Skip to content

✪ A framework for designing hybrid effectiveness-implementation trials for digital health interventions

Authors:

Theresa E. Matson, Eric D.A. Hermes, Aaron R. Lyon, Andrew Quanbeck, Stephen M. Schueller, Sarah M. Wilson, and Joseph E. Glass

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2025

Read the full text open access in the journal Annals of Epidemiology

Abstract:

This article proposes methods for designing randomized controlled trials studying the implementation and effectiveness of digital interventions, meaning websites or applications ("apps") that patients use in healthcare. Deploying digital interventions for behavioral health differs from implementing traditional interventions such as medications or human-delivered therapy. Prior trial design guidance has ignored the existence of international governmental evidence standards, has paid insufficient attention to implementation reporting guidelines, and has not described methods for empirically testing the approach for organizing the delivery of digital interventions.

This framework for designing hybrid effectiveness-implementation trials of digital behavioral health interventions helps researchers articulate research questions that matter to decision-makers and meaningfully contribute to implementation. The framework outlines three phases: 1) frame effectiveness and implementation questions in terms of the digital intervention components, types of clinical support for the digital intervention, and specific strategies for implementing the digital intervention; 2) define and delineate actors, activities, action targets, dose, temporality, and outcomes to maximize inference and reproducibility; and 3) specify trial design features used for hybrid classification.

We illustrate the utility of this framework with two effectiveness-implementation studies of digital interventions for substance use. This framework can help researchers decide on appropriate methodology and help decision-makers apply findings.

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

✪ Acceptability of single-dose HPV vaccination schedule among health-care professionals in Kenya: a mixed-methods study

Authors:

Grace Umutesi, Bryan J Weiner, Lynda Oluoch, Elizabeth Bukusi, Maricianah Onono, Betty Njoroge, Lucy Mecca, Kenneth Ngure, Nelly R Mugo, Ruanne V Barnabas

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: November 2024

Read the full text in the open access journal JNCI Monographs

Abstract:

Background

The World Health Organization recommends a single-dose human papillomavirus (HPV) vaccination schedule for girls and boys to accelerate progress toward cervical cancer elimination. We applied the Theoretical Framework of Acceptability (TFA) within the context of HPV vaccination to assess the acceptability of a single-dose schedule among health-care professionals in Kenya.

Methods

A REDCap survey was developed using relevant Theoretical Framework of Acceptability domains and validated with health-care professionals. Descriptive analyses and multivariate Poisson regression were conducted to assess factors associated with increased acceptability. Free-text responses were analyzed using a rapid qualitative approach, and findings were presented using a joint display.

Results

Among 385 responses, 74.2% of health-care professionals were female and 48.6% were nurses. On average, respondents had been in their position for 60 months, and one-third (33.2%) were based at level-4 facilities. The majority (75.84%) thought that giving a single-dose of the HPV vaccine to adolescent girls and young women was either acceptable or very acceptable. Qualitative findings highlighted that lack of information was the underlying reason for health-care professionals who were resistant, and most clinicians thought that a singled-dose schedule was less burdensome to clinicians and patients. Hospital directors had a non–statistically significantly lower acceptability likelihood than nurses (incident rate ratio = 0.93, 95% confidence interval = 0.45 to 1.71) and health-care professionals at urban facilities had a non–statistically significantly lower acceptability likelihood than clinicians in rural facilities (incident rate ratio = 0.97, 95% confidence interval = 0.83 to 1.13).

Conclusion

Although not statistically significant, predictors of increased acceptability provide information to tailor strategies to increase HPV vaccination coverage and accelerate progress toward cervical cancer elimination.

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

✪ Reimagining policy implementation science in a global context: a theoretical discussion

Authors:

Kellie List, Peter Agamile, Didier Yélognissè Alia, Peter Cherutich, Kristen Danforth, John Kinuthia, Arianna Rubin Means, Irene Mukui, Nancy Ngumbau, Yanfang Su, Anjuli Dawn Wagner, Bryan J Weiner, and Sarah Masyuko

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

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

Abstract:

Introduction

Policy implementation science (IS) is defined here as generating knowledge and deploying implementation strategies to effectively adopt and integrate evidence-based interventions (EBIs) into policy designs and improve policy implementation and effectiveness (1–3). Most existing policy IS scholarly works originate from the Global North (United States, Canada, and Western Europe) and describe or evaluate strategies to increase the uptake of EBIs (4). The existing Global North-generated frameworks focus less on the critical resources needed to formulate and implement a policy in diverse settings. Current approaches to policy IS lack sufficient contextual nuance to be applicable to...[read more].

