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✪ 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

Authors:

Carmen E. Hazim , Igor Dobe, Stephen Pope, Kristjana H. Ásbjörnsdóttir, Orvalho Augusto, Fernando Pereira Bruno, Sergio Chicumbe, Norberto Lumbandali, Inocêncio Mate, Elso Ofumhan, Sam Patel, Riaze Rafik, Kenneth Sherr, Veronica Tonwe, Onei Uetela, David Watkins, Sarah Gimbel, & Ana O. Mocumbi

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2024

Read the full text in the open access journal Implementation Science Communication

Abstract:

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.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Assessing drivers of implementing “Scaling-up the Systems Analysis and Improvement Approach” for Prevention of Mother-to-Child HIV Transmission in Mozambique (SAIA-SCALE) over implementation waves

Authors:

Celso Inguane, Sarah Gimbel, Caroline Soi, Esperança Tavede, Filipe Murgorgo, Xavier Isidoro, Yaesh Sidat, Regina Nassiaca, Joana Coutinho, Maria Cruz, Mery Agostinho, Fernando Amaral, Aneth Dinis, Kristjana Ásbjörnsdóttir, Jonny Crocker, Nélia Manaca, Isaias Ramiro, James Pfeiffer, Maria de Fátima Cuembelo, & Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2023

Read the full text in the open access journal Implementation Science Communication

Abstract:

Background

The Systems Analysis and Improvement Approach (SAIA) is an evidence-based package of systems engineering tools originally designed to improve patient flow through the prevention of Mother-to-Child transmission of HIV (PMTCT) cascade. SAIA is a potentially scalable model for maximizing the benefits of universal antiretroviral therapy (ART) for mothers and their babies. SAIA-SCALE was a stepped wedge trial implemented in Manica Province, Mozambique, to evaluate SAIA’s effectiveness when led by district health managers, rather than by study nurses. We present the results of a qualitative assessment of implementation determinants of the SAIA-SCALE strategy during two intensive and one maintenance phases.

Methods

We used an extended case study design that embedded the Consolidated Framework for Implementation Research (CFIR) to guide data collection, analysis, and interpretation. From March 2019 to April 2020, we conducted in-depth individual interviews (IDIs) and focus group discussions (FGDs) with district managers, health facility maternal and child health (MCH) managers, and frontline nurses at 21 health facilities and seven districts of Manica Province (Chimoio, Báruè, Gondola, Macate, Manica, Sussundenga, and Vanduzi).

Results

We included 85 participants: 50 through IDIs and 35 from three FGDs. Most study participants were women (98%), frontline nurses (49.4%), and MCH health facility managers (32.5%). An identified facilitator of successful intervention implementation (regardless of intervention phase) was related to SAIA’s compatibility with organizational structures, processes, and priorities of Mozambique’s health system at the district and health facility levels. Identified barriers to successful implementation included (a) inadequate health facility and road infrastructure preventing mothers from accessing MCH/PMTCT services at study health facilities and preventing nurses from dedicating time to improving service provision, and (b) challenges in managing intervention funds.

Conclusions

The SAIA-SCALE qualitative evaluation suggests that the scalability of SAIA for PMTCT is enhanced by its fit within organizational structures, processes, and priorities at the primary level of healthcare delivery and health system management in Mozambique. Barriers to implementation that impact the scalability of SAIA include district-level financial management capabilities and lack of infrastructure at the health facility level. SAIA cannot be successfully scaled up to adequately address PMTCT needs without leveraging central-level resources and priorities.

Trial registration

ClinicalTrials.gov, NCT03425136. Registered on 02/06/2018.

