Getting cozy with causality: Advances to the causal pathway diagramming method to enhance implementation precision.

Background: Implementation strategies are theorized to work well when carefully matched to implementation determinants and when factors-preconditions, moderators, etc.-that influence strategy effectiveness are prospectively identified and addressed. Existing methods for strategy selection are either imprecise or require significant technical expertise and resources, undermining their utility. This article outlines refinements to causal pathway diagrams (CPDs), a method for articulating the causal process through which implementation strategies work and offers illustrations of their use. Method: CPDs are a visualization tool to represent an implementation strategy, its mechanism(s) (i.e., the processes through which a strategy is thought to operate), determinants it is intended to address, factors that may impede or facilitate its effectiveness, and the series of outcomes that should be expected if the strategy is operating as intended. We offer principles for constructing CPDs and describe their key functions. Results: Applications of the CPD method by study teams from two National Institute of Health-funded Implementation Science Centers and a research grant are presented. These include the use of CPDs to (a) match implementation strategies to determinants, (b) understand the conditions under which an implementation strategy works, and (c) develop causal theories of implementation strategies. Conclusions: CPDs offer a novel method for implementers to select, understand, and improve the effectiveness of implementation strategies. They make explicit theoretical assumptions about strategy operation while supporting practical planning. Early applications have led to method refinements and guidance for the field.

Advances to the Causal Pathway Diagramming Method to Enhance Implementation Precision Plain Language Summary Implementation strategies often fail to produce meaningful improvements in the outcomes we hope to impact. Better tools for choosing, designing, and evaluating implementation strategies may improve their performance. We developed a tool, causal pathway diagrams (CPD), to visualize and describe how implementation strategies are expected to work. In this article, we describe refinements to the CPD tool and accompanying approach. We use real illustrations to show how CPDs can be used to improve how to match strategies to barriers, understand the conditions in which those strategies work best, and develop generalizable theories describing how implementation strategies work. CPDs can serve as both a practical and scientific tool to improve the planning, deployment, and evaluation of implementation strategies. We demonstrate the range of ways that CPDs are being used, from a highly practical tool to improve implementation practice to a scientific approach to advance testing and theorizing about implementation strategies.

Reliability and validity of intervention characteristic measures for assessing barriers to evidence-based practice use.

Assessing barriers before implementing an evidence-based practice can increase the chances of successful implementation. This project evaluated measures of intervention characteristics that could affect implementation: evidence strength and quality; relative advantage; adaptability; trialability; complexity; design quality and packaging; perceived cost; compatibility; observability; risk; and burden. Measures (109 items total) for each intervention characteristic were developed in a previous study, using prior measures, and expert feedback. Measures were scored such that higher scores meant a more positive view. Healthcare personnel implementing a new practice (n = 175) completed two surveys, 1 month apart. Participants completed the intervention characteristic item banks and questions on the use of the evidence-based practice. Reliability and validity were assessed for each item bank. All measures had Cronbach's alphas over 0.7 (range: 0.700-0.932) indicating good reliability. Frequent users of the practice reported better levels of each determinant at the first (Cohen's d range: -0.239 to -0.687) and second surveys (Cohen's d range: -0.043 to -1.081) except for costs (0.096) with use on the second survey. This preliminary test of measures to assess determinants of implementing evidence-based practice supports the validity and reliability of these tools. Additional studies are needed to further test the psychometric properties of the measures and develop short forms of each intervention characteristic measure.

Measuring perceptions of healthcare personnel can help increase the use of evidence-based care. This study developed measures of eleven different types of perceptions. The measures were tested in a sample of 175 healthcare personnel. All eleven measures showed good reliability and validity. The measures can be used to assess perceptions in research and clinical care.

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.

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.

Implementation outcomes of the integrated district evidence to action (IDEAs) program to reduce neonatal mortality in central Mozambique: an application of the RE-AIM evaluation framework.

