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.

Inconsistencies in Adolescent Self-Reported Sexual Behavior: Experience from Four Randomized Controlled Trials.

To examine the degree, correlates, and implications of inconsistent self-report data on sexual risk behaviors of adolescents. We analyzed data from four longitudinal group-randomized controlled trials of evidence-based HIV/STI/pregnancy prevention programs in Texas and California from 2000 to 2010. Across- and within-time logical inconsistencies in sexual behavior survey responses were analyzed using multilevel logistic regression. Rates of any inconsistencies ranged from 12 to 18% across the four trials. In all trials, rates were higher in males than in females. Age, normative beliefs, and race/ethnicity were most strongly associated with inconsistencies. We found substantial rates of inconsistencies in adolescents' self-reports of their sexual behavior, which did not occur at random. Studies should routinely report observed rates of inconsistencies and methods used to adjust for them so that any biases in the population to which the study generalizes are understood by public health practitioners and policy-makers looking to adopt programs for their particular population.

High School FLASH Sexual Health Education Curriculum: LGBTQ Inclusivity Strategies Reduce Homophobia and Transphobia.

Homophobic and transphobic beliefs that lead to bias-based harassment remain a critical concern for young people in the USA. The aim of the present study was to examine the impact of an inclusive comprehensive sex education program (High School FLASH) on homophobic and transphobic beliefs. Data from this study come from a randomized controlled trial that evaluated the impact of High School FLASH on students' sexual behaviors and related outcomes with 20 schools in two U.S. regions (Midwest and South). Following the baseline survey, the 20 schools were randomly assigned to receive FLASH or a comparison curriculum. Ninth and 10th grade students completed follow-up surveys 3 and 12 months after the instructional period. We examined changes in homophobic beliefs using multilevel linear regression models in the full sample and two sub-groups: straight cisgender young people versus those who identified as not straight or cisgender. Mean scores on the homophobic and transphobic beliefs scale were statistically significantly lower among young people receiving FLASH relative to the comparison at both the 3- and 12-month timepoints (p-values for adjusted mean differences were < 0.01, n = 1357 and 1275, respectively). Specifically, FLASH's positive impact on reducing homophobic and transphobic beliefs was statistically significant for straight and cisgender youth at both survey follow-ups (p < 0.01, n = 1144 and p = 0.05, n = 1078, respectively); the effects for the LGBTQ sub-group reached statistical significance at only the final follow-up (p = 0.01, n = 197). Our results show that carefully designed, inclusive comprehensive sexual health education programs like High School FLASH can play a role in promoting better school climates for all youth by reducing beliefs that may lead to bullying, violence, and victimization.

Who Benefits from School-Based Teen Pregnancy Prevention Programs? Examining Multidimensional Moderators of Program Effectiveness Across Four Studies.

Recent research has suggested the importance of understanding for whom programs are most effective (Supplee et al., 2013) and that multidimensional profiles of risk and protective factors may moderate the effectiveness of programs (Lanza & Rhoades, 2012). For school-based prevention programs, moderators of program effectiveness may occur at both the individual and school levels. However, due to the relatively small number of schools in most individual trials, integrative data analysis across multiple studies may be necessary to fully understand the multidimensional individual and school factors that may influence program effectiveness. In this study, we applied multilevel latent class analysis to integrated data across four studies of a middle school pregnancy prevention program to examine moderators of program effectiveness on initiation of vaginal sex. Findings suggest that the program may be particularly effective for schools with USA-born students who speak another language at home. In addition, findings suggest potential positive outcomes of the program for individuals who are lower risk and engaging in normative dating or individuals with family risk. Findings suggest potential mechanisms by which teen pregnancy prevention programs may be effective.

Using the Exploration-Preparation-Implementation-Sustainment (EPIS) Framework to prepare for the implementation of evidence-based practices into adolescent HIV settings.

Despite advances in evidence-based practices (EBP) to support HIV prevention and treatment, youth ages 13-24 experience significant disparities in HIV risk and outcomes. An important factor in this disparity is poor EBP implementation, yet implementation research is limited, particularly in youth-serving settings. This study used the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to guide the implementation of four Motivational Interviewing (MI) and MI-framed interventions into youth-serving HIV prevention and treatment settings. Key stakeholders (n = 153) across 13 sites completed pre-implementation interviews. Stakeholders' comments identified two critical factors for effective implementation: fit with the patient population and provider receptivity, including concerns about scope of practice, buy-in, and time. Stakeholders recommended strategies for structuring training, fidelity monitoring, and facilitating implementation including engaging informal leaders, collaboratively developing the implementation strategy, and site-wide implementation. Results highlight the importance of pre-implementation contextual assessment and strategic planning for identifying provider concerns and developing responsive implementation strategies.

