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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

The Positive Choices trial: update to study protocol for a phase-III RCT trial of a whole-school social-marketing intervention to promote sexual health and reduce health inequalities.

BACKGROUND: Positive Choices is a whole-school social-marketing intervention to promote sexual health among secondary school students. Intervention comprises the following: school health promotion council involving staff and students coordinating delivery, student survey to inform local tailoring, teacher-delivered classroom curriculum, student-run campaigns, parent information and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot-RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by 'whole-school' (e.g. student campaigns, sexual health services) and 'social marketing' (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK. METHODS: We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022, implement the intervention over the 2022-2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025 and engage in knowledge exchange from December 2024. DISCUSSION: This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices. TRIAL REGISTRATION: ISRCTN No: ISRCTN16723909 . Registered on 3 September 2021.

The Positive Choices trial: study protocol for a Phase-III RCT trial of a whole-school social marketing intervention to promote sexual health and reduce health inequalities.

BACKGROUND: Positive Choices is a whole-school social marketing intervention to promote sexual health among secondary school students. Intervention comprises school health promotion council involving staff and students coordinating delivery; student survey to inform local tailoring; teacher-delivered classroom curriculum; student-run campaigns; parent information; and review of sexual/reproductive health services to inform improvements. This trial builds on an optimisation/pilot RCT study which met progression criteria, plus findings from another pilot RCT of the Project Respect school-based intervention to prevent dating and relationship violence which concluded such work should be integrated within Positive Choices. Young people carry a disproportionate burden of adverse sexual health; most do not report competence at first sex. Relationships and sex education in schools can contribute to promoting sexual health but effects are small, inconsistent and not sustained. Such work needs to be supplemented by 'whole-school' (e.g. student campaigns, sexual health services) and 'social marketing' (harnessing commercial marketing to social ends) approaches for which there is good review-level evidence but not from the UK. METHODS: We will conduct a cluster RCT across 50 schools (minimum 6440, maximum 8500 students) allocated 1:1 to intervention/control assessing outcomes at 33 months. Our primary outcome is non-competent first sex. Secondary outcomes are non-competent last sex, age at sexual debut, non-use of contraception at first and last sex among those reporting heterosexual intercourse, number of sexual partners, dating and relationship violence, sexually transmitted infections, and pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys. We will recruit 50 school and undertake baseline surveys by March 2022; implement the intervention over the 2022-2024 school years and conduct the economic and process evaluations by July 2024; undertake follow-up surveys by December 2024; complete analyses, all patient and policy involvement and draft the study report by March 2025; and engage in knowledge exchange from December 2024. DISCUSSION: This trial is one of a growing number focused on whole-school approaches to public health in schools. The key scientific output will be evidence about the effectiveness, costs and potential scalability and transferability of Positive Choices. TRIAL REGISTRATION: ISRCTN No: ISRCTN16723909 . Trial registration summary: Date:. Funded by: National Institute for Health Research Public Health Research Programme (NIHR131487). SPONSOR: LSHTM. Public/scientific contact: Chris Bonell. Public title: Positive Choices trial. Scientific title: Phase-III RCT of Positive Choices: a whole-school social marketing intervention to promote sexual health and reduce health inequalities. Countries of recruitment: UK. INTERVENTION: Positive Choices. INCLUSION CRITERIA: Students in year 8 (age 12-13 years) at baseline deemed competent by schools to participate in secondary schools excluding pupil referral units, schools for those with special educational needs and disabilities, and schools with 'inadequate' Ofsted inspections. STUDY TYPE: interventional study with superiority phase III cluster RCT design. Enrollment: 1/9/21-31/3/22. SAMPLE SIZE: 50 schools and 6440-8500 students. Recruitment status: pending. PRIMARY OUTCOME: binary measure of non-competent first sex. SECONDARY OUTCOMES: non-competent last sex; age at sexual debut; non-use of contraception at first and last sex; number of sexual partners; dating and relationship violence (DRV) victimisation; sexually transmitted infections; pregnancy and unintended pregnancy for girls and initiation of pregnancy for boys using adapted versions of the RIPPLE measures. Ethics review: LSHTM research ethics committee (reference 26411). Completion data: 1/3/25. Sharing statement: Data will be made available after the main trial analyses have been completed on reasonable request from researchers with ethics approval and a clear protocol. Amendments to the protocol will be communicated to the investigators, sponsor, funder, research ethics committee, trial registration and the journal publishing the protocol. Amendments affecting participants' experience of the intervention or important amendments affecting the overall design and conduct of the trial will be communicated to participants.

Implementation of Evidence-Based Practices to Reduce Youth HIV Transmission and Improve Self-Management: A Survey of Key Stakeholder Perspectives.

Understanding the implementation process is critical to disseminating effective interventions that reduce HIV risk and improve self-management in youth populations. As part of a multi-center implementation study, providers (N = 128) from 13 HIV prevention and care sites were surveyed to capture their perspectives on evidence-based practices (EBPs) and their discharge. We employ a descriptive analysis of their perspectives before implementation as defined by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model, with comparisons between organizational role and study site. Factors of interest included the following: attitudes toward EBPs, perceptions of organizational climate, perceptions of leadership behavior, implementation climate, and provider views on organizational support. These factors were assessed using scales with 5-point Likert response options. Attitudinal domains such as Appeal (α = 3.24), Fit (α = 3.31), and Requirements (α = 3.20), were positive. Similarly, providers on average perceived organizational support efforts meant to facilitate EBP implementation (α = 2.74). Our findings point to provider attitudes, perceptions of work climate, general organizational support, and leadership as impacting adoption and sustainment of EBPs. Secondary analysis indicates that some perceptions and attitudes differ by site and by professional role in some assessment domains. Our study highlights factors such as provider attitudes and perspectives on the organizational and implementation climates and on leadership behaviors as impacting EPB implementation.

