James Pfeiffer Archives - Implementation Science at UW

✪ 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**}

✪ Applying the Consolidated Framework for Implementation Research to Identify Implementation Determinants for the Integrated District Evidence-to-Action Program, Mozambique

Abstract

Introduction

The Integrated District Evidence-to-Action program is an audit and feedback intervention introduced in 2017 in Manica and Sofala provinces, Mozambique, to reduce mortality in children younger than 5 years. We describe barriers and facilitators to early-stage effectiveness of that intervention.

Method

We embedded the Consolidated Framework for Implementation Research (CFIR) into an extended case study design to inform sampling, data collection, analysis, and interpretation. We collected data in 4 districts in Manica and Sofala Provinces in November 2018. Data collection included document review, 22 in-depth individual interviews, and 2 focus group discussions (FGDs) with 19 provincial, district, and facility managers and nurses. Most participants (70.2%) were nurses and facility managers and the majority were women (87.8%). We audio-recorded all but 2 interviews and FGDs and conducted a consensus-based iterative analysis.

Results

Facilitators of effective intervention implementation included: implementation of the core intervention components of audit and feedback meetings, supportive supervision and mentorship, and small grants as originally planned; positive pressure from district managers and study nurses on health facility staff to strive for excellence; and easy access to knowledge and information about the intervention. Implementation barriers were the intervention’s lack of compatibility in not addressing the scarcity of human and financial resources and inadequate infrastructures for maternal and child health services at district and facility levels and; the intervention’s lack of adaptability in having little flexibility in the design and decision making about the use of intervention funds and data collection tools.

Discussion

Our comprehensive and systematic use of the CFIR within an extended case study design generated granular evidence on CFIR’s contribution to implementation science efforts to describe determinants of early-stage intervention implementation. It also provided baseline findings to assess subsequent implementation phases, considering similarities and differences in barriers and facilitators across study districts and facilities. Sharing preliminary findings with stakeholders promoted timely decision making about intervention implementation.

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

✪ HIV-exposed infant follow-up in Mozambique: Formative research findings for the design of a cluster randomized controlled trial to improve testing and ART initiation

Abstract:

Background

Early infant diagnosis (EID) of HIV-exposed and initiation of HIV-positive infants on anti-retroviral therapy (ART) requires a well-coordinated cascade of care. Loss-to-follow-up (LTFU) can occur at multiple steps and effective EID is impeded by human resource constraints, difficulty with patient tracking, and long waiting periods. The objective of this research was to conduct formative research to guide the development of an intervention to improve the pediatric HIV care cascade in central Mozambique. The study was conducted in Manica and Sofala Provinces where the adult HIV burden is higher than the national average. The research focused on 3 large clinics in each province, along the highly populated Beira corridor.

Methods

The research was conducted in 2014 over 3 months at six facilities and consisted of 1) patient flow mapping and collection of health systems data from postpartum, child-at-risk, and ART service registries, 2) measurement of clinic waiting times, and 3) patient and health worker focus groups.

Results

HIV testing and ART initiation coverage for mothers tends to be high, but EID and pediatric ART initiation are hampered by lack of patient tracking, long waiting times, and inadequate counseling to navigate the care cascade. About 76% of HIV-positive infants were LTFU and did not initiate ART.

Conclusions

Effective interventions to reduce LTFU in EID and improve pediatric ART initiation should focus on patient tracking, active follow-up of defaulting patients, reduction in EID turn-around times for PCR results, and initiation of ART by nurses in child-at-risk services.

Trial registration

Retrospectively registered, ISRCTN67747315, July 24, 2019.

^{**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**}

✪ Scaling-up the Systems Analysis and Improvement Approach for prevention of mother-to-child HIV transmission in Mozambique (SAIA-SCALE): a stepped-wedge cluster randomized trial

Abstract:

Background

The introduction of option B+ — rapid initiation of lifelong antiretroviral therapy regardless of disease status for HIV-infected pregnant and breastfeeding women — can dramatically reduce HIV transmission during pregnancy, birth, and breastfeeding. Despite significant investments to scale-up Option B+, results have been mixed, with high rates of loss to follow-up, sub-optimal viral suppression, continued pediatric HIV transmission, and HIV-associated maternal morbidity. The Systems Analysis and Improvement Approach (SAIA) cluster randomized trial demonstrated that a package of systems engineering tools improved flow through the prevention of mother-to-child HIV transmission (PMTCT) cascade. This five-step, facility-level intervention is designed 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). This protocol describes a novel model for SAIA delivery (SAIA-SCALE) led by district nurse supervisors (rather than research nurses), and evaluation procedures, to serve as a foundation for national scale-up.

Methods

The SAIA-SCALE stepped wedge trial includes three implementation waves, each 12 months in duration. Districts are the unit of assignment, with four districts randomly assigned per wave, covering all 12 districts in Manica province, Mozambique. In each district, the three highest volume health facilities will receive the SAIA-SCALE intervention (totaling 36 intervention facilities). The RE-AIM framework will guide SAIA-SCALE’s evaluation. Reach describes the proportion of clinics and population in Manica province reached, and sub-groups not reached. Effectiveness assesses impact on PMTCT process measures and patient-level outcomes. Adoption describes the proportion of districts/clinics adopting SAIA-SCALE, and determinants of adoption using the Organizational Readiness for Implementing Change (ORIC) tool. Implementation will identify SAIA-SCALE core elements and determinants of successful implementation using the Consolidated Framework for Implementation Research (CFIR). Maintenance describes the proportion of districts sustaining the intervention. We will also estimate the budget and program impact from the payer perspective for national scale-up.

Discussion

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

Trial Registration

ClinicalTrials.gov NCT03425136 (registered 02/06/2018).

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

✪ Stepped-Wedge Cluster Randomized Controlled Trial to Promote Option B+ Retention in Central Mozambique

✪ Evaluation of a Systems Analysis and Improvement Approach to Optimize Prevention of Mother-To-Child Transmission of HIV Using the Consolidated Framework for Implementation Research

Authors:

✪ Open Access

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

Abstract:

Background

Methods

Results

Conclusions

Trial registration

Authors:

✪ Open Access

Read the full text in the open access journal Global Health: Science and Practice

Abstract

Introduction

Method

Results

Discussion

Authors:

✪ Open Access

Read the full text in the open access journal BMC Health Services Research

Abstract:

Background

Methods

Results

Conclusions

Trial registration

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial registration

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods

Discussion

Trial Registration

Authors:

✪ Open Access

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

Authors:

✪ Open Access

Read the full text open access in the subscription journal JAIDS