RESUMEN: A pesar de los avances en las prácticas basadas en evidencia (EBP, por sus siglas en inglés) para apoyar la prevención y el tratamiento del VIH, los jóvenes de 13 a 24 años atraviesan disparidades significativas en el riesgo y los desenlaces del VIH. Un factor importante en esta disparidad es la implementación deficiente de las EBP, aunque la investigación sobre la implementación es limitada, particularmente en entornos que atienden a jóvenes. Este estudio utilizó el marco de Exploración, Preparación, Implementación, Mantenimiento (EPIS) para guiar la implementación de cuatro entrevistas motivacionales (MI) e intervenciones enmarcadas en MI en entornos de prevención y tratamiento del VIH que atienden a jóvenes. Las partes interesadas clave (n = 153) en 13 sitios completaron las entrevistas previas a la implementación. Los comentarios de las partes interesadas identificaron dos factores críticos para una implementación efectiva: idoneidad para la población de pacientes y receptividad de los proveedores, incluidas las preocupaciones sobre el alcance de la práctica, la aceptación y el tiempo. Las partes interesadas recomendaron estrategias para estructurar la capacitación, monitorear la fidelidad, y facilitar la implementación, incluyendo la participación de líderes informales, el desarrollo colaborativo de la estrategia de implementación y la implementación en todo el sitio. Los resultados destacan la importancia de la evaluación contextual previa a la implementación y la planificación estratégica para identificar las preocupaciones de los proveedores y desarrollar estrategias de implementación que respondan a ellas.

The Health Equity Framework: A Science- and Justice-Based Model for Public Health Researchers and Practitioners.

In this article, we describe a science- and justice-based framework for promoting health equity designed for researchers and practitioners working across public health and social science fields. We developed the health equity framework (HEF; etr.org/healthequityframework) in two phases of iterative development. Building on existing models, the HEF illustrates how health outcomes are influenced by complex interactions between people and their environments. The framework centers on three foundational concepts: equity at the core of health outcomes; multiple, interacting spheres of influence; and a historical and life-course perspective. Health equity is defined as having the personal agency and fair access to resources and opportunities needed to achieve the best possible physical, emotional, and social well-being. By centering population outcomes, the HEF encourages researchers and practitioners to think beyond traditional approaches that focus on individual behaviors and choices to assess and identify their gaps in acknowledging and addressing factors from multiple spheres of influence. We identified four, interacting spheres of influence that represent both categories of risk and protective factors for health outcomes as well as opportunities for strategies and interventions that address those factors. The HEF highlights the explicit and implicit interactions of multilevel influences on health outcomes and emphasizes that health inequities are the result of cumulative experiences across the life span and generations. The HEF is a practical tool for leaders and professionals in public health research and practice to reflect on and support a shift toward addressing health inequities resulting from the interplay of structural, relational, individual, and physiological factors.

Condom Use and Error Experience Among Young Adolescents: Implications for Classroom Instruction.

We examine condom failure and use error experienced by high school youth in two regions of the United States. Data are from a baseline survey of a randomized controlled trial to evaluate FLASH, a sexual health education curriculum for high school students. Participants were 1,597 ninth- or 10th-grade students in health class who had parental consent and who assented to participate in the study. This study examines condom use behavior among students who reported vaginal or anal sex at baseline. Of the 222 participants who reported having vaginal or anal sex in the 3 months prior to baseline survey, 180 of them reported using a condom at least once. Of these youth, 70.6% reported that they did not squeeze the tip of the condom before sex, 25.0% of youth reported that they did not roll the condom all the way down to the base of the penis, and 49.4% reported that they did not hold the base of the penis when pulling out; 36.9% reported experiencing condom breakage or slippage. The frequency of condom error and/or failure reported by young adolescents in this study indicates a need for further education on potential condom use errors with an emphasis on the correct steps for using a condom to prevent condom failure. High rates of error and failure suggest an opportunity for educators to tailor preexisting condom use interventions to further reinforce the skills necessary for effective condom use and to educate on what to do in the event of condom failure.

