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Background
The objective of the prevention of Mother-to-Child Transmission (pMTCT) cascade analysis tool is to provide frontline health managers at the facility level with the means to rapidly, independently and quantitatively track patient flows through the pMTCT cascade, and readily identify priority areas for clinic-level improvement interventio...
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Background:
Prevention of mother-to-child transmission of HIV implementation faces significant challenges globally, particularly in the context of universal lifelong antiretroviral therapy (ART) for all HIV-infected pregnant women.
Methods:
We describe the rationale and methods of the Maternal and Child Health-Antiretroviral Therapy (MCH-ART) st...
Citations
... Keywords Capacity building, Implementation science, Infectious disease, Sub-Saharan Africa The Systems Analysis and Improvement Approach (SAIA) is an evidence-based implementation strategy designed to optimize cascade performance, is feasible for frontline healthcare workers and managers, and may be applicable to optimize TB care [41]. We aim to adapt SAIA for TB (SAIA-TB), expanding upon successful SAIA adaptations that have been trialed across a range of clinical settings, in sub-Saharan Africa and the USA, and leverage preliminary TB cascade data collected in this setting [4,5,[41][42][43][44][45][46][47]. Preliminary work developing the SAIA-TB cascade by the investigative team has identified six routinely collected TB data points to serve as linked steps across TB services (screening, evaluation, diagnosis, linkage to care, treatment completion, and TB-free survival). ...
Background
The use of systems engineering tools, including the development and use of care cascades using routinely collected data, process mapping, and continuous quality improvement, is used for frontline healthcare workers to devise systems level change. South Africa experiences high rates of tuberculosis (TB) infection and disease as well as HIV co-infection. The Department of Health has made significant gains in HIV services over the last two decades, reaching their set “90–90-90” targets for HIV. However, TB services, although robust, have lagged in comparison for both disease and infection. The Systems Analysis and Improvement Approach (SAIA) is a five-step implementation science method, drawn from systems engineering, to identify, define, and implement workflow modifications using cascade analysis, process mapping, and repeated quality improvement cycles within healthcare facilities.
Methods
This stepped-wedge cluster randomized trial will evaluate the effectiveness of SAIA on TB (SAIA-TB) cascade optimization for patients with TB and high-risk contacts across 16 clinics in four local municipalities in the Sarah Baartman district, Eastern Cape, South Africa. We hypothesize that SAIA-TB implementation will lead to a 20% increase in each of: TB screening, TB preventive treatment initiation, and TB disease treatment initiation during the 18-month intervention period. Focus group discussions and key informant interviews with clinic staff will also be conducted to determine drivers of implementation variability across clinics.
Discussion
This study has the potential to improve TB screening, treatment initiation, and completion for both active disease and preventive measures among individuals with and without HIV in a high burden setting. SAIA-TB provides frontline health care workers with a systems-level view of their care delivery system with the aim of sustainable systems-level improvements.
Trial registration
Clinicaltrials.gov, NCT06314386. Registered 18 March 2024, https://clinicaltrials.gov/study/NCT06314386. NCT06314386.
... Tailored to the hypertension care cascade, SAIA-HTN is a strategy that engages health care workers in the use of a series of systems engineering tools including cascade analysis using the Hypertension Cascade Analysis Tool (HCAT), process mapping, and continuous quality improvement (CQI), in order to improve and sustain iterative improvement to their service delivery [31]. As part of each "SAIA cycle, " the HCAT is first completed using routine data to quantify patient flow through the hypertension care cascade, providing clinic staff and managers with a systems view of cascade performance [44][45][46]. This is followed by process mapping of the steps patients take at their facility to obtain care, which helps staff come to a consensus on how their system operates, supports the identification of modifiable bottlenecks, and guides discussion and group problem-solving on opportunities for workflow modifications [47]. ...
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).
... Additionally, a good case management system should be set up. As seen in Mozambique (21), this could be an effective way to identify improvement strategies for mother and child care. Furthermore, if implemented as a case-based system, this could serve as a reminder to health care providers to follow up with individual pregnant women to prevent loss-to-follow-up and delays. ...