BACKGROUND: Scarce evidence exists on audit and feedback implementation processes in low-resource health systems. The Integrated District Evidence to Action (IDEAs) is a multi-component audit and feedback strategy designed to improve the implementation of maternal and child guidelines in Mozambique. We report IDEAs implementation outcomes. METHODS: IDEAs was implemented in 154 health facilities across 12 districts in Manica and Sofala provinces between 2016 and 2020 and evaluated using a quasi-experimental design guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Reach is the proportion of pregnant women attending IDEAs facilities. Adoption is the proportion of facilities initiating audit and feedback meetings. Implementation is the fidelity to the strategy components, including readiness assessments, meetings (frequency, participation, action plan development), and targeted financial support and supervision. Maintenance is the sustainment at 12, 24, and 54 months. RESULTS: Across both provinces, 56% of facilities were exposed to IDEAs (target 57%). Sixty-nine and 73% of pregnant women attended those facilities' first and fourth antenatal consultations (target 70%). All facilities adopted the intervention. 99% of the expected meetings occurred with an average interval of 5.9 out of 6 months. Participation of maternal and child managers was high, with 3076 attending meetings, of which 64% were from the facility, 29% from the district, and 7% from the province level. 97% of expected action plans were created, and 41 specific problems were identified. "Weak diagnosis or management of obstetric complications" was identified as the main problem, and "actions to reinforce norms and protocols" was the dominant subcategory of micro-interventions selected. Fidelity to semiannual readiness assessments was low (52% of expected facilities), and in completing micro-interventions (17% were completed). Ninety-six and 95% of facilities sustained the intervention at 12 and 24 months, respectively, and 71% had completed nine cycles at 54 months. CONCLUSION: Maternal and child managers can lead audit and feedback processes in primary health care in Mozambique with high reach, adoption, and maintenance. The IDEAs strategy should be adapted to promote higher fidelity around implementing action plans and conducting readiness assessments. Adding effectiveness to these findings will help to inform strategy scale-up.

Perspectives of clinical stakeholders and patients from four VA liver clinics to tailor practice facilitation for implementing evidence-based alcohol-related care.

BACKGROUND: Unhealthy alcohol use (UAU) is particularly dangerous for people with chronic liver disease. Liver clinics may be an important setting in which to provide effective alcohol-related care by integrating evidence-based strategies, such as brief intervention and medications for alcohol use disorder. We conducted qualitative interviews with clinical stakeholders and patients at liver clinics in four Veterans Health Administration (VA) medical centers to understand barriers and facilitators of integrating alcohol-related care and to support tailoring of a practice facilitation implementation intervention. METHODS: Data collection and analysis were guided by the Consolidated Framework for Implementation Research (CFIR). Interviews were transcribed and qualitatively analyzed using a Rapid Assessment Process (RAP) guided by the CFIR. RESULTS: We interviewed 46 clinical stakeholders and 41 patient participants and analyzed findings based on the CFIR. Clinical stakeholders described barriers and facilitators that ranged from operations/clinic resource-based (e.g., time and capacity, desire for additional provider types, referral processes) to individual perspective and preference-based (e.g., supportiveness of leadership, individual experiences/beliefs). Patient participants shared barriers and facilitators that ranged from relationship-based (e.g., trusting the provider and feeling judged) to resource and education-based (e.g., connection to a range of treatment options, education about impact of alcohol). Many barriers and facilitators to integrating alcohol-related care in liver clinics were similar to those identified in other clinical settings (e.g., time, resources, role clarity, stigmatizing beliefs). However, some barriers (e.g., fellow-led care and lack of integration of liver clinics with addictions specialists) and facilitators (e.g., presence of quality improvement staff in clinics and integrated pharmacists and behavioral health specialists) were more unique to liver clinics. CONCLUSIONS: These findings support the possibility of integrating alcohol-related care into liver clinics but highlight the importance of tailoring efforts to account for variation in provider beliefs and experiences and clinic resources. The barriers and facilitators identified in these interviews were used to tailor a practice facilitation implementation intervention in each clinic setting.

Integrating HPV self-collect into primary care to address cervical cancer screening disparities.

