Regulatory Issues in Electronic Health Records for Adolescent HIV Research: Strategies and Lessons Learned.

BACKGROUND: Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance. OBJECTIVE: As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines. METHODS: Eight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements. RESULTS: Due to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites. CONCLUSIONS: The process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.

Building an HIV Learning Health Care Community for Youth in Florida: Opportunities and Challenges.

In Florida, 33% of new HIV infections among men and 21% of new infections among women are among those younger than 29 years of age. We describe the development of a Learning Health Care Community for youth (Y-LHCC) in Orange County, FL. Its core implementation team (iTeam) was composed of representatives from community agencies and academics, whose work was informed by data from the Florida Department of Health (FDOH) and regional research, in-depth interviews (IDIs) with agency representatives, and a pilot implementation of Tailored Motivational Interviewing (TMI) to improve service provision. IDIs revealed limited programming specifically for youth, significant structural challenges providing them with PrEP, and differences in use of evidence-based behavioral interventions to improve HIV services. FDOH provided data on new HIV infections, linkage to care, viral suppression, and PrEP coverage, however, limitations such as minimal data on PrEP referrals and use, agency level data, and inability to generate data quarterly (which would facilitate program improvement) were encountered. Thirty staff members from five agencies serving youth in Orange County participated in TMI training. About half the agency staff (n = 16) completed at least three of the four online training sessions. MI skills improved from pre- (n = 28; M = 1.96) to post TMI training (n = 11; M = 2.48, SD = 0.57); (t(37) = - 3.14, p = 0.0033). The iTeam held seven remote meetings and two in-person half-day meetings at the end of the study, during which they reassessed areas of focus for improving youth services. They also reiterated their commitment to continuing to meet beyond the study period and to engage other agencies in the newly established coalition. Findings highlight the potential of creating a Y-LHCC in Florida as well as some of the challenges that will need to be overcome to achieve ending the HIV Epidemic goals for young people in the region.

RESUMEN: En Florida, el 33% y 21% de las nuevas infecciones del VIH entre hombres y mujeres, respectivamente, fueron entre personas menores de 29 años de edad. Describimos el desarrollo de una Comunidad de Aprendizaje de Atención Médica para jóvenes (Y-LHCC) en el Condado de Orange, FL. Su equipo central de implementación (iTeam) estuvo compuesto de representantes de agencias comunitarias y académicos, cuyo trabajo se basó en datos del Departamento de Salud de Florida (FDOH) e investigaciones regionales, entrevistas en profundidad con representantes de agencias y un programa piloto de implementación de la Entrevista Motivacional a la Medida (TMI) para mejorar la prestación de servicios. Las entrevistas revelaron poca programación específica para los jóvenes, desafíos estructurales significativos para proporcionarles PrEP, y diferencias en el uso de intervenciones conductuales basadas en evidencia para mejorar los servicios de VIH. El FDOH proporcionó datos sobre nuevas infecciones por el VIH, vinculación con la atención médica, supresión viral y cobertura de PrEP. Sin embargo, se encontraron limitaciones en la data, tales como datos limitados sobre derivaciones u uso de PrEP, falta de datos a nivel de agencia, e incapacidad para generar datos trimestrales (lo que facilitaría la mejora de programas en la agencia). Treinta miembros del personal de cinco agencias que atienden a jóvenes en el Condado de Orange participaron en la capacitación de TMI. Aproximadamente la mitad del personal de la agencia (n = 16) completó al menos tres de las cuatro sesiones de capacitación remota. Las habilidades de MI mejoraron desde antes (n = 28; M = 1.96, SD = .042) hasta después del entrenamiento de TMI (n = 11; M = 2.48, SD = 0.57); (t(37) = − 3.14, p = 0.0033). El iTeam realizó siete reuniones remotas y dos reuniones en persona de medio día al final del estudio, durante las cuales reevaluaron las áreas de enfoque para mejorar los servicios para jóvenes. También reiteraron su compromiso de continuar reuniéndose más allá del período de estudio y de involucrar a otras agencias en la coalición recién establecida. Los hallazgos destacan el potencial de crear un Y-LHCC en Florida, así como algunos de los desafíos que deberán superarse para lograr los objetivos de terminar con la epidemia de VIH para los jóvenes de la región.

Influence of provider openness and leadership behaviors on adherence to motivational interviewing training implementation strategies: Considerations for evidence-based practice delivery.

