Background Patient recruitment and retention are major challenges in efforts to diversify clinical trials, particularly in resource-limited settings. Understanding factors that influence participation is critical for effective trial implementation. This study explores factors influencing participation and refusal in the Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS) implementation trial among women living with HIV (WLHIV) in Nigeria. Methods A phenomenological qualitative approach was employed. In-depth interviews were conducted with 21 participants (12 acceptors, 9 decliners), purposively sampled from 12 NISA-MIRC HIV treatment facilities across Nigeria’s six geopolitical zones. Interviews were conducted in English, Hausa, or Yoruba and translated for thematic analysis. Data was analyzed using comparative thematic analysis to identify cross-cutting domains influencing decision-making. Results Nine themes emerged, including comprehension of information, fear and risk perception, perceived benefits and opportunities, logistical barriers, willingness to participate in the future, suggestions for improvement, privacy concerns, and preferred recruitment approaches. Acceptors overcame concerns through clear communication, emotional reassurance, trust, and perceived personal relevance. Decliners experienced “barrier dominance,” where unresolved fears, logistical constraints, mistrust, and poorly timed recruitment outweighed potential benefits. Both groups suggested improvements, such as enhanced communication, community outreach, confidentiality assurances, and logistical support. Conclusions Trial participation decisions reflect distinct cognitive, emotional, and structural pathways. Patient-centered communication, culturally appropriate explanations, trust-building, and logistical support are critical to improving trial recruitment and retention. Addressing these factors can enhance equitable participation and strengthen the quality and generalizability of trial evidence in Nigeria and similar low-resource contexts.

Abstract Background The Evidence-Based Practice Attitude Scale (EBPAS) is a widely used measurement tool to assess mental health providers’ attitudes toward adopting research-based interventions. To date, this scale has not been used or validated in an interdisciplinary sample of mental health professionals in Latin America. This study investigated the factor structure, psychometric properties, cross-cultural validity, and model fit of the EBPAS in a sample of Spanish-speaking and Latino social workers, counselors, and psychologists. Methods A culturally and linguistically tailored version of the 15-item EBPAS scale was administered to a sample of Puerto Rican mental health professionals (N = 222) working across various settings, including schools, healthcare clinics, and community organizations. The EBPAS’s scores were derived from four distinct constructs involving willingness to adopt EBPs (i.e., requirements, openness to innovation, appeal, and divergence from research). A Confirmatory Factor Analysis (CFA) examined the psychometric properties of the EBPAS scale. Several first and second-order factor models were specified. A global and approximate fit examination of the measurement model and composite reliability estimation for each subscale was conducted. RStudio version 4.3.1 software was used for the CFA. Results The CFA supported a first-order factor model. Most subscales showed strong reliability coefficients ranging from 0.83 to 0.91, except for the divergence subscale, which showed a coefficient of 0.77. After allowing for covariance between two items in the appeal dimension, the correlated factor model demonstrated a satisfactory fit to the data, although some misspecification was observed. Conclusions The tailored EBPAS-15 demonstrated adequate psychometric properties in this Latinx sample of mental health professionals, suggesting that its factor structure and reliability may be useful in a Spanish-speaking and Caribbean sample of mental health professionals working across a variety of settings and contexts. Findings contribute to the scant literature on culturally and linguistically validated measures examining attitudes toward EBPs in Latin America.

