Scaling-up and scaling-out the Systems Analysis and Improvement Approach to optimize the hypertension diagnosis and care cascade for HIV infected individuals (SCALE SAIA-HTN): a stepped-wedge cluster randomized trial.

BACKGROUND: Undiagnosed and untreated hypertension is a main driver of cardiovascular disease and disproportionately affects persons living with HIV (PLHIV) in low- and middle-income countries. Across sub-Saharan Africa, guideline application to screen and manage hypertension among PLHIV is inconsistent due to poor service readiness, low health worker motivation, and limited integration of hypertension screening and management within HIV care services. In Mozambique, where the adult HIV prevalence is over 13%, an estimated 39% of adults have hypertension. As the only scaled chronic care service in the county, the HIV treatment platform presents an opportunity to standardize and scale hypertension care services. Low-cost, multi-component systems-level strategies such as the Systems Analysis and Improvement Approach (SAIA) have been found effective at integrating hypertension and HIV services to improve the effectiveness of hypertension care delivery for PLHIV, reduce drop-offs in care, and improve service quality. To build off lessons learned from a recently completed cluster randomized trial (SAIA-HTN) and establish a robust evidence base on the effectiveness of SAIA at scale, we evaluated a scaled-delivery model of SAIA (SCALE SAIA-HTN) using existing district health management structures to facilitate SAIA across six districts of Maputo Province, Mozambique. METHODS: This study employs a stepped-wedge design with randomization at the district level. The SAIA strategy will be "scaled up" with delivery by district health supervisors (rather than research staff) and will be "scaled out" via expansion to Southern Mozambique, to 18 facilities across six districts in Maputo Province. SCALE SAIA-HTN will be introduced over three, 9-month waves of intensive intervention, where technical support will be provided to facilities and district managers by study team members from the Mozambican National Institute of Health. Our evaluation of SCALE SAIA-HTN will be guided by the RE-AIM framework and will seek to estimate the budget impact from the payer's perspective. DISCUSSION: SAIA packages user-friendly systems engineering tools to support decision-making by frontline health workers and to identify low-cost, contextually relevant improvement strategies. By integrating SAIA delivery into routine management structures, this pragmatic trial will determine an effective strategy for national scale-up and inform program planning. TRIAL REGISTRATION: ClinicalTrials.gov NCT05002322 (registered 02/15/2023).

A sequential, multiple assignment randomized trial comparing web-based education to mobile video interpreter access for improving provider interpreter use in primary care clinics: the mVOCAL hybrid type 3 study protocol.

BACKGROUND: Individuals who use a language other than English for medical care are at risk for disparities related to healthcare safety, patient-centered care, and quality. Professional interpreter use decreases these disparities but remains underutilized, despite widespread access and legal mandates. In this study, we compare two discrete implementation strategies for improving interpreter use: (1) enhanced education targeting intrapersonal barriers to use delivered in a scalable format (interactive web-based educational modules) and (2) a strategy targeting system barriers to use in which mobile video interpreting is enabled on providers' own mobile devices. METHODS: We will conduct a type 3 hybrid implementation-effectiveness study in 3-5 primary care organizations, using a sequential multiple assignment randomized trial (SMART) design. Our primary implementation outcome is interpreter use, calculated by matching clinic visits to interpreter invoices. Our secondary effectiveness outcome is patient comprehension, determined by comparing patient-reported to provider-documented visit diagnosis. Enrolled providers (n = 55) will be randomized to mobile video interpreting or educational modules, plus standard interpreter access. After 9 months, providers with high interpreter use will continue as assigned; those with lower use will be randomized to continue as before or add the alternative strategy. After another 9 months, both strategies will be available to enrolled providers for 9 more months. Providers will complete 2 surveys (beginning and end) and 3 in-depth interviews (beginning, middle, and end) to understand barriers to interpreter use, based on the Theoretical Domains Framework. Patients who use a language other than English will be surveyed (n = 648) and interviewed (n = 75) following visits with enrolled providers to understand their experiences with communication. Visits will be video recorded (n = 100) to assess fidelity to assigned strategies. We will explore strategy mechanism activation to refine causal pathway models using a quantitative plus qualitative approach. We will also determine the incremental cost-effectiveness of each implementation strategy from a healthcare organization perspective, using administrative and provider survey data. DISCUSSION: Determining how these two scalable strategies, alone and in sequence, perform for improving interpreter use, the mechanisms by which they do so, and at what cost, will provide critical insights for addressing a persistent cause of healthcare disparities. TRIAL REGISTRATION: NCT05591586.

