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Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations

Authors:

Margaret M. Paschen-Wolff, Aimee N.C. Campbell, Ángel Vásquez, Jill Kessler, Kelley Jansen, Catherine P. Arnatt, Carmen Rosa, Hanna M. Hebden, Sandra Radin, Antony Stately, Jennifer Shaw, Favian Kennedy, Abigail G. Matthews, & Kamilla L. Venner

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: August 2025

Read the full text in the subscription access journal Contemporary Clinical Trials

✪ Optimizing healthcare for blood donors at risk of transfusion-transmissible infections: pre-implementation mixed methods protocol

Authors:

Juan Macalupu, Elsa González-Lagos, Sarah Gimbel, & Eduardo Gotuzzo

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2025

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

Abstract:

In the Peruvian Amazon, a significant proportion of replacement blood donors test reactive for HIV, HTLV-1/2, and other transfusion-transmissible infections but often receive no subsequent care. Optimizing healthcare for these individuals can mitigate adverse outcomes by enabling early diagnosis and management. Effective coordination between Blood Bank and Infectious Diseases services is essential to provide comprehensive care. To address this challenge, this study applies an Implementation Science approach to design and assess an innovation that enhances healthcare for blood donors affected by transfusion-transmissible infections. A pre-implementation mixed methods study will be conducted at two hospitals in the Peruvian Amazon, employing the Consolidated Framework for Implementation Research (CFIR) and a systems engineering tool (mapping). The study will focus on the inner setting domain of CFIR and map the care continuum to identify contextual determinants that may influence implementation. It has three specific aims planned for the future: first, to use a convergent mixed methods approach to examine the care continuum of blood donors and the inner settings; second, to co-design an innovation through qualitative and participatory methods, integrating Blood Bank and Infectious Diseases services via the hospital information management system; and third, to evaluate the feasibility, appropriateness, and acceptability of the co-designed innovation through a pilot. Replacement blood donation and fragmented healthcare systems are common challenges in other low- and middle-income countries. The findings of this study can inform future implementation research and policy in similar settings.

Paper context

Main findings: This study will co-design and pilot an innovation to improve how blood donors at risk of transfusion-transmissible infections receive screening results, confirmatory testing, and care, by integrating Blood Bank and Infectious Diseases services through digital tools.

Added knowledge: This study employs a participatory, mixed-methods implementation science approach to systematically assess and address gaps in blood donor healthcare, providing a scalable methodology while ensuring context-specific, actionable interventions for resource-limited settings.

Global health impact for policy and action: This study will drive digital innovations in blood donor healthcare to strengthen blood safety and infectious disease control, while framing a pragmatic, adaptable approach for integrating fragmented healthcare systems in resource-limited settings.

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

✪ Comparing the effectiveness of implementation strategies to improve liver and colon cancer screening for Veterans: protocol for a large cluster-randomized implementation study

Authors:

Shari S. Rogal, Vera Yakovchenko, Timothy R. Morgan, Jason A. Dominitz, Heather McCurdy, Anna Nobbe, Nsikak R. Ekanem, Chaeryon Kang, Rachel I. Gonzalez, Angela Park, Jennifer Anwar, Brittney Neely, Sandra Gibson, Carolyn Lamorte, Jasmohan S. Bajaj, Heather M. Patton, Yiwen Yao & Andrew J. Gawron

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2025

Read the full text in the open access journal Implementation Science

Abstract:

Background

Screening for gastrointestinal (GI) cancers, specifically colorectal cancer (CRC) and hepatocellular carcinoma (HCC), is often inadequately and inequitably implemented, leading to preventable morbidity and mortality. This protocol paper describes a study designed to compare the effectiveness of external facilitation with patient navigation across hospitals in the Veterans Health Administration (VA).

Methods

Two hybrid type 3, cluster-randomized trials will compare the effectiveness of patient navigation versus external facilitation for supporting HCC and CRC screening completion. Twenty-four sites will be included in the HCC trial and 32 in the CRC trial, cluster-randomizing Veterans by their site of primary care. The primary outcome of reach of cancer screening completion will be measured after intervention and during sustainment. Multi-level implementation determinants (i.e., barriers and facilitators), preconditions, and moderators will be evaluated pre- and post-intervention, using Consolidated Framework for Implementation Research (CFIR)-mapped surveys and interviews of Veteran participants and provider participants.

