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✪ Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya

Authors:

Benn Kwach, Josephine B Odoyo, Amber R Lauff, Victor Omollo, Bernard Rono, Vallery Ogello, Victoria Mann, Zachary Kwena, Katherine Thomas, Monisha Sharma, Jennifer F Morton, Kenneth Ngure, Elizabeth Bukusi, Kenneth K Mugwanya & One-Stop PrEP Care Team

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2025

Read the full text in the open access journal BMJ Open

Abstract:

Introduction

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

Methods and analysis

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethics and dissemination

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Protocol amendments

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

Protocol version V. 2.0 dated 21 May 2024.

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

Treating seizures faster: The quality improvement in time to treat status epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol

Authors:

Adam P. Ostendorf, Tobias Loddenkemper, Lindsey A. Morgan, Brian Appavu, Raquel Farias-Moeller, Dana Harrar, Craig Press, Nicholas S. Abend, William D. Gaillard, Shasha Bai, Mariah Eisner, Lauren McHenry, Emily Kroshus, Kathryn Vannatta, and Howard P. Goodkin

University of Washington affiliated authors are displayed in bold.

Subscription Required for Full Text Access

Published: February 2025

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

✪ Integrating causal pathway diagrams into practice facilitation to address colorectal cancer screening disparities in primary care

Authors:

Brooke Ike, Ashley Johnson, Rosemary Meza, & Allison Cole

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

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

Abstract:

Background

Colorectal cancer (CRC) is the second leading cause of cancer death and the second most common cancer diagnosis among the Hispanic population in the United States. However, CRC screening prevalence remains lower among Hispanic adults than among non-Hispanic white adults. To reduce CRC screening disparities, efforts to implement CRC screening evidence-based interventions in primary care organizations (PCOs) must consider their potential effect on existing screening disparities. More research is needed to understand how to leverage existing implementation science methodologies to improve health disparities. The Coaching to Improve Colorectal Cancer Screening Equity (CoachIQ) pilot study explores whether integrating two implementation science tools, Causal Pathway Diagrams and practice facilitation, is a feasible and effective way to address CRC screening disparities among Hispanic patients.

Methods

We used a quasi-experimental, mixed methods design to evaluate feasibility and assess initial signals of effectiveness of the CoachIQ approach. Three PCOs received coaching from CoachIQ practice facilitators over a 12-month period. Three non-equivalent comparison group PCOs received coaching during the same period as participants in a state quality improvement program. We conducted descriptive analyses of screening rates and coaching activities.

Results

The CoachIQ practice facilitators discussed equity, facilitated prioritization of QI activities, and reviewed CRC screening disparities during a higher proportion of coaching encounters than the comparison group practice facilitator. While the mean overall CRC screening rate in the comparison PCOs increased from 34 to 41%, the mean CRC screening rate for Hispanic patients did not increase from 30%. In contrast, the mean overall CRC screening rate at the CoachIQ PCOs increased from 41 to 44%, and the mean CRC screening rate for Hispanic patients increased from 35 to 39%.

Conclusions

The CoachIQ program merges two implementation science methodologies, practice facilitation and causal pathway diagrams, to help PCOs focus quality improvement efforts on improving CRC screening while also reducing screening disparities. Results from this pilot study demonstrate key differences between CoachIQ facilitation and standard facilitation, and point to the potential of the CoachIQ approach to decrease disparities in CRC screening.

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

✪ Reported quality indicators and implementation outcomes of community partnership in autism intervention research: A systematic review

Authors:

Jessica E. Tschida, James D. Lee, Anamiguel Pomales-Ramos, Vivien Koo

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: February 2024

Read the full text in the open access journal Autism Research

Abstract:

There is minimal research on the quality of community partnerships in studies of interventions for autistic children. However, building high quality community engagement in autism intervention research may improve implementation outcomes. This systematic review examined studies that report community partnership in autism intervention research. A total of 135 articles were identified and 11 of these articles were included in the final review. Community partnership data were extracted using indicators from the conceptual framework for assessing research-practice partnerships (RPP; Henrick et al., Henrick et al., Assessing research-practice partnerships: Five dimensions of effectiveness, William T. Grant Foundation, 2017) and implementation outcomes data were extracted using the taxonomy of distinct implementation outcomes (Proctor et al., Administration and Policy in Mental Health and Mental Health Services Research, 38:65–76, 2011). Quality of studies were appraised using JBIs critical appraisal tools (Munn et al., JBI Evidence Synthesis, 18:2127–2133, 2020). RPP indicators and implementation outcomes were variably reported across studies. RPP indicators and implementation outcomes more likely to be reported were related to building trust, cultivating partnership relationships, conducting rigorous research to inform action, acceptability, and feasibility. RPP indicators and implementation outcomes less likely to be reported were related to building capacity to engage in partnership work, sustainability, cost, and penetration. Together, these results may suggest the need for increased sustainability and capacity building efforts in partnerships and increased guidelines for reporting outcomes.

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

✪ Supporting Psychosis Research, Implementation, and Training Through an Academic Intermediary–Purveyor Organization

Authors:

Sarah L. Kopelovich, Rachel M. Brian, Akansha Vaswani-Bye, Lydia Chwastiak, Chris McCain, Victoria Shepard, Wenqi Zhang, Mackenzie Tennison, Sarah Fikre, and Maria Monroe-DeVita

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2024

Read the full text open access in the journal Psychological Services

✪ Characterizing provider-led adaptations to mobile phone delivery of the Adolescent Transition Package (ATP) in Kenya using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS): a mixed methods approach

Authors:

Dorothy Imbuka Mangale, Alvin Onyango, Cyrus Mugo, Caren Mburu, Nok Chhun, Dalton Wamalwa, Irene Njuguna, Arianna Rubin Means, Grace John-Stewart, Bryan J. Weiner & Kristin Beima-Sofie

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2023

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

Abstract:

Background

The COVID-19 pandemic resulted in disruptions to routine HIV services for youth living with HIV (YLH), provoking rapid adaptation to mitigate interruptions in care. The Adolescent Transition to Adult Care for HIV-infected adolescents (ATTACH) study (NCT03574129) was a hybrid I cluster randomized trial testing the effectiveness of a healthcare worker (HCW)-delivered disclosure and transition intervention — the Adolescent Transition Package (ATP). During the pandemic, HCWs leveraged phone delivery of the ATP and were supported to make adaptations. We characterized real-time, provider-driven adaptations made to support phone delivery of the ATP.

Methods

We conducted continuous quality improvement (CQI) meetings with HCWs involved in phone delivery of the ATP at 10 intervention sites. CQI meetings used plan-do-study-act (PDSA) cycles and were audio-recorded. Adaptations were coded by two-independent coders using the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS). Adaptation testing outcomes (adopt, retest, or abandon) and provider experience implementing the adaptations were also recorded. We summarized adaptation characteristics, provider experience, and outcomes.

Results

We identified 72 adaptations, 32 were unique. Overall, adaptations included modification to context (53%, n = 38), content (49%, n = 35), and evaluation processes (13%, n = 9). Context adaptations primarily featured changes to personnel, format, and setting, while content and evaluation adaptations were frequently achieved by simple additions, repetition, and tailoring/refining of the phone delivery strategy. Nine adaptations involved abandoning, then returning to phone delivery. HCWs sought to increase reach, improve fidelity, and intervention fit within their context. Most adaptations (96%, n = 69) were perceived to increase the feasibility of phone delivery when compared to before the changes were introduced, and HCWs felt 83% (n = 60) of adaptations made phone delivery easier. Most adaptations were either incorporated into routine workflows (47%) or tested again (47%).

Conclusion

Adaptation of phone delivery was a feasible and effective way of addressing challenges with continuity of care for YLH during the COVID-19 pandemic. Adaptations were primarily context adaptions. While FRAME-IS was apt for characterizing adaptations, more use cases are needed to explore the range of its utility.

Trial registration

Trial registered on ClinicalTrial.gov as NCT03574129.