Human papillomavirus (HPV) self-collect shows promise to increase cervical cancer screening rates in underscreened populations, such as Somali patients, but little is known about how to integrate such an approach in primary care. In this study, primary care providers and staff who provide primary care services to Somali women were asked for their views on integrating HPV self-collect into routine care to address cervical cancer screening disparities. Thirty primary care providers and staff participated in semi-structured interviews exploring their views on HPV self-collect and their anticipated needs or barriers to implementing this approach into the clinic generally and with specific patient populations, such as Somali women. A thematic analysis using the constructivist version of grounded theory was undertaken. Providers and staff anticipate positive patient reaction to the option of HPV self-collect, and were interested in using this approach both for Somali patients and for all patients in general. HPV self-collect was viewed as straightforward to integrate into existing clinic workflows. Providers largely lacked awareness of the evidence supporting primary HPV testing and HPV self-collect specifically, sharing concerns about effectiveness of self-collect and the lack of a physical exam. Providers felt clinic-wide staff education and patient education, along with strategies to address disparities, such as cultural and linguistic tailoring would be needed for successful implementation. Integrating HPV self-collect as an option in the cervical cancer screening process in a primary care clinical encounter offers considerable opportunity to address health disparities and may benefit all patients.

Study protocol: Novel Methods for Implementing Measurement-Based Care with youth in Low-Resource Environments (NIMBLE).

BACKGROUND: For youth receiving care in community mental health centers, comorbidities are the rule rather than the exception. Using measurement-based care (MBC), or the routine evaluation of symptoms to inform care decisions, as the foundation of treatment for youth with comorbid problems significantly improves the impact of psychotherapy by focusing care and building engagement and alliance. MBC increases the rate of symptom improvement, detects clients who would otherwise deteriorate, and alerts clinicians to non-responders. Despite its demonstrated utility, MBC is rarely implemented with fidelity; less than 15% of providers report using MBC per recommendations. Previous efforts to support MBC implementation have yielded suboptimal outcomes, in part, due to organizations' challenges with identifying and prioritizing barriers and selecting and developing strategies to overcome them. New methods are needed for identifying and prioritizing barriers, and matching strategies to barriers to optimize MBC implementation and treatment quality to improve youth mental health outcomes in community settings. METHODS: Pragmatic implementation methods will be piloted in four diverse community mental health centers. Methods include (a) rapid evidence synthesis; (b) rapid ethnography; (c) design kits (e.g., kits with disposable cameras, journals, maps); (d) barrier prioritization, and (e) causal pathway diagramming. These activities will generate actionable barriers; subsequently, we will use facilitated group processes to prioritize barriers and develop causal pathway diagrams to match strategies to barriers to create implementation plans that optimize MBC fidelity (Aim 1). We will track strategy deployment for 6 months, then compare MBC fidelity for another 6 months post-implementation with data from 2 years of historical controls (Aim 2). Finally, we will co-design a toolkit for design kit methods with youth and the practice and scientific communities (Aim 3). DISCUSSION: Optimizing MBC implementation in community mental health centers could transform youth mental health care by ensuring the most pressing symptoms are targeted early in treatment. The discussion section highlights expected challenges and limits to using the five methods, including recruitment and engagement given the high pressure on community mental health settings. TRIAL REGISTRATION: Clinicaltrials.gov. NCT05644756 . Registered on 18 November 2022. This trial was retrospectively registered.

The Impact of Childhood Mortality on Fertility in Rural Tanzania: Evidence From the Ifakara and Rufiji Health and Demographic Surveillance Systems.

This manuscript examines the relationship between child mortality and subsequent fertility using longitudinal data on births and childhood deaths occurring among 15,291 Tanzanian mothers between 2000 and 2015. Generalized hazard regression analyses assess the effect of child loss on the hazard of conception, adjusting for child-level, mother-level, and contextual covariates. Results show that time to conception is most reduced if an index child dies during the subsequent birth interval, representing the combined effect of biological and volitional replacement. Deaths occurring during prior birth intervals were associated with accelerated time to conception during future intervals, consistent with hypothesized insurance effects of anticipating future child loss, but this effect is smaller than replacement effects. The analysis reveals that residence in areas of relatively high child mortality is associated with hastened parity progression, again consistent with the insurance hypothesis. Investigation of high-order interactions suggests that insurance effects tend to be greater in low-mortality communities, replacement effects tend to be stronger in high-mortality community contexts, and wealthier families tend to exhibit a weaker insurance response but a stronger replacement response to childhood mortality relative to poorer families.

Content validity of an item bank to assess intervention characteristic determinants of implementing evidence-based practices.

