Skip to content

✪ Protocol for the Australian Type 1 Diabetes National Screening Pilot: Assessing the feasibility and acceptability of three general population screening models in children

Authors:

Kirstine J. Bell, Shannon Brodie, Jennifer J. Couper, Peter Colman, Elizabeth Davis, Gary Deed, William Hagopian, Aveni Haynes, Christel Hendrieckx, Amanda Henry, Adrienne Gordon, Kirsten Howard, Tony Huynh, Bernadette Kerr, Kara Mikler, Natasha Nassar, Sarah Norris, Richard Oram, Dorota Pawlak, Antonia Shand, Richard O. Sinnott, Bethany Wadling, John M. Wentworth, Maria E. Craig & the Type 1 Diabetes National Screening Pilot Study Group

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal Diabetes Medicine

Abstract:

Aim

One third of Australian children diagnosed with type 1 diabetes present with life-threatening diabetic ketoacidosis (DKA) at diagnosis. Screening for early-stage, presymptomatic type 1 diabetes, with ongoing follow-up, can substantially reduce this risk (<5% risk). Several screening models are being trialled internationally, without consensus on the optimal approach. This pilot study aims to assess three models for a routine, population-wide screening programme in Australia.

Methods

An implementation science-guided pilot study to evaluate the feasibility, acceptability and costs of three screening models in children will be conducted between July 2022 and June 2024. These models are as follows: (1) Genetic risk-stratified screening using newborn heel prick dried bloodspots, followed by autoantibody testing from 11 months of age; (2) genetic risk-stratified screening of infant (6–12 months) saliva followed by autoantibody testing from 10 months of age; and (3) autoantibody screening using capillary dried bloodspots collected from children aged 2, 6 or 10 years. Cohorts for each model will be recruited from targeted geographic areas across Australia involving ≥2 states per cohort, with a recruitment target of up to 3000 children per cohort (total up to 9000 children). The primary outcome is screening uptake for each cohort. Secondary outcomes include programme feasibility, costs, parental anxiety, risk perception, satisfaction, well-being and quality of life, and health professional attitudes and satisfaction.

Conclusions

This pilot is the first direct comparison of three screening implementation models for general population screening. Findings will provide evidence to inform a potential national screening programme for Australian children.

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

Measuring perceived utility of genomic sequencing: Development and validation of the GENEtic Utility (GENE-U) scale for adult screening

Authors:

Hadley Stevens Smith, Caryn Kseniya Rubanovich, Jill Oliver Robinson, Ariel N. Levchenko, Sarah A. Classen, Janet Malek, Adam H. Buchanan, Barbara Biesecker, Kyle B. Brothers, Benjamin S. Wilfond, Christine Rini, Cinnamon S. Bloss, Amy L. McGuire & Sara J. Knight

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2024

Read the full text in the subscription access journal Genetics in Medicine

✪ Using FRAME to characterize provider-identified adaptations to a stepped care intervention for adolescents and youth living with HIV in Kenya: a mixed methods approach

Authors:

Nok Chhun, Dorothy Oketch, Kawango Agot, Dorothy I. Mangale, Jacinta Badia, James Kibugi, Wenwen Jiang, Mary Kirk, Barbra A. Richardson, Pamela K. Kohler, Grace John-Stewart & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Introduction

The Data-informed Stepped Care (DiSC) study is a cluster-randomized trial implemented in 24 HIV care clinics in Kenya, aimed at improving retention in care for adolescents and youth living with HIV (AYLHIV). DiSC is a multi-component intervention that assigns AYLHIV to different intensity (steps) of services according to risk. We used the Framework for Reporting Adaptations and Modifications-Expanded (FRAME) to characterize provider-identified adaptations to the implementation of DiSC to optimize uptake and delivery, and determine the influence on implementation outcomes.

Methods

Between May and December 2022, we conducted continuous quality improvement (CQI) meetings with providers to optimize DiSC implementation at 12 intervention sites. The meetings were guided by plan-do-study-act processes to identify challenges during early phase implementation and propose targeted adaptations. Meetings were audio-recorded and analysed using FRAME to categorize the level, context and content of planned adaptations and determine if adaptations were fidelity consistent. Providers completed surveys to quantify perceptions of DiSC acceptability, appropriateness and feasibility. Mixed effects linear regression models were used to evaluate these implementation outcomes over time.