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

✪ Learning from national implementation of the Veterans Affairs Clinical Resource Hub (CRH) program for improving access to care: protocol for a six year evaluation

Authors:

Lisa V. Rubenstein, Idamay Curtis, Chelle L. Wheat, David E. Grembowski, Susan E. Stockdale, Peter J. Kaboli, Jean Yoon, Bradford L. Felker, Ashok S. Reddy & Karin M. Nelson

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published:August 2023

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

Abstract:

Background

The Veterans Affairs (VA) Clinical Resource Hub (CRH) program aims to improve patient access to care by implementing time-limited, regionally based primary or mental health staffing support to cover local staffing vacancies. VA’s Office of Primary Care (OPC) designed CRH to support more than 1000 geographically disparate VA outpatient sites, many of which are in rural areas, by providing virtual contingency clinical staffing for sites experiencing primary care and mental health staffing deficits. The subsequently funded CRH evaluation, carried out by the VA Primary Care Analytics Team (PCAT), partnered with CRH program leaders and evaluation stakeholders to develop a protocol for a six-year CRH evaluation.
The objectives for developing the CRH evaluation protocol were to prospectively: 1) identify the outcomes CRH aimed to achieve, and the key program elements designed to achieve them; 2) specify evaluation designs and data collection approaches for assessing CRH progress and success; and 3) guide the activities of five geographically dispersed evaluation teams.

Methods

The protocol documents a multi-method CRH program evaluation design with qualitative and quantitative elements. The evaluation’s overall goal is to assess CRH’s return on investment to the VA and Veterans at six years through synthesis of findings on program effectiveness. The evaluation includes both observational and quasi-experimental elements reflecting impacts at the national, regional, outpatient site, and patient levels. The protocol is based on program evaluation theory, implementation science frameworks, literature on contingency staffing, and iterative review and revision by both research and clinical operations partners.

Discussion

Health systems increasingly seek to use data to guide management and decision-making for newly implemented clinical programs and policies. Approaches for planning evaluations to accomplish this goal, however, are not well-established. By publishing the protocol, we aim to increase the validity and usefulness of subsequent evaluation findings. We also aim to provide an example of a program evaluation protocol developed within a learning health systems partnership.

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

✪ De-implementing and sustaining an intervention to eliminate nursing home resident bed and chair alarms: Interviews on leadership and staff perspectives

Authors:

Christine W. Hartmann, Christopher Gillespie, George G. Sayre, & A. Lynn Snow

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2021

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

Abstract:

Background

Improving nursing home quality of care relies partly on reducing or stopping ineffective or harmful practices, a process known as de-implementation. We know little about de-implementation in this setting. Relatively recent policy changes reclassified resident position-change (bed and chair) alarms, which monitor resident movement, as restraints. This created an optimal environment in which to study impressions of an alarm de-implementation and sustainment intervention.

Methods

This cross-sectional interview study focused on understanding participants’ experience of a quality improvement program in the Department of Veterans Affairs Community Living Centers (nursing homes). The program’s goal was to improve resident outcomes and staff communication and teamwork through, among other foci, eliminating resident position-change alarms. The Community Living Centers were located in geographically dispersed areas of the continental United States. Interview participants were leadership and staff members from seven Community Living Centers. We conducted in-depth, semi-structured qualitative interviews using a convenience sample and used a thematic analytic approach.

Results

We conducted seventeen interviews. We identified five main themes: Initiating De-implementation (compelling participants with evidence, engaging local leadership, and site-level education and training), Changing Expectations (educating staff and family members), Using Contrasting Approaches (gradual or abrupt elimination of alarms), Witnessing Positive Effects of De-implementation (reduction in resident falls, improved resident sleep, reduction in distressing behaviors, and increased resident engagement), and Staying the Course (sustainment of the initiative).

Conclusions

Findings highlight how participants overcame barriers and successfully eliminated resident position-change alarms and sustained the de-implementation through using convincing evidence for the initiative, local leadership involvement and support, and staff and family member education and engagement. These findings and the resulting three-phase process to support nursing homes' de-implementation efforts expand the de-implementation science knowledge base and provide a promising framework for other nursing home-based de-implementation initiatives.