Objectives
To evaluate the cascade of care for the elimination of mother-to-child-transmission of human immunodeficiency virus (HIV) in Suriname and identify sociodemographic and clinical factors preventing transmission to exposed infants.
Methods
A mixed-methods study design was used. Antenatal care data from the 2018 cross-sectional multi-indicator cluster survey on 1 026 women aged 15–49 years who had had a live birth in the previous 2 years were used. Furthermore, national data on a cohort of 279 mothers with HIV and their 317 infants born from 2016 to 2018 were evaluated. Additionally, 13 cases of mother-to-child-transmission of HIV were reviewed.
Results
In 89.3% of cases, no mother-to-child HIV transmission occurred. Early cascade steps show that 28.4% of women had unmet family planning needs, 15% had no antenatal visits, 8% delivered outside a health facility, and 71.5% received an HIV test during antenatal care. Of the pregnant women with HIV, 84.2% received antiretroviral therapy, while 95.5% of their infants received HIV prophylactic treatment. Receiving antiretroviral therapy for the mother (odds ratio (OR) 45.4, 95% confidence interval (CI) 9.6–215.3) and the child (OR 145.7, 95% CI 14.4–1477.4) significantly increased the odds of a negative HIV test result in infants. Conversely, living in the interior decreased the odds (OR 0.2, 95% CI 0.4–0.7) compared with urban living.
Conclusions
HIV medication for mothers with HIV and their infants remains key in the prevention of mother-to-child-transmission of HIV. Early prenatal care with follow-up should be strengthened in Suriname.
... Given the implementation gap between the proven effectiveness of cervical cancer screening and the integration of this evidenced-based intervention into routine care, this cluster randomized trial aimed to test whether a specific implementation strategy, the Systems Analysis and Improvement Approach (SAIA), was effective at increasing cervical cancer screening in FP clinics in Mombasa County, Kenya. SAIA is a multicomponent implementation strategy that uses plan-do-study-act cycles with a cascade analysis tool, sequential process flow mapping, and small tests of change (micro-interventions) to improve care cascades [12][13][14][15]. It was hypothesized that clinics randomized to SAIA would have a higher prevalence of cervical cancer screening compared to control clinics that received no intervention. ...
... This study evaluated SAIA, an evidenced-based fivestep cycle composed of multiple implementation strategies [12][13][14][15]. The first step uses an Excel-based "cascade analysis" tool (CAT) to quantify the numbers of individuals who complete each cascade step and identify priority steps for improvement [20]. ...
Background
Cervical cancer is the leading cause of cancer death in Kenyan women. Integrating cervical cancer screening into family planning (FP) clinics is a promising strategy to improve health for reproductive-aged women. The objective of this cluster randomized trial was to test the efficacy of an implementation strategy, the Systems Analysis and Improvement Approach (SAIA), as a tool to increase cervical cancer screening in FP clinics in Mombasa County, Kenya.
Methods
Twenty FP clinics in Mombasa County were randomized 1:1 to SAIA versus usual procedures. SAIA has five steps: (1) cascade analysis tool to understand the cascade and identify inefficiencies, (2) sequential process flow mapping to identify bottlenecks, (3) develop and implement workflow modifications (micro-interventions) to address identified bottlenecks, (4) assess the micro-intervention in the cascade analysis tool, and (5) repeat the cycle. Prevalence ratios were calculated using Poisson regression with robust standard errors to compare the proportion of visits where women were screened for cervical cancer in SAIA clinics compared to control clinics.
Results
In the primary intent-to-treat analysis in the last quarter of the trial, 2.5% (37/1507) of visits with eligible FP clients at intervention facilities included cervical cancer screening compared to 3.7% (66/1793) in control clinics (prevalence ratio [PR] 0.67, 95% CI 0.45–1.00). When adjusted for having at least one provider trained to perform cervical cancer screening at baseline, there was no significant difference between screening in intervention clinics compared to control clinics (adjusted PR 1.14, 95% CI 0.74–1.75).