Background: Adherence to intervention training implementation strategies is at the foundation of fidelity; however, few studies have linked training adherence to trainee attitudes and leadership behaviors to identify what practically matters for the adoption and dissemination of evidence-based practices. Through the conduct of this hybrid type 3 effectiveness-implementation cluster randomized controlled trial, we collected Exploration, Preparation, Implementation, and Sustainment (EPIS) data and merged it with tailored motivational interviewing training adherence data, to elucidate the relationship between provider attitudes toward evidence-based practices, leadership behaviors, and training implementation strategy (e.g., workshop attendance and participation in one-on-one coaching) adherence. Method: Our sample included data from providers who completed baseline (pre-intervention) surveys that captured inner and outer contexts affecting implementation and participated in tailored motivational interviewing training, producing a dataset that included training implementation strategies adherence and barriers and facilitators to implementation (N = 77). Leadership was assessed by two scales: the director leadership scale and implementation leadership scale. Attitudes were measured with the evidence-based practice attitude scale (EBPAS-50). Adherence to training implementation strategies was modeled as a continuous outcome with a Gaussian distribution. Analyses were conducted in SPSS. Results: Of the nine general attitudes toward evidence-based practice, openness was associated with training adherence (estimate [EST] = 0.096, p < .001; 95% CI = [0.040, 0.151]). Provider general (EST = 0.054, 95% CI = [0.007, 0.102]) and motivational interviewing-specific (EST = 0.044, 95% CI = [0.002, 0.086]) leadership behaviors were positively associated with training adherence (p < .05). Of the four motivational interviewing-specific leadership domains, knowledge and perseverant were associated with training adherence (p < .05). As these leadership behaviors increased, knowledge (EST = 0.042, 95% CI = [0.001, 0.083]) and perseverant (EST = 0.039, 95% CI = [0.004, 0.075]), so did provider adherence to training implementation strategies. Conclusions: As implementation science places more emphasis on assessing readiness prior to delivering evidence-based practices by evaluating organizational climate, funding streams, and change culture, consideration should also be given to metrics of leadership. A potential mechanism to overcome resistance is via the implementation of training strategies focused on addressing leadership prior to conducting training for the evidence-based practice of interest.

Researchers and practitioners, who aim to improve the uptake of evidence-based practices, continue to seek ways in which to improve provider participation in training implementation strategies. The persistent challenge in addressing provider disengagement, while linking this disinterest to poor patient outcomes, has been ascertaining how to quantify relevant delivery considerations, for example, provider attitudes and leadership behaviors that may influence commitment to learning or apathy to behavior change, concurrently with training adherence. Through the conduct of this study, we collected both types of data: (1) provider attitudes and leadership behaviors and (2) training adherence outcomes. We found that provider openness, general leadership behaviors, and motivational interviewing-specific leadership behaviors were associated with adherence to training implementation strategies. As more emphasis is placed on assessing clinic readiness prior to adopting new evidence-based practices, a discussion on including metrics of provider attitudes to evidence-based practice, innovation, and the specific intervention is warranted, alongside consideration for how implementation training strategies focused on addressing leadership can bolster change-supportive behaviors prior to delivery of innovations.

Adapting the self-assessment of contextual fit scale for implementation of evidence-based practices in adolescent HIV settings.

BACKGROUND: Contextual fit is an important variable in the implementation of evidence-based programs (EBPs). The objectives of the current study were to examine the psychometric properties of the adapted Self-Assessment of Contextual Fit (SACF) measure for HIV clinical care settings (calling it SACF-HIV) and explore how perceptions of contextual fit varied across two different interventions (an intervention to scale up tailored motivational interviewing and an individually focused HIV prevention intervention) and 12 clinical sites. METHODS: We collected SACF-HIV data as part of a larger cross-project implementation science study (ATN 153). The study sample includes 128 clinicians, community health workers, interventionists, adherence counselors, and other members of the prevention and care team who engage in the implementation of EBPs at 12 HIV prevention and clinical care sites in the USA. We assessed the internal consistency of the SACF-HIV using Cronbach's alpha and examined the sub-dimensionality of the scale with an exploratory factor analysis. To explore concurrent validity, we examined Pearson's correlation coefficients between the adapted scale and fit-related sub-scale scores from the Evidence-Based Practice Attitudes Scale-50 (EBPAS-50). Variation in perceptions of fit by intervention was examined using descriptive statistics. RESULTS: Internal consistency of the adapted scale was strong (α=0.895). Factor analyses revealed two sub-scales-one capturing general insights regarding contextual fit, such as perceptions of skill, experience, and alignment with client needs (loadings ranging from .5 to .84), and a second centering perceptions regarding implementation support, such as resources and administrative support (loadings ranging from .89 to .97). Concurrent validity was supported by statistically significant correlations in the expected direction with EBPAS-50 fit-related sub-scales (r=.33-.35, p ≤ 0.05). SACF-HIV mean fit scores varied by intervention and the difference was statistically significant (2.78 vs. 2.53, p < 0.05). CONCLUSIONS: There are relatively few tools assessing perceptions of contextual fit in HIV clinical settings. These results suggest the 12-item adapted SACF is a reliable, valid global assessment of perceptions of contextual fit and implementation support. The SACF-HIV can be used by practitioners and researchers interested in understanding an implementation context when planning to prepare and support EBP implementation. TRIAL REGISTRATION: TMI ClinicalTrials.gov NCT03681912; YMPH ClinicalTrials.gov NCT03488914.