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

✪ An implementation evaluation of “Zero Suicide” using normalization process theory to support high-quality care for patients at risk of suicide

Authors:

Julie E. Richards, Gregory E. Simon, Jennifer M. Boggs, Rinad Beidas, Bobbi Jo H. Yarborough, Karen J. Coleman, Stacy A. Sterling, Arne Beck, Jean P. Flores, Cambria Bruschke, Julie Goldstein Grumet, Christine C. Stewart, Michael Schoenbaum, Joslyn Westphal, & Brian K. Ahmedani

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: May 2021

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

Suicide rates continue to rise across the United States, galvanizing the need for increased suicide prevention and intervention efforts. The Zero Suicide (ZS) model was developed in response to this need and highlights four key clinical functions of high-quality health care for patients at risk of suicide. The goal of this quality improvement study was to understand how six large health care systems operationalized practices to support these functions—identification, engagement, treatment and care transitions.

Methods

Using a key informant interview guide and data collection template, researchers who were embedded in each health care system cataloged and summarized current and future practices supporting ZS, including, (1) the function addressed; (2) a description of practice intent and mechanism of intervention; (3) the target patient population and service setting; (4) when/how the practice was (or will be) implemented; and (5) whether/how the practice was documented and/or measured. Normalization process theory (NPT), an implementation evaluation framework, was applied to help understand how ZS had been operationalized in routine clinical practices and, specifically, what ZS practices were described by key informants (coherence), the current state of norms/conventions supporting these practices (cognitive participation), how health care teams performed these practices (collective action), and whether/how practices were measured when they occurred (reflexive monitoring).

Results

The most well-defined and consistently measured ZS practices (current and future) focused on the identification of patients at high risk of suicide. Stakeholders also described numerous engagement and treatment practices, and some practices intended to support care transitions. However, few engagement and transition practices were systematically measured, and few treatment practices were designed specifically for patients at risk of suicide.

Conclusions

The findings from this study will support large-scale evaluation of the effectiveness of ZS implementation and inform recommendations for implementation of high-quality suicide-related care in health care systems nationwide.

Plain Language Summary

Many individuals see a health care provider prior to death by suicide, therefore health care organizations have an important role to play in suicide prevention. The Zero Suicide model is designed to address four key functions of high-quality care for patients at risk of suicide: (1) identification of suicide risk via routine screening/assessment practices, (2) engagement of patients at risk in care, (3) effective treatment, and (4) care transition support, particularly after hospitalizations for suicide attempts. Researchers embedded in six large health care systems, together caring for nearly 11.5 million patients, are evaluating the effectiveness of the Zero Suicide model for suicide prevention. This evaluation focused on understanding how these systems had implemented clinical practices supporting Zero Suicide. Researchers collected qualitative data from providers, administrators, and support staff in each system who were responsible for implementation of practices supporting Zero Suicide. Normalization process theory, an implementation evaluation framework, was applied following data collection to: (A) help researchers catalog all Zero Suicide practices described, (B) describe the norms/conventions supporting these practices, (C) describe how health care teams were performing these practices, and (D) describe how practices were being measured. The findings from this evaluation will be vital for measuring the effectiveness of different Zero Suicide practices. This work will also provide a blueprint to help health care leaders, providers, and other stakeholders “normalize” new and existing suicide prevention practices in their own organizations.

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

✪ Implementation of a Telemental Health Training Program Across a Mental Health Department

Authors:

Bradford L. Felker, Meghan M. McGinn, Erika M. Shearer, Gina T. Raza, Sari D. Gold, Jean M. Kim, Sasha M. Rojas, Milena S. Roussev, Ruth L. Varkovitzky, Huiting Liu, Kate L. Morrison, and Russell A. McCann

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: January 2021

Read the full text in the open access journal Telemedicine Reports

Abstract:

Introduction

Telemental health (TMH) has increased substantially. However, health care systems have found it challenging to implement TMH ubiquitously. A quality improvement project guided by implementation science methodology was used to design and implement a TMH training program.

Materials and Methods

Implementation science methodology (Promoting Access to Research Implementation in Health Services, Reach-Effectiveness-Adoption-Implementation-Maintenance, Implementation/Facilitation) provided the framework to design and implement the training program. A total of 100 interdisciplinary mental health providers from outpatient mental health clinics participated.

Results

Providers reported satisfaction with the training program. Results indicated that the training increased providers' TMH knowledge and competence. The number of providers using TMH and patients who received TMH nearly doubled.

Conclusions

Implementation science methodology was important in creating an organizational framework at this facility to design, evaluate, and implement an innovative TMH training program.

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