The Systems Analysis and Improvement Approach: specifying core components of an implementation strategy to optimize care cascades in public health.

BACKGROUND: Healthcare systems in low-resource settings need simple, low-cost interventions to improve services and address gaps in care. Though routine data provide opportunities to guide these efforts, frontline providers are rarely engaged in analyzing them for facility-level decision making. The Systems Analysis and Improvement Approach (SAIA) is an evidence-based, multi-component implementation strategy that engages providers in use of facility-level data to promote systems-level thinking and quality improvement (QI) efforts within multi-step care cascades. SAIA was originally developed to address HIV care in resource-limited settings but has since been adapted to a variety of clinical care systems including cervical cancer screening, mental health treatment, and hypertension management, among others; and across a variety of settings in sub-Saharan Africa and the USA. We aimed to extend the growing body of SAIA research by defining the core elements of SAIA using established specification approaches and thus improve reproducibility, guide future adaptations, and lay the groundwork to define its mechanisms of action. METHODS: Specification of the SAIA strategy was undertaken over 12 months by an expert panel of SAIA-researchers, implementing agents and stakeholders using a three-round, modified nominal group technique approach to match core SAIA components to the Expert Recommendations for Implementing Change (ERIC) list of distinct implementation strategies. Core implementation strategies were then specified according to Proctor's recommendations for specifying and reporting, followed by synthesis of data on related implementation outcomes linked to the SAIA strategy across projects. RESULTS: Based on this review and clarification of the operational definitions of the components of the SAIA, the four components of SAIA were mapped to 13 ERIC strategies. SAIA strategy meetings encompassed external facilitation, organization of provider implementation meetings, and provision of ongoing consultation. Cascade analysis mapped to three ERIC strategies: facilitating relay of clinical data to providers, use of audit and feedback of routine data with healthcare teams, and modeling and simulation of change. Process mapping matched to local needs assessment, local consensus discussions and assessment of readiness and identification of barriers and facilitators. Finally, continuous quality improvement encompassed tailoring strategies, developing a formal implementation blueprint, cyclical tests of change, and purposefully re-examining the implementation process. CONCLUSIONS: Specifying the components of SAIA provides improved conceptual clarity to enhance reproducibility for other researchers and practitioners interested in applying the SAIA across novel settings.

Infection Prevention and Control Initiatives to Prevent Healthcare-Associated Transmission of SARS-CoV-2, East Africa.

The coronavirus disease pandemic has highlighted the need to establish and maintain strong infection prevention and control (IPC) practices, not only to prevent healthcare-associated transmission of SARS-CoV-2 to healthcare workers and patients but also to prevent disruptions of essential healthcare services. In East Africa, where basic IPC capacity in healthcare facilities is limited, the US Centers for Disease Control and Prevention (CDC) supported rapid IPC capacity building in healthcare facilities in 4 target countries: Tanzania, Ethiopia, Kenya, and Uganda. CDC supported IPC capacity-building initiatives at the healthcare facility and national levels according to each country's specific needs, priorities, available resources, and existing IPC capacity and systems. In addition, CDC established a multicountry learning network to strengthen hospital level IPC, with an emphasis on peer-to-peer learning. We present an overview of the key strategies used to strengthen IPC in these countries and lessons learned from implementation.

Association between service readiness and PMTCT cascade effectiveness: a 2018 cross-sectional analysis from Manica province, Mozambique.

