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✪ Healthcare worker perceived barriers and facilitators to implementing a tuberculosis preventive therapy program in rural South Africa: a content analysis using the consolidated framework for implementation research

Authors:

Brittney J. van de Water, Michael Wilson, Karl le Roux, Ben Gaunt, Sarah Gimbel, & Norma C. Ware

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published:August 2023

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

Abstract:

Background

South African national tuberculosis (TB) guidelines, in accordance with the World Health Organization, recommend conducting routine household TB contact investigation with provision of TB preventive therapy (TPT) for those who qualify. However, implementation of TPT has been suboptimal in rural South Africa. We sought to identify barriers and facilitators to TB contact investigations and TPT management in rural Eastern Cape, South Africa, to inform the development of an implementation strategy to launch a comprehensive TB program.

Methods

We collected qualitative data through individual semi-structured interviews with 19 healthcare workers at a district hospital and four surrounding primary-care clinics referring to the hospital. The consolidated framework for implementation research (CFIR) was used to develop interview questions as well as guide deductive content analysis to determine potential drivers of implementation success or failure

Results

A total of 19 healthcare workers were interviewed. Identified common barriers included lack of provider knowledge regarding efficacy of TPT, lack of TPT documentation workflows for clinicians, and widespread community resource constraints. Facilitators identified included healthcare workers high interest to learn more about the effectiveness of TPT, interest in problem-solving logistical barriers in provision of comprehensive TB care (including TPT), and desire for clinic and nurse-led TB prevention efforts.

Conclusion

The use of the CFIR, a validated implementation determinants framework, provided a systematic approach to identify barriers and facilitators to TB household contact investigation, specifically the provision and management of TPT in this rural, high TB burden setting. Specific resources—time, trainings, and evidence—are necessary to ensure healthcare providers feel knowledgeable and competent about TPT prior to prescribing it more broadly. Tangible resources such as improved data systems coupled with political coordination and funding for TPT programming are essential for sustainability.

**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**

✪ Implementation and scale-up of a single-visit, screen-and-treat approach with thermal ablation for sustainable cervical cancer prevention services: a protocol for a stepped-wedge cluster randomized trial in Kenya

Authors:

Michelle B. Shin, Lynda Myra Oluoch, Ruanne V. Barnabas, Colin Baynes, Harriet Fridah, Jesse Heitner, Mary Bernadette Kerubo, Kenneth Ngure, Leeya F. Pinder, Katherine K. Thomas, Nelly Rwamba Mugo & Sarah Gimbel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2023

Read the full text in the open access journal Implementation Science

Abstract:

Background

An important cervical cancer prevention strategy in low- and middle-income countries (LMICs) has been single-visit screen-and-treat (SV-SAT) approach, using visual inspection with acetic acid (VIA) and ablative treatment with cryotherapy to manage precancerous lesions. While SV-SAT with VIA and cryotherapy have established efficacy, its population level coverage and impact on reducing cervical cancer burden remains low. In Kenya, the estimated cervical cancer screening uptake among women aged 30–49 is 16% and up to 70% of screen-positive women do not receive treatment. Thermal ablation for treatment of precancerous lesions of the cervix is recommended by the World Health Organization and has the potential to overcome logistical challenges associated with cryotherapy and facilitate implementation of SV-SAT approach and increase treatment rates of screen-positive women. In this 5-year prospective, stepped-wedge randomized trial, we plan to implement and evaluate the SV-SAT approach using VIA and thermal ablation in ten reproductive health clinics in central Kenya.

Methods

The study aims to develop and evaluate implementation strategies to inform the national scale-up of SV-SAT approach with VIA and thermal ablation through three aims: (1) develop locally tailored implementation strategies using multi-level participatory method with key stakeholders (patient, provider, system-level), (2) implement SV-SAT approach with VIA and thermal ablation and evaluate clinical and implementation outcomes, and (3) assess the budget impact of SV-SAT approach with VIA and thermal ablation compared to single-visit, screen-and-treat method using cryotherapy.

Discussion

Our findings will inform national scale-up of the SV-SAT approach with VIA and thermal ablation. We anticipate that this intervention, along with tailored implementation strategies will enhance the adoption and sustainability of cervical cancer screening and treatment compared to the standard of care using cryotherapy.