Conclusions
The primary analysis did not show an effect on cervical cancer screening. However, the COVID-19 pandemic and a healthcare worker strike likely impacted SAIA’s implementation with significant disruptions in FP care delivery during the trial. While SAIA’s data-informed decision-making and clinic-derived solutions are likely important, future work should directly study the mechanisms through which SAIA operates and the influence of contextual factors on implementation.
Trial registration
ClinicalTrials.gov, NCT03514459. Registered on April 19, 2018.
... To improve naloxone distribution overall and address disparities in distribution throughout California, we designed a randomized controlled trial to test the ability of an implementation strategy (the Systems Analysis and Improvement Approach [SAIA]) to enhance naloxone distribution by SSPs and ultimately reduce overdose deaths and overdose mortality disparities. SAIA is a multifaceted implementation strategy that supports frontline service providers in gaining a comprehensive view of the cascade of services they provide, identifying areas for improvement, and iteratively testing new approaches to improve their delivery of the full cascade [19,20]. The original SAIA trial improved services to prevent motherto-child HIV transmission [21], with clinic staff describing the strategy as easy to use and practical [22]. ...
Background
More than half a million Americans died of an opioid-related overdose between 1999 and 2020, the majority occurring between 2015 and 2020. The opioid overdose mortality epidemic disproportionately impacts Black, Indigenous, and people of color (BIPOC): since 2015, overdose mortality rates have increased substantially more among Black (114%) and Latinx (97%) populations compared with White populations (32%). This is in part due to disparities in access to naloxone, an opioid antagonist that can effectively reverse opioid overdose to prevent death. Our recent pilot work determined that many barriers to naloxone access can be identified and addressed by syringe service programs (SSPs) using the Systems Analysis and Improvement Approach to Naloxone distribution (SAIA-Naloxone). This randomized controlled trial will test SAIA-Naloxone’s ability to improve naloxone distribution in general and among BIPOC specifically.
Methods
We will conduct a trial with 32 SSPs across California, randomly assigning 16 to the SAIA-Naloxone arm and 16 to receive implementation as usual. SAIA-Naloxone is a multifaceted, multilevel implementation strategy through which trained facilitators work closely with SSPs to (1) assess organization-level barriers, (2) prioritize barriers for improvement, and (3) test solutions through iterative change cycles until achieving and sustaining improvements. SSPs receiving SAIA-Naloxone will work with a trained facilitator for a period of 12 months. We will test SAIA-Naloxone’s ability to improve SSPs’ naloxone distribution using an interrupted time series approach. Data collection will take place during a 3-month lead-in period, the 12-month active period, and for an additional 6 months afterward to determine whether impacts are sustained. We will use a structured approach to specify SAIA-Naloxone to ensure strategy activities are clearly defined and to assess SAIA-Naloxone fidelity to aid in interpreting study results. We will also assess the costs associated with SAIA-Naloxone and its cost-effectiveness.
Discussion
This trial takes a novel approach to improving equitable distribution of naloxone amid the ongoing epidemic and associated racial disparities. If successful, SAIA-Naloxone represents an important organizational-level solution to the multifaceted and multilevel barriers to equitable naloxone distribution.
... Cascade Analysis is defined as use of a Cascade Analysis Tool (CAT, Additional file 2a) to analyze the implementing unit's data, assess current performance of a multistep care cascade, identify gaps, and quantify potential improvement to the system if a given step were optimized [9,29,30]. ...
... Cascade analysis is accomplished in SAIA through the CAT [9,29]. Sequentially linked, summarized outcome data from the site over a previous period (typically 1-3 months) is fed into the CAT and provides the team with a snapshot of current performance, including drop offs across steps. ...
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.