Results

Providers participated in eight CQI meetings per facility over a 6-month period. A total of 65 adaptations were included in the analysis. The majority focused on optimizing the integration of DiSC within the clinic (83%, n = 54), and consisted of improving documentation, addressing scheduling challenges and improving clinic workflow. Primary reasons for adaptation were to align delivery with AYLHIV needs and preferences and to increase reach among AYLHIV: with reminder calls to AYLHIV, collaborating with schools to ensure AYLHIV attended clinic appointments and addressing transportation challenges. All adaptations to optimize DiSC implementation were fidelity-consistent. Provider perceptions of implementation were consistently high throughout the process, and on average, slightly improved each month for intervention acceptability (β = 0.011, 95% CI: 0.002, 0.020, p = 0.016), appropriateness (β = 0.012, 95% CI: 0.007, 0.027, p<0.001) and feasibility (β = 0.013, 95% CI: 0.004, 0.022, p = 0.005).

Conclusions

Provider-identified adaptations targeted improved integration into routine clinic practices and aimed to reduce barriers to service access unique to AYLHIV. Characterizing types of adaptations and adaptation rationale may enrich our understanding of the implementation context and improve abilities to tailor implementation strategies when scaling to new settings.

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

✪ Integrating a mental health intervention into PrEP services for South African young women: a human-centered implementation research approach to intervention development

Authors:

Jennifer Velloza, Nomhle Ndimande-Khoza, Lisa Mills, Tessa Concepcion, Sanele Gumede, Hlukelo Chauke, Ruth Verhey, Dixon Chibanda, Sybil Hosek, Bryan J. Weiner, Connie Celum, Sinead Delany-Moretlwe

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Introduction

Adolescent girls and young women (AGYW) who may benefit from HIV pre-exposure prophylaxis (PrEP) face high levels of common mental disorders (e.g. depression, anxiety). Common mental disorders can reduce PrEP adherence and increase HIV risk, yet mental health interventions have not been well-integrated into PrEP delivery.

Methods

We conducted a four-phase human-centered design process, from December 2020 to April 2022, to understand mental health challenges among AGYW in Johannesburg, South Africa and barriers to integrated mental health and PrEP services. In the “Discover” phase, we conducted in-depth interviews with AGYW and key informants (KIs) in Johannesburg. We conducted a rapid qualitative analysis, informed by the Consolidated Framework for Implementation Research (CFIR), to identify facilitators and barriers of integrated mental health and PrEP services and mapped barriers to potential implementation strategies. In the “Design” and “Build” phases, we conducted stakeholder workshops to iteratively adapt an evidence-based mental health intervention, the Friendship Bench, and refine implementation strategies for South African PrEP delivery settings. In the “Test” phase, we piloted our adapted Friendship Bench package.

Results

Interviews with 70 Discover phase participants (48 AGYW, 22 KIs) revealed the importance of integrated mental health and PrEP services for South African AGYW. Interviewees described barriers and implementation strategies for mental health and PrEP services around the CFIR domains: intervention characteristics (e.g. challenges with AGYW “opening up”); outer Johannesburg setting (e.g. community stigma); inner clinic setting (e.g. judgmental healthcare providers); characteristics of counsellors (e.g. training gaps); and the implementation process (e.g. need for demand creation). The Design and Build workshops included 13 AGYW and 15 KIs. Implementation barriers related to the quality and accessibility of public-sector clinic services, lay counsellor training, and community education and demand creation activities were prioritized. This led to 12 key Friendship Bench adaptations and the specification of 10 implementation strategies that were acceptable and feasible in initial pilot testing with three AGYW.

Conclusions

Using a human-centered approach, we identified determinants and potential solutions for integrating mental health interventions within PrEP services for South African AGYW. This design process centered stakeholders’ perspectives, enabling rapid development of an adapted Friendship Bench intervention implementation package.

