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✪ 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 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**

✪ 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

✪ Adapting and testing measures of organizational context in primary care clinics in KwaZulu-Natal, South Africa

Authors:

Hannah H. Leslie, Sheri A. Lippman, Alastair van Heerden, Mbali Nokulunga Manaka, Phillip Joseph, Bryan J. Weiner & Wayne T. Steward

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: June 2024

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

Abstract:

Background

Implementation science frameworks situate intervention implementation and sustainment within the context of the implementing organization and system. Aspects of organizational context such as leadership have been defined and measured largely within US health care settings characterized by decentralization and individual autonomy. The relevance of these constructs in other settings may be limited by differences like collectivist orientation, resource constraints, and hierarchical power structures. We aimed to adapt measures of organizational context in South African primary care clinics.

Methods

We convened a panel of South African experts in social science and HIV care delivery and presented implementation domains informed by existing frameworks and prior work in South Africa. Based on panel input, we selected contextual domains and adapted candidate items. We conducted cognitive interviews with 25 providers in KwaZulu-Natal Province to refine measures. We then conducted a cross-sectional survey of 16 clinics with 5–20 providers per clinic (N = 186). We assessed reliability using Cronbach’s alpha and calculated interrater agreement (awg) and intraclass correlation coefficient (ICC) at the clinic level. Within clinics with moderate agreement, we calculated correlation of clinic-level measures with each other and with hypothesized predictors – staff continuity and infrastructure – and a clinical outcome, patient retention on antiretroviral therapy.

Results

Panelists emphasized contextual factors; we therefore focused on elements of clinic leadership, stress, cohesion, and collective problem solving (critical consciousness). Cognitive interviews confirmed salience of the domains and improved item clarity. After excluding items related to leaders’ coordination abilities due to missingness and low agreement, all other scales demonstrated individual-level reliability and at least moderate interrater agreement in most facilities. ICC was low for most leadership measures and moderate for others. Measures tended to correlate within facility, and higher stress was significantly correlated with lower staff continuity. Organizational context was generally more positively rated in facilities that showed consistent agreement.

Conclusions

As theorized, organizational context is important in understanding program implementation within the South African health system. Most adapted measures show good reliability at individual and clinic levels. Additional revision of existing frameworks to suit this context and further testing in high and low performing clinics is warranted.

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

✪ How pharmacists would design and implement a community pharmacy-based colorectal cancer screening program

Authors:

Austin R Waters, Katherine Meehan, Dana L Atkins, Annika H Ittes, Renée M Ferrari, Catherine L Rohweder, Mary Wangen, Rachel M Ceballos, Rachel B Issaka, Daniel S Reuland, Stephanie B Wheeler, Alison T Brenner, and Parth D Shah

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal Preventive Oncology & Epidemiology

Abstract:

Background

Distributing CRC screening through pharmacies, a highly accessible health service, may create opportunities for more equitable access to CRC screening. However, providing CRC screening in a new context introduces a substantial implementation challenge.

Methods

We conducted 23 semi-structured interviews with community pharmacists practicing in Washington state and North Carolina about distributing fecal immunochemical tests (FIT) to patients in the pharmacy. The Consolidated Framework for Implementation Research (CFIR) was used to guide analysis.

Results

Pharmacists believed that delivering FITs was highly compatible with their environment, workflow, and scope of practice. While knowledge about FIT eligibility criteria varied, pharmacists felt comfortable screening patients. They identified standardized eligibility criteria, patient-facing educational materials, and continuing education as essential design features. Pharmacists proposed adapting existing pharmacy electronic health record systems for patient reminders/prompts to facilitate FIT completion. While pharmacists felt confident that they could discuss test results with patients, they also expressed a need for stronger communication and care coordination with primary care providers.

Discussion

When designing a pharmacy-based CRC screening program, pharmacists desired programmatic procedures to fit their current knowledge and context. Findings indicate that if proper attention is given to multi-level factors, FIT delivery can be extended to pharmacies.