Background The enhancement of evidence-based practice (EBP) implementation is essential within healthcare systems. The attitudes of practitioners towards EBP can significantly influence the adoption of these practices. This study sought to validate the French version of the Evidence-Based Practice Attitudes Scale 36 (EBPAS-36F), assess the attitudes towards EBP among professionals in child and adolescent psychiatry in France, and examine the factors potentially associated with these attitudes in this context. Methods A cross-sectional observational study was conducted. Data were gathered through an online survey distributed to medical, paramedical, and educational professionals and students engaged in diagnostic or care activities in child and adolescent psychiatry in France. The study utilized a French-language version of the EBPAS-36 scale, which underwent translation and back-translation. Population and attitude characteristics were described, and validation tests of the EBPAS-36F were performed. A multiple linear regression model was employed to assess the association between attitudes and various individual and organizational factors. Results A total of 400 professionals responded to at least one question, with 211 respondents completing all items of the questionnaire and thus being included in the analysis. The face, content, and convergent validity, as well as the internal consistency of the EBPAS-36F, were found to be satisfactory. The mean attitude level in the study population was 2.63 (95% CI = 2.57–2.69). Two factors were significantly associated with attitude level: affiliation with a university center and employment in a tertiary care facility. Conclusions This study is the first to validate the French version of the Evidence-Based Practice Attitude Scale (EBPAS-36F). The attitude towards evidence-based practices in child and adolescent psychiatry in France was consistent with those in other European countries. These findings will enable the development of targeted strategies to improve EBP implementation in mental health services in France.

The global shortage of trained mental health workers disproportionately impacts mental health care access in low- and middle-income countries. In Kenya, effective strategies are needed to scale-up the workforce to meet the demand for depression and post-traumatic stress disorder treatment. Task-shifting – delegating specific tasks to non-specialist workers – is one workforce expansion approach. However, non-specialist workers remain underutilized in Kenya due to a paucity of research on how to scale-up and sustain such service models. Purposive sampling was used to recruit experts from policy, healthcare practice, research, and mental health advocacy roles in Kenya (N = 30). Participants completed concept mapping activities to explore factors likely to facilitate or hinder a collaborative Ministry of Health-researcher training of the mental health non-specialist workforce. Participants brainstormed 71 statements describing determinants and implementation strategies, sorted and rated the importance and changeability of each. Multidimensional scaling and hierarchical cluster analysis quantified relationships between statements. The Exploration, Preparation, Implementation, and Sustainment (EPIS) framework guided cluster interpretation activities. Twelve determinant clusters were identified: 1) Current workforce characteristics, 2) Exploration considerations, 3) Preparation considerations, 4) Sustainment considerations, 5) Inner context implementation processes and tools, 6) Local capacity and partnerships, 7) Financing for community health teams, 8) Outer context resource allocation/policy into action, 9) Workforce characteristics to enhance during implementation, 10) Workforce implementation strategies, 11) Cross-level workforce strategies, and 12) Training and education recommendations. Cluster 8 was rated the most important and changeable. Concept mapping offers a rapid, community-engaged approach for identifying determinants and implementation strategies to address workforce shortages. Organizing results by EPIS phases can help prioritize strategy deployment to achieve implementation goals. Scale-up and sustainment of the non-specialist workforce in Kenya requires formal partnerships between the Ministry of Health and community health worker teams to distribute financial resources and collaboratively standardize training curriculum.

Employee behaviors that strategically support implementation (i.e., implementation citizenship behavior [ICB]) theoretically promote the adoption and high-fidelity use of evidence-based practices (EBPs). ICB (e.g., helping colleagues overcome implementation barriers) may vary across contexts, including schools where children are most likely to access and receive mental and behavioral health services. Pragmatic measures are needed to advance nascent research on school-based ICB and inform how these behaviors can be used to support successful implementation. The current study expanded the Implementation Citizenship Behavior Scale (ICBS) to create and validate the School Implementation Citizenship Behavior Scale (SICBS) in a sample of elementary school teachers implementing evidence-based prevention programs to support children’s mental and behavioral health. Based on subject matter expert feedback, items were refined from the original ICBS and items for two new subscales (taking initiative, advocacy) were created for the SICBS. A sample of 441 public school teachers from 52 elementary schools in the Midwest and Western United States of America completed a survey that included the SICBS and additional measures to assess convergent and divergent validity. SICBS was refined and validated via examination of item characteristics curves to reduce items and develop a pragmatic instrument, confirmatory factor analyses to evaluate the hypothesized measurement structure, and assessment of convergent and divergent validity. The original two ICBS subscales (helping others, keeping informed) were retained, and two new three-item subscales resulted from item reduction analyses (taking initiative, advocacy). The hypothesized second-order factor model was generally well fit to the data (CFI = .99, TLI = .99, RMSEA = .09), all first- (λs = .85-.96) and second-order factor loadings (λs = .93-.95) were high. All SICBS subscales demonstrated acceptable reliability (αs = .88-.92). Convergent validity was evidenced by moderate correlations with organizational citizenship behavior items (rs = .42-.49). Divergent validity was demonstrated by weak correlations with teachers’ beliefs about teaching (rs = .31-.38) and null correlations with most school demographics. Results support the structural, convergent, and divergent validity of the 12-item, 4-factor SICBS. The SICBS provides a deeper understanding of individual implementer actions that may serve as implementation mechanisms or outcomes.