... The SAIA steps and roles played by the clinic staff and facilitators are explained in Table 1. As previously described [16], this included the creation of a "cascade analysis tool, " an Excel-based system for quantifying and displaying the number of individuals who complete each step of a process to identify where improvement may be needed [9,17]. The tool also shows the expected impact on HIV testing when each step of the cascade is optimized to full performance. ...
Background
In Kenya, HIV incidence is highest among reproductive-age women. A key HIV mitigation strategy is the integration of HIV testing and counseling (HTC) into family planning services, but successful integration remains problematic. We conducted a cluster-randomized trial using the Systems Analysis and Improvement Approach (SAIA) to identify and address bottlenecks in HTC integration in family planning clinics in Mombasa County, Kenya. This trial (1) assessed the efficacy of this approach and (2) examined if SAIA could be sustainably incorporated into the Department of Health Services (DOHS) programmatic activities. In Stage 1, SAIA was effective at increasing HTC uptake. Here, we present Stage 2, which assessed if SAIA delivery would be sustained when implemented by the Mombasa County DOHS and if high HTC performance would continue to be observed.
Methods
Twenty-four family planning clinics in Mombasa County were randomized to either the SAIA implementation strategy or standard care. In Stage 1, the study staff conducted all study activities. In Stage 2, we transitioned SAIA implementation to DOHS staff and compared HTC in the intervention versus control clinics 1-year post-transition. Study staff provided training and minimal support to DOHS implementers and collected quarterly HTC outcome data. Interviews were conducted with family planning clinic staff to assess barriers and facilitators to sustaining HTC delivery.
Results
Only 39% (56/144) of planned SAIA visits were completed, largely due to the COVID-19 pandemic and a prolonged healthcare worker strike. In the final study quarter, 81.6% (160/196) of new clients at intervention facilities received HIV counseling, compared to 22.4% (55/245) in control facilities (prevalence rate ratio [PRR]=3.64, 95% confidence interval [CI]=2.68–4.94). HIV testing was conducted with 60.5% (118/195) of new family planning clients in intervention clinics, compared to 18.8% (45/240) in control clinics (PRR=3.23, 95% CI=2.29–4.55). Interviews with family planning clinic staff suggested institutionalization contributed to sustained HTC delivery, facilitated by low implementation strategy complexity and continued oversight.
Conclusions
Intervention clinics demonstrated sustained improvement in HTC after SAIA was transitioned to DOHS leadership despite wide-scale healthcare disruptions and incomplete delivery of the implementation strategy. These findings suggest that system interventions may be sustained when integrated into DOHS programmatic activities.
Trial registration
ClinicalTrials.gov (NCT02994355) registered on 16 December 2016.
... Step 1 uses an Excel-based "cascade analysis" tool to quantify the number of individuals who complete each step of a process and identify priority steps for improvement [10,11]. ...
Background
Significant gaps remain in HIV testing and counseling (HTC) in family planning (FP) clinics. To address these gaps, our group tested an implementation strategy called the Systems Analysis and Improvement Approach (SAIA), an evidenced-based multi-component implementation strategy focused on improving entire care cascades. In a cluster randomized trial of 24 FP clinics in Mombasa County, Kenya, SAIA led to a significant increase in HTC in intervention clinics compared to control clinics. The objective of this manuscript was to evaluate SAIA using the Consolidated Framework for Implementation Research (CFIR) and assess the Implementation Outcomes Framework outcomes of acceptability, appropriateness, and feasibility.
Methods
This qualitative assessment was nested within the cluster-randomized trial. Data collection included questionnaires to assess modifiable and non-modifiable health system factors related to HTC and in-depth interviews to query clinic norms, priorities, communication strategies, and readiness for change. The primary outcomes of interest were feasibility, appropriateness, and acceptability of SAIA. Data on inner setting and structural characteristics of FP clinics were collected to inform how context may impact outcomes. All interviews were recorded and analyzed using a rapid assessment approach.