Background: Barriers and facilitators, collectively called determinants, of evidence-based practice implementation are key to identifying the best strategies for promoting implementation. Assessing determinants before implementation can help tailor strategies to those that would be most effective. Current measures of determinants are not comparable across implementation settings and implementation scientists and practitioners often have to create their own measures. This study was the first step in creating determinants item banks that are usable across settings and focused on intervention characteristics. We aimed to establish the content validity of the item bank. Method: This study used a concurrent mixed methods approach. Items for assessing intervention characteristic determinants were first identified through systematic reviews. Implementation scientists then completed a survey where they provided both quantitative and qualitative feedback on the items. Finally, three experts with both clinical and implementation experience provided feedback on redundancy and representativeness. Results: The systematic reviews identified over 1,959 items so subsequent steps were limited to focus on intervention characteristic determinants (271 items) such as adaptability of the practice. Based on feedback from thirty implementation scientists, the items were reduced to 92 but an additional 53 were added, most due to qualitative feedback. Items were also rewritten based on qualitative results. Three experts reviewed the remaining 145 items. Based on their feedback, the number of items was reduced to 109. Conclusions: Creating a determinants item bank was feasible and the final items had content validity. The next steps include testing reliability and validity in a larger sample of clinicians implementing evidence-based practices.

Barriers prevent or impede an organization from using a new practice or innovation. Facilitators help promote the use of a new practice or innovation within an organization. Assessing barriers and facilitators before starting a new practice can help target barriers and increase the chances of successfully using the practice. This study created new measures of barriers and facilitators of using a new practice or innovation. Previous measures were identified through literature reviews. Implementation scientists provided feedback on the measures through an online survey. Three experts with clinical and implementation experience provided additional feedback. Measures were revised based on the survey and expert feedback. The next steps are to test the measures with clinicians implementing a new practice.

Implementation determinants and strategies in integration of PrEP into maternal and child health and family planning services: experiences of frontline healthcare workers in Kenya.

Background: Delivery of PrEP to adolescent girls and young women (AGYW) and to pregnant women through maternal and child health (MCH) and family planning (FP) clinics is scaling up in Kenya. Evaluation of implementation challenges and strategies is critical to optimize delivery. Methods: We conducted focus group discussions (FGDs) with healthcare workers (HCWs) in MCH and FP clinics offering PrEP in a large implementation project in Kisumu, Kenya. Discussion guides were based on the Consolidated Framework for Implementation Research (CFIR). FGDs were audio recorded and transcribed. Directed content analysis was used to identify implementation challenges and strategies to overcome them. Results: Fifty HCWs from 26 facilities participated in 8 FGDs. HCWs believed PrEP integration was appropriate because it met the needs of AGYW and pregnant women by providing a female-controlled prevention strategy and aligned with policy priorities of elimination of vertical HIV transmission. They were universally accepting of PrEP provision, especially through MCH clinics, noting the relative advantage of this approach because it: (1) enabled high coverage, (2) harmonized PrEP and MCH visits, and (3) minimized stigma compared to PrEP offered through HIV care clinics. However, HCWs noted implementation challenges affecting feasibility and adoption including: (1) increased workload and documentation burden amid workforce shortages, (2) insufficient health care worker knowledge (3) multiple implementing partners with competing priorities (4) drug and documentation form stockouts. HCWs employed various implementation strategies to overcome challenges, including task shifting from nurses to HIV testing providers, patient flow modifications (e.g., fast-tracking PrEP clients to reduce wait times), PrEP demand generation and myth clarification during health talks, provider education, dedicated PrEP delivery rooms, and coordination with adolescent-friendly services. Additional suggested strategies to improve PrEP integration included community education to increase broader PrEP awareness and enable shorter counseling sessions, and task-shifting data entry and client risk assessments. Conclusions: HCWs were enthusiastic about the appropriateness and acceptability of integrating PrEP services into MCH and FP clinics but noted challenges to adoption and feasibility. Strategies to address challenges focused on improving provider time and space constraints, and increasing provider and client knowledge.

Health System-Provided Rideshare Is Safe and Addresses Barriers to Colonoscopy Completion.