Introduction A large public university added health insurance coverage of 50 % co-insurance for up to two cycles of in vitro fertilization (IVF) to eligible faculty and staff. Methods We describe the design and conduct of a randomized controlled trial to evaluate the effectiveness of a health insurance educational intervention on health insurance literacy and IVF benefit utilization. The intervention materials included 1) Key insurance terms; 2) Examples of premiums and deductibles across the insurance plan options; 3) Examples of how premiums and deductibles affect out-of-pocket costs; and 4) A guide to find in-network providers/facilities. The primary outcome is health insurance literacy. Secondary outcomes are IVF services and insurance benefit utilization, out-of-pocket costs, and financial hardship related to fertility care. We will integrate mixed methods data to explore whether the intervention was effective, feasible, acceptable, and appropriate. Results Among 394 faculty and staff screened, 217 (55 %) reproductive-aged (18 to 50 years) employees consented, completed the baseline survey and were randomized in a 2:1 fashion. Participants were female (81 %), married (63 %), and worked as a staff employee (72 %). At baseline, approximately 39 % reported an infertility diagnosis, and 28 % had undergone prior IVF treatment. Participants reported feeling slightly confident when using their health insurance plans and moderately confident being proactive when using their health insurance. Discussion Our goal is to improve health insurance literacy and utilization of health insurance benefits for IVF care, thereby expanding family-building options for reproductive-aged individuals.Trial registration: Clinicaltrials.gov Identifier: NCT05663645https://clinicaltrials.gov/study/NCT05663645

INTRODUCTION:Although there are evidence-based strategies (EBSs) for alcohol and other drug (AOD) prevention and treatment for college students, there has been little focus on evaluating AOD EBS implementation in higher education. The use of implementation strategies in higher education may help bridge the gap between research and practice and improve students' access to EBSs. However, it is important to first understand determinants of AOD EBS program implementation to support AOD EBS selection and implementation strategy selection. METHODS:We used mixed-methods to examine determinants occurring in the EBS selection and adoption process for AOD prevention and treatment using the Exploration, Preparation, Implementation, and Sustainment (EPIS) Framework (Aarons et al., 2011), with a focus on the inner organizational context and early EPIS phases. Participants (N = 142) were student affairs professionals across 23 campuses engaged in a statewide prevention coalition. Participants completed a survey assessing constructs relevant to EBS selection. A subset of participants (n = 16) completed semi-structured interviews designed to generate an in-depth understanding of the EBS implementation process on their respective campuses. Content analysis was employed to identify determinants present in the EBS selection process. RESULTS:Provider perspectives of Inner Context aligning with the exploration phase suggested higher education contexts were generally supportive of EBS implementation via ratings of absorptive capacity (e.g., mechanisms supporting knowledge acquisition) and implementation climate. Leadership support was rated as present "to a moderate extent". Qualitative data highlighted the importance of attending to six key determinants of the implementation process for substance EBSs: collaboration, evidence for initiative, leadership, institution priorities, resources, and student needs and perspectives. Collectively, the integration of qualitative and quantitative data suggests there are important facilitators to address with implementation strategies, and support is needed across campuses to prepare for implementation. CONCLUSIONS:Student affairs professionals within a statewide coalition identified features of EPIS Inner Context (climate, readiness, leadership support) that align with EBS selection and implementation processes and identified key determinants to selecting and adopting AOD prevention EBSs in higher education. Addressing these areas may help build capacity and scale up EBS selection.

