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✪ Implementation Research at NHLBI: Methodological and Design Challenges and Lessons Learned from the DECIPHeR Initiative

Authors:

David M Murray, Patrick Heagerty, James Troendle, Feng-Chang Lin, Jonathan Moyer, June Stevens, Leslie Lytle, Xinzhi Zhang, Maliha Ilias, Mary Y Masterson, Nicole Redmond, Veronica Tonwe, Dave Clark & George A Mensah

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Ethnicity & Disease

Abstract:

NHLBI funded seven projects as part of the Disparities Elimination through Coordinated Interventions to Prevent and Control Heart and Lung Disease Risk (DECIPHeR) Initiative. They were expected to collaborate with community partners to (1) employ validated theoretical or conceptual implementation research frameworks, (2) include implementation research study designs, (3) include implementation measures as primary outcomes, and (4) inform our understanding of mediators and mechanisms of action of the implementation strategy. Several projects focused on late-stage implementation strategies that optimally and sustainably delivered two or more evidence-based multilevel interventions to reduce or eliminate cardiovascular and/or pulmonary health disparities and to improve population health in high-burden communities. Projects that were successful in the three-year planning phase transitioned to a 4-year execution phase. NHLBI formed a Technical Assistance Workgroup during the planning phase to help awardees refine study aims, strengthen research designs, detail analytic plans, and to use valid sample size methods. This paper highlights methodological and study design challenges encountered during this process. Important lessons learned included (1) the need for greater emphasis on implementation outcomes, (2) the need to clearly distinguish between intervention and implementation strategies in the protocol, (3) the need to address clustering due to randomization of groups or clusters, (4) the need to address the cross-classification that results when intervention agents work across multiple units of randomization in the same arm, (5) the need to accommodate time-varying intervention effects in stepped-wedge designs, and (6) the need for data-based estimates of the parameters required for sample size estimation.

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

✪ Centering School Leaders’ Expertise: Usability Evaluation of a Leadership-Focused Implementation Strategy to Support Tier 1 Programs in Schools

Authors:

Vaughan K. Collins, Catherine M. Corbin, Jill J. Locke, Clayton R. Cook, Mark G. Ehrhart, Kurt D. Hatch & Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2024

Read the full text open access in the journal School Mental Health

Abstract:

Although there are a growing number of implementation strategies to increase the adoption, fidelity, and sustainment of evidence-based practices (EBP), they are often complex and bulky, which can interfere with their widespread application. To address these challenges, the Helping Educational Leaders Mobilize Evidence (HELM) strategy was created as an adaptation of the evidence-based Leadership and Organizational Change for Implementation (LOCI) implementation strategy to enhance elementary school principals’ use of strategic implementation leadership to support the adoption and delivery of Tier 1 (i.e., universal social, emotional, and behavioral) EBP. In service of its iterative development, a human-centered design methodology was employed to increase the successful uptake and use of HELM. The Cognitive Walkthrough for Implementation Strategies (CWIS), a novel mixed-methods approach to evaluate implementation strategy usability, was applied to identify and test HELM strategy tasks of critical importance. A sample of 15 elementary school principals participated in group cognitive walkthrough testing as either school principal recipients or HELM coaches. Both user types rated the strategy as acceptable (principal M = 77.8, SD = 15.5; coach M = 87.5, SD = 7.9). Five usability issues were identified using a highly structured common usability issue framework and provided direction for the generation of redesign solutions to be incorporated in a subsequent version of the HELM strategy. The evaluation of the strategy’s usability improved its alignment with user needs, expectations, and contextual constraints, rendering a more usable strategy and broadly applicable information surrounding the development of psychosocial implementation strategies in real-world settings.

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

✪ The Effect of Stigma on Family Planning and HIV Pre-exposure Prophylaxis Decisions of Young Women Accessing Post-Abortion Care in Kenya

Authors:

Yasaman Zia, Lydia Etyang, Margaret Mwangi, Roy Njiru, Felix Mogaka, Lavender June, Irene Njeru, Job Makoyo, Susan Kimani, Kenneth Ngure, Inviolata Wanyama, Elizabeth Bukusi, Bernard Nyerere, Cyprian Nyamwaro, Nelly Mugo, Renee Heffron & PrEDIRA team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2024

Read the full text in the open access journal AIDS and Behavior

Abstract:

Adolescent girls and young women (AGYW) in Eastern and Southern Africa face parallel epidemics of unintended pregnancy and HIV. Their sexual health decisions are often dominated by intersecting stigmas. In an implementation science project integrating delivery of daily, oral pre-exposure prophylaxis (PrEP) for HIV prevention into 14 post-abortion care (PAC) clinics in Kenya, we enrolled a subset of PrEP initiating AGYW (aged 15 to 30 years) into a research cohort. Utilizing log binomial models, we estimated the effect of PrEP stigma on PrEP continuation (measured via self-report and urine assay for tenofovir) and abortion stigma on contraceptive initiation. Between April 2022 and February 2023, 401 AGYW were enrolled after initiating PrEP through their PAC provider, of which 120 (29.9%) initiated highly-effective contraception. Overall, abortion and PrEP stigmas were high in this cohort. Abortion stigma was more prevalent among those that were adolescents, unmarried, and reported social harm. Among 114 AGYW returning for the month 1 follow-up visit, 83.5% reported continuing PrEP and 52.5% had tenofovir detected. In this subset, higher levels of PrEP stigma were significantly associated with greater likelihood of PrEP adherence, but not PrEP continuation. For abortion stigma, greater scores in the subdomain of isolation were significantly associated with greater likelihood of initiating a highly-effective contraception, while greater scores in the subdomain of community condemnation were significantly associated with reduced likelihood of initiating a highly-effective contraception. Given the burden of stigma documented by our work, PAC settings are a pivotal space to integrate stigma-informed counseling and to empower young women to optimize contraceptive and PrEP decisions.

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

✪ Adaptation of a Tailored Lung Cancer Screening Decision Aid for People With HIV

Authors:

Meagan C. Brown, Madison Snidarich, Jehan Z. Budak, Nicholas Murphy, Nicholas Giustini, Perrin E. Romine, Bryan J. Weiner, Tanner Caverly, Kristina Crothers, and Matthew Triplette.

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal CHEST Pulmonary

Abstract:

Background

People with HIV are both at elevated risk of lung cancer and at high risk of multimorbidity, which makes shared decision-making (SDM) for lung cancer screening (LCS) in people with HIV complex. Currently no known tools have been adapted for SDM in people with HIV.

Research Question

Can an SDM decision aid be adapted to include HIV-specific measures with input from both people with HIV and their providers?

Study Design and Methods

This study used qualitative methods including focus groups of people with HIV and interviews with HIV care providers to adapt and iterate an SDM tool for people with HIV. Eligible participants were those with HIV enrolled in an HIV primary care clinic who met age and smoking eligibility criteria for LCS and HIV care providers at the clinic. Both the focus groups and interviews included semistructured discussions of SDM and decision aid elements for people with HIV. We used a framework-guided thematic analysis, mapping themes onto the Health Equity Implementation framework.

Results

Forty-three people with HIV participated in eight focus groups; 10 providers were interviewed. Key themes from patients included broad interest in adapting LCS SDM specifically for people with HIV, a preference for clear LCS recommendations, and the need for positive framing emphasizing survival. Providers were enthusiastic about personalized LCS risk assessments and point-of-care tools. Both patients and providers gave mixed views on the usefulness of HIV-specific risk measures in patient-facing tools. Themes were used to adapt a personalized and flexible SDM tool for LCS in people with HIV.

Interpretation

People with HIV and providers were enthusiastic about specific tools for SDM that are personalized and tailored for people with HIV, that make recommendations, and that inform LCS decision-making. Divergent views on presenting patient-facing quantitative risk assessments suggests that these elements could be optional but available for review. This tool may have usefulness in complex decision-making for LCS in this population and currently is being evaluated in a pilot prospective trial.

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

✪ Enhanced or hindered research benefits? A realist review of community engagement and participatory research practices for non-communicable disease prevention in low- and middle-income countries

Authors:

Sonja Klingberg, Bipin Adhikari, Catherine E Draper, Edna Bosire, Deborah Nyirenda, Priscilla Tiigah, & Ferdinand C Mukumbang

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal BMJ Global Health

Abstract:

Introduction

Community engagement and participatory research are widely used and considered important for ethical health research and interventions. Based on calls to unpack their complexity and observed biases in their favour, we conducted a realist review with a focus on non-communicable disease prevention. The aim was to generate an understanding of how and why engagement or participatory practices enhance or hinder the benefits of non-communicable disease research and interventions in low- and middle-income countries.

Methods

We retroductively formulated theories based on existing literature and realist interviews. After initial searches, preliminary theories and a search strategy were developed. We searched three databases and screened records with a focus on theoretical and empirical relevance. Insights about contexts, strategies, mechanisms and outcomes were extracted and synthesised into six theories. Five realist interviews were conducted to complement literature-based theorising. The final synthesis included 17 quality-appraised articles describing 15 studies.

Results

We developed six theories explaining how community engagement or participatory research practices either enhance or hinder the benefits of non-communicable disease research or interventions. Benefit-enhancing mechanisms include community members’ agency being realised, a shared understanding of the benefits of health promotion, communities feeling empowered, and community members feeling solidarity and unity. Benefit-hindering mechanisms include community members’ agency remaining unrealised and participation being driven by financial motives or reputational expectations

Conclusion

Our review challenges assumptions about community engagement and participatory research being solely beneficial in the context of non-communicable disease prevention in low- and middle-income countries. We present both helpful and harmful pathways through which health and research outcomes are affected. Our practical recommendations relate to maximising benefits and minimising harm by addressing institutional inflexibility and researcher capabilities, managing expectations on research, promoting solidarity in solving public health challenges and sharing decision-making power.

