Adolescent Trials Network for HIV-AIDS Scale It Up Program: Protocol for a Rational and Overview

Background: The past 30 years have witnessed such significant progress in the prevention and treatment of HIV/AIDS that an AIDS-free generation and the end to the global AIDS epidemic are ambitious, but achievable, national and global goals. Despite growing optimism, globally, youth living with HIV are markedly less likely to receive antiretroviral therapy than adults (23% vs 38%). Furthermore, marked health disparities exist regarding HIV infection risk, with young men of color who have sex with men disproportionately affected. A large body of research has identified highly impactful facilitators of and barriers to behavior change. Several efficacious interventions have been created that decrease the rate of new HIV infections among youth and reduce morbidity among youth living with HIV. However, full benefits that should be possible based on the tools and interventions currently available are yet to be realized in youth, in large part, because efficacious interventions have not been implemented in real-world settings. Scale It Up (SIU) primarily aims to assemble research teams that will ultimately bring to practice evidence-based interventions that positively impact the youth HIV prevention and care cascades, and in turn, advance the fields of implementation science and self-management science. Objective: This paper aims to describe the structure of the U19-SIU and the effectiveness-implementation hybrid trials, as well as other center-wide protocols and initiatives, implemented within SIU. Methods: SIU will achieve its aims through 4 individual primary protocols, 2 center-wide protocols, and 3 cross-project initiatives. Results: SIU was funded by National Institute for Child Health and Human Development (U19HD089875) and began in October 2016. As of November 2018, 6 SIU protocols have launched at least the first phase of work (ATN 144 SMART: Sequential Multiple Assignment Randomized Trial; ATN 145 YMHP: Young Men’s Health Project; ATN 146 TMI: Tailored Motivational Interviewing Intervention; ATN 153 EPIS: Exploration, Preparation, Implementation, Sustainment model; ATN 154 CM: Cascade Monitoring; ATN 156 We Test: Couples\u27 Communication and HIV Testing). Further details can be found in the individual protocol papers. Conclusions: To date, the youth HIV research portfolio has not adequately advanced the important care area of self-management. SIU protocols and initiatives address this broad issue by focusing on evaluating the effectiveness and implementation of self-management interventions. SIU is highly innovative for 5 primary reasons: (1) our research framework expands the application of “self-management”; (2) the 4 primary protocols utilize innovative hybrid designs; (3) our Analytic Core will conduct cost-effectiveness analyses of each intervention; (4) across all 4 primary protocols, our Implementation Science Core will apply implementation scales designed to assess inner and outer context factors; and (5) we shall advance understanding of the dynamics between provider and patient through analysis of recorded interactions

Recruitment Strategies and the Retention of Obese Urban Racial/Ethnic Minority Adolescents in Clinical Trials: The FIT Families Project, Michigan, 2010–2014

Introduction The successful recruitment and retention of participants is integral to the translation of research findings. We examined the recruitment and retention rates of racial/ethnic minority adolescents at a center involved in the National Institutes of Health Obesity Research for Behavioral Intervention Trials (ORBIT) initiative by the 3 recruitment strategies used: clinic, informatics, and community. Methods During the 9-month study, 186 family dyads, each composed of an obese African American adolescent and a caregiver, enrolled in a 6-month weight-loss intervention, a sequential multiple assignment randomized trial. We compared recruitment and retention rates by recruitment strategy and examined whether recruitment strategy was related to dyad baseline characteristics. Results Of the 186 enrolled families, 110 (59.1%) were recruited through clinics, 53 (28.5%) through informatics, and 23 (12.4%) through community. Of those recruited through community, 40.4% enrolled in the study, compared with 32.7% through clinics and 8.2% through informatics. Active refusal rate was 3%. Of the 1,036 families identified for the study, 402 passively refused to participate: 290 (45.1%) identified through informatics, 17 (29.8%) through community, and 95 (28.3%) through clinics. Recruitment strategy was not related to the age of the adolescent, adolescent comorbidities, body mass index of the adolescent or caregiver, income or education of the caregiver, or retention rates at 3 months, 7 months, or 9 months. Study retention rate was 87.8%. Conclusion Using multiple recruitment strategies is beneficial when working with racial/ethnic minority adolescents, and each strategy can yield good retention. Research affiliated with health care systems would benefit from the continued specification, refinement, and dissemination of these strategies