Developing a Video Intervention to Prevent Unplanned Pregnancies and Sexually Transmitted Infections Among Older Adolescents.

Older adolescent African American and Latina females have disproportionately high rates of unintended pregnancies and sexually transmitted infections (STIs). This article describes the development of a new video intervention for this population, modeled on Safe in the City (SITC), an evidence-based STI prevention video. Plan A was created from 2015 to 2016, using a systematic process similar to SITC. This included forming a project team with reproductive health experts, hiring a video production company and screenwriter, conducting a clinic staff survey (n = 8), and soliciting priority population input using three focus groups (n = 41) followed by a review panel (n = 9). The expert input, clinic staff survey, focus groups, and review panel informed the content and format of Plan A. The 23-minute video includes three interconnected stories with relatable characters and two animated sequences. Topics covered include condoms, long-acting reversible contraception, emergency contraception, STI prevention and testing, and patient-provider communication. SITC provided a model to create a new entertainment-education intervention for a different audience and to address pregnancy prevention as well as STIs. Sustained priority population involvement, input from stakeholders, and a highly iterative process were vital to developing Plan A, which is currently being evaluated in a randomized controlled trial.

You-Me-Us: Results of a Cluster Randomized Trial of a Healthy Relationships Approach to Sexual Risk Reduction.

By middle adolescence, most young people have been involved in at least one romantic relationship, a context in which many sexual interactions occur. Indeed, researchers have suggested the importance of attending to relationships in programs focused on sexual risk, yet few evidence-based programs have a strong relationships focus. Our study examined the impact of a healthy relationship program called You-Me-Us that included a classroom curriculum and a school-wide peer norms approach. We evaluated the intervention using a small group randomized trial that included nine participating urban middle schools (defined as schools that include grades 6-8) in three urban school districts. We invited all 7th grade students within the study schools to enroll. Students completed three surveys during 7th and 8th grades (baseline plus two follow up surveys at 6 and 18 months following baseline). A total of 911 youth with positive consent and assent were enrolled in the study. Follow up survey response rates among those taking the baseline were 92% at 6 months and 80% at 18 months. Multilevel regression models were used to adjust for the correlation among students within the same school, and the correlation of repeated measurements taken on the same student over time. The intervention reduced vaginal sexual initiation by about half at the 6-month follow-up, and this approached significance. Further, youth in the intervention condition were less likely to believe it is okay for people their age to have vaginal sex without using condoms if the girl is on birth control. None of the remaining variables differed significantly by intervention condition. This study provides insights on using a healthy relationship approach for younger urban adolescents. This approach produced a programmatically significant reduction in sexual initiation that did not reach standard levels of statistical significance, and warrants further exploration.

Replication of It's Your Game Keep It Real! in Southeast Texas.

Despite the recent efforts of the Office of Adolescent Health to replicate programs with demonstrated efficacy, there are still few evidence-based HIV, sexually transmitted infection (STI), and teen pregnancy prevention programs that have been replicated in "real-world" settings. To test the effectiveness of It's Your Game…Keep It Real! (IYG), an evidence-based STI and pregnancy prevention program for middle schools, the curriculum was implemented by teachers in urban and suburban middle schools in Southeast Texas from 2012 to 2015. IYG was evaluated using a group-randomized wait-list controlled effectiveness trial design in which 20 middle schools in nine urban and suburban school districts in Southeast Texas were randomized equally, using a multi-attribute randomization protocol, to either the intervention condition (received IYG) (n = 10 schools comprising 1936 eligible seventh graders) or the comparison condition (received usual care) (n = 10 schools comprising 1825 eligible seventh graders). All students were blinded to condition prior to administering the baseline survey. The analytic sample comprised 1543 students (n = 804, intervention; n = 739, comparison) who were followed from baseline (seventh grade) to the 24-month follow-up (ninth grade). Multilevel regression analyses were conducted to assess behavioral and psychosocial outcomes at follow-up. There were no significant differences in initiation of vaginal or oral sex between study conditions at follow-up. However, at 12-month follow-up, compared with students in the comparison condition, students in the intervention condition reported increased knowledge, self-efficacy, and perceived favorable norms related to HIV/STIs, condoms, and/or abstinence; decreased intentions to have sex; and increased intentions to use birth control. Knowledge outcomes were statistically significant at 24-month follow-up. This IYG effectiveness trial did not replicate the behavioral effects of the original IYG efficacy trials. However, it adds to the growing literature on the replication of evidence-based programs, and underscores the need to better understand how variations in implementation, setting, and measurement affect the behavioral impact of such programs.Clinical trial registration clinicaltrials.gov (NCT03533192).