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

✪ Implementation outcomes of the integrated district evidence to action (IDEAs) program to reduce neonatal mortality in central Mozambique: an application of the RE-AIM evaluation framework

Authors:

Aneth Dinis, Quinhas Fernandes, Bradley H Wagenaar, Sarah Gimbel, Bryan J Weiner, Grace John-Stewart, Ermyas Birru, Stephen Gloyd, Ruth Etzioni, Dorlim Uetela, Isaías Ramiro, Artur Gremu, Orvalho Augusto, Stélio Tembe, Jaime L Mário, Jalilo E Chinai, Alfredo F Covele, Cassimo M Sáide, Nélia Manaca & Kenneth Sherr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

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

Abstract:

Background

Scarce evidence exists on audit and feedback implementation processes in low-resource health systems. The Integrated District Evidence to Action (IDEAs) is a multi-component audit and feedback strategy designed to improve the implementation of maternal and child guidelines in Mozambique. We report IDEAs implementation outcomes.

Methods

IDEAs was implemented in 154 health facilities across 12 districts in Manica and Sofala provinces between 2016 and 2020 and evaluated using a quasi-experimental design guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Reach is the proportion of pregnant women attending IDEAs facilities. Adoption is the proportion of facilities initiating audit and feedback meetings. Implementation is the fidelity to the strategy components, including readiness assessments, meetings (frequency, participation, action plan development), and targeted financial support and supervision. Maintenance is the sustainment at 12, 24, and 54 months.

Results

Across both provinces, 56% of facilities were exposed to IDEAs (target 57%). Sixty-nine and 73% of pregnant women attended those facilities’ first and fourth antenatal consultations (target 70%). All facilities adopted the intervention. 99% of the expected meetings occurred with an average interval of 5.9 out of 6 months. Participation of maternal and child managers was high, with 3076 attending meetings, of which 64% were from the facility, 29% from the district, and 7% from the province level. 97% of expected action plans were created, and 41 specific problems were identified. “Weak diagnosis or management of obstetric complications” was identified as the main problem, and “actions to reinforce norms and protocols” was the dominant subcategory of micro-interventions selected. Fidelity to semiannual readiness assessments was low (52% of expected facilities), and in completing micro-interventions (17% were completed). Ninety-six and 95% of facilities sustained the intervention at 12 and 24 months, respectively, and 71% had completed nine cycles at 54 months.

Conclusion

Maternal and child managers can lead audit and feedback processes in primary health care in Mozambique with high reach, adoption, and maintenance. The IDEAs strategy should be adapted to promote higher fidelity around implementing action plans and conducting readiness assessments. Adding effectiveness to these findings will help to inform strategy scale-up.

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

✪ Participatory development of a target policy profile to support soil-transmitted helminth elimination

Authors:

Arianna Rubin Means, Kellie List, Amy Roll, Marie-Claire Gwayi-Chore, Shawn Dolley, Holger J. Schünemann, Thea C. Norman and Judd L. Walson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text in the open access journal Frontiers in Health Services

Abstract:

Introduction

Soil-transmitted helminths (STH) are parasitic worms that infect nearly a quarter of the world's population, particularly those living in communities without access to adequate water, sanitation, and housing. Emerging evidence suggests that it may be possible to interrupt transmission of STH by deworming individuals of all ages via community-wide MDA (cMDA), as opposed to only treating children and other focal populations. Transitioning from a policy of STH control to STH elimination in targeted areas would require a fundamental shift in STH policy and programming. This policy change would require updated guidance to support countries as they adapt their current approaches for STH surveillance, supply chain management, community mobilization, and core programmatic activities in pursuit of STH elimination. There is an opportunity to engage with key stakeholders, such as program implementers and implementation partners, to understand what evidence they need to confidently adopt a new policy guideline and to deliver guideline adherent management at scale.

Methods

We aimed to engage with STH stakeholders to develop a Target Policy Profile (TPoP), a single document that describes optimal characteristics and evidence requirements that STH stakeholders prioritized in future potential STH transmission interruption efforts. Steps in TPoP development included a scoping review and key informant interviews (KIIs), which were used to design a two-stage Delphi technique to identify and verify TPoP components.