Implementation Science Research Examining the Integration of Evidence-Based Practices Into HIV Prevention and Clinical Care: Protocol for a Mixed-Methods Study Using the Exploration, Preparation, Implementation, and Sustainment (EPIS) Model

BACKGROUND: The Exploration, Preparation, Implementation, and Sustainment (EPIS) model is an implementation framework for studying the integration of evidence-based practices (EBPs) into real-world settings. The EPIS model conceptualizes implementation as a process starting with the earliest stages of problem recognition (Exploration) through the continued use of an EBP in a given clinical context (Sustainment). This is the first implementation science (IS) study of the integration of EBPs into adolescent HIV prevention and care settings. OBJECTIVE: This protocol (ATN 153 EPIS) is part of the Scale It Up program, a research program administered by the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN), described in this issue by Naar et al. The EPIS study is a descriptive study of the uptake of 4 EBPs within the Scale It Up program. The goal of EPIS is to understand the barriers and facilitators associated with the Preparation, Implementation, and Sustainment of EBPs into HIV prevention and clinical care settings. METHODS: The EPIS study is a convergent parallel mixed-methods IS study. Key implementation stakeholders, that is, clinical care providers and leaders, located within 13 ATN sites across the United States will complete a qualitative interview conducted by telephone and Web-based surveys at 3 key implementation stages. The Preparation assessment occurs before EBP implementation, Implementation occurs immediately after sites finish implementation activities and prepare for sustainment, and Sustainment occurs 1 year postimplementation. Assessments will examine stakeholders\u27 perceptions of the barriers and facilitators to EBP implementation within their clinical site as outlined by the EPIS framework. RESULTS: The EPIS baseline period began in June 2017 and concluded in May 2018; analysis of the baseline data is underway. To date, 153 stakeholders have completed qualitative interviews, and 91.5% (140/153) completed the quantitative survey. CONCLUSIONS: The knowledge gained from the EPIS study will strengthen the implementation and sustainment of EBPs in adolescent prevention and clinical care contexts by offering insights into the barriers and facilitators of successful EBP implementation and sustainment in real-world clinical contexts

Clinic-Based Delivery of the Young Men’s Health Project (YMHP) Targeting HIV Risk Reduction and Substance Use Among Young Men Who Have Sex with Men: Protocol for a Type 2, Hybrid Implementation-Effectiveness Trial

Background: Young men who have sex with men (YMSM) are disproportionately at risk for HIV and sexually transmitted infections. Adapting and testing the effectiveness of the Young Men’s Health Project (YMHP), an efficacious intervention designed to reduce substance use and condomless anal sex (CAS) among YMSM, at clinics in Miami, Detroit, and Philadelphia has the potential to reduce HIV and STI disparities among urban YMSM. Objective: This study (Adolescent Medicine Trials Network for HIV/AIDS Interventions [ATN] 145 YMHP) aims to adapt YMHP for clinic and remote delivery by existing clinic staff and compare their effectiveness in real-world adolescent HIV clinics. This protocol is part of the ATN Scale It Upprogram described in a recently published article by Naar et al. Methods: This is a comparative effectiveness hybrid type-2 trial of the YMHP intervention with 2 delivery formats—clinic-based versus remote delivery—offered following HIV counseling and testing. Phase 1 includes conducting focus groups with youth to obtain implementation feedback about the delivery of the YMHP intervention and intervention components to ensure culturally competent, feasible, and scalable implementation. Phase 2 includes recruitment and enrollment of 270 YMSM, aged 15 to 24 years, 90 at each of the 3 sites. Enrollment will be limited to HIV-negative YMSM who report recent substance use and either CAS or a positive STI test result. Participants will be randomized to receive the YMHP intervention either in person or by remote delivery. Both conditions involve completion of the 4 YMHP sessions and the delivery of pre-exposure prophylaxis information and navigation services. A minimum of 2 community health workers (CHWs) will be trained to deliver the intervention sessions at each site. Sessions will be audio-recorded for Motivational Interviewing Treatment Integrity (MITI) fidelity coding, and CHWs and supervisors will be given implementation support throughout the study period. Results: Phase 1 focus groups were completed in July 2017 (n=25). Feedback from these focus groups at the 3 sites informed adaptations to the YMHP intervention manual, implementation of the intervention, and recruitment plans for phase 2. Baseline enrollment for phase 2 began in November 2018, and assessments will be at immediate posttest (IP)-, 3-, 6-, 9-, and 12-months after the intervention. Upon collection of both baseline and follow-up data, we will compare the effectiveness and cost-effectiveness of clinic-based versus remote delivery of YMHP in the context of health care access. Conclusions: We are conducting YMHP in 3 cities with high rates of YMSM at risk for HIV and STIs. When adapted for real-world clinics, this study will help substance-using YMSM at risk for HIV and STIs and allow us to examine differences in effectiveness and cost by the method of delivery

