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

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

Cardiovascular Risk Assessment Among Adolescents and Youths Living With HIV: Evaluation of Electronic Health Record Findings and Implications.

BACKGROUND: The HIV epidemic remains a major public health concern, particularly among youths living with HIV. While the availability of antiretroviral therapy has significantly improved the health outcomes of people living with HIV, there is growing evidence that youths living with HIV may be at increased risk of cardiovascular disease. However, the underlying mechanisms linking HIV and cardiovascular disease among youths living with HIV remain poorly understood. One potential explanation is that HIV-related biomarkers, including detectable viral load (VL) and low cluster of differentiation 4 (CD4) lymphocyte counts, may contribute to increased cardiovascular risk. Despite the potential importance of these biomarkers, the relationship between HIV-related biomarkers and cardiovascular risk among youths living with HIV has been understudied. OBJECTIVE: To address this gap, we examined whether detectable VL and low CD4 lymphocyte counts, both of which are indications of unsuppressed HIV, were associated with cardiovascular risk among youths living with HIV. METHODS: We analyzed electronic health record data from 7 adolescent HIV clinics in the United States (813 youths living with HIV). We used multivariable linear regression to examine the relationship between detectable VL and CD4 lymphocyte counts of ≤200 and cardiovascular risk scores, which were adapted from the gender-specific Framingham algorithm. RESULTS: In our study, nearly half of the participants (366/766, 47.8%) had detectable VL, indicating unsuppressed HIV, while 8.6% (51/593) of them had CD4 lymphocyte counts of ≤200, suggesting weakened immune function. We found that those with CD4 lymphocyte counts of ≤200 had significantly higher cardiovascular risk, as assessed by Cardiac Risk Score2, than those with CD4 lymphocyte counts of >200 (P=.002). After adjusting for demographic and clinical factors, we found that for every 1000-point increase in VL copies/mL, the probability of having cardiovascular risk (Cardiac Risk Score2) increased by 38%. When measuring the strength of this connection, we observed a minor effect of VL on increased cardiovascular risk (ß=.134, SE 0.014; P=.006). We obtained similar results with Cardiac Risk Score1, but the effect of CD4 lymphocyte counts of ≤200 was no longer significant. Overall, our findings suggest that detectable VL is associated with increased cardiovascular risk among youths living with HIV, and that CD4 lymphocyte counts may play a role in this relationship as well. CONCLUSIONS: Our study highlights a significant association between unsuppressed HIV, indicated by detectable VL, and increased cardiovascular risk in youths living with HIV. These findings emphasize the importance of implementing interventions that address both VL suppression and cardiovascular risk reduction in this population. By tailoring interventions to meet the unique needs of youths, we can promote overall well-being throughout the HIV care continuum and across the life span. Ultimately, these efforts have the potential to improve the health outcomes and quality of life of youths living with HIV. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11185.

Examining Recruitment Strategies in the Enrollment Cascade of Youth Living With HIV: Descriptive Findings From a Nationwide Web-Based Adherence Protocol.

BACKGROUND: Digital strategies and broadened eligibility criteria may optimize the enrollment of youth living with HIV in mobile health adaptive interventions. Prior research suggests that digital recruitment strategies are more efficient than traditional methods for overcoming enrollment challenges of youth living with HIV in the United States. OBJECTIVE: This study highlights the challenges and strategies that explain screening and enrollment milestones in a national web-based adherence protocol for youth living with HIV. METHODS: Baseline data from a national web-based HIV adherence protocol for youth living with HIV, collected from July 2018 to February 2021, were analyzed. A centralized recruitment procedure was developed, which used web-based recruitment via Online Master Screener; paid targeted advertisements on social media platforms (eg, Facebook and Reddit) and geosocial networking dating apps (eg, Grindr and Jack'd); and site and provider referrals from Subject Recruitment Venues and other AIDS service organizations, website referrals, and text-in recruitment. RESULTS: A total of 3 distinct cohorts of youth living with HIV were identified, marked by changes in recruitment strategies. Overall, 3270 individuals consented to screening, 2721 completed screening, 581 were eligible, and 83 completed enrollment. We examined sociodemographic and behavioral differences in completing milestones from eligibility to full enrollment (ie, submitting antiretroviral therapy and viral load data and completing the baseline web-based survey). Those with the most recent viral load tests >6 months ago were half as likely to enroll (odds ratio 0.45, 95% CI 0.21-0.94). Moreover, eligible participants with self-reported antiretroviral therapy adherence (SRA) between 50% and 80% were statistically significant (P<.001 to P=.03) and more likely to enroll than those with SRA >80%. CONCLUSIONS: The findings add to our knowledge on the use of digital technologies for youth living with HIV before and during the COVID-19 pandemic and provide insight into the impact of expanding eligibility criteria on enrollment. As the COVID-19 pandemic continues and the use of and engagement with social media and dating apps among youth living with HIV changes, these platforms should continue to be investigated as potential recruitment tools. Using a wide variety of recruitment strategies such as using social media and dating apps as well as provider referral mechanisms, increasing compensation amounts, and including SRA in enrollment criteria should continue to be studied with respect to their ability to successfully recruit and enroll eligible participants. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/11183.