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

✪ Managers’ and providers’ perspectives on barriers and facilitators for the implementation of differentiated service delivery models for HIV treatment in Mozambique: a qualitative study

Authors:

Dorlim Moiana Uetela, Sarah Gimbel, Celso Inguane, Onei Uetela, Aneth Dinis, Aleny Couto, Irénio Gaspar, Eduardo S. Gudo, Sérgio Chicumbe, Sandra Gaveta, Orvalho Augusto & Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal Journal of the International AIDS Society

Abstract:

Introduction

In 2018, Mozambique's Ministry of Health launched a guideline for a nationwide implementation of eight differentiated service delivery models to optimize HIV service delivery and achieve universal coverage of HIV care and treatment. The models were (1) Fast-track, (2) Three-month Antiretrovirals Dispensing, (3) Community Antiretroviral Therapy Groups, (4) Adherence Clubs, (5) Family-approach, and three one-stop shop models for (6) Tuberculosis, (7) Maternal and Child Health, and (8) Adolescent-friendly Health Services. This study identified drivers of implementation success and failure across these differentiated service delivery models.

Methods

Twenty in-depth individual interviews were conducted with managers and providers from the Ministry of Health and implementing partners from all levels of the health system between July and September 2021. National-level participants were based in the capital city of Maputo, and participants at provincial, district and health facility levels were from Sofala province, a purposively selected setting. The Consolidated Framework for Implementation Research (CFIR) guided data collection and thematic analysis. Deductively selected constructs were assessed while allowing for additional themes to emerge inductively.

Results

The CFIR constructs of Relative Advantage, Complexity, Patient Needs and Resources, and Reflecting and Evaluating were identified as drivers of implementation, whereas Available Resources and Access to Knowledge and Information were identified as barriers. Fast-track and Three-month Antiretrovirals Dispensing models were deemed easier to implement and more effective in reducing workload. Adherence Clubs and Community Antiretroviral Therapy Groups were believed to be less preferred by clients in urban settings. COVID-19 (an inductive theme) improved acceptance and uptake of individual differentiated service delivery models that reduced client visits, but it temporarily interrupted the implementation of group models.

Conclusions

This study described important determinants to be addressed or leveraged for the successful implementation of differentiated service delivery models in Mozambique. The models were considered advantageous overall for the health system and clients when compared with the standard of care. However, successful implementation requires resources and ongoing training for frontline providers. COVID-19 expedited individual models by loosening the inclusion criteria; this experience can be leveraged to optimize the design and implementation of differentiated service delivery models in Mozambique and other countries.

**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

Authors:

Celso Inguane, Caroline Soi, Sarah Gimbel, Nélia Manaca, Isaías Ramiro, Florência Floriano, Georgina de Castro, Orvalho Augusto, Stélio Tembe, James Pfeiffer, Quinhas Fernandes, and Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2022

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

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**

✪ How to evaluate the implementation of complex health programmes in low-income settings: the approach of the Gavi Full Country Evaluations

Authors:

Caroline Soi, Jessica C Shearer, Ashwin Budden, Emily Carnahan, Nicole Salisbury, Gilbert Asiimwe, Baltazar Chilundo, Haribondhu Sarma, Sarah Gimbel, Moses Simuyemba, Jasim Uddin, Felix Masiye, Moses Kamya, Dai Hozumi, Julie K Rajaratnam, and Stephen S Lim

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2020

Read the full text in the open access journal Health Policy and Planning

Abstract:

Vaccination, like most other public health services, relies on a complex package of intervention components, functioning systems and committed actors to achieve universal coverage. Despite significant investment in immunization programmes, national coverage trends have slowed and equity gaps have grown. This paper describes the design and implementation of the Gavi Full Country Evaluations, a multi-country, prospective, mixed-methods approach whose goal was to monitor and evaluate processes, inputs, outputs and outcomes of immunization programmes in Bangladesh, Mozambique, Uganda and Zambia.

We implemented the Full Country Evaluations from 2013 to 2018 with the goal of identifying the drivers of immunization programme improvement to support programme implementation and increase equitable immunization coverage. The framework supported methodological and paradigmatic flexibility to respond to a broad range of evaluation and implementation research questions at global, national and cross-country levels, but was primarily underpinned by a focus on evaluating processes and identifying the root causes of implementation breakdowns. Process evaluation was driven by theories of change for each Gavi funding stream (e.g. Health Systems Strengthening) or activity, ranging from global policy development to district-level programme implementation.