BACKGROUND: Despite high coverage of maternal and child  health services in Mozambique, prevention of mother-to-child transmission of HIV (PMTCT) cascade outcomes remain sub-optimal. Delivery effectiveness is modified by health system preparedness. Identifying modifiable factors that impact quality of care and service uptake can inform strategies to improve the effectiveness of PMTCT programs. We estimated associations between facility-level modifiable health system readiness measures and three PMTCT outcomes: Early infant diagnosis (polymerase chain reaction (PCR) before 8 weeks of life), PCR ever (before or after 8 weeks), and positive PCR test result. METHODS: A 2018 cross-sectional, facility-level survey was conducted in a sample of 36 health facilities covering all 12 districts in Manica province, central Mozambique, as part of a baseline assessment for the SAIA-SCALE trial (NCT03425136). Data on HIV testing outcomes among 3,427 exposed infants were abstracted from at-risk child service registries. Nine health system readiness measures were included in the analysis. Logistic regressions were used to estimate associations between readiness measures and pediatric HIV testing outcomes. Odds ratios (OR) and 95% confidence intervals (95%CI) are reported. RESULTS: Forty-eight percent of HIV-exposed infants had a PCR test within 8 weeks of life, 69% had a PCR test ever, and 6% tested positive. Staffing levels, glove stockouts, and distance to the reference laboratory were positively associated with early PCR (OR = 1.02 [95%CI: 1.01-1.02], OR = 1.73 [95%CI: 1.24-2.40] and OR = 1.01 [95%CI: 1.00-1.01], respectively) and ever PCR (OR = 1.02 [95%CI: 1.01-1.02], OR = 1.80 [95%CI: 1.26-2.58] and OR = 1.01 [95%CI: 1.00-1.01], respectively). Catchment area size and multiple NGOs supporting PMTCT services were associated with early PCR testing OR = 1.02 [95%CI: 1.01-1.03] and OR = 0.54 [95%CI: 0.30-0.97], respectively). Facility type, stockout of prophylactic antiretrovirals, the presence of quality improvement programs and mothers' support groups in the health facility were not associated with PCR testing. No significant associations with positive HIV diagnosis were found. CONCLUSION: Salient modifiable factors associated with HIV testing for exposed infants include staffing levels, NGO support, stockout of essential commodities and accessibility of reference laboratories. Our study provides insights into modifiable factors that could be targeted to improve PMTCT performance, particularly at small and rural facilities.

Ebola virus disease nosocomial infections in the Democratic Republic of the Congo: a descriptive study of cases during the 2018-2020 outbreak.

OBJECTIVES: To describe the characteristics of nosocomial cases of Ebola virus disease (EVD) in the Democratic Republic of the Congo between July 2018 and May 2020 in order to inform future interventions. METHODS: Nosocomial cases of EVD were identified during outbreak response surveillance, and a retrospective analysis of cases was conducted according to demographic characteristics and type of health facility (HF). RESULTS: Of 3481 cases of EVD, 579 (16.6%) were nosocomial. Of these, 332 cases occurred in women (57.3%). Patients and visitors accounted for 419 cases (72.4%), of which 79 (18.9%) were aged 6-≤18 years and 108 (25.8%) were aged ≤5 years. Health workers (HWs) accounted for the remaining 160 (27.6%) nosocomial cases. The case fatality rate (CFR) for HWs (66/160, 41.3%) was significantly lower than the CFR for patients and visitors (292/419, 69.7%) (P<0.001). The CFR was higher among cases aged 6-≤18 years (54/79, 68.4%) and ≤5 years (89/108, 82.4%). Referral HFs (>39 beds) had the highest prevalence of nosocomial EVD (148/579, 25.6%). Among HFs with at least one case of nosocomial infection, 50.0% (98/196) were privately owned. CONCLUSIONS: Nurses and traditional healers should be targeted for infection prevention and control training, and supportive supervision should be provided to HFs to mitigate EVD transmission.

Standardizing clinical culture specimen collection in Ethiopia: a training-of-trainers.

BACKGROUND: Proper specimen collection is central to improving patient care by ensuring optimal yield of diagnostic tests, guiding appropriate management, and targeting treatment. The purpose of this article is to describe the development and implementation of a training-of-trainers educational program designed to improve clinical culture specimen collection among healthcare personnel (HCP) in Ethiopia. METHODS: A Clinical Specimen Collection training package was created consisting of a Trainer's Manual, Reference Manual, Assessment Tools, Step-by-Step Instruction Guides (i.e., job aides), and Core Module PowerPoint Slides. RESULTS: A two-day course was used in training 16 master trainers and 47 facility-based trainers responsible for cascading trainings on clinical specimen collection to HCP at the pre-service, in-service, or national-levels. The Clinical Specimen Collection Package is offered online via The Ohio State University's CANVAS online platform. CONCLUSIONS: The training-of-trainers approach may be an effective model for development of enhanced specimen collection practices in low-resource countries.