In 2019, nearly 14 million colonoscopies were performed in the United States.1 In these settings, the accepted practice is that a responsible person drives and chaperones patients home after receiving procedural sedation, including colonoscopy.2 Lack of access to transportation and/or a chaperone is a persistent barrier to care in safety-net health systems and federally qualified health centers as a result of lower incomes, underinsurance, and higher social needs.3 Given racial, ethnic, and socioeconomic disparities in many digestive diseases that require colonoscopy for diagnosis and management, innovative solutions are needed to overcome logistical barriers to colonoscopy completion, especially in these settings.

Co-developed implementation guidelines to maximize acceptability, feasibility, and usability of mobile phone supervision in Kenya.

Opportunities exist to leverage mobile phones to replace or supplement in-person supervision of lay counselors. However, contextual variables, such as network connectivity and provider preferences, must be considered. Using an iterative and mixed methods approach, we co-developed implementation guidelines to support the implementation of mobile phone supervision with lay counselors and supervisors delivering a culturally adapted trauma-focused cognitive behavioral therapy in Western Kenya. Guidelines were shared and discussed with lay counselors in educational outreach visits led by supervisors. We evaluated the impact of guidelines and outreach on the acceptability, feasibility, and usability of mobile phone supervision. Guidelines were associated with significant improvements in acceptability and usability of mobile phone supervision. There was no evidence of a significant difference in feasibility. Qualitative interviews with lay counselors and supervisors contextualized how guidelines impacted acceptability and feasibility - by setting expectations for mobile phone supervision, emphasizing importance, increasing comfort, and sharing strategies to improve mobile phone supervision. Introducing and discussing co-developed implementation guidelines significantly improved the acceptability and usability of mobile phone supervision. This approach may provide a flexible and scalable model to address challenges with implementing evidence-based practices and implementation strategies in lower-resourced areas.

How and why might interprofessional patient- and family-centered rounds improve outcomes among healthcare teams and hospitalized patients? A conceptual framework informed by scoping and narrative literature review methods.

Poor communication within healthcare contributes to inefficiencies, medical errors, conflict, and other adverse outcomes. A promising model to improve outcomes resulting from poor communication in the inpatient hospital setting is Interprofessional Patient- and Family-Centered rounds (IPFCR). IPFCR brings two or more health professions together with hospitalized patients and families as part of a consistent, team-based routine to share information and collaboratively arrive at a daily plan of care. A growing body of literature focuses on implementation and outcomes of IPFCR to improve healthcare quality and team and patient outcomes. Most studies report positive changes following IPFCR implementation. However, conceptual frameworks and theoretical models are lacking in the IPFCR literature and represent a major gap that needs to be addressed to move this field forward. The purpose of this two-part review is to propose a conceptual framework of how IPFCR works. The goal is to articulate a framework that can be tested in subsequent research studies. Published IPFCR literature and relevant theories and frameworks were examined and synthesized to explore how IPFCR works, to situate IPFCR in relation to existing models and frameworks, and to postulate core components and underlying causal mechanisms. A preliminary, context-specific, conceptual framework is proposed illustrating interrelationships between four core components of IPFCR (interprofessional approach, intentional patient and family engagement, rounding structure, shared development of a daily care plan), improvements in communication, and better outcomes.

The implementation and effectiveness of multi-tasked, paid community health workers on maternal and child health: A cluster-randomized pragmatic trial and qualitative process evaluation in Tanzania.

Community health worker programs have proliferated worldwide based on evidence that they help prevent mortality, particularly among children. However, there is limited evidence from randomized studies on the processes and effectiveness of implementing community health worker programs through public health systems. This paper describes the results of a cluster-randomized pragmatic implementation trial (registration number ISRCTN96819844) and qualitative process evaluation of a community health worker program in Tanzania that was implemented from 2011-2015. Program effects on maternal, newborn and child health service utilization, childhood morbidity and sick childcare seeking were evaluated using difference-in-difference regression analysis with outcomes measured through pre- and post-intervention household surveys in intervention and comparison trial arms. A qualitative process evaluation was conducted between 2012 and 2014 and comprised of in-depth interviews and focus group discussions with community health workers, community members, facility-based health workers and staff of district health management teams. The community health worker program reduced incidence of illness and improved access to timely and appropriate curative care for children under five; however, there was no effect on facility-based maternal and newborn health service utilization. The positive outcomes occurred because of high levels of acceptability of community health workers within communities, as well as the durability of community health workers' motivation and confidence. Implementation factors that generated these effects were the engagement of communities in program startup; the training, remuneration and supervision of the community health workers from the local health system and community. The lack of program effects on maternal and newborn health service utilization at facilities were attributed to lapses in the availability of needed care at facilities. Strategies that strengthen and align communities' and health systems core capacities, and their ability to learn, adapt and integrate evidence-based interventions, are needed to maximize the health impact of community health workers.