It's Your Game Keep It Real in South Carolina: A Group Randomized Trial Evaluating the Replication of an Evidence-Based Adolescent Pregnancy and Sexually Transmitted Infection Prevention Program.

OBJECTIVES: To evaluate the effectiveness of an evidence-based HIV/sexually transmitted infection (STI)/pregnancy prevention program for middle schools implemented by school staff in South Carolina. METHODS: Twenty-four schools, representing 3143 youths, participated in a randomized trial from 2011 to 2014. Students completed surveys before programming (fall of seventh grade), after completing the 2-year It's Your Game…Keep It Real program (spring of eighth grade), and 1-year postprogram (spring of ninth grade). RESULTS: There was no statistically significant effect on initiation of vaginal sex between baseline and eighth grade. Significantly fewer students in the comparison condition reported initiating sex at ninth grade, relative to the intervention condition. No group differences existed on other behavioral outcomes that addressed sexual activity in the past 3 months at ninth grade. Seven of 26 psychosocial outcomes (3 knowledge, 1 attitude, 1 self-efficacy, 2 personal limits) were positively affected at eighth grade; 4 remained significant at ninth grade. CONCLUSIONS: The original studies' behavioral effects were not replicated in this population, possibly as a result of this being an effectiveness trial instead of an efficacy trial, counterfactual exposure design issues, or postprogram exposure to evidence-based programming.

Dual Contraceptive Method Use Among Youth in Alternative Schools.

Dual contraceptive method use, or using a highly effective contraceptive method plus a barrier method like condoms, is gaining attention as a strategy for preventing unplanned pregnancy and sexually transmitted diseases. We investigated rates of dual method use among a sample of youth in urban alternative schools, and explored the relationship between dual method use and sexual partner type. The study analyzed data from 765 students enrolled in 11 district-run continuation high schools in northern California. We explored the association between dual method use and sexual partner type (steady only, a mix of steady and non-steady, and non-steady only) using logistic regression. Differences in dual rates by partner type were statistically significant, with higher rates of dual methods use reported among young people reporting non-steady sexual partners only, as compared to those with steady partners only. The data illustrate that young people in alternative school settings could gain from further intervention on the benefits, skills, and challenges of using two methods of contraception as opposed to one with both steady and non-steady sexual partners.

An exploratory study of adolescent pimping relationships.

In the last decade, public attention to the problem of commercially sexually exploited children (CSEC) has grown. This exploratory qualitative study examines adolescent pimping relationships, including how urban youth perceive these types of relationships. Study data stem from interviews with three young adult informants with first-hand knowledge of adolescent pimping, as well as three gender-specific focus group discussions with a convenience sample of 26 urban high school students who have first- or second-hand knowledge of adolescent pimping. Findings indicate that respondents believe teen pimping exists in their schools and communities, and that those exploited typically do not self-identify as victims. Respondents also believed that younger pimps are more likely to use violence to induce compliance among the girls they exploit, whereas older pimps are more likely to emotionally manipulate young women into exploitation. Further, respondents indicated that some young people agreed to exchange or sell sex for money as a favor to their boyfriends or girlfriends, and some young people believed that selling sex is acceptable under certain circumstances. The growing attention to CSEC provides an important opportunity to expand prevention efforts to reach those most affected and at risk for exploitation. The findings highlight critical areas for augmenting traditional content in school-based HIV/STI and sexuality education classes.

Exploring the Influence of Romantic Relationship Communication on Adolescents' Self-Efficacy to Ask for Sexual Consent.

