Skip to content

✪ The pathway to delivering injectable CAB for HIV prevention: strategies from global PrEP leaders leveraging an adapted version of the Intervention Scalability Assessment Tool (ISAT)

Authors:

Lauren R. Violette, Kidist Zewdie, Nyawira Gitahi, Kristin Beima-Sofie, & Renee Heffron

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: September 2024

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

Abstract:

Background

Longer-acting cabotegravir (CAB) is a novel, safe, and efficacious pre-exposure prophylaxis (PrEP) for HIV prevention. As we near a time for CAB scale-up, the experience of global leaders in PrEP research and implementation can be leveraged to identify optimal strategies for scaling and integrating CAB into existing PrEP infrastructure worldwide.

Methods

We recruited leaders of HIV prevention clinical trials and large PrEP programs through a combination of purposive and snowball sampling for participation in individual interviews. We conducted interviews using a semi-structured guide that compared CAB to oral PrEP and sought perspectives on barriers and strategies for CAB scale-up. Interviews were conducted virtually, audio recorded, and transcribed. We used thematic analysis, grounded in an adapted version of the Intervention Scalability Assessment Tool (ISAT), to identify critical elements for optimizing delivery of CAB.

Results

From October 2021 to April 2022, we interviewed 30 participants with extensive experience in PrEP research, care, and programming. Participants worked in all seven WHO regions and reported a median of 20 years working in HIV and 10 years in PrEP. Participants agreed that CAB was efficacious and discrete, therefore having the potential to address current concerns about oral PrEP adherence and stigma. Participants indicated direct and indirect costs for provider training, expansion of existing medical infrastructure, and the current medication cost of CAB as major concerns for roll out. The true cost to the end-user and health system were unknown. There were some conflicting strategies on how to best address product targeting, presentation of efficacy, and timing of product availability with scale-up. Some thought that targeting CAB for the general population could normalize PrEP and decrease stigma, while others thought that prioritizing key populations could optimize impact by targeting those with highest risk. Overall, participants emphasized that to ensure successful CAB scale-up, communities and stakeholders must be involved at every stage of planning and implementation.

Conclusions

Our evaluation found that although there is a clear and urgent need for additional HIV PrEP options beyond daily oral PrEP, CAB scale-up must be thoughtful, flexible, and based in lessons learned from oral PrEP rollout.

Contributions to the literature
  • We used the Intervention Scalability Assessment Tool (ISAT), a quantitative tool used to inform decision-making for the scale-up of health interventions, as a framework for a qualitative analysis.
  • To our knowledge, this is the first use of the ISAT to assess scalability of injectable cabotegravir (CAB) for HIV pre-exposure prophylaxis (PrEP).
  • Our findings offer a summary of perspectives from global HIV PrEP leaders, experts, and advocates that can be used to map the process of CAB implementation using existing HIV prevention infrastructure.

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

✪ Are we being equitable enough? Lessons learned from sites lost in an implementation trial

Authors:

Elizabeth J Austin, Jessica Chen, Lori Ferro, Andrew J Saxon, John C Fortney, Geoffrey M Curran, Anna D Ratzliff, & Emily C Williams

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

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

Abstract:

Background

There is a growing interest in practice-based implementation research, yet too often research prioritizes and is most successful in academic settings. During a national implementation trial to evaluate the effectiveness of Collaborative Care for co-occurring opioid use and mental health disorders, we lost three of our 11 participating implementation sites, all representing community sites.

Method

To better understand needed supports for implementation trial participation, we conducted exit interviews (n = 5) with key staff at these community sites. Interview transcripts were double-coded and analyzed using Rapid Assessment Process. Qualitative themes were iteratively reviewed by the study team.

Results

Three themes emerged characterizing challenges for community sites, including that: (1) research threatens sites’ most precious resource—staff; (2) staff lack comfort with and skills for research; and (3) research participation in its current form does not offer a clear return on investment.

Conclusions

Learnings from this work illuminate some of the barriers community sites face when trying to participate in multisite implementation research. An undercurrent of participant perspectives was the belief that community sites like theirs are just not set up to successfully participate in clinical trial research, including population-based implementation trials. Future implementation trials should consider strategies that disrupt traditional approaches, increasing the equitable inclusion of diverse practice settings in implementation research.

Plain Language Summary

There is a growing interest in research that reflects community settings. Yet too often, research is most successful in academic settings. During a national implementation trial to evaluate the effectiveness of Collaborative Care for co-occurring opioid use and mental health disorders, we lost three of our 11 participating implementation sites, all representing community sites. To better understand their perspectives, we conducted exit interviews (n = 5) with staff at these community sites. Interview transcripts were double-coded and analyzed using thematic analysis. Analysis identified three themes: (1) research threatens sites’ most precious resource—staff; (2) staff lack comfort with and skills for research, and (3) research participation in its current form does not offer a clear return on investment. Community sites face many barriers to participating in implementation research trials. Future trials should consider ways to disrupt traditional approaches and increase the equitable inclusion of community settings in implementation research.