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.

The importance of domain-specific self-efficacy assessment for substance use and HIV care continuum outcomes among adults in an urban HIV clinic network.

Despite the prominence of self-efficacy as a predictor of antiretroviral therapy (ART) adherence, relatively little work has examined domain-specific associations with steps in the care continuum or the possibility that substance use may have domain-specific associations with self-efficacy. This study analyzed data from a sample of 174 people living with HIV recruited through three clinics in the New York City metro area. Consistent with hypotheses, path analysis showed that appointments kept and viral load were each predicted only by their respective domain-specific self-efficacy components (i.e., self-efficacy for keeping appointments, B = 0.01, p = .04; and self-efficacy for taking ART medications, B = -0.02, p < .01). Path models also indicated domain-specific associations with substance use. Self-efficacy for keeping appointments was negatively associated with severity of drug use (B = -1.81, p < .01); meanwhile, self-efficacy for taking ART medications was negatively associated with severity of alcohol use (B = -0.52, p < .01). Accordingly, studies assessing barriers to retention in the HIV care continuum should conduct multi-domain assessments of self-efficacy for differential associations with specific behaviors. Furthermore, HIV care providers might consider screening for domain-specific self-efficacy to identify patients at risk of drop-out and tailoring interventions to various care continuum domains.

Effectiveness of a Combined Motivational Interviewing and Cognitive Behavioral Intervention to Reduce Substance Use and Improve HIV-Related Immune Functioning.

This study evaluated the effectiveness of Project PLUS, a 6-session Motivational Interviewing and Cognitive Behavioral intervention to reduce substance use and improve antiretroviral therapy (ART) adherence among PLWH. In a quasi-experimental design, 84 participants from a network of three comprehensive care clinics in New York City received the intervention immediately post-baseline (the Immediate condition) and 90 were assigned to a Waitlist control. Viral load and CD4 data were extracted from electronic medical records (EMR) for a No-Intervention comparison cohort (n = 120). Latent growth curve analyses did not show a consistent pattern of significant between-group differences post-intervention or across time in ART adherence or substance use severity between Immediate and Waitlist participants. Additionally, Immediate intervention participants did not differ significantly from the Waitlist or No-Treatment groups on viral load or CD4 post-intervention or across time. The potential to detect intervention effects may have been limited by the use of a quasi-experimental design, the high quality of standard care at these clinics, or inadequate intervention dose.Trial Registration: ClinicalTrials.gov (NIH U.S. National Library of Medicine) Identifier: NCT02390908; https://clinicaltrials.gov/ct2/show/NCT02390908.

The Mediating Role of Psychological Distress in the Association between Harassment and Alcohol Use among Lesbian, Gay, and Bisexual Military Personnel.

BACKGROUND: The purpose of this study was to examine the mediating role of psychological distress on the associations between two forms of harassment, military sexual trauma (MST) and sexual orientation-based discrimination (SOBD), and alcohol use in a sample of lesbian, gay, and bisexual (LGB) military personnel. Methods: Data were analyzed from 254 LGB military service members in the United States. Bivariate associations were examined between MST, SOBD, anxiety and depression, distress in response to stressful military events, and alcohol use. A latent psychological distress factor was estimated using anxiety and depression, and distress in response to stressful military events. Path analyses were used to estimate the direct effects of MST and SOBD on alcohol use and the indirect effects of MST and SOBD on alcohol use through psychological distress. Results: All bivariate associations were positive and significant between MST, SOBD, anxiety and depression, distress in response to military events, and alcohol use. In multivariable analyses, after adjusting for demographic covariates, a significant indirect effect was observed for SOBD on alcohol use through psychological distress. MST was not directly or indirectly associated with alcohol use when SOBD was included in the path model. Conclusion: Overall, findings suggest SOBD is associated with poorer mental health, which in turn places LGB military personnel at greater risk of alcohol use and associated problems. These results affirm the need for interventions that reduce SOBD in the military and suggest that these interventions will have a positive impact on the health of LGB military personnel.