Adolescence represents a crucial period for sexual and romantic relationship development, and acquisition of skills and confidence essential for effective sexual consent communication. However, various barriers may interfere with adolescents' belief in their ability (i.e., their self-efficacy) to negotiate consent in practice. This study aimed to investigate the state of adolescents' self-efficacy to ask for consent and explore the influence of romantic relationship communication (a construct comprised of three characteristics: relationship assertiveness skills, positive conflict resolution, and communication awkwardness). Participants were 411 adolescents who had current or past relationships (61% girls, 77% Latine, 79% heterosexual). Participants generally reported above-average levels of self-efficacy to ask for consent (M = 4.14 out of 7, SD = 1.24), with LGBQ+ adolescents exhibiting statistically significantly higher levels of self-efficacy compared to heterosexual adolescents (M = 4.51 vs. 4.09, t = -2.66, p = .008). Self-efficacy to ask for consent was positively individually related to positive conflict resolution and relationship assertiveness skills, and negatively related to communication awkwardness (all ps < .001). In a path model, romantic relationship communication displayed a statistically significant association with adolescents' self-efficacy to ask for consent, with high positive conflict resolution, low communication awkwardness, and high relationship assertiveness skills being associated with higher self-efficacy to ask for consent. Findings suggest improving adolescents' romantic communication skills may enhance their self-efficacy to ask for consent, and contribute to increased rates of sexual consent communication. Intervention strategies should target multiple levels of influence to promote positive consent cognitions, behaviors, and cultural norms.

Promoting Healthy Adolescent Romantic Relationships: Results of a Multisite, Two-group Parallel Randomized Clinical Trial.

PURPOSE: To examine the impact of About Us, an innovative healthy relationships intervention that promotes positive adolescent romantic relationships and the use of effective contraceptives, on improving behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution at 3- and 9-month follow-up, compared to services as usual. METHODS: This was a multi-site, two-group, parallel, randomized-controlled trial with an intervention/comparison allocation ratio of 3:2 conducted at seven high schools in California between February 2018 and May 2021. RESULTS: Overall, our study did not find statistically significant evidence of improved behavior, attitudes, and intentions related to sexual intercourse, relationship communication, and conflict resolution among participants (14-18 years old) randomized to the intervention group (n = 316) compared to services as usual (n = 217) during follow-up (group x time; p > .05). Exploratory within group analyses showed that, compared to baseline, at the 3-month follow-up, the prevalence of reporting having had sex increased in the control group relative to intervention group (+19% vs. +9%, p < .01). Our sub-group analyses showed that changes in condom use intentions scores differed across school sites (group x time x school; p < .01); mixed (positive and negative) trends were observed for intervention effect, and schools with positive intervention effect trends tended to have greater program participation. DISCUSSION: About Us did not show statistically significant positive impacts on primary or secondary outcomes as anticipated. Our exploratory findings show evidence of some promising trends of intervention effects at the school-level, suggesting a need for better tailored intervention components and/or delivery to address the unique environmental contexts of participants. Overall, the context of study implementation was negatively affected by the COVID-19 pandemic and challenges related to using a non-classroom delivery intervention approach. Combined, these factors may have contributed to the study null findings. Moreover, it is difficult to know (or determine) the intervention's impact under more ideal conditions (i.e., no COVID pandemic).

Effectiveness, Acceptability, and Feasibility of a Telehealth HIV Pre-Exposure Prophylaxis Care Intervention Among Young Cisgender Men and Transgender Women Who Have Sex With Men: Protocol for a Randomized Controlled Trial.