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

✪ Implementation Science for HIV Prevention and Treatment in Indigenous Communities: a Systematic Review and Commentary

Authors:

Christopher G. Kemp (Ngāi Tahu), Abagail J. Edwards, Lauren White (Choctaw Nation of Oklahoma), Gauri Kore, Pamela Jumper Thurman (Cherokee), Tommi Gaines (Navajo, Hopi), Paula Toko King (Te Aupōuri, Te Rarawa, Ngāpuhi, Ngāti Whātua, Waikato Tainui, Ngāti Maniapoto), Marama Cole (Ngāti Kahungunu, Ngāti Porou) & E. Roberto Orellana (Maya)

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal Current HIV/AIDS Reports

Abstract:

Purpose of Review

We systematically reviewed implementation research conducted in Indigenous communities in the Americas and the Pacific that focused on improving delivery of HIV preventive or treatment services. We highlight strengths and opportunities in the literature and outline principles for Indigenous-led, HIV-related implementation science.

Recent Findings

We identified 31 studies, revealing a consistent emphasis on cultural tailoring of services to Indigenous communities. Common barriers to implementation included stigma, geographic limitations, confidentiality concerns, language barriers, and mistrust. Community involvement in intervention development and delivery emerged as a key facilitator, and nearly half of the studies used community-based participatory research methods. While behavioral HIV prevention, especially among Indigenous youth, was a major focus, there was limited research on biomedical HIV prevention and treatment. No randomized implementation trials were identified.

Summary

The findings underscore the importance of community engagement, the need for interventions developed within Indigenous communities rather than merely adapted, and the value of addressing the social determinants of implementation success. Aligned to these principles, an indigenized implementation science could enhance the acceptability and reach of critical HIV preventive and treatment services in Indigenous communities while also honoring their knowledge, wisdom, and strength.

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

✪ Implementation of a bilingual and bicultural navigation program for Hispanic children with traumatic brain injuries

Authors:

Celeste N. Garcia, Magaly Ramirez, Tasnia Alam, Linda K. Ko & Nathalia Jimenez

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: August 2024

Read the full text in the open access journal Brain Injury

Abstract:

Background

Traumatic brain injury (TBI) disproportionately affects Hispanic children, with higher rates of severe injuries and worse outcomes compared to non-Hispanic White children. Patient navigation has shown effectiveness in improving health outcomes among Hispanic populations. However, culturally tailored navigation programs for pediatric TBI are lacking, and knowledge gaps remain regarding contextual factors influencing the implementation of these programs. This study examined factors that facilitate or hinder the implementation of a bilingual and bicultural navigation program for caregivers of Hispanic children with TBIs.

Methods

In-depth interviews were conducted with 12 personnel involved in implementing the 1st Brain Injury Education and Outpatient Navigation (1st BIEN) program across four states. Directed content analysis was used based on the Consolidated Framework for Implementation Research (CFIR) to guide the development of the interview guide and data analysis.

Results

Key facilitators included the program’s adaptability to patient needs, bilingual/bicultural patient navigator’s skills, and alignment with organizational values. Barriers included restrictive healthcare regulatory policies hindering interinstitutional work, incomplete medical records, and gaps in behavioral support training.

Discussion

These findings offer insights for optimizing the implementation of patient navigation programs in pediatric TBI care, potentially improving access to care and reducing disparities for Hispanic children with brain injuries.

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

✪ Increasing goals of care conversations in primary care: Study protocol for a cluster randomized, pragmatic, sequential multiple assignment randomized trial

Authors:

David B. Bekelman, Karleen Giannitrapani, Kristin A. Linn, Paula Langner, Rebecca L. Sudore, Borsika Rabin, Karl A. Lorenz, Marybeth Foglia, Amanda Glickman, Scott Pawlikowski, Marilyn Sloan, Raziel C. Gamboa, Matthew D. McCaa, Anne Hines & Anne M. Walling

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Background

Goals of care conversations explore seriously ill patients' values to guide medical decision making and often inform decisions about life sustaining treatments. Ideally, conversations occur before a health crisis between patients and clinicians in the outpatient setting. In the United States Veterans Affairs (VA) healthcare system, most conversations still occur in the inpatient setting. Strategies are needed to improve implementation of outpatient, primary care goals of care conversations.