Mixing of methods increased in relevance and rigour over time as we learned to build multiple methods into increasingly tailored evaluation questions. Evaluation teams in country-based research institutes increasingly strengthened their level of embeddedness with immunization programmes as the emphasis shifted over time to focus more heavily on the use of findings for programme learning and adaptation. Based on our experiences implementing this approach, we recommend it for the evaluation of other complex interventions, health programmes or development assistance.

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

✪ Evaluating and optimizing the consolidated framework for implementation research (CFIR) for use in low- and middle-income countries: a systematic review

Authors:

Arianna Rubin Means, Christopher G. Kemp, Marie-Claire Gwayi-Chore, Sarah Gimbel, Caroline Soi, Kenneth Sherr, Bradley H. Wagenaar, Judith N. Wasserheit, & Bryan J. Weiner

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

The Consolidated Framework for Implementation Research (CFIR) is a determinants framework that may require adaptation or contextualization to fit the needs of implementation scientists in low- and middle-income countries (LMICs). The purpose of this review is to characterize how the CFIR has been applied in LMIC contexts, to evaluate the utility of specific constructs to global implementation science research, and to identify opportunities to refine the CFIR to optimize utility in LMIC settings.

Methods

A systematic literature review was performed to evaluate the use of the CFIR in LMICs. Citation searches were conducted in Medline, CINAHL, PsycINFO, CINAHL, SCOPUS, and Web of Science. Data abstraction included study location, study design, phase of implementation, manner of implementation (ex., data analysis), domains and constructs used, and justifications for use, among other variables. A standardized questionnaire was sent to the corresponding authors of included studies to determine which CFIR domains and constructs authors found to be compatible with use in LMICs and to solicit feedback regarding ways in which CFIR performance could be improved for use in LMICs.

Results

Our database search yielded 504 articles, of which 34 met final inclusion criteria. The studies took place across 21 countries and focused on 18 different health topics. The studies primarily used qualitative study designs (68%). Over half (59%) of the studies applied the CFIR at study endline, primarily to guide data analysis or to contextualize study findings. Nineteen (59%) of the contacted authors participated in the survey. Authors unanimously identified culture and engaging as compatible with use in global implementation research. Only two constructs, patient needs and resources and individual stages of change were commonly identified as incompatible with use. Author feedback centered on team level influences on implementation, as well as systems characteristics, such as health system architecture. We propose a “Characteristics of Systems” domain and eleven novel constructs be added to the CFIR to increase its compatibility for use in LMICs.

Conclusions

These additions provide global implementation science practitioners opportunities to account for systems-level determinants operating independently of the implementing organization. Newly proposed constructs require further reliability and validity assessments.

Trial registration

PROSPERO, CRD42018095762

**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**

Validation of a counseling guide for adherence to antiretroviral therapy using implementation science

Authors:

Flor Yesenia Musayón-Oblitas, Cesar Paul Cárcamo, Sarah Gimbel, Juan Ignacio Echevarria Zarate, and Ana Beatriz Graña Espinoza

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2020

Read the full text in the open access journal Revista Latino-Americana de Enfermagem

Abstract:

Objective:

To determine the contents that must be included in the usual counseling to improve the adherence to antiretroviral therapy (ART) of HIV patients, according to their different levels of alcohol consumption, and to determine the validity of the Counseling Guide in improving the adherence to ART in patients who consume alcohol using Implementation Science.

Method:

This is an observational study with formative and validation phases. The formative phase defined the content, approach and structure of the counseling. Validation included focus groups with patients and nurses, trial process by an expert and a pilot test. The criteria evaluated based on Implementation Science were: intervention source, evidence strength and quality, relative advantage, and complexity. The following criteria were also evaluated: usefulness, practicality, acceptability, sustainability, effectiveness; content consistency and congruence; procedural compliance and difficulties, and time spent in counseling.

Results:

The strength of evidence of the counseling is High-IIA, with strong level of recommendation and presenting usefulness, practicality, acceptability, sustainability and effectiveness. Eight in 11 experts argued that the Guide is clear, consistent and congruent. Initial counseling takes around 24 minutes; and follow-up counseling, 21. The instruments of the Guide present reliability levels between good and high (0.65 ≥ alpha ≤ 0.92).

Conclusion:

The Counseling Guide is valid to improve the adherence to antiretroviral therapy in patients who consume alcohol.

**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