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

A tailored decision aid improves understanding of lung cancer screening in people with HIV

Authors:

Nicholas R. Murphy, Kristina Crothers, Madison Snidarich, Jehan Z. Budak, Meagan C. Brown, Bryan J. Weiner, Nicholas Giustini, Tanner Caverly, Katherine Durette, Katie DeCell, and Matthew Triplette

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: July 2024

Read the full text in the subscription access CHEST Journal

✪ Development of a method for Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI): a modified Delphi study

Authors:

Stephanie K. Brewer, Catherine M. Corbin, Ana A. Baumann, Shannon Wiltsey Stirman, Janine M. Jones, Michael D. Pullmann, Aaron R. Lyon & MODIFI Expert Panel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

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

Abstract:

Background

Intervention adaptation is often necessary to improve the fit between evidence-based practices/programs and implementation contexts. Existing frameworks describe intervention adaptation processes but do not provide detailed steps for prospectively designing adaptations, are designed for researchers, and require substantial time and resources to complete. A pragmatic approach to guide implementers through developing and assessing adaptations in local contexts is needed. The goal of this project was to develop Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI), a method for intervention adaptation that leverages human centered design methods and is tailored to the needs of intervention implementers working in applied settings with limited time and resources.

Method

MODIFI was iteratively developed via a mixed-methods modified Delphi process. Feedback was collected from 43 implementation research and practice experts. Two rounds of data collection gathered quantitative ratings of acceptability and inclusion (Round 1) and feasibility (Round 2), as well as qualitative feedback regarding MODIFI revisions analyzed using conventional content analysis.

Results

In Round 1, most participants rated all proposed components as essential but identified important avenues for revision which were incorporated into MODIFI prior to Round 2. Round 2 emphasized feasibility, where ratings were generally high and fewer substantive revisions were recommended. Round 2 changes largely surrounded operationalization of terms/processes and sequencing of content. Results include a detailed presentation of the final version of the three-step MODIFI method (Step 1: Learn about the users, local context, and intervention; Step 2: Adapt the intervention; Step 3: Evaluate the adaptation) along with a case example of its application.

Discussion

MODIFI is a pragmatic method that was developed to extend the contributions of other research-based adaptation theories, models, and frameworks while integrating methods that are tailored to the needs of intervention implementers. Guiding teams to tailor evidence-based interventions to their local context may extend for whom, where, and under what conditions an intervention can be effective.

Contributions to the literature
  • Adaptation of evidence-based practices, programs, and treatments is often needed to ensure successful implementation. However, existing theories/models/frameworks do not outline concrete adaptation steps that are feasible for real-world settings.
  • We created a resource-efficient method (MODIFI) for developing and assessing intervention adaptations in local settings. This method was iteratively developed through a mixed-methods modified Delphi process, which resulted in consensus among experts in implementation science and practice.
  • MODIFI leverages human centered design techniques and is tailored to the needs of intervention implementers in applied settings, filling a crucial gap in the research to practice pipeline.

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

✪ Development of a method for Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI): a modified Delphi study

Authors:

Stephanie K. Brewer, Catherine M. Corbin, Ana A. Baumann, Shannon Wiltsey Stirman, Janine M. Jones, Michael D. Pullmann, Aaron R. Lyon & MODIFI Expert Panel

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

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

Abstract:

Background

Intervention adaptation is often necessary to improve the fit between evidence-based practices/programs and implementation contexts. Existing frameworks describe intervention adaptation processes but do not provide detailed steps for prospectively designing adaptations, are designed for researchers, and require substantial time and resources to complete. A pragmatic approach to guide implementers through developing and assessing adaptations in local contexts is needed. The goal of this project was to develop Making Optimal Decisions for Intervention Flexibility during Implementation (MODIFI), a method for intervention adaptation that leverages human centered design methods and is tailored to the needs of intervention implementers working in applied settings with limited time and resources.

Method

MODIFI was iteratively developed via a mixed-methods modified Delphi process. Feedback was collected from 43 implementation research and practice experts. Two rounds of data collection gathered quantitative ratings of acceptability and inclusion (Round 1) and feasibility (Round 2), as well as qualitative feedback regarding MODIFI revisions analyzed using conventional content analysis.

Results

In Round 1, most participants rated all proposed components as essential but identified important avenues for revision which were incorporated into MODIFI prior to Round 2. Round 2 emphasized feasibility, where ratings were generally high and fewer substantive revisions were recommended. Round 2 changes largely surrounded operationalization of terms/processes and sequencing of content. Results include a detailed presentation of the final version of the three-step MODIFI method (Step 1: Learn about the users, local context, and intervention; Step 2: Adapt the intervention; Step 3: Evaluate the adaptation) along with a case example of its application.

