.-à-d., obtenir un résultat de test de dépistage négatif ou ne pas obtenir de test de dépistage). Nos analyses comprennent des tests de dépistage réalisés entre le 1er mars et le 20 juin 2020. RÉSULTATS: Sur 14 695 579 personnes, nous avons constaté que 758 691 d'entre elles ont passé un test de dépistage du SRAS-CoV-2, parmi lesquelles 25 030 (3,3 %) ont obtenu un résultat positif. Plus la probabilité d'obtenir un test de dépistage s'éloignait de zéro, plus la variabilité généralement observée dans la probabilité d'un diagnostic était grande parmi les modèles d'études analytiques, particulièrement en ce qui a trait aux facteurs individuels. Nous avons constaté que la variabilité dans l'obtention d'un test de dépistage était moins importante en fonction des déterminants sociaux dans l'ensemble des études analytiques. Les facteurs tels que le fait d'habiter dans une région ayant une plus haute densité des ménages (rapport de cotes corrigé 1,86; intervalle de confiance [IC] à 95 % 1,75­1,98), une plus grande proportion de travailleurs essentiels (rapport de cotes corrigé 1,58; IC à 95 % 1,48­1,69), une population atteignant un plus faible niveau de scolarité (rapport de cotes corrigé 1,33; IC à 95 % 1,26­1,41) et une plus grande proportion d'immigrants récents (rapport de cotes corrigé 1,10; IC à 95 % 1,05­1,15), étaient systématiquement corrélés à une probabilité plus importante d'obtenir un diagnostic de SRAS-CoV-2, peu importe le modèle d'étude analytique employé. INTERPRÉTATION: Lorsque la capacité de dépister est limitée, nos résultats suggèrent que les facteurs de risque peuvent être estimés plus adéquatement en utilisant des comparateurs populationnels plutôt que des comparateurs de résultat négatif au test de dépistage. Optimiser la lutte contre la COVID-19 nécessite des investissements dans des interventions structurelles déployées de façon suffisante et adaptées à l'hétérogénéité des déterminants sociaux du risque, dont le surpeuplement des ménages, l'occupation professionnelle et le racisme structurel.

Process evaluation of an implementation strategy to support uptake of a tuberculosis treatment adherence intervention to improve TB care and outcomes in Malawi.

OBJECTIVE: To assess implementation and to identify barriers and facilitators to implementation, sustainability and scalability of an implementation strategy to provide lay health workers (LHWs) with the knowledge, skills and tools needed to implement an intervention to support patient tuberculosis (TB) treatment adherence. DESIGN: Mixed-methods design including a cluster randomised controlled trial and process evaluation informed by the RE-AIM framework. SETTING: Forty-five health centres (HCs) in four districts in the south east zone of Malawi, who had an opportunity to receive cascade training. PARTICIPANTS: Forty-five peer-trainers (PTs), 23 patients and 20 LHWs. INTERVENTION: Implementation strategy employing peer-led educational outreach, a clinical support tool and peer support network to implement a TB treatment adherence intervention. OUTCOME MEASURES: Process data were collected from study initiation to the end-of-study PT meeting, and included: LHW and patient interviews, quarterly PT meeting notes, training logs and study team observations and meeting notes. Data sources were first analysed in isolation, followed by method, data source and analyst triangulation. Analyses were conducted independently by two study team members, and themes revised through discussion and involvement of additional study team members as needed. RESULTS: Forty-one HCs (91%) trained at least one LHW. Of 256 LHWs eligible to participate at study start 152 (59%) completed training, with the proportion trained per HC ranging from 0% to 100% at the end of initial cascade training. Lack of training incentives was the primary barrier to implementation, with intrinsic motivation to improve knowledge and skills, and to improve patient care and outcomes the primary facilitators of participation. CONCLUSION: We identified important challenges to and potential facilitators of implementation, scalability and sustainability, of the TB treatment adherence intervention. Findings provide guidance to scale-up, and use of the implementation strategies employed, to address LHW training and supervision in other areas. TRIAL REGISTRATION NUMBER: NCT02533089.