Results

The scoping review resulted in 25 articles, and 8 experts participated in KII's. Twenty respondents completed the first Delphi survey and 10 respondents completed the second. This systematic effort resulted in a net of 3 key information domains (background/context, clinical considerations, and implementation considerations) encompassing 24 evidence categories (examples include evidence regarding safety and adverse events, implementation feasibility, or evidence dissemination). For each evidence category, STH stakeholders reviewed, endorsed, or revised a range of options for how the evidence could be presented.

Discussion

This information can be used by guideline committees or global policy makers prior to convening guideline advisory groups. The TPoP tool may also speed the process of stakeholder consensus building around guidelines, accelerating progress towards implementing evidence-based policy at scale.

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

✪ Core Components and Implementation Determinants of Multilevel Service Delivery Frameworks Across Child Mental Health Service Settings

Authors:

Stephanie A. Moore, Jennifer McGrory Cooper, JoAnne Malloy, & Aaron R. Lyon

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: December 2023

Read the full text in the open access journal Administration and Policy in Mental Health

Abstract:

Multilevel service delivery frameworks are approaches to structuring and organizing a spectrum of evidence-based services and supports, focused on assessment, prevention, and intervention designed for the local context. Exemplar frameworks in child mental health include positive behavioral interventions and supports in education, collaborative care in primary care, and systems of care in community mental health settings. Yet, their high-quality implementation has lagged. This work proposes a conceptual foundation for multilevel service delivery frameworks spanning diverse mental health service settings that can inform development of strategic implementation supports. We draw upon the existing literature for three exemplar multilevel service delivery frameworks in different child mental health service settings to (1) identify core components common to each framework, and (2) to highlight prominent implementation determinants that interface with each core component. Six interrelated components of multilevel service delivery frameworks were identified, including, (1) a systems-level approach, (2) data-driven problem solving and decision-making, (3) multiple levels of service intensity using evidence-based practices, (4) cross-linking service sectors, (5) multiple providers working together, including in teams, and (6) built-in implementation strategies that facilitate delivery of the overall model. Implementation determinants that interface with core components were identified at each contextual level. The conceptual foundation provided in this paper has the potential to facilitate cross-sector knowledge sharing, promote generalization across service settings, and provide direction for researchers, system leaders, and implementation intermediaries/practitioners working to strategically support the high-quality implementation of these frameworks.

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

✪ Higher rates of mental health screening of adolescents recorded after provider training using simulated patients in a Kenyan HIV clinic: results of a pilot study

Authors:

Tessa Concepcion, Peter Mogere, Kenneth Ngure, Njoroge Mwathi, Roy Njiru, Boaz Kipkorir, Catherine Kiptinness, Gakuo Maina, Emmah Owidi, Tamara Owens, Pamela Kohler, Bradley H. Wagenaar, Shannon Dorsey, Pamela Y. Collins, and Jennifer Velloza

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2023

Read the full text in the open access journal Frontiers in Public Health

Abstract:

Background

Kenyan adolescent girls and young women (AGYW) experience a dual burden of HIV and common mental disorders (CMD). HIV clinics are a key entry point for AGYW in need of integrated CMD and HIV care; however, rates of screening and referral for CMDs are low. Our objective was to test an evidence-based provider training strategy, simulated patient encounters (SPEs), on CMD service delivery for AGYW in a Kenyan HIV clinic.

Methods

This pilot study was conducted in a public HIV clinic in Thika, Kenya from January to November 2021. The simulated patient encounter (SPE) implementation strategy included case script development from prior qualitative work, patient actor training, and a three-day SPE training including four standardized mock clinical encounters followed by quantitative surveys assessing provider competencies for each encounter. We abstracted medical record data related to HIV and CMDs such as HIV status, reason for visit, CMD screening test performed, and counselling or referral information. We conducted an interrupted time series analysis using abstracted HIV and CMD screening rates from AGYW ages 16–25 years visiting the clinic 7 months before and 3 months after SPE training. We used generalized linear models to assess changes in CMD screening rates after training.

Results

A total of 10 providers participated in the training. Competency ratings improved across four mock encounters (mean score from 8.1 to 13.7) between first and fourth encounters. We abstracted all medical records (n = 1,154) including from 888 (76%) AGYW seeking HIV treatment, 243 (21%) seeking prevention services, and 34 (3%) seeking other services. CMD screening rates increased immediately following training from 8 to 21% [relative risk (RR) = 2.57, 95% confidence interval (CI) = 1.34–4.90, p < 0.01]. The 3 months following the SPE training resulted in an 11% relative increase in CMD screening proportion compared to the 7 months pre-SPE (RR: 1.11, 95% CI: 1.04–1.17, p < 0.01). Finally, 1% of all pre-SPE screens resulted in referral versus 5% of post-SPE screens (p = 0.07).

Conclusions

The SPE model is a promising implementation strategy for improving HIV provider competencies and CMD service delivery for adolescents in HIV clinics. Future research is needed to explore effects on adolescent clinical outcomes in larger trials.

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