Measuring Experiences of Minority Stress for Transgender Women: Adaptation and Evaluation of Internalized and Anticipated Transgender Stigma Scales.

Purpose: Transgender women (TGW) experience high rates of stigma based on their gender identity. Research has documented how transgender stigma and other discrimination negatively contribute to health inequities, including higher rates of depression compared with the general population. However, few scales measuring transgender stigma exist, even fewer that specifically assess anticipated or internalized transgender stigma. We sought to validate an adapted transgender stigma scale in a diverse sample of TGW. Methods: We adapted an existing stigma measure to capture experiences of anticipated and internalized transgender stigma for TGW. Adapted measures were completed by 213 diverse TGW. Factor analysis was completed to reduce the number of items in each scale and sociodemographic differences in each construct were explored. Results: The final nine items comprising anticipated transgender stigma and the five items for internalized transgender stigma both showed evidence of adequate model fit, unidimensionality, and internal consistency. The two constructs were moderately correlated with one another (r=0.36, p<0.001). We identified educational and HIV status differences in anticipated transgender stigma but no sociodemographic differences in internalized transgender stigma. Conclusion: We developed brief measures of internalized and anticipated transgender stigma through initial adaptation by TGW themselves and subsequent psychometric evaluation, demonstrating evidence of unidimensionality and internal consistency. These subscales were only moderately associated with one another and may provide unique insights in future research on minority stress among TGW.

Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial.

BACKGROUND: Young men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many-possibly most-new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent. OBJECTIVE: The aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue. METHODS: This is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework. RESULTS: Phase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (ncouples=36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (ncouples=144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention. CONCLUSIONS: Although MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03386110; http://clinicaltrials.gov/ct2/show/NCT03386110 (Archived by WebCite at http://www.webcitation.org/75mlO7GCx). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11186.

Testing a Motivational Interviewing Implementation Intervention in Adolescent HIV Clinics: Protocol for a Type 3, Hybrid Implementation-Effectiveness Trial.

BACKGROUND: Motivational interviewing (MI) has been shown to effectively improve self-management for youth living with HIV (YLH) and has demonstrated success across the youth HIV care cascade-currently, the only behavioral intervention to do so. Substantial barriers prevent the effective implementation of MI in real-world settings. Thus, there is a critical need to understand how to implement evidence-based practices (EBPs), such as MI, and promote behavior change in youth HIV treatment settings as risk-taking behaviors peak during adolescence and young adulthood. OBJECTIVE: This study aims to describe the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) protocol of a tailored MI (TMI) implementation-effectiveness trial (ATN 146 TMI) to scale up an EBP in multidisciplinary adolescent HIV settings while balancing flexibility and fidelity. This protocol is part of the Scale It Up program described in this issue. METHODS: This study is a type 3, hybrid implementation-effectiveness trial that tests the effect of TMI on fidelity (MI competency and adherence to program requirements) while integrating findings from two other ATN protocols described in this issue-ATN 153 Exploration, Preparations, Implementation, Sustainment and ATN 154 Cascade Monitoring. ATN 153 guides the mixed methods investigation of barriers and facilitators of implementation, while ATN 154 provides effectiveness outcomes. The TMI study population consists of providers at 10 adolescent HIV care sites around the United States. These 10 clinics are randomly assigned to 5 blocks to receive the TMI implementation intervention (workshop and trigger-based coaching guided by local implementation teams) utilizing the dynamic wait-listed controlled design. After 12 months of implementation, a second randomization compares a combination of internal facilitator coaching with the encouragement of communities of practice (CoPs) to CoPs alone. Participants receive MI competency assessments on a quarterly basis during preimplementation, during the 12 months of implementation and during the sustainment period for a total of 36 months. We hypothesize that MI competency ratings will be higher among providers during the TMI implementation phase compared with the standard care phase, and successful implementation will be associated with improved cascade-related outcomes, namely undetectable viral load and a greater number of clinic visits among YLH. RESULTS: Participant recruitment began in August 2017 and is ongoing. As of mid-May 2018, TMI has 150 active participants. CONCLUSIONS: This protocol describes the underlying theoretical framework, study design, measures, and lessons learned for TMI, a type 3, hybrid implementation-effectiveness trial, which has the potential to scale up MI and improve patient outcomes in adolescent HIV settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03681912; https://clinicaltrials.gov/ct2/show/NCT03681912 (Archived by WebCite at http://www.webcitation.org/754oT7Khx). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11200.

Cascade Monitoring in Multidisciplinary Adolescent HIV Care Settings: Protocol for Utilizing Electronic Health Records.