Discussion

Comparing findings in the two trials will allow researchers to understand how implementation barriers and strategies operate differently for a one-time screening in a relatively healthy population (CRC) vs. repeated screening in a more medically complex population (HCC).

Trial registration

This project was registered at ClinicalTrials.Gov (NCT06458998) on 6/13/24.

Contributions to the literature
  • This comparative effectiveness trial will compare two evidence-based implementation strategies to improve cancer screening reach.
  • Comparing a patient-facing to a clinician-facing approach will offer novel insights into what works and for whom.
  • This trial will assess mechanisms and heterogeneity of treatment effects to inform the science of implementation.

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

✪ High acceptability, feasibility and sustainability of a direct-to-pharmacy differentiated PrEP delivery model in public health HIV clinics in Kenya: perspectives of PrEP clients and healthcare providers

Authors:

Emmah Owidi, Kenneth Ngure, Vallery Ogello, Njeri Wairimu, Lydia Etyang’, Winnie Waituika, Margaret Mwangi, Dominic Mwangi, Simon Maina, Elizabeth Irungu, Catherine Kiptinness, Nelly Mugo, Kenneth Mugwanya, for the Efficiency Study Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2025

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

Abstract:

Introduction

High client opportunity costs and a burdened healthcare system limit oral pre-exposure prophylaxis (PrEP) delivery in Kenyan public HIV clinics. We conducted a qualitative study among PrEP clients and providers to understand the acceptability, feasibility and willingness to implement a client-centred, differentiated direct-to-pharmacy (DTP) PrEP refill visits intervention aimed at improving the efficiency of PrEP implementation in real-world clinics.

Methods

From March 2021 to March 2022, we conducted in-depth interviews with clients and healthcare providers participating in an individual facility pharmacy-based PrEP delivery model for PrEP refills among clients in the continuation phase at two public HIV clinics in central Kenya. The core components of the DTP model included directed-to-PrEP pharmacy refill visits conducted by facility pharmacy staff and client HIV self-testing (HIVST) while waiting for services at the pharmacy. We used semi-structured interview guides informed by the Consolidated Framework for Implementation Research (CFIR). We analysed data using thematic content analysis and organised findings by CFIR constructs.

Results

We interviewed 20 PrEP clients and 20 healthcare providers. PrEP clients included 15 females and had a median age of 39 years (interquartile range [IQR]: 33–48). Providers included 13 females, had a median age of 32 years (IQR: 30–41), and included 10 HIV counsellors, 5 pharmacy and 3 clinical providers. Both providers and clients reported high satisfaction with DTP PrEP refill visits derived from improved clinic flow and quality of service. Among clients, shorter waiting times and less movement between multiple clinic rooms reduced delays, improved privacy and reduced stigma associated with visiting HIV clinics. Furthermore, shorter waiting times and infrequent clinic visits reduced loss of working hours and income among clients, motivating PrEP continuation. Providers reported improved clinic flow, reduced work burden among non-pharmacy providers, improved knowledge and ease of implementing DTP refill visits. However, providers expressed concerns about the potential loss of roles among HIV counsellors and the shifting of workload burden to pharmacy providers.

Conclusions

Differentiated DTP refill visits with HIVST were highly acceptable and feasible among PrEP clients and providers. Context-specific modifications and scale-up of the intervention could improve the efficiency of PrEP delivery within public HIV clinics in Kenya and similar settings.

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

✪ Getting to Implementation for HIV Pre-Exposure Prophylaxis (GTI-PrEP): A data-driven approach to PrEP prescribing

Authors:

Shari S. Rogal, Brittney Neely, Monica Merante, Karen Slazinski, Lorenzo McFarland, Christina Brodkorb, Jada Cooper, Carolyn Lamorte, Sandra Gibson, Emily Comstock, Jamie Morano, Marissa Maier, Lauren A. Beste, Karine Rozenberg, Maggie Chartier, Matthew J. Chinman, David Ross & Vera Yakovchenko

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2025

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

Abstract:

Background

Pre-Exposure Prophylaxis (PrEP) dramatically reduces the likelihood of acquiring human immunodeficiency virus (HIV), yet it remains under-prescribed, particularly for people in communities with high HIV incidence. While implementation science and health services researchers aim to address disparities in care, few interventions have proven effective in doing so. We aimed to identify implementation strategies associated with higher PrEP prescribing rates and pilot test a tailored intervention as a proof-of-concept in a single Veterans Health Administration (VA) facility.