Promoting Adolescent Healthy Relationships (The About Us Program): Protocol for a Randomized Clinical Trial.

BACKGROUND: Romantic relationships play a critical role in adolescent development, and by middle adolescence, most young people have been involved in at least one romantic relationship, a context in which most sexual interactions occur. Research suggests adolescents lack positive models and skills related to building healthy relationships. OBJECTIVE: This project aims to test the impact of an innovative healthy relationships intervention, called About Us, implemented in school-based health centers (SBHCs) in California in a randomized controlled trial. METHODS: About Us is being tested using a 7-site, 2-group, parallel randomized controlled trial with a treatment versus control allocation ratio of 3:2 to assess the impact of the intervention relative to the standard of care among adolescents aged 14 to 18 years. Adolescents with active parental consent provide study assent at each of the 3 survey time points: baseline, 3 months postintervention, and 9 months postintervention. A stratified randomization procedure was used to ensure balance in key covariates and screening criteria across intervention groups. Through benchmark intent-to-treat analyses, we will examine the primary outcome of this study-the impact of About Us relative to the standard of care 9 months following the end of the intervention on the prevalence of vaginal or anal sex without condoms in the past 3 months. The secondary outcomes are four-fold: what is the impact of About Us relative to the standard of care 3 and 9 months following the end of the intervention, on (1) the prevalence of abstinence from vaginal or anal sex in the past 3 months, (2) composite scores of relationship communication and positive conflict resolution among participants involved in a relationship at baseline, (3) the prevalence of SBHC service use or information receipt in the past 3 months, and (4) composite scores of condom use intentions and attitudes regarding condoms and other birth control? Additionally, as part of our sensitivity analyses, two additional analyses will be implemented: modified intent-to-treat and complete case analysis. RESULTS: This project (ClinicalTrials.gov #NCT03736876) was funded in 2016 through the Family Youth Services Bureau as part of the Personal Responsibility Education Innovative Strategies program. Baseline data collection took place between February 2018 and March 2020, yielding a total of 5 cohorts and 533 study participants: 316 assigned to treatment and 217 assigned to control. Ongoing follow-up data collection continued through May 2021. CONCLUSIONS: About Us draws on developmental science to create a contextually and developmentally relevant program that addresses motivation and emotional influences in sexual decision-making. The intervention was designed for implementation within SBHCs, an understudied venue for relationship and sexual health promotion interventions. Unfortunately, COVID-19 pandemic restrictions led to school closures, interrupting ongoing programming, and in-person follow-up data collection, which has affected study attrition. TRIAL REGISTRATION: ClinicalTrials.gov NCT03736876; https://clinicaltrials.gov/ct2/show/NCT03736876. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30499.

A Group Randomized Trial Evaluating High School FLASH, a Comprehensive Sexual Health Curriculum.

PURPOSE: To evaluate the effectiveness of a school-based comprehensive sexual health curriculum (FLASH) on high-school students' sexual behavior and related outcomes. METHODS: A cohort of 1,597 9th and 10th grade students representing 20 schools from two regions in the U.S. (Midwest and South) were enrolled and completed the baseline survey. Following baseline, the 20 schools were randomly assigned to receive FLASH (n = 10 schools, five per region) or a knowledge-based sexual health curriculum (n = 10 schools, five per region). Follow-up surveys were administered at 3 months and 12 months after the instruction period. RESULTS: There were no statistically significant differences between conditions for the overall sample on rates of vaginal sex in the past 3 months or the rates of vaginal sex without a condom or other birth control. In supplementary subgroup analyses of students who were not sexually experienced at baseline, FLASH showed a statistically significant protective impact at the 3-month follow-up on vaginal sex without a condom or birth control (p = .04). FLASH also showed statistically significant gains in psychosocial outcomes, such as refusal and condom use self-efficacy, attitudes toward birth control and condoms, and perceived norms. CONCLUSIONS: FLASH demonstrated consistent short-term and long-term impacts on key behavioral determinants. It also showed a significant impact on vaginal sex without a condom or other birth control for the subgroup of students who were not sexually experienced at baseline. Behavioral impacts were not evident for the entire study population.

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.

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.

Socio-Ecological Factors Associated With Students' Perceived Impact of an Evidence-Based Sexual Health Education Curriculum.

BACKGROUND: Although schools often implement evidence-based sexual health education programs to address sexual and reproductive health disparities, multiple factors may influence program effectiveness. METHODS: Using student-reported perceived impact measures as a proxy for program effectiveness, we employed a socio-ecological approach to examine student, teacher, school, and district factors associated with greater perceived impact of It's Your Game (IYG), an evidence-based middle school sexual health education program. The student sample was 58.7% female, 51.8% Hispanic, mean age 13.2 years, from 73 middle schools. We assessed students' (N = 4531) perceived impact of IYG on healthy decision-making (α = 0.75) and sexual communication (α = 0.71); satisfaction with IYG activities and teacher; and demographics. We assessed teachers' (N = 56) self-efficacy to teach IYG, perceived administrative support, implementation barriers, and demographics. School and district data were abstracted from state records. We used multilevel logistic regression to estimate associations between independent variables and student-reported perceived impact. RESULTS: In final multivariate models, students' demographics (sex, ß = 0.06, SE = 0.015), satisfaction with IYG (ß = 0.21, SE = 0.012), and their IYG teacher (ß = 0.18, SE = 0.013) (all p = .000) were significantly associated with perceived impact on healthy decision-making. Similar findings resulted for sexual communication. No other variables were significantly associated with perceived impact. CONCLUSIONS: Helping schools select age-appropriate, culturally relevant programs, and facilitate supportive learning environments may enhance the perceived impact of sexual health education programs.