Adolescent Medicine Trials Network Research Articles

Discordance Between HIV Risk Perception, Sexual Behavior, and Pre-exposure Prophylaxis Adherence Among Young Sexual and Gender Minorities in the United States

PurposeIn the United States, youth experience suboptimal HIV pre-exposure prophylaxis (PrEP) adherence. One common idea posits that this is due to their developing decision-making skills. However, quantitative evidence of this assumption is limited. We therefore examined whether individual decision-making factors, such as HIV risk perception and sexual behavior, predicted PrEP adherence in a national trial of young sexual and gender minorities (YSGMs). MethodsIn 