Methods

We plan a cluster randomized (clinician-level) sequential, multiple assignment randomized trial to evaluate the effectiveness of patient implementation strategies on the outcome of goals of care conversation documentation when delivered in combination with clinician implementation strategies. Across three VA healthcare system sites, we will enroll primary care clinicians with low rates of goals of care conversations and their patients with serious medical illness in the top 10th percentile of risk of hospitalization or death. We will compare the effectiveness of sequences of implementation strategies and explore how patient and site factors modify implementation strategy effects. Finally, we will conduct a mixed-methods evaluation to understand implementation strategy success or failure. The design includes two key innovations: (1) strategies that target both clinicians and patients and (2) sequential strategies with increased intensity for non-responders.

Conclusion

This study aims to determine the effect of different sequences and combinations of implementation strategies on primary care documentation of goals of care conversations. Study partners, including the VA National Center for Ethics in Health Care and Office of Primary Care, can consider policies based on study findings.

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

✪ Implementing evidence-based practices to improve primary care for high-risk patients: study protocol for the VA high-RIsk VETerans (RIVET) type III effectiveness-implementation trial

Authors:

Elvira E. Jimenez, Ann-Marie Rosland, Susan E. Stockdale, Ashok Reddy, Michelle S. Wong, Natasha Torrence, Alexis Huynh & Evelyn T. Chang

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

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

Abstract:

Background

Patients with significant multimorbidity and other factors that make healthcare challenging to access and coordinate are at high risk for poor health outcomes. Although most (93%) of Veterans’ Health Administration (VHA) patients at high risk for hospitalization or death (“high-risk Veterans”) are primarily managed by primary care teams, few of these teams have implemented evidence-based practices (EBPs) known to improve outcomes for the high-risk patient population’s complex healthcare issues. Effective implementation strategies could increase adoption of these EBPs in primary care; however, the most effective implementation strategies to increase evidence-based care for high-risk patients are unknown.

The high-RIsk VETerans (RIVET) Quality Enhancement Research Initiative (QUERI) will compare two variants of Evidence-Based Quality Improvement (EBQI) strategies to implement two distinct EBPs for high-risk Veterans: individual coaching (EBQI-IC; tailored training with individual implementation sites to meet site-specific needs) versus learning collaborative (EBQI-LC; implementation sites trained in groups to encourage collaboration among sites). One EBP, Comprehensive Assessment and Care Planning (CACP), guides teams in addressing patients’ cognitive, functional, and social needs through a comprehensive care plan. The other EBP, Medication Adherence Assessment (MAA), addresses common challenges to medication adherence using a patient-centered approach.

Methods

We will recruit and randomize 16 sites to either EBQI-IC or EBQI-LC to implement one of the EBPs, chosen by the site. Each site will have a site champion (front-line staff) who will participate in 18 months of EBQI facilitation.

Analysis

We will use a mixed-methods type 3 hybrid Effectiveness-Implementation trial to test EBQI-IC versus EBQI-LC versus usual care using a Concurrent Stepped Wedge design. We will use the Practical, Robust Implementation and Sustainability Model (PRISM) framework to compare and evaluate Reach, Effectiveness, Adoption, Implementation, and costs. We will then assess the maintenance/sustainment and spread of both EBPs in primary care after the 18-month implementation period. Our primary outcome will be Reach, measured by the percentage of eligible high-risk patients who received the EBP.

Discussion

Our study will identify which implementation strategy is most effective overall, and under various contexts, accounting for unique barriers, facilitators, EBP characteristics, and adaptations. Ultimately this study will identify ways for primary care clinics and teams to choose implementation strategies that can improve care and outcomes for patients with complex healthcare needs.

Trial registration

ClinicalTrials.gov, NCT05050643. Registered September 9th, 2021, https://clinicaltrials.gov/study/NCT05050643

Protocol version

This protocol is Version 1.0 which was created on 6/3/2020.

Contributions to the literature
  • The first study to compare the effectiveness of Evidence-Based Quality Improvement (EBQI) conducted individually with one site or conducted with a group of sites.
  • Implementation of evidence-based practices to improve care for high-risk patients in primary care.

**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**

✪ “Veteran to Veteran, there’s automatically a trust”: A qualitative study of Veterans’ experiences in a peer health coaching program for hypertension

Authors:

C. Bradley Kramer, Karin M. Nelson, George Sayre, Jennifer L Williams, Leon Spruill, Tiffanie Fennell, Kristen E. Gray, Bryan J. Weiner, Vincent Fan, Jessica Jones-Smith, & Mayuree Rao

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: July 2024

Read the full text open access in the journal AJPM Focus

✪ 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**