OBJECTIVE:This study tests the effectiveness of leader- and provider-level implementation strategies to implement evidence-based interventions (EBIs) in 2 of the service systems caring for autistic children. The TEAMS Leadership Institute (TLI) targets implementation leadership and climate, and TEAMS Individualized Provider Strategy (TIPS) targets provider motivation and engagement. METHOD:A cluster randomized hybrid type 3 implementation-effectiveness trial tested the effects of the implementations strategies when paired with AIM HI (An Individualized Mental Health Intervention for Autism) in mental health programs (study 1) and CPRT (Classroom Pivotal Response Teaching) in classrooms (study 2). The combined sample included 65 programs/districts across 4 training cohorts (2018-2019 to 2020-2021). Organizations were randomized to receive a leader-level strategy, provider strategy, both strategies, or neither strategy (EBI provider training only). Leader and provider participants were recruited from enrolled programs/districts, and child participants were recruited from providers' caseloads or classrooms. Data from a total of 387 providers (mean age = 36.39 years; 91% female participants; 30% Latino/a/x participants) and 385 children (mean age = 8 years; 80% male participants; 45% Latino/a/x participants) were analyzed. Outcomes were assessed over 6 months. Provider outcome measures included provider EBI certification and observed EBI fidelity. Clinical outcome measures included the Eyberg Child Behavior Inventory (ECBI) (study 1) and the Pervasive Developmental Disorder Behavior Inventory (PDD-BI) (study 2). Outcomes were analyzed using intent-to-treat models. RESULTS:There was no significant effect of TLI on EBI Certification. TLI was associated with significantly higher EBI fidelity compared to non-TLI (B = 0.37, p = .04). Moreover, a statistically significant TLIxTime interaction was found for child outcome T scores (B = -10.47, p = .03), with a significant reduction in T scores across time only for those in the TLI condition. There were no significant effects of TIPS on any outcomes. CONCLUSION:Findings support the effectiveness of leader-focused strategies to promote implementation and clinical outcomes of autism EBIs in multiple public service systems and for multiple EBIs. PLAIN LANGUAGE SUMMARY:Although many evidence-based interventions have been developed for autistic children, they are not routinely delivered in usual-care services. This randomized controlled trial tested two implementation strategies, one focused on leadership and climate, the other focused on provider motivation and engagement. These implementation strategies were paired with two different autism interventions (An Individualized Mental Health Intervention for Autism [AIM HI], and Classroom Pivotal Response Teaching [CPRT]). The study took place in 65 mental health programs and school districts in California with 387 providers and 385 child participants. The authors found that the leadership and climate-focused implementation strategy, but not the provider-focused strategy, increased providers' use of the autism interventions and improved child outcome over 6 months. The study highlights the important role of organizational and district leaders in improving intervention delivery and child outcomes in usual care. CLINICAL TRIAL REGISTRATION INFORMATION:Translating Evidence-based Interventions for ASD: Multi-Level Implementation Strategy (TEAMS); https://clinicaltrials.gov/study/NCT03380078.

OBJECTIVE:Little is known about how to sustain evidence-based interventions with fidelity in community mental health settings. Phase 1 of the Working to Implement and Sustain Digital Outcome Measures (WISDOM) trial showed that an organizational strategy improved the implementation of measurement-based care (MBC) in mental health services for youths 1-12 months after clinician MBC training. The authors report results from phase 2 of the trial, in which the strategy's effects on MBC sustainment 13-26 months after clinician MBC training were examined. METHODS:Twenty-one outpatient mental health clinics were randomly assigned to MBC training and technical assistance plus the Leadership and Organizational Change for Implementation (LOCI) strategy (11 clinics) or to training and technical assistance only (10 clinics). In phase 2, the primary outcomes of MBC completion rate, youth symptom improvement, and MBC fidelity were examined for 452 youths who entered treatment 13-26 months after clinician MBC training. RESULTS:No differences were found in MBC completion rate or symptom improvement between the two conditions; however, among the 81 youths who received MBC, fidelity was significantly higher at LOCI sites relative to control sites (24%, SE=11.1 vs. 1%, SE=1.0, respectively; p=0.003). CONCLUSIONS:During phase 2, LOCI sites (vs. control sites) sustained superior MBC fidelity when MBC was used; however, superior MBC completion rates and clinical outcomes were not sustained. Sustainment of MBC may require strategies that improve its fit with regulatory and reimbursement environments in addition to strategies that develop clinic infrastructure.