Establishment of a Sentinel Laboratory-Based Antimicrobial Resistance Surveillance Network in Ethiopia.

In 2014, as part of the Global Health Security Agenda, Ethiopia was provided the technical and financial resources needed to prioritize antimicrobial resistance (AMR) in the national public health sphere. Under the direction of a multi-stakeholder working group, AMR surveillance was launched in July 2017 at 4 sentinel sites across the country. The AMR surveillance initiative in Ethiopia represents one of the first systematic efforts to prospectively collect, analyze, and report national-level microbiology results from a network of hospitals and public health laboratories in the country. Baseline readiness assessments were conducted to identify potential challenges to implementation to be addressed through capacity-building efforts. As part of these efforts, the working group leveraged existing resources, initiated laboratory capacity building through mentorship, and established infrastructure and systems for quality assurance, data management, and improved coordination. As a result, AMR surveillance data are being reported and analyzed for use; data from more than 1,700 patients were collected between July 2017 and March 2018. The critical challenges and effective solutions identified through surveillance planning and implementation have provided lessons to help guide successful AMR surveillance in other settings. Ultimately, the surveillance infrastructure, laboratory expertise, and communication frameworks built specifically for AMR surveillance in Ethiopia can be extended for use with other infectious diseases and potential public health emergencies. Thus, building AMR surveillance in Ethiopia has illustrated how laying the foundation for a specific public health initiative can develop capacity for core public health functions with potential benefit.

Infection prevention and control training and capacity building during the Ebola epidemic in Guinea.

BACKGROUND: During the 2014-2016 Ebola epidemic in West Africa, a key epidemiological feature was disease transmission within healthcare facilities, indicating a need for infection prevention and control (IPC) training and support. METHODS: IPC training was provided to frontline healthcare workers (HCW) in healthcare facilities that were not Ebola treatment units, as well as to IPC trainers and IPC supervisors placed in healthcare facilities. Trainings included both didactic and hands-on components, and were assessed using pre-tests, post-tests and practical evaluations. We calculated median percent increase in knowledge. RESULTS: From October-December 2014, 20 IPC courses trained 1,625 Guineans: 1,521 HCW, 55 IPC trainers, and 49 IPC supervisors. Median test scores increased 40% (interquartile range [IQR]: 19-86%) among HCW, 15% (IQR: 8-33%) among IPC trainers, and 21% (IQR: 15-30%) among IPC supervisors (all P<0.0001) to post-test scores of 83%, 93%, and 93%, respectively. CONCLUSIONS: IPC training resulted in clear improvements in knowledge and was feasible in a public health emergency setting. This method of IPC training addressed a high demand among HCW. Valuable lessons were learned to facilitate expansion of IPC training to other prefectures; this model may be considered when responding to other large outbreaks.

Infection Prevention and Control for Ebola in Health Care Settings - West Africa and United States.

The 2014-2016 Ebola virus disease (Ebola) epidemic in West Africa underscores the need for health care infection prevention and control (IPC) practices to be implemented properly and consistently to interrupt transmission of pathogens in health care settings to patients and health care workers. Training and assessing IPC practices in general health care facilities not designated as Ebola treatment units or centers became a priority for CDC as the number of Ebola virus transmissions among health care workers in West Africa began to affect the West African health care system and increasingly more persons became infected. CDC and partners developed policies, procedures, and training materials tailored to the affected countries. Safety training courses were also provided to U.S. health care workers intending to work with Ebola patients in West Africa. As the Ebola epidemic continued in West Africa, the possibility that patients with Ebola could be identified and treated in the United States became more realistic. In response, CDC, other federal components (e.g., Office of the Assistant Secretary for Preparedness and Response) and public health partners focused on health care worker training and preparedness for U.S. health care facilities. CDC used the input from these partners to develop guidelines on IPC for hospitalized patients with known or suspected Ebola, which was updated based on feedback from partners who provided care for Ebola patients in the United States. Strengthening and sustaining IPC helps health care systems be better prepared to prevent and respond to current and future infectious disease threats.The activities summarized in this report would not have been possible without collaboration with many U.S. and international partners (http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/partners.html).