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

✪ A Community-Partnered Research Process for Implementation Strategy Design: Developing Resources to Support Behavioral Classroom Interventions

Authors:

Gwendolyn M. Lawson, Julie Sarno Owens, David S. Mandell, Samantha Tavlin, Steven Rufe, Aubrey Depa, Aaron R. Lyon, & Thomas J. Power

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

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

Abstract:

Schools need effective, sustainable implementation strategies to support teachers in using effective Tier 1 (i.e., whole class) and Tier 2 (i.e., targeted) behavioral interventions in the classroom. This paper describes an iterative, community-partnered process of developing implementation resources to support teachers in using Tier 1 and 2 positive behavior management interventions; we call these resources the Positive Behavior Management Toolkit (PBMT). There were two key aspects to the iterative development process: 1) working with a Program Development Team of district—and school-employed partners to identify priorities, interpret data, provide feedback on resources, and plan for sustainment; and 2) conducting a series of tryouts in which teachers used a version of the PBMT in their classrooms and provided quantitative and qualitative feedback on acceptability, appropriateness, feasibility, and recommendations for improvement. In partnership with the Program Development Team, we used data from the tryouts to inform revisions to the PBMT. This paper presents quantitative and qualitative data from the tryouts and describes how these data informed revisions to the PBMT. We also describe the processes by which we engaged the team, considerations related to contextual appropriateness, and lessons learned related to community-engaged intervention development research.

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

✪ A 4D Theoretical Framework for Measuring Topic-Specific Influence on Twitter: Development and Usability Study on Dietary Sodium Tweets

Authors:

Lingchao Mao, Emily Chu, Jinghong Gu, Tao Hu, Bryan J Weiner, Yanfang Su

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2023

Read the full text in the open access journal Journal of Medical Internet Research

Abstract:

Background

Social media has emerged as a prominent approach for health education and promotion. However, it is challenging to understand how to best promote health-related information on social media platforms such as Twitter. Despite commercial tools and prior studies attempting to analyze influence, there is a gap to fill in developing a publicly accessible and consolidated framework to measure influence and analyze dissemination strategies.

Objective

We aimed to develop a theoretical framework to measure topic-specific user influence on Twitter and to examine its usability by analyzing dietary sodium tweets to support public health agencies in improving their dissemination strategies.

Methods

We designed a consolidated framework for measuring influence that can capture topic-specific tweeting behaviors. The core of the framework is a summary indicator of influence decomposable into 4 dimensions: activity, priority, originality, and popularity. These measures can be easily visualized and efficiently computed for any Twitter account without the need for private access. We demonstrated the proposed methods by using a case study on dietary sodium tweets with sampled stakeholders and then compared the framework with a traditional measure of influence.

Results

More than half a million dietary sodium tweets from 2006 to 2022 were retrieved for 16 US domestic and international stakeholders in 4 categories, that is, public agencies, academic institutions, professional associations, and experts. We discovered that World Health Organization, American Heart Association, Food and Agriculture Organization of the United Nations (UN-FAO), and World Action on Salt (WASH) were the top 4 sodium influencers in the sample. Each had different strengths and weaknesses in their dissemination strategies, and 2 stakeholders with similar overall influence, that is, UN-FAO and WASH, could have significantly different tweeting patterns. In addition, we identified exemplars in each dimension of influence. Regarding tweeting activity, a dedicated expert published more sodium tweets than any organization in the sample in the past 16 years. In terms of priority, WASH had more than half of its tweets dedicated to sodium. UN-FAO had both the highest proportion of original sodium tweets and posted the most popular sodium tweets among all sampled stakeholders. Regardless of excellence in 1 dimension, the 4 most influential stakeholders excelled in at least 2 out of 4 dimensions of influence.

Conclusions

Our findings demonstrate that our method not only aligned with a traditional measure of influence but also advanced influence analysis by analyzing the 4 dimensions that contribute to topic-specific influence. This consolidated framework provides quantifiable measures for public health entities to understand their bottleneck of influence and refine their social media campaign strategies. Our framework can be applied to improve the dissemination of other health topics as well as assist policy makers and public campaign experts to maximize population impact.