The Healing Experiences of Adversity Among Latinos (HEALthy4You; H4Y) study was a multi-sector partnership between an academic research institution, a Federally Qualified Health Center (FQHC), and a multi-sector collective impact coalition focused on childhood obesity prevention. The goal of HEALthy4You was to develop community-centered and culturally appropriate precision interventions within FQHCs for Latino families to address predictors of adverse child experiences and treat childhood obesity. A multidisciplinary and multi-sector research, clinical, and community team (N = 29) was formed in September 2020 to co-design the study, which launched in June 2022. The team utilized a co-creation approach combined with the Exploration, Preparation, Implementation, and Sustainment framework to facilitate a collaborative design process. We conducted an internal and retrospective process evaluation in March 2023 to identify antecedents and situational factors associated with project formation, with a focus on understanding tensions and challenges with a broad partnership structure. We outline the team's co-creation process and describe internal challenges and pitfalls that emerged when developing the project. We sought to better understand the impact of differing perspectives, priorities, and goals between disciplines, sectors, and roles; differing approaches to evidence and evidence production; and team strategies to mitigate and manage competing pressures and priorities. This case report describes lessons learned, intending to share insights to support future development of best practices in project, partner, and team formation between researchers, clinicians, and community members. More specifically, these lessons could help inform community-led research endeavors between academic institutions, FQHCs, and community-based organizations (CBOs).

Multisite implementation research in justice and health settings often does not systematically assess differential degrees of project involvement among participating sites, despite its implications for both research and the intervention. Tracking organization and participant involvement across sites, when attempted, has typically entailed the use of discrete and sometimes disjointed fidelity measures that may not accurately reflect engagement with a project. This article advances a more comprehensive and sophisticated conceptual model for measuring and monitoring site engagement. This conceptual model was developed from a literature review of the implementation science and related disciplines while being informed by multisite project implementation experience. We propose the Site Engagement Activity Model Leveraging Implementation Science (SEAMLIS), a conceptual model that holistically identifies the breadth of agency participation (diverse activities such as trainings, meetings, etc.) and duration of site engagement (participation levels from inception to completion) to be measured, assessed, and reported. We also describe Juvenile Justice Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS), a 36-site implementation research project, as an illustrative case example of our proposed model. We then operationalize all proposed domains and subdomains and specify key measures from the project. We provide analytical recommendations for the application and future research of the proposed model in health and justice settings. In multisite implementation research, site engagement could be fruitfully used as an independent, dependent, or intervening (moderating or mediating) variable. NCT02672150, February 3, 2016.

Adverse Childhood Experiences (ACEs) screenings are increasingly being used in primary care clinics to identify toxic stress and potential trauma in children. ACEs are negative life events (e.g., violence exposure) occurring before age 18, that can increase health risks when unaddressed. However, we lack evidence on the impact of ACEs screenings and how they can be feasibly implemented in community-based clinics. We partnered with federally qualified health clinics to test the impact of a multifaceted implementation strategy on ACEs screening reach and mental health referrals for children ages 0–5. We conducted a Hybrid Type 2 pilot trial using a stepped-wedge design (2021–2024). Reach data was measured as the proportion of eligible children screened for ACEs, with data collected from Electronic Health Records. We also assessed the percentage of mental health service referrals among all eligible children. Study clinics (n = 3) switched from no ACEs screenings (control) to implementing ACEs screenings supported by the multi-faceted ACE implementation strategy (intervention). The tested strategy comprised personnel training (e.g., trauma-informed care), integrated technology, team-based screening workflows, and ongoing care team implementation support. Additional clinics (n = 2) implemented ACEs screenings as usual without the strategy and served as additional comparison sites for exploratory analyses. Log-binomial and robust Poisson regression models examined differences in screening reach and referrals and were adjusted for site and patient race. Screening reach rates increased in the intervention period, from 0.0 https://clinicaltrials.gov/study/NCT04916587