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

✪ Acceptability of venue-based HIV testing and prevention interventions for men who have sex with transgender women and transgender women in Lima, Perú: a formative, qualitative study

Authors:

Alexander Lankowski, Deanna Tollefson, Hugo Sánchez, Robinson Cabello, José Hidalgo, Mary N Mathison, Yamilé Molina & Ann Duerr

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: April 2024

Read the full text in the open access journal HIV Research & Clinical Practice

Abstract:

Background

Despite being at elevated risk for HIV, men who have sex with transgender women (MSTW) are an overlooked population in the global HIV response. Venue-based HIV interventions have previously had success reaching other HIV priority populations, including transgender women (TW). Similar approaches could be applied for MSTW.

Objective

To evaluate the prospective acceptability of venue-based HIV testing and prevention interventions for MSTW and TW in Lima, Peru.

Methods

In this exploratory qualitative study, we conducted in-depth interviews (IDI) and focus group discussions (FGD) with three types of participants: MSTW (7 IDIs, 1 FGD), TW (1 FGD), and owners of social venues frequented by MSTW/TW in Lima (2 IDIs). We elicited participants’ attitudes and perceptions related to the following four hypothetical interventions delivered at social venues in Lima: rapid HIV testing; HIV self-test distribution; condom/lubricant distribution; and enrolment in a mobile app supporting HIV prevention. We performed a mixed deductive-inductive thematic analysis using the framework method, then applied the Theoretical Framework of Acceptability to classify the overall acceptability of each intervention.

Results

Condom/lubricant distribution and app-based HIV prevention information were highly acceptable among all participant types. The two HIV testing interventions had relatively lower acceptability; however, participants suggested this could be overcome if such interventions focused on ensuring discretion, providing access to healthcare professionals, and offering appropriate incentives.

Conclusions

Overall, MSTW and TW shared similar favourable attitudes towards venue-based HIV interventions. Venue-based outreach warrants further exploration as a strategy for engaging MSTW and TW in HIV prevention activities.

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

✪ Leveraging human-centered design and causal pathway diagramming toward enhanced specification and development of innovative implementation strategies: a case example of an outreach tool to address racial inequities in breast cancer screening

Authors:

Leah M. Marcotte, Raina Langevin, Bridgette H. Hempstead, Anisha Ganguly, Aaron R. Lyon, Bryan J. Weiner, Nkem Akinsoto, Paula L. Houston, Victoria Fang, & Gary Hsieh

University of Washington affiliated authors are displayed in bold.

✪ Open Access

Published: March 2024

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

Abstract:

Background

Implementation strategies are strategies to improve uptake of evidence-based practices or interventions and are essential to implementation science. Developing or tailoring implementation strategies may benefit from integrating approaches from other disciplines; yet current guidance on how to effectively incorporate methods from other disciplines to develop and refine innovative implementation strategies is limited. We describe an approach that combines community-engaged methods, human-centered design (HCD) methods, and causal pathway diagramming (CPD)—an implementation science tool to map an implementation strategy as it is intended to work—to develop innovative implementation strategies.

Methods

We use a case example of developing a conversational agent or chatbot to address racial inequities in breast cancer screening via mammography. With an interdisciplinary team including community members and operational leaders, we conducted a rapid evidence review and elicited qualitative data through interviews and focus groups using HCD methods to identify and prioritize key determinants (facilitators and barriers) of the evidence-based intervention (breast cancer screening) and the implementation strategy (chatbot). We developed a CPD using key determinants and proposed strategy mechanisms and proximal outcomes based in conceptual frameworks.

Results

We identified key determinants for breast cancer screening and for the chatbot implementation strategy. Mistrust was a key barrier to both completing breast cancer screening and using the chatbot. We focused design for the initial chatbot interaction to engender trust and developed a CPD to guide chatbot development. We used the persuasive health message framework and conceptual frameworks about trust from marketing and artificial intelligence disciplines. We developed a CPD for the initial interaction with the chatbot with engagement as a mechanism to use and trust as a proximal outcome leading to further engagement with the chatbot.

Conclusions

The use of interdisciplinary methods is core to implementation science. HCD is a particularly synergistic discipline with multiple existing applications of HCD to implementation research. We present an extension of this work and an example of the potential value in an integrated community-engaged approach of HCD and implementation science researchers and methods to combine strengths of both disciplines and develop human-centered implementation strategies rooted in causal perspective and healthcare equity.

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