BACKGROUND: Past research shows that youth living with HIV (YLH) are not as engaged in the HIV treatment cascade as other HIV-positive populations. To achieve the health benefits of rapid and widespread testing and advanced pharmacologic treatment, YLH must be fully engaged in every stage of the treatment cascade. Cascade monitoring provides an opportunity to assess the youth care cascade, including engagement in care and when youth commonly drop out of care, across 10 clinical sites in the United States. Collecting electronic health record (EHR) data for prevention and care across participant recruitment venues within the Adolescent Medicine Trials Network (ATN) allows for monitoring of the prevention and care cascades within the ATN, for comparing the ATN population to large-scale surveillance, for future integration of technology-based interventions into EHRs, and for informing ATN strategic planning. OBJECTIVE: The aim of this protocol study is to examine the trends in treatment cascade, including whether patients are receiving antiretroviral therapy, adhering to regimens, attending care appointments, and maintaining suppressed viral loads, to guide new protocol development and to facilitate community engagement. This protocol is part of the ATN Scale It Up (SIU) program described in this issue. METHODS: Deidentified EHR data of YLH, aged 15 to 24 years, will be collected annually (2017 to 2022) from 10 ATN clinical sites, resulting in patient data from 2016 to 2021. These data will be transferred and stored using Dropbox Business, a Health Insurance Portability and Accountability Act-compliant site and then analyzed by the SIU analytic core. RESULTS: This study was launched in December 2017 in 10 clinical sites, with 2016's EHR data due on January 31, 2017. All 10 sites electronically uploaded their EHR data. The mandatory variables requested to monitor cascade of care include date of visit, age, gender, height, weight, race, ethnicity, viral load, and International Classification of Diseases codes for other diagnosis. In total, 70% of the sites provided data for all mandatory variables. The remaining mandatory variables were manually extracted. CONCLUSIONS: This study will provide a platform to determine how YLH across the nation progress through or drop out of the HIV treatment cascade. It will also provide a foundation for assessing impact of SIU projects on treatment cascade outcomes. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11185.

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 Up program 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT03488914; https://clinicaltrials.gov/ct2/show/NCT03488914 (Archived by WebCite at http://www.webcitation.org/770WaWWfi). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11184.

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' 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. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11202.

Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Message and Cell Phone Support With and Without Incentives: Protocol for a Sequential Multiple Assignment Randomized Trial (SMART).

BACKGROUND: Youth living with HIV (YLH) aged 13 to 24 years made up over a fifth (21%) of new HIV diagnoses in 2016, yet only 27% of YLH are virally suppressed. YLH have been shown to be poorly adherent to antiretroviral therapy (ART); however, there has been limited research investigating how to increase adherence in YLH. Mobile health (mHealth) interventions may be one promising way to do this. OBJECTIVE: This study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined. This protocol is part of the ATN Scale It Up program described in this issue by Naar et al. METHODS: This study uses a Sequential Multiple Assignment Randomized Trial design. Approximately 190 participants are being recruited, enrolled, and randomized to either cell phone support or text message support. Both intervention groups receive 3 months of intervention, followed by a second randomization based on response to the intervention. Responders test tapering their intervention, and nonresponders test receiving incentives. RESULTS: Data collection for this study is projected to begin in August 2018 and last until June 2020. CONCLUSIONS: This is an innovative study, particularly in terms of population, intervention types, focus on cost-effectiveness, and recruitment. This study could be particularly effective in improving adherence in YLH while reducing long-term individual and societal costs. TRIAL REGISTRATION: ClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/11183.

Prevalence of Military Sexual Trauma and Sexual Orientation Discrimination Among Lesbian, Gay, Bisexual, and Transgender Military Personnel: a Descriptive Study.

Despite the repeal of Don't Ask, Don't Tell, Don't Pursue (DADT) and the update to the Transgender Policy, there remain concerns about the persistence of military sexual trauma (MST) and sexual orientation discrimination against lesbian, gay, bisexual, and transgender (LGBT) service members. A sample of 253 participants (89 women, 164 men) completed an Internet-based survey that assessed the prevalence of sexual orientation discrimination (e.g., offensive speech, physical or discriminatory behaviors) and MST (e.g., sexual harassment and sexual assault). The survey was conducted between April 2012 and October 2013. Women and men reported similar levels of sexual orientation discrimination in the military. Participants reported experiencing more threats and intimation, vandalism, and physical assault outside of the military than inside the military (p < 0.05). Although the prevalence of MST (both sexual harassment and sexual assault) in the military was high among both genders, women were more likely to report experiences of sexual harassment compared to men (p < 0.05). Our findings demonstrate the prevalence of MST and sexual orientation discrimination among LGBT service members in the military and point to the need for strong accountability and oversight to protect sexual minority persons while they are serving their country.