Methods

VA clinicians were surveyed using an instrument derived from the Evidence-based Recommendations for Implementing Change taxonomy to assess the use of various strategies for PrEP in fiscal years 2019–2021. Correlational analyses identified the strategies associated with the frequency of PrEP prescribing and semi-structured interviews with personnel from 11 VA medical facilities with high PrEP prescribing refined and manualized these strategies into the Getting to Implementation (GTI)-PrEP playbook. The playbook was subsequently pilot tested in a VA facility with high new HIV diagnosis rates and low PrEP prescribing rates.

Results

The clinician survey collected 157 responses from 95 unique VA facilities on implementation strategy use. Analysis identified eight strategies significantly associated with PrEP prescribing, including: networking, clinician education, clinical support tools, dashboard utilization, telehealth, pharmacist involvement, direct patient engagement, and enhanced sexual health history taking. In the pilot study, the site completed the GTI-PrEP Playbook with high fidelity and newly implemented seven of the eight strategies, achieving a 363% increase in PrEP prescribing rates among Black Veterans over the one-year period.

Conclusions

This multi-year national evaluation identified a core subset of effective implementation strategies for increasing PrEP prescribing. The process of empirically specifying these strategies and pilot testing them through the GTI-PrEP playbook demonstrates a promising, data-driven approach to improve PrEP prescribing rates and reduce racial disparities in HIV prevention.

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

✪ Acceptability, feasibility, and factors affecting implementation of a gender-sensitivity training for HIV providers and staff in Uganda: a mixed methods, quasi-experimental controlled pilot trial

Authors:

K. M. Sileo, R. K. Wanyenze, A. Anecho, R. L. Luttinen, K. Weston, B. Mukasa, S. C. Mukama, S. H. Vermund, S. L. Dworkin, J. F. Dovidio, B. S. Taylor & T. S. Kershaw

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

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

Abstract:

Background

Health workers play a critical role in providing gender-sensitive HIV care. However, without adequate training, they may inadvertently reinforce negative gender norms that hinder engagement in care. To improve ART services in sub-Saharan Africa, effective implementation strategies, including trainings, are essential.

Methods

This study evaluated the feasibility and acceptability of a novel 4-session, gender-sensitivity training for HIV health and lay workers in rural and peri-urban Uganda. We conducted a pilot quasi-experimental controlled trial in 2022–23, utilizing data from three sources: process data from 144 providers and 238 clients, qualitative post-intervention focus groups and interviews with 53 training attendees, and stakeholder interviews with 12 community leaders and facilitators. We employed thematic analysis guided by the Consolidated Framework for Implementation Research (CFIR).

Results

The training was highly rated by attendees via brief post-session surveys, with 99% of sessions deemed satisfactory. Qualitative feedback indicated that the sessions were perceived as appropriate for addressing providers’ gaps in delivering gender-sensitive care and as beneficial for participants. High feasibility was evidenced by 100% of intervention steps delivered (fidelity checklists), 86% attendance (attendance logs), and 98.6% and 94.8% recruitment of eligible providers and clients (study records), respectively. Through qualitative exit focus groups, factors that positively affected acceptability and feasibility included tactics to gain support from supervisors, the use of experienced facilitators and active learning approaches, and the consideration of the health system context in delivery (e.g., cadre mix, location). Suggested improvements encompassed addressing interpersonal and structural barriers to client-centered care, incorporating community sensitization, streamlining content, and enhancing mentorship follow-ups. Stakeholders recognized the training’s alignment with national health priorities and emphasized the need for clarity regarding its integration with existing training curricula and ongoing stakeholder engagement.

Conclusions

This study underscores the acceptability and feasibility of a gender-sensitivity training program for HIV providers; further evaluation of the program is warranted. Identified factors influencing implementation can inform enhancements to gender-focused training initiatives to improve the quality of HIV services and enhance client engagement and health outcomes.

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

✪ Determinants of implementation of a stepped care intervention for adolescents and youth living with HIV in Kenya: a qualitative evaluation

Authors:

Nok Chhun, Dorothy I. Mangale, Kawango Agot, Winnie A. Owade, Julie Kadima, Jacinta Badia, James K. Kibugi, Pamela K. Kohler, Grace John-Stewart & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

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

Abstract:

Background

Differentiation of HIV services, a client-centered strategy, may improve care outcomes among adolescents and youth living with HIV (AYLHIV). Understanding health provider perceptions of barriers and facilitators that influence implementation can optimize adoption and sustainment of health systems interventions.