Results
Of the 12 intervention clinics, 6 (50%) were public facilities. Availability of resources varied by clinic. Most clinics had a positive implementation climate, engaged leadership, and access to resources and information. While not all clinics identified HTC as a clinic priority, most reported a strong culture of embracing change and recognition of the importance of HIV testing within FP clinics. Interviews highlighted very high acceptability, appropriateness, and feasibility of SAIA. The implementation strategy was not complicated and fit well into existing clinic processes. In particular, staff appreciated that SAIA allowed clinic staff to generate contextually relevant solutions that they implemented.
Conclusions
SAIA was implemented in FP clinics of varying sizes, capacity, and management support and was found to be acceptable, appropriate, and feasible. The agency that clinic staff felt in proposing and implementing their own solutions was likely part of SAIA’s success. We anticipate this will continue to be a mechanism of SAIA’s success when it is scaled up to more clinics in future trials.
Trial registration
ClinicalTrials.gov (NCT02994355) registered 16 December 2016.
... Step 1: Cascade analysis-understand MH cascade performance and identify priority areas for systems improvement [38,39]. The MHCAT (Fig. 3) uses routine facility-level data to provide a systems-level view of the interdependent components determining care delivery. ...
Background
Significant investments are being made to close the mental health (MH) treatment gap, which often exceeds 90% in many low- and middle-income countries (LMICs). However, limited attention has been paid to patient quality of care in nascent and evolving LMIC MH systems. In system assessments across sub-Saharan Africa, MH loss-to-follow-up often exceeds 50% and sub-optimal medication adherence often exceeds 60%. This study aims to fill a gap of evidence-based implementation strategies targeting the optimization of MH treatment cascades in LMICs by testing a low-cost multicomponent implementation strategy integrated into routine government MH care in Mozambique.
Methods
Using a cluster-randomized trial design, 16 clinics (8 intervention and 8 control) providing primary MH care will be randomized to the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) or an attentional placebo control. SAIA-MH is a multicomponent implementation strategy blending external facilitation, clinical consultation, and provider team meetings with system-engineering tools in an overall continuous quality improvement framework. Following a 6-month baseline period, intervention facilities will implement the SAIA-MH strategy for a 2-year intensive implementation period, followed by a 1-year sustainment phase. Primary outcomes will be the proportion of all patients diagnosed with a MH condition and receiving pharmaceutical-based treatment who achieve functional improvement, adherence to medication, and retention in MH care. The Consolidated Framework for Implementation Research (CFIR) will be used to assess determinants of implementation success. Specific Aim 1b will include the evaluation of mechanisms of the SAIA-MH strategy using longitudinal structural equation modeling as well as specific aim 2 estimating cost and cost-effectiveness of scaling-up SAIA-MH in Mozambique to provincial and national levels.
Discussion
This study is innovative in being the first, to our knowledge, to test a multicomponent implementation strategy for MH care cascade optimization in LMICs. By design, SAIA-MH is a low-cost strategy to generate contextually relevant solutions to barriers to effective primary MH care, and thus focuses on system improvements that can be sustained over the long term. Since SAIA-MH is integrated into routine government MH service delivery, this pragmatic trial has the potential to inform potential SAIA-MH scale-up in Mozambique and other similar LMICs.
Trial registration
ClinicalTrials.gov; NCT05103033 ; 11/2/2021.
... Although studies have highlighted the benefits of integration, there has been concern that integrated service delivery may be less efficient, more work for providers, and that clinics lacked adequate staffing and infrastructure to support integration [18,19]. The Systems Analysis and Improvement Approach (SAIA), a blended implementation strategy grounded in systems engineering, holds potential for addressing these concerns by systematically identifying and addressing implementation barriers [20][21][22][23][24]. The objective of this cluster-randomized trial was to compare SAIA versus usual procedures for increasing HTC in family planning clinics in Mombasa County, Kenya. ...
... This study evaluated SAIA, an evidenced-based five-step multicomponent implementation strategy, focused on improving care cascades [20][21][22][23]. The first step uses an Excel-based ''cascade analysis'' tool to quantify numbers of individuals who complete each cascade step and identify priority steps for improvement [24]. ...