Unexpected capacity-building experiences of multicultural, multilingual participants in a public health initiative.

AIMS: This study of a levy-voter funded public health initiative program (1) identifies capacity-building concerns, (2) summarizes those concerns at the community-based organization (CBO) level, and (3) documents the desired CBO capacity-building outcome. PARTICIPANTS: Nineteen participants from nine CBOs were included, representing 95% of participants (19/20) and 90% of CBOs (9/10) from the initiative's program population. METHODS: Interviews were conducted. A focus group validated data. Demographic surveys were completed. METHODOLOGY AND ANALYSIS: Data were analyzed using demographic and inductive content analyses. Fifteen capacity-building unexpected concerns were identified. Participants from eight out of nine (88.8%) CBOs shared at least ten concerns. Seven CBO capacity-building outcomes were identified. RESULTS: Capacity-building providers helped participants mitigate the Initiative's capacity-building testing of the National Implementation Research Network (NIRN) model. Participants' NIRN processes were Western and mainstream. Participants wanted community-designed processes and the funder to understand CBO clients' backgrounds, cultures, and languages. The contract money did not match the needed capacity-building processes, time, and workload. DISCUSSION: The funder's pre-selected the NIRN Western majority approach did not fit. Participants wanted to lead. Capacity-building only for home-based program development was less desired. Social justice leadership could have made a difference.

HPV vaccination in Kenya: a study protocol to assess stakeholders' perspectives on implementation drivers of HPV vaccination and the acceptability of the reduced dose strategy among providers.

Background: Cervical cancer is the leading cause of cancer-related deaths among Kenyan women. Persistent infection with high-risk oncogenic Human papillomavirus (HPV) genotypes is a necessary cause of cervical cancer. HPV vaccines are safe, durable, and efficacious in preventing incident HPV infections. In Kenya, despite efforts to increase HPV vaccination, coverage remains low. We sought to assess: (1) barriers and facilitators of HPV vaccination from the perspective of adolescent girls and young women (AGYW), their guardians as well as stakeholders involved in HPV vaccine delivery, and (2) the acceptability of the single dose of the HPV vaccination among healthcare providers (HCPs). Methods: Our study is nested within the KENya Single-dose HPV-vaccine Efficacy study (KEN SHE) that sought to test the efficacy of single-dose bivalent (HPV 16/18) and single-dose nonavalent (HPV 16/18/31/33/45/52/58/6/11) vaccination. We are conducting this study in Kiambu, Nairobi, and Kisumu counties. In these counties, we are interviewing stakeholders (n = ∼25), selected based on their role in HPV vaccination at the county and national levels. Interviews are audio recorded and conducted in English or Swahili. The semi-structured interview guides were designed based on: (1) the Theoretical Domains Framework (TDF) for AGYW and guardians and (2) the Consolidated Framework for Implementation Research (CFIR) for other stakeholders. The Theoretical Framework of Acceptability (TFA) was leveraged to design the survey administered to HCPs (n = ∼309) involved in HPV vaccination. We will develop a codebook based on emerging codes from the transcripts and constructs from the TDF and CFIR. Emerging themes will be summarized highlighting similarities and differences between and within the different stakeholder groups and counties. Descriptive statistics and a χ2 test will be used to assess the distribution of responses between the different sites and regression analysis will be used to assess factors associated with high acceptability of the single-dose strategy while controlling for confounding variables. Discussion: Our study will describe key barriers and facilitators that affect HPV vaccination from the perspective of multiple stakeholders as well as insights on the perspective of HCPs towards the single-dose strategy to inform the designing of strategies to increase HPV vaccination uptake in Kenya and comparable settings.

Selecting implementation strategies to improve implementation of integrated PrEP for pregnant and postpartum populations in Kenya: a sequential explanatory mixed methods analysis.