Methods

The Data-informed Stepped Care (DiSC) study was a cluster randomized controlled trial of a stepped care intervention in 24 HIV care facilities in Kenya. At each visit, providers used an assessment tool to allocate AYLHIV to services according to level of need. Stable clients were allocated to differentiated service delivery (DSD) with less frequent visits. Intensified services, including behavioral counseling, were provided for those with greater likelihood of loss to follow-up, mental health issues, or viral non-suppression. We conducted focus group discussions (FGDs) with providers across 12 intervention sites between January-February 2023. FGDs used a semi-structured interview guide, grounded in the Consolidated Framework for Implementation Research, which were audio-recorded and transcribed. Transcripts were analyzed using a team-based rapid turnaround approach to characterize key determinants influencing adoption, reach, and fidelity.

Results

Providers were enthusiastic about, and quick to adopt, the DiSC intervention. They found the DiSC tool easy to use and felt it provided a relative advantage by improving service delivery efficiency and prioritizing time with higher need AYLHIV. Providers noted the importance of tool flexibility to align with changing national guidelines. They expressed concerns about compatibility with existing workflows at facilities exclusively using electronic medical record (EMR) systems, suggesting EMR integration will be needed for intervention sustainment. AYLHIV eligible for DSD benefited from clinic visit intervals that aligned with the school calendar, which posed a challenge for reaching AYLHIV in more intensive steps. Provider collective efficacy was important in consistent implementation of DiSC and was facilitated by continuous quality improvement meetings, access to knowledge and information, and perceived intervention effectiveness. Supportive leadership was an important driver of implementation success, through availing space for mental health counseling sessions and time for client-provider interactions outside standard operating hours.

Conclusions

Consideration of alignment with national policy, integration into clinic workflows, school schedules, and leadership engagement, will be important for sustained use of differentiated care interventions.

Trial registration

ClinicalTrials.gov, NCT05007717. Registration date: July 13, 2021.

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

✪ Advancing implementation of single session interventions in schools: a protocol for a qualitative study

Authors:

Katherine A. Cohen, Eric Bruns, Aaron Lyon, Tali Raviv, Sara Becker & Jessica L. Schleider

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

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

Abstract:

Background

Schools are one of the most common settings in which youth seek mental health services, yet existing school-based mental health interventions are often difficult to implement due to time, cost, and staffing limitations. Digital, self-administered Single Session Interventions (SSIs) are evidence-based supports that are intentionally structured to deliver a clinically-meaningful dosage of evidence-based content within one session. Although multiple studies have demonstrated the clinical effectiveness of school-based SSIs, there have been no systemic efforts to understand how SSIs can be practically implemented in schools. The goal of this project is to partner with students, parents, and school staff to identify factors that impact the implementation of SSIs and understand how SSIs can be sustainably integrated as mental health supports into school mental health infrastructure.

Methods

We will conduct focus groups (five groups, total n = 35–45) among community members (i.e., students, parents/caregivers, teachers, school administrators, and school mental health providers) to assess perceived facilitators and barriers to the effective implementation of evidence-based SSIs in schools (Aim 1). We will then work in partnership with community members (n = 10–15) to co-design multi-level implementation strategies (i.e., student-directed, staff-directed, system-directed) for increasing uptake and promoting sustainability of school-based SSIs (Aim 2). We will use inductive coding to thematically analyze qualitative data from group sessions. This study is being conducted within the Lake Washington School District in the Seattle, Washington region.

Discussion

The proposed project will be the first to investigate facilitators and barriers to real-world implementation of SSIs in schools and strategies to improve implementation. Future studies may test the effectiveness of the generated implementation strategies on outcomes such as SSI uptake over time.