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

✪ Integration of a Digital Health Intervention Into Immunization Clinic Workflows in Kenya: Qualitative, Realist Evaluation of Technology Usability

Authors:

Samantha B Dolan, Rachel Wittenauer, Jessica C Shearer, Anne Njoroge, Penina Onyango, George Owisom, William B Lober, Shan Liu, Nancy Puttkammer, & Peter Rabinowitz

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2023

Read the full text in the open access journal JMIR Formative Research

Abstract:

Background

In an effort to increase vaccination coverage in low-resource settings, digital tools have been introduced to better track immunization records, improve data management practices, and provide improved access to vaccination coverage data for decision-making. Despite the potential of these electronic systems to improve the provision of health services, few digital health interventions have been institutionalized at scale in low- and middle-income countries.

Objective

In this paper, we aimed to describe how health care workers in Kenya had integrated an electronic immunization registry into their immunization clinic workflows and to use these findings to inform the development of a refined program theory on the registry’s usability.

Methods

Informed by realist methodology, we developed a program theory to explain usability of the electronic immunization registry. We designed a qualitative study based on our theory to describe the barriers and facilitators influencing data entry and use. Qualitative data were collected through semistructured interviews with users and workflow observations of immunization clinic sessions. Our findings were summarized by context-mechanism-outcome relationships formed after analyzing our key themes across interviews and workflow observations. Using these relationships, we were able to identify common rules for future implementers.

Results

Across the 12 facilities included in our study, 19 health care workers were interviewed, and 58 workflow sessions were observed. The common rules developed from our qualitative findings are as follows: rule 1—ensure that the users complete training to build familiarity with the system, understand the value of the system and data, and know where to find support; rule 2—confirm that the system captures all data needed for users to provide routine health care services and is easy to navigate; rule 3—identify work-arounds for poor network, system performance, and too few staff or resources; and rule 4—make users aware of expected changes to their workflow, and how these changes might differ over time and by facility size or number of patients. Upon study completion, we revised the program theory to reflect the importance of the goals and workflows of electronic immunization registries aligning with reality.

Conclusions

We created a deeper understanding of the underlying mechanisms for usability of the registry. We found that the electronic immunization registry had high acceptability among users; however, there were numerous barriers to using the system, even under ideal conditions, causing a misalignment between the system and the reality of the users’ workflows and their environment. Human-centered design and human-factors methods can assist during pilot stages to better align systems with users’ needs and again after scale-up to ensure that interventions are suitable for all user settings."

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

✪ Creating research-ready partnerships: the initial development of seven implementation laboratories to advance cancer control

Authors:

Gina R. Kruse, Erica Hale, Justin E. Bekelman, Jennifer E. DeVoe, Rachel Gold, Peggy A. Hannon, Thomas K. Houston, Aimee S. James, Ashley Johnson, Lisa M. Klesges & Andrea L. Nederveld

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2023

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

Abstract:

Background

In 2019–2020, with National Cancer Institute funding, seven implementation laboratory (I-Lab) partnerships between scientists and stakeholders in ‘real-world’ settings working to implement evidence-based interventions were developed within the Implementation Science Centers in Cancer Control (ISC3) consortium. This paper describes and compares approaches to the initial development of seven I-Labs in order to gain an understanding of the development of research partnerships representing various implementation science designs.

Methods

In April-June 2021, members of the ISC3 Implementation Laboratories workgroup interviewed research teams involved in I-Lab development in each center. This cross-sectional study used semi-structured interviews and case-study-based methods to collect and analyze data about I-Lab designs and activities. Interview notes were analyzed to identify a set of comparable domains across sites. These domains served as the framework for seven case descriptions summarizing design decisions and partnership elements across sites.

Results

Domains identified from interviews as comparable across sites included engagement of community and clinical I-Lab members in research activities, data sources, engagement methods, dissemination strategies, and health equity. The I-Labs use a variety of research partnership designs to support engagement including participatory research, community-engaged research, and learning health systems of embedded research. Regarding data, I-Labs in which members use common electronic health records (EHRs) leverage these both as a data source and a digital implementation strategy. I-Labs without a shared EHR among partners also leverage other sources for research or surveillance, most commonly qualitative data, surveys, and public health data systems. All seven I-Labs use advisory boards or partnership meetings to engage with members; six use stakeholder interviews and regular communications. Most (70%) tools or methods used to engage I-Lab members such as advisory groups, coalitions, or regular communications, were pre-existing. Think tanks, which two I-Labs developed, represented novel engagement approaches. To disseminate research results, all centers developed web-based products, and most (n = 6) use publications, learning collaboratives, and community forums. Important variations emerged in approaches to health equity, ranging from partnering with members serving historically marginalized populations to the development of novel methods.