Opening the Black Box of Family-Based Treatments: an artificial intelligence Framework to Examine therapeutic alliance and therapist Empathy

The evidence-based treatment (EBT) movement has primarily focused on core intervention content or treatment fidelity and has largely ignored practitioner skills to manage interpersonal process issues that emerge during treatment, especially with difficult-to-treat adolescents (delinquent, substance-using, medical non-adherence) and those of color. A chief complaint of real world practitioners about manualized treatments is the lack of correspondence between following a manual and managing microsocial interpersonal processes (e.g. negative affect) that arise in treating real world clients. Although family-based EBTs share core similarities (e.g. focus on family interactions, emphasis on practitioner engagement, family involvement), most of these treatments do not have an evidence base regarding common implementation and treatment process problems that practitioners experience in delivering particular models, especially in mid-treatment when demands on families to change their behavior is greatest in treatment - a lack that characterizes the field as a whole. Failure to effectively address common interpersonal processes with difficult-to-treat families likely undermines treatment fidelity and sustained use of EBTs, treatment outcome, and contributes to treatment dropout and treatment nonadherence. Recent advancements in wearables, sensing technologies, multivariate time-series analyses, and machine learning allow scientists to make significant advancements in the study of psychotherapy processes by looking under the skin of the provider-client interpersonal interactions that define therapeutic alliance, empathy, and empathic accuracy, along with the predictive validity of these therapy processes (therapeutic alliance, therapist empathy) to treatment outcome. Moreover, assessment of these processes can be extended to develop procedures for training providers to manage difficult interpersonal processes while maintaining a physiological profile that is consistent with astute skills in psychotherapeutic processes. This paper argues for opening the black box of therapy to advance the science of evidence-based psychotherapy by examining the clinical interior of evidence-based treatments to develop the next generation of audit- and feedback- (i.e., systemic review of professional performance) supervision systems

Impact of the COVID-19 Pandemic on the Care Continuum of Youth Living with HIV: Qualitative Study of the Scale It Up Program Clinical Sites

The study objective was to explore the impact of COVID-19 pandemic restrictions on the clinics’ ability to provide continuous healthcare services to youth (15–24 years) living with HIV (YLWH). One focused semi-structured interview was conducted with each HIV clinic site—resulting in ten interviews. Data were analyzed using thematic analysis techniques assisted by NVIVO coding software and themes indicating barriers and facilitators to providing uninterrupted healthcare were elicited. Six themes were identified that affected the care continuum of YLWH: Timeframe of clinic preparation to address COVID-19 restrictions; impact on treatment cascade monitoring data; impact on patient care; impact on staff and services offered; software use and virtual visits; community impact. With careful planning and preparation, clinics were able to successfully implement a process of care that adapted to COVID-19 restrictions. Guidance is provided on how healthcare facilities can effectively incorporate strategies to provide continued services during pandemics and natural disasters

Feasibility of Using Electronic Health Records for Cascade Monitoring and Cost Estimates in Implementation Science Studies in the Adolescent Trials Network for HIV/AIDS Interventions