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

✪ Integrating behavioral health care into a low-barrier HIV clinic using the Collaborative Care Model: a mixed methods evaluation of patient care cascade outcomes and determinants

Authors:

Scott Halliday, Lydia A. Chwastiak, Kaitlin Zinsli, Ramona Emerson, Teagan Wood, Meena S. Ramchandani, Kenneth Sherr, Judith I. Tsui, Bradley H. Wagenaar, Deepa Rao, & Julia C. Dombrowski

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2025

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

Abstract:

Background

Low-barrier HIV care is an evidence-based intervention to improve HIV outcomes among those who have complex barriers to care, but the walk-in model poses challenges to integrating behavioral health services. We evaluated the acceptability and feasibility of a Collaborative Care Model (CoCM) for treatment of depression and opioid use disorder in a low-barrier clinic.

Methods

In a sequential explanatory mixed methods pilot study, we accessed data from patient records to generate a care cascade for the number of patients enrolled in the first six months of the program and conducted individual interviews with patients and staff to interpret the care cascade findings.

Results

Among 175 patients who visited the clinic, 36% were screened for, 24% were referred to, 15% completed an intake for, and 9% engaged in CoCM. The interviews revealed that screening was limited by a lack of clarity among staff about services offered in CoCM, staff forgetting the screening process, and limited time during patent visits. Referrals were limited by low buy-in among staff and patient complexity. Intakes were limited by time and space constraints in the care setting and competing acute patient needs. The care manager’s ability to embody the clinic’s culture facilitated engagement among patients who completed intakes.

Conclusions

Staff perceived CoCM to be acceptable and feasible to implement, but only in the context of multiple barriers to implementation and challenges to systematic screening and measurement-based care.

Trial registration

Not applicable.

Contributions to the literature

  • We evaluated implementation of the Collaborative Care Model, an evidence-based model for integrating behavioral healthcare into primary care settings, for treating depression and opioid-use disorder in a low-barrier HIV clinic. To our knowledge, this is the first implementation of the Collaborative Care Model in a low-barrier HIV clinic.
  • By specifying a multi-component implementation strategy, our evaluation provides a foundation for selecting and tailoring implementation strategies for use with integrated behavioral healthcare interventions.
  • Through use of a joint visual display showing a care cascade with illustrative quotes, our evaluation demonstrates a novel approach to using explanatory mixed methods in implementation science.

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

✪ Lessons learnt from the 2021 Pacific Northwest heat dome: a qualitative study of western Washington’s healthcare community response

Authors:

Matias Korfmacher, Cat Hartwell, Kelly Hill, Nathaniel Matthews-Trigg, Jeremy Hess, Amruta Nori-Sarma, & Gregory Wellenius

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2025

Read the full text in the open access journal BMJ Open

Abstract:

Objective

The 2021 Pacific Northwest heat dome was Washington state’s deadliest recorded weather event and presented unprecedented response challenges to the state’s health sector. Understanding the impacts of this extreme heat event (EHE) on the sector as well as the barriers to and facilitators of implementing effective heat response is critical to preparing for future events, which are happening more frequently in the region due to climate change.

Design

Guided by an implementation science framework, we convened listening sessions and focus groups of the health sector in western Washington to reflect on regional response efforts.

Setting

Health sector organisations in 15 counties in western Washington State, USA: Clallam, Grays Harbor, Island, Jefferson, King, Kitsap, Lewis, Mason, Pacific, Pierce, San Juan, Skagit, Snohomish, Thurston and Whatcom.

Participants

A convenience sample of 109 listening group participants was recruited through the professional networks of the Northwest Healthcare Response Network, a regional healthcare coalition. 27 of the health sector professionals were recruited using purposive sampling to participate in seven focus groups organised by organisation type.

Results

The co-presence of the COVID-19 pandemic, limited staff capacity, resource acquisition challenges and inadequate regional collaboration emerged as key barriers, while advanced planning, indoor cooling capabilities, adapting strategies to local needs, robust internal relationships and strong external partnerships were reported to facilitate effective response. Establishing centralised coordination ahead of heat events, making improvements to the cooling capabilities of the built environment, developing plans and policies for EHEs that have co-benefits for other events, adopting evidence-informed response strategies, institutionalising the knowledge and relationships developed through prior events and improving evaluative processes (such as developing real-time monitoring capacity) will enable more effective response to future EHEs.

Conclusions

Western Washington’s health sector implemented EHE response activities that enabled essential service continuity, despite limited resources, unfamiliarity with EHEs and other systemic challenges. The recency of the heat dome presents an opportunity to incorporate lessons learnt into practice, policies, plans and built environment; these are necessary improvements ahead of future large-scale events the region may experience in the coming decades.

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