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

✪ Systems analysis and improvement approach to optimize the hypertension diagnosis and care cascade for PLHIV individuals (SAIA-HTN): A hybrid type III cluster randomized trial

Authors:

Sarah Gimbel, Ana Olga Mocumbi, Kristjana Ásbjörnsdóttir, Joana Coutinho, Leonel Andela, Bonifacio Cebola, Heidi Craine, Jonny Crocker, Leecreesha Hicks, Sarah Holte, Rodrigues Hossieke, Edgar Itai, Carol Levin, Nelia Manaca, Filipe Murgorgo, Miguel Nhumba, James Pfeiffer, Isaias Ramiro, Keshet Ronen, Nona Sotoodehnia, Onei Uetela, Anjuli Wagner, Bryan J. Weiner, & Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2020

Read the full text in the open access journal Implementation Science

Abstract:

Background

Across sub-Saharan Africa, evidence-based clinical guidelines to screen and manage hypertension exist; however, country level application is low due to lack of service readiness, uneven health worker motivation, weak accountability of health worker performance, and poor integration of hypertension screening and management with chronic care services. The systems analysis and improvement approach (SAIA) is an evidence-based implementation strategy that combines systems engineering tools into a five-step, facility-level package to improve understanding of gaps (cascade analysis), guide identification and prioritization of low-cost workflow modifications (process mapping), and iteratively test and redesign these modifications (continuous quality improvement). As hypertension screening and management are integrated into chronic care services in sub-Saharan Africa, an opportunity exists to test whether SAIA interventions shown to be effective in improving efficiency and coverage of HIV services can be effective when applied to the non-communicable disease services that leverage the same platform. We hypothesize that SAIA-hypertension (SAIA-HTN) will be effective as an adaptable, scalable model for broad implementation.

Methods

We will deploy a hybrid type III cluster randomized trial to evaluate the impact of SAIA-HTN on hypertension management in eight intervention and eight control facilities in central Mozambique. Effectiveness outcomes include hypertension cascade flow measures (screening, diagnosis, management, control), as well as hypertension and HIV clinical outcomes among people living with HIV. Cost-effectiveness will be estimated as the incremental costs per additional patient passing through the hypertension cascade steps and the cost per additional disability-adjusted life year averted, from the payer perspective (Ministry of Health). SAIA-HTN implementation fidelity will be measured, and the Consolidated Framework for Implementation Research will guide qualitative evaluation of the implementation process in high- and low-performing facilities to identify determinants of intervention success and failure, and define core and adaptable components of the SAIA-HTN intervention. The Organizational Readiness for Implementing Change scale will measure facility-level readiness for adopting SAIA-HTN.

Discussion

SAIA packages user-friendly systems engineering tools to guide decision-making by front-line health workers to identify low-cost, contextually appropriate chronic care improvement strategies. By integrating SAIA into routine hypertension screening and management structures, this pragmatic trial is designed to test a model for national scale-up.

Trial registration

Registered 09/13/2019; NCT04088656).

**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**

Cascade Analysis: An Adaptable Implementation Strategy Across HIV and Non-HIV Delivery Platforms

Anjuli D. Wagner, Sarah Gimbel, Kristjana H. Ásbjörnsdóttir, Peter Cherutich, Joana Coutinho, Jonny Crocker, Emiliae Cruz, Fatima Cuembelo, Vasco Cumbe, McKenna Eastment, Jennifer Einberg, Florencia Floriano, Douglas Gaitho, Brandon L. Guthrie, Grace John-Stewart, Alex H. Kral, Barrot H. Lambdin, Shan Liu, Martin Bcom Maina, Nelia Manaca, Mika Matsuzaki, Loris Mattox, Nancy Mburu, R. Scott McClelland, Mark A. Micek, Ana Olga Mocumbi, Albertoe Muanido, Ruth Nduati, Irene N. Njuguna, Geoffrey Oluoch, Laura B. Oyiengo, Keshet Ronen, Caroline Soi, Bradley H. Wagenaar, George Wanje, Lynn D. Wenger, and Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

Published: December 2019

Read the full text in the subscription access JAIDS: Journal of Acquired Immune Deficiency Syndromes