BACKGROUND: Despite its promise for HIV prevention, the uptake of pre-exposure prophylaxis (PrEP) has been slow, and there have been substantial inequities in PrEP access. Young men who have sex with men and transgender women of color are most in need of PrEP and least likely to have that need fulfilled. PrEP telehealth care, which provides remote PrEP care via electronic communication, seems well suited to address several of the challenges of PrEP provision, including discomfort with stigmatizing and difficult-to-access health care systems, transportation challenges, and privacy concerns, and address disparities in PrEP access. Research suggests that PrEP telehealth care has promise and is a favored option for many prospective recipients of PrEP. However, despite growing attention to telehealth approaches as an avenue for increasing access to PrEP amidst the COVID-19 pandemic, there have been no published randomized controlled trials (RCTs) on PrEP telehealth care to date, making it difficult to draw strong conclusions about the advantages or disadvantages of telehealth compared with usual PrEP care. We developed PrEPTECH, a telehealth intervention that focuses specifically on alleviating issues of stigma, access, cost, and confidentiality for young people with risk factors for HIV infection who are seeking PrEP care. Leveraging data from the 2017 observational pilot study, we redesigned and enhanced PrEPTECH. OBJECTIVE: This study aims to assess the effectiveness, acceptability, and feasibility of a telehealth HIV PrEP care intervention, PrEPTECH, in increasing PrEP uptake. METHODS: This is the protocol for an RCT of young cisgender men and transgender women who have sex with men in 4 regions within the United States: the San Francisco Bay Area, California; Los Angeles County, California; Miami-Dade County, Florida; and Broward County, Florida. Participants in the intervention arm received access to a web-based telehealth program, PrEPTECH, which offers a fully web-based pathway to PrEP, whereas those in the control arm received access to a dynamic web page containing publicly available informational resources about PrEP. Follow-up data collection occurred at 3 and 6 months. An analysis will be conducted on outcomes, including PrEP initiation, persistence, adherence, coverage, and medication prescription, as well as PrEPTECH acceptability and feasibility. RESULTS: The study was funded in 2019 and received institutional review board approval in 2020. The PrEPTECH intervention was developed over the next 1.5 years. Study recruitment was launched in February 2022 and completed in September 2022, with 229 participants recruited in total. Data collection was completed in April 2023. CONCLUSIONS: The results of this RCT will offer valuable evidence regarding the effectiveness, acceptability, and feasibility of telehealth HIV PrEP care interventions among young cisgender men and transgender women who have sex with men. TRIAL REGISTRATION: ClinicalTrials.gov NCT04902820; https://clinicaltrials.gov/ct2/show/NCT04902820. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/47932.

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.

Understanding implementation completion of tailored motivational interviewing in multidisciplinary adolescent HIV clinics.

Background: Understanding the barriers and facilitators of implementation completion is critical to determining why some implementation efforts fail and some succeed. Such studies provide the foundation for developing further strategies to support implementation completion when scaling up evidence-based practices (EBPs) such as Motivational Interviewing. Method: This mixed-methods study utilized the Exploration, Preparation, Implementation, and Sustainment framework in an iterative analytic design to compare adolescent HIV clinics that demonstrated either high or low implementation completion in the context of a hybrid Type III trial of tailored motivational interviewing. Ten clinics were assigned to one of three completion categories (high, medium, and low) based on percentage of staff who adhered to three components of implementation strategies. Comparative analysis of staff qualitative interviews compared and contrasted the three high-completion clinics with the three low-completion clinics. Results: Results suggested several factors that distinguished high-completion clinics compared to low-completion clinics including optimism, problem-solving barriers, leadership, and staff stress and turnover. Conclusions: Implementation strategies targeting these factors can be added to EBP implementation packages to improve implementation success. Plain Language Summary: While studies have begun to address adherence to intervention techniques, this is one of the first studies to address organizational adherence to implementation strategies. Youth HIV providers from different disciplines completed interviews about critical factors in both the inner and outer context that can support or hinder an organization's adherence to implementation strategies. Compared to less adherent clinics, more adherent clinics reported more optimism, problem-solving, and leadership strengths and less staff stress and turnover. Implementation strategies addressing these factors could be added to implementation packages to improve implementation success.

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.

Monitoring unplanned sexual health curricula adaptations: Using results to improve fidelity and support implementation.

Maintaining fidelity to an evidence-based curriculum is important, yet educators may need to adapt to unexpected situations or particular contexts. The purpose of this study is to identify the reasons for unplanned adaptations during implementation of an evidence-based sexual health education program in California. Evaluators reviewed fidelity checklists from the implementation of 571 cohorts for activities with reported unplanned adaptations. Reasons were qualitatively coded and compared across two phases of implementation and by setting. Educators reported 319 unplanned adaptations, affecting 21.5% of the 571 cohorts and 2.9% of 13,782 activities. The most common reasons for unplanned adaptations were due to time management issues, site logistic issues, and to increase participant engagement. Over time, health educators reported fewer unplanned adaptations, particularly those due to time management, resulting in a decrease in the cohorts and activities affected. Adaptations to evidence-based curricula are necessary and often occur during implementation to fit local conditions and populations. Ongoing review of adaptation data provides an opportunity to refine training and technical assistance efforts. Guidance about the types of permitted adaptations and how to anticipate and plan for adaptations for future implementation can ensure fidelity to the core curriculum components and responsiveness to youth participants.