Introduction:Demonstrating the relevance and impact of translational research across diverse settings is crucial making the research-to-practice pipeline more efficient. The Translational Science Benefits Model (TSBM) is a framework used to report societal and health impacts of clinical and translational research. Methods:A four-phase process was used to co-develop 12 TSBM Impact Profiles aimed at evaluating the impact of clinical and translational research and disseminating this information among diverse audiences. Content analysis was used to understand common and unique themes related to the TSBM domains and benefits across 12 projects. Results:Across the 12 TSBM Impact Profiles, TSBM benefits covered all four TSBM domains (Clinical, Community, Economic, and Policy), with a notable focus on Clinical and Community-related benefits. TSBM Impact Profiles took an average of 9 h to complete, with each phase taking 1-3 h to complete. Common themes included Clinical Innovation and Care Integration, Advancing Health Equity and Accessibility, Community and Stakeholder Engagement, and Policy and Systems-Level Change. Three case exemplars that contextualize findings from the content analysis are presented. Conclusion:This work validates and extends the processes originally developed by the creators of the TSBM and offers a process-oriented example of its successful application at an external institution & CTSA hub. Co-creating TSBM Impact Profiles and documenting their development ensured that information was synthesized for broad dissemination and accessibility. Results highlight an effective process for capturing a multitude of impacts and benefits across diverse research projects with future efforts aimed at expanding the application of this method.

BACKGROUND:American Indian and Alaska Native (AI/AN) communities' resiliency perseveres despite the disproportionate impact of the opioid crisis. Medication-assisted treatment (MAT) combines traditional psychosocial therapy with pharmacotherapies and has emerged as the standard of care for individuals with alcohol and opioid misuse. Combining traditional healing, evidence-based practices, and medications for the treatment of substance misuse to create a form of MAT that is culturally appropriate for AI/AN communities has proven challenging. This study explores how AI/AN culture and community perceptions impact the acceptability and feasibly of MAT and insights into what intervention components would support its provision. METHODS:Two health and human service care systems serving primarily AI/AN populations participated in the study. An Advisory Board consisting of clinical providers, program administrators, evaluation specialists, tribal members, and researchers led this project following community-based participatory research principles. Qualitative data was obtained over two waves of data collection, the first wave focusing on describing the cultural, community, systems, and clinical contexts for MAT implementation. The second wave gathered feedback on the feasibility and acceptability of intervention components developed from findings from the first wave. Participants in focus groups and key informant interviews (N = 41 with 29 participating in both waves of data collection) were at least 18 years of age and involved in substance misuse treatment services. Analysis involved extracting themes following principles of grounded theory to identify perspectives within and across each participating community. RESULTS:In the first wave of data collection, major themes included regulatory issues, procedural issues, clinical issues and the availability of consultation to therapists and counselors regarding MAT. In the second wave of data collection, participants reported that tribal, state, and federal resources for prescribing providers in response to the opioid crisis were robust and the gap was in supporting patients, their families, and therapists. CONCLUSIONS:These results supported the Advisory Board in identifying the following intervention components to improve access to MAT: 1) the provision of patient and family educational materials and 2) education and clinical consultation opportunities for therapists and counselors to support them in discussing MAT as a treatment option for their patients.

Incorporating research evidence within child welfare systems can improve services and health equity for vulnerable youth. Bidirectional collaboration between researchers and system-level actors may foster evidence-informed policies and programs through cultural exchange. This anthropological analysis of longitudinal qualitative data from the Community-Academic Partnership for Translational Use of Research Evidence (CAPTURE) illuminates the complexities of cultural exchange involving a child welfare system, including capacity for research use, trust, communication, and power dynamics. Successful cultural exchange for catalyzing the use of research evidence requires a multilevel approach attentive to power structures, institutions, and community perspectives. Anthropology must play a central role in critiquing power within partnerships while exploring pragmatic and ethical ways to collaborate with influential entities to implement data-driven policies and programs to enhance health equity.