BACKGROUND: There is a higher risk for HIV acquisition during pregnancy and postpartum. Pre-exposure prophylaxis (PrEP) is recommended during this period for those at high risk of infection; integrated delivery in maternal and child health (MCH) clinics is feasible and acceptable but requires implementation optimization. METHODS: The PrEP in Pregnancy, Accelerating Reach and Efficiency study (PrEPARE; NCT04712994) engaged stakeholders to prioritize determinants of PrEP delivery (using Likert scores) and prioritize PrEP delivery implementation strategies. Using a sequential explanatory mixed methods design, we conducted quantitative surveys with healthcare workers at 55 facilities in Western Kenya and a stakeholder workshop (including nurses, pharmacists, counselors, and county and national policymakers), yielding visual plots of stakeholders' perceived feasibility and effectiveness of the strategies. A stepwise elimination process was used to identify seven strategies for empirical testing. Facilitator debriefing reports from the workshop were used to qualitatively assess the decision-making process. RESULTS: Among 146 healthcare workers, the strongest reported barriers to PrEP delivery were insufficient providers and inadequate training, insufficient space, and high volume of patients. Sixteen strategies were assessed, 14 of which were included in the final analysis. Among rankings from 182 healthcare workers and 44 PrEP policymakers and implementers, seven strategies were eliminated based on low post-workshop ranking scores (bottom 50th percentile) or being perceived as low feasibility or low effectiveness for at least 50% of the workshop groups. The top seven strategies included delivering PrEP within MCH clinics instead of pharmacies, fast-tracking PrEP clients to reduce waiting time, delivering PrEP-related health talks in waiting bays, task shifting PrEP counseling, task shifting PrEP risk assessments, training different providers to deliver PrEP, and retraining providers on PrEP delivery. All top seven ranked strategies were grouped into bundles for subsequent testing. Facilitator debriefing reports generally aligned with rankings but noted how stakeholders' decision-making changed when considering the impact of strategies on facility staff and non-PrEP clients. CONCLUSIONS: The most impactful barriers to integrated PrEP delivery in MCH clinics were insufficient staffing and space. Implementation strategies prioritized through multiple methods of stakeholder input focused on co-location of services and increasing clinic efficiency. Future testing of these stakeholder-prioritized strategy bundles will be conducted to assess the effectiveness and implementation outcomes.

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.

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.

Comparison of methods to engage diverse stakeholder populations in prioritizing PrEP implementation strategies for testing in resource-limited settings: a cross-sectional study.

BACKGROUND: There is a lack of consensus about how to prioritize potential implementation strategies for HIV pre-exposure prophylaxis (PrEP) delivery. We compared several prioritization methods for their agreement and pragmatism in practice in a resource-limited setting. METHODS: We engaged diverse stakeholders with clinical PrEP delivery and PrEP decision-making experience across 55 facilities in Kenya to prioritize 16 PrEP delivery strategies. We compared four strategy prioritization methods: (1) "past experience surveys" with experienced practitioners reflecting on implementation experience (N = 182); (2 and 3) "pre- and post-small-group ranking" surveys before and after group discussion (N = 44 and 40); (4) "go-zone" quadrant plots of perceived effectiveness vs feasibility. Kendall's correlation analysis was used to compare strategy prioritization using the four methods. Additionally, participants were requested to group strategies into three bundles with up to four strategies/bundle by phone and online survey. RESULTS: The strategy ranking correlation was strongest between the pre- and post-small-group rankings (Tau: 0.648; p < 0.001). There was moderate correlation between go-zone plots and post-small-group rankings (Tau: 0.363; p = 0.079) and between past-experience surveys and post-small-group rankings (Tau: 0.385; p = 0.062). For strategy bundling, participants primarily chose bundles of strategies in the order in which they were listed, reflecting option ordering bias. Neither the phone nor online approach was effective in selecting strategy bundles. Participants agreed that the strategy ranking activities conducted during the workshop were useful in prioritizing a final set of strategies. CONCLUSIONS: Both experienced and inexperienced stakeholder participants' strategy rankings tended to prioritize strategies perceived as feasible. Small group discussions focused on feasibility and effectiveness revealed moderately different priorities than individual rankings. The strategy bundling approach, though less time- and resource-intensive, was not effective. Future research should further compare the relative effectiveness and pragmatism of methodologies to prioritize implementation strategies.