Background:One of the most difficult areas in the fight against HIV/AIDS is reaching out to youth aged 13 to 24 years. The proportion of youth living with HIV/AIDS on antiretroviral therapy (ART) and who are virally undetectable is low, highlighting significant challenges for reaching the Joint United Nations Program on HIV targets. Objective:This study aimed to assess the feasibility of obtaining key clinical indicators and monitoring treatment, viral suppression, and retention components of the youth HIV treatment cascade in Adolescent Trials Network for HIV/AIDS Interventions clinics using electronic health record (EHR) downloads and to provide baseline characteristics for the study participants. Methods:EHR data were systematically obtained from multiple clinical sites and used to meaningfully capture clinical characteristics, initiation of antiretrovirals, and retention in care, which are part of the Centers for Disease Control and Prevention’s 4 continuum of care measures. In addition, this study used standard cost values attached to Current Procedural Terminology codes to estimate the cost per visit. Results:Only 2 of the 4 Centers for Disease Control and Prevention treatment cascade measures were assessed using routine EHR data. EHR data are not adequate for monitoring HIV testing or linkage to care because denominator data are not available. However, the data work well for measuring ART initiation and adequately for retention in care. The sites were broadly able to provide information for the required data. However, in most cases, these data are insufficient for identifying patterns of missed appointments because such misses are not captured in the EHR system. Sites with good access to data management resources can operate more efficiently for cascade monitoring study purposes. Conclusions:Data other than EHRs are needed to measure HIV testing and linkage to youth care. EHR data are useful for measuring ART initiation and work moderately well for measuring retention in care. Site data management resources should be part of the selection process when looking for site partners for clinical studies that plan to use EHR data. Study planners should determine the feasibility of additional funding for organizations in need of additional information technology or data management resources

Study Protocol For Clinical Trial of the Fit Families Multicomponent Obesity intervention For african american adolescents and their Caregivers: Next Step From the orbit initiative

INTRODUCTION: This study will test the effectiveness of FIT Families (FIT), a multicomponent family-based behavioural intervention, against a credible attention control condition, Home-Based Family Support (HBFS). This protocol paper describes the design of a randomised clinical trial testing the efficacy of the FIT intervention. The protocol will assess the efficacy of FIT to improve health status in African American adolescents with obesity (AAAO) and their primary caregivers on primary (percent body fat) and secondary (physical activity, metabolic control, weight loss) outcomes and its cost-effectiveness. METHODS: 180 youth/caregiver dyads are randomised into FIT or HBFS, stratified by age, gender and baseline per cent overweight. The proposed study follows a two condition (FIT, HBFS) by four assessment time points. Tests will be conducted to identify potential relationship of baseline demographic and clinical variables to our dependent variables and see whether they are balanced between groups. It is hypothesised that youth/caregiver dyads randomised to FIT will show significantly greater reductions in percent body fat over a 12-month follow-up period compared with AAAO receiving HBFS. Preliminary findings are expected by November 2023. ETHICS: This protocol received IRB approval from the Medical University of South Carolina (Pro00106021; see \u27MUSC IRB 106021 Main Approval.doxc\u27 in online supplemental materials). DISSEMINATION: Dissemination activities will include summary documents designed for distribution to the broader medical community/family audience and submission of manuscripts, based on study results, to relevant peer-reviewed scientific high-impact journals. TRIAL REGISTRATION NUMBER: NCT04974554

Sexual attitudes, pattern of communication, and sexual behavior among unmarried out-of-school youth in China

<p>Abstract</p> <p>Background</p> <p>In recent years, more adolescents are engaging in premarital sex in China. However, only a limited number of studies have explored out-of-school youth's sexual attitudes and behaviors, critical for prevention intervention development.</p> <p>Methods</p> <p>Using data from the baseline survey of a comprehensive sex education program that was conducted in a suburb of Shanghai in 2000–2002, this study describes sexual attitudes, patterns of communication on sexual matters, and premarital sexual behavior among 1,304 out-of-school youth. Multivariate logistic regression analysis was conducted to examine the factors associated with youth's premarital sexual intercourse.</p> <p>Results</p> <p>The majority (60%) of out-of-school youth held favorable attitudes towards premarital sex. Males were more likely to have favorable attitudes compared with females. Male youth generally did not communicate with either parent about sex, while one-third of female youth talked to their mothers about sexual matters. Both males and females chose their friends as the person with whom they were most likely to talk about sexual matters. About 18% of the youth reported having engaged in sexual intercourse. One-fifth of sexually active youth had always used a contraceptive method, and one-quarter had been pregnant (or had impregnated a partner). There were no gender differences in rate of premarital sex or frequency of contraceptive use. Multivariate analysis revealed that age, education, family structure, parent's discipline, attitudes towards premarital sex, pattern of communication and dating were significantly associated with youth premarital sex.</p> <p>Conclusion</p> <p>A substantial proportion of out-of-school youth engage in risky sexual behaviors. Prevention programs that empower communication and sexual negotiation skills, and promote condom use should be implemented for this vulnerable group.</p