Discussion

MODIFI is a pragmatic method that was developed to extend the contributions of other research-based adaptation theories, models, and frameworks while integrating methods that are tailored to the needs of intervention implementers. Guiding teams to tailor evidence-based interventions to their local context may extend for whom, where, and under what conditions an intervention can be effective.

Contributions to the literature
  • Adaptation of evidence-based practices, programs, and treatments is often needed to ensure successful implementation. However, existing theories/models/frameworks do not outline concrete adaptation steps that are feasible for real-world settings.
  • We created a resource-efficient method (MODIFI) for developing and assessing intervention adaptations in local settings. This method was iteratively developed through a mixed-methods modified Delphi process, which resulted in consensus among experts in implementation science and practice.
  • MODIFI leverages human centered design techniques and is tailored to the needs of intervention implementers in applied settings, filling a crucial gap in the research to practice pipeline.

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

✪ Scaling up a brief alcohol intervention to prevent HIV infection in Vietnam: a cluster randomized, implementation trial

Authors:

Sophia M. Bartels, Huong T. T. Phan, Heidi E. Hutton, Do T. Nhan, Teerada Sripaipan, Jane S. Chen, Sarah L. Rossi, Olivia Ferguson, Ha T. T. Nong, Ngan T. K. Nguyen, Le Minh Giang, Hao T. M. Bui, Geetanjali Chander, Hojoon Sohn, Sol Kim, Ha V. Tran, Minh X. Nguyen, Byron J. Powell, Brian W. Pence, William C. Miller & Vivian F. Go

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

Read the full text in the open access journal Implementation Science

Abstract:

Background

Evidence-based interventions (EBIs) often address normative behaviors. If a behavior is also common among clinicians, they may be skeptical about the necessity or effectiveness of an EBI. Alternatively, clinicians’ attitudes and behaviors may be misaligned, or they may lack the knowledge and self-efficacy to deliver the EBI. Several EBIs address unhealthy alcohol use, a common and often culturally acceptable behavior. But unhealthy alcohol use may be particularly harmful to people with HIV (PWH). Here, we present an implementation trial using an experiential implementation strategy to address clinicians’ knowledge, attitudes, and behaviors. Clinicians receive the experiential intervention before they begin delivering an evidence-based brief alcohol intervention (BAI) to PWH with unhealthy alcohol use.

Methods

Design: In this hybrid type 3 implementation-effectiveness cluster randomized controlled trial, ART clinics (n = 30) will be randomized 1:1 to facilitation, a flexible strategy to address implementation barriers, or facilitation plus the experiential brief alcohol intervention (EBAI). In the EBAI arm, clinicians, irrespective of their alcohol use, will be offered the BAI as experiential learning. EBAI will address clinicians’ alcohol-related attitudes and behaviors and increase their knowledge and confidence to deliver the BAI.

Participants: ART clinic staff will be enrolled and assessed at pre-BAI training, post-BAI training, 3, 12, and 24 months. All PWH at the ART clinics who screen positive for unhealthy alcohol use will be offered the BAI. A subset of PWH (n = 810) will be enrolled and assessed at baseline, 3, and 12 months.

Outcomes: We will compare implementation outcomes (acceptability, fidelity, penetration, costs, and sustainability) and effectiveness outcomes (viral suppression and alcohol use) between the two arms. We will assess the impact of site-level characteristics on scaling-up the BAI. We will also evaluate how experiencing the BAI affected clinical staff’s alcohol use and clinic-level alcohol expectations in the EBAI arm.

Discussion

This trial contributes to implementation science by testing a novel strategy to implement a behavior change intervention in a setting in which clinicians themselves may engage in the behavior. Experiential learning may be useful to address normative and difficult to change lifestyle behaviors that contribute to chronic diseases.

Trial Registration

NCT06358885 (04/10/2024), https://clinicaltrials.gov/study/NCT06358885.

Contributions to the literature
  • This study tests a novel implementation strategy to educate ART providers and address their attitudes and knowledge about alcohol use and treatment in Vietnam. Few implementation strategies are grounded in an experiential approach to changing provider attitudes and behaviors in contexts where these behaviors are pervasive.
  • It uses mixed-methods to determine mechanisms influencing scale-up of the brief alcohol intervention (BAI) to inform future implementation of alcohol interventions for people with HIV across settings where alcohol is normalized.
  • It assesses resource-related costs associated with the experiential BAI (EBAI) and EBAI implementation, which can inform policymakers working to prevent HIV transmission.