Conclusions

The development of the ISC3 implementation laboratories, which represented a variety of research partnership designs, offers the opportunity to advance understanding of how researchers developed and built partnerships to effectively engage stakeholders throughout the cancer control research lifecycle. In future years, we will be able to share lessons learned for the development and sustainment of implementation laboratories.

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

✪ Soil-transmitted helminth surveillance in Benin: A mixed-methods analysis of factors influencing non-participation in longitudinal surveillance activities

Authors:

Emma Murphy, Innocent Comlanvi Togbevi, Moudachirou Ibikounlé, Euripide FGA Avokpaho, Judd L. Walson, & Arianna Rubin Means

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2023

Read the full text in the open access journal PLOS Neglected Tropical Diseases

Abstract:

Background

Despite the significant success of deworming programs in reducing morbidity due to soil-transmitted helminth (STH) infections globally, efforts to achieve elimination of STH as a public health problem or to potentially interrupt transmission will require improving and intensifying surveillance. However, non-participation in surveillance threatens the ability of programs to adequately monitor program status and limited research has been conducted to investigate drivers of non-participation in stool-based surveillance.

Despite the significant success of deworming programs in reducing morbidity due to soil-transmitted helminth (STH) infections globally, efforts to achieve elimination of STH as a public health problem or to potentially interrupt transmission will require improving and intensifying surveillance. However, non-participation in surveillance threatens the ability of programs to adequately monitor program status and limited research has been conducted to investigate drivers of non-participation in stool-based surveillance.

Methodology/Principal findings

This mixed-methods exploratory sequential study took place in Comé, Benin in association with the DeWorm3 Project. Six focus group discussions were conducted with individuals invited to participate in annual DeWorm3 stool surveillance. Thematic analysis was used to identify facilitators and barriers to participation and inform the quantitative analysis. A mixed-effects logistic regression model was built using baseline DeWorm3 survey data to identify factors associated with non-participation. Qualitative and quantitative findings were merged for interpretation. Among the 7,039 individuals invited to participate in baseline stool surveillance, the refusal rate was 8.1%. Qualitative themes included: community members weighing community-level benefits against individual-level risks, circulating rumors about misuse of stool samples, interpersonal communication with field agents, and cultural norms around handling adult feces. The quantitative analysis demonstrated that adults were significantly less likely to provide a stool sample than school-aged children (OR:0.69, 95%CI: 0.55–0.88), a finding that converged with the qualitative results. Individuals from areas in the highest quartile of population density were more likely to refuse to participate (OR:1.71, 95%CI:1.16–2.52). Several variables linked to community-affinity aligned with qualitative results; residing mainly in the community (OR:0.36, 95%CI:0.20–0.66) and having lived in the community for more than 10 years (OR:0.82, 95%CI:0.54–1.25) decreased likelihood of refusal.

Conclusions/Significance

Optimizing STH surveillance will require that programs reimagine STH surveillance activities to address community concerns and ensure that no subpopulations are inadvertently excluded from surveillance data.

Author summary:

Soil-transmitted helminths (STH) are a group of intestinal parasites infecting approximately 1.5 billion people globally and resulting in significant adverse health outcomes. STH surveillance is conducted across endemic regions to assess prevalence of infection, to identify areas for mass drug administration implementation, and to monitor progress. The World Health Organization targets the elimination of STH as a public health problem in endemic settings with research currently being conducted to determine the feasibility of interrupting transmission of STH. In order to optimally design and manage programs towards these goals, and to verify whether elimination of STH as a public health problem has occurred, improvements in surveillance are needed. This mixed-methods study took place in Comé, Benin in association with the DeWorm3 Project, to identify drivers of non-participation in stool-based STH surveillance. This study found that certain individuals are more likely to refuse to participate in STH surveillance activities than others, including adults, individuals in urban areas, short-term residents in communities, and those perceiving their families to not be at risk for STH. As STH surveillance is intensified, programs will need to reimagine how surveillance is conducted to address community concerns and ensure that no subpopulations are inadvertently excluded from surveillance data.

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