Syndemic Conditions, HIV Transmission Risk Behavior, and Transactional Sex Among Transgender Women.

This study examined the effect of four syndemic conditions-namely, polydrug use, depression, childhood sexual abuse, and intimate partner violence-on rates of HIV transmission risk behavior (TRB) and separately, transactional sex among transgender women. TRB was defined as the number of condomless penetrative sex events with a casual or main partner of discordant or unknown HIV status. Using data from 212 transgender women in New York City, multivariable analyses revealed that, compared to those with no syndemic conditions, dramatically higher rates of recent HIV TRB events (ARR = 8.84, p < 0.001) and recent transactional sex events (ARR = 8.32, p < 0.001) were reported by participants with all four syndemic conditions. These findings highlight the importance of considering the role of syndemic conditions in HIV risk among transgender women, and the need for comprehensive psychosocial interventions to improve sexual health among this population.

Alcohol and substance use diagnoses among HIV-positive patients receiving care in NYC clinic settings.

BACKGROUND: Substance use among HIV-positive persons exacerbates health problems. This study sought to estimate the prevalence of alcohol and drug-use diagnoses and examined hypothesized predictors associated with alcohol and drug-use diagnoses among HIV-positive patients in New York City (NYC). METHODS: This cohort study reviewed electronic medical records (EMRs) of 4965 HIV-positive patients based on diagnostic codes. These patients attended a comprehensive care clinic in NYC in 2012. Multinomial logistic regression was used to predict the odds of classification into substance use diagnosis grouping. RESULTS: Of the full sample, only 12.7% of patients had an alcohol use diagnosis documented in their EMR compared with more than one-quarter (26.4%) of patients having a recorded drug use diagnosis (p<0.001). Compared with the No Alcohol or Drugs group, the regression model showed that older age and having a recent inpatient hospital stay independently predicted being in the Alcohol Only group; years living with HIV, having an unsuppressed viral load, and having a recent inpatient hospital stay were associated with higher odds of being in the Drugs Only and Alcohol and Drugs groups; and being women and men who have sex with men (MSM) were associated with decreased odds of being in the Drugs Only and Alcohol and Drugs groups. CONCLUSIONS: Substance use diagnosis was associated with viremia and low CD4 counts and hospital stays. This implies that providers should screen for substance use in HIV-positive patients with poor health. Further examination of the extent of such comorbidity is instrumental for intervention efforts.

Feasibility of an Emotion Regulation Intervention to Improve Mental Health and Reduce HIV Transmission Risk Behaviors for HIV-Positive Gay and Bisexual Men with Sexual Compulsivity.

Gay and bisexual men (GBM) report high rates of sexual compulsivity (SC), yet no empirically based treatments exist. An intervention based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders was pilot tested in a sample of 13 HIV-positive GBM with SC. Participants completed a baseline interview, and were offered up to ten intervention sessions. Of those, 11 completed a 3-month follow-up assessment. Despite problems with session attendance (only 4 men completed all 10 sessions), improvements were observed in all psychological outcomes, including SC, depression, and anxiety. Decreases were observed in drug use and HIV risk. The Unified Protocol may be useful in improving the health of HIV-positive GBM, however challenges with session attendance must be addressed. Future work should consider if fewer sessions produce similar results, whether barriers to attending all sessions could be alleviated, and how the intervention would perform compared to treatments.

The Impact of Comorbidities, Depression, and Substance Use Problems on Quality of Life Among Older Adults Living With HIV.

Older adults living with HIV (OALWH) comprise a growing population with a range of complex and interconnecting medical and psychosocial needs. Based on the biopsychosocial model with its emphasis on a holistic approach to various aspects of people's lives, the current study explored associations between physical health, psychological health, substance use, and overall quality of life. Drawing on data from 114 substance-using OALWH (aged 50 or older), we employed linear regression to show associations between the number of current comorbid health conditions on quality of life, over and above depression, substance use problems, and demographic characteristics (age, race/ethnicity, gender, sexual orientation, education, and relationship status). In both bivariate and multivariable contexts, the number of comorbid conditions was associated with reduced quality of life. Depression and substance use were also negatively associated with quality of life. These findings indicate that clinical and supportive care for OALWH, particularly when related to mental health and substance use, should also include an integrated focus on the comparatively high number of current comorbid conditions that often accompany, and potentially complicate, HIV treatment and quality of life.