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

✪ “A problem shared is a problem solved:” integrating human-centered design and implementation science to optimize lay counselor supervision in Western Kenya

Authors:

Noah S. Triplett, Anne Mbwayo, Sharon Kiche, Enoch Sackey, Rashed AlRasheed, Daisy Anyango Okoth, Omariba Anne Nyaboke, Cyrilla Amanya & Shannon Dorsey

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2024

Read the full text in the open access journal Social Science and Medicine - Mental Health

Abstract:

Implementation science and human-centered design (HCD) offer useful frameworks and methods for considering and designing for individuals' needs and preferences when implementing new interventions or technologies in global health. When used in tandem, the two approaches may blend creative and partnered research methods with a focus on the factors necessary to design, implement, and sustain interventions. However, research is needed that describes the process of blending these two approaches and explores the experiences of community partners. This study builds from a stepped-wedge cluster-randomized trial in Western Kenya, wherein teachers and community health volunteers have been trained to provide trauma-focused cognitive behavioral therapy (TF-CBT). Mobile phones emerged as a tool to supervise lay counselors from afar; however, their use was characterized by unique challenges. Informed by human-centered design and implementation science, we first engaged lay counselors (n = 24) and supervisors (n = 3) in individual semi-structured interviews then hosted an in-person participatory workshop to “co-design” solutions to optimize the use of mobile phone supervision. Lay counselors participated in focus group discussions regarding their experiences in the workshop. Focus group transcripts were analyzed using thematic analysis. We describe our approach as well as focus group discussion results. Counselors felt the workshop was a valuable experience to learn new strategies from their colleagues, and they enjoyed the “collaborative spirit” that emerged as they worked together. Counselors felt that varying small and large group discussions fostered participation by creating opportunities for more people to engage and share their thoughts. Counselors suggested the approach be improved by providing more tangible materials (e.g., hand-outs) and more closely following a schedule of activities. It is important to also center stakeholders’ experiences as partners in the research process. Though counselors largely expressed positive sentiments, they also shared valuable suggestions for how to improve participatory research practices in the future.

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

✪ Using policy codesign to achieve multi-sector alignment in adolescent behavioral health: a study protocol

Authors:

Sarah Cusworth Walker, Kym R. Ahrens, Mandy D. Owens, McKenna Parnes, Joe Langley, Christine Ackerley, Jonathan Purtle, Lisa Saldana, Gregory A. Aarons, Aaron Hogue & Lawrence A. Palinkas

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2024

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

Abstract:

Background

Policymaking is quickly gaining focus in the field of implementation science as a potential opportunity for aligning cross-sector systems and introducing incentives to promote population health, including substance use disorders (SUD) and their prevention in adolescents. Policymakers are seen as holding the necessary levers for realigning service infrastructure to more rapidly and effectively address adolescent behavioral health across the continuum of need (prevention through crisis care, mental health, and SUD) and in multiple locations (schools, primary care, community settings). The difficulty of aligning policy intent, policy design, and successful policy implementation is a well-known challenge in the broader public policy and public administration literature that also affects local behavioral health policymaking. This study will examine a blended approach of coproduction and codesign (i.e., Policy Codesign), iteratively developed over multiple years to address problems in policy formation that often lead to poor implementation outcomes. The current study evaluates this scalable approach using reproducible measures to grow the knowledge base in this field of study.

Methods

This is a single-arm, longitudinal, staggered implementation study to examine the acceptability and short-term impacts of Policy Codesign in resolving critical challenges in behavioral health policy formation. The aims are to (1) examine the acceptability, feasibility, and reach of Policy Codesign within two geographically distinct counties in Washington state, USA; (2) examine the impact of Policy Codesign on multisector policy development within these counties using social network analysis; and (3) assess the perceived replicability of Policy Codesign among leaders and other staff of policy-oriented state behavioral health intermediary organizations across the USA.

Discussion

This study will assess the feasibility of a specific approach to collaborative policy development, Policy Codesign, in two diverse regions. Results will inform a subsequent multi-state study measuring the impact and effectiveness of this approach for achieving multi-sector and evidence informed policy development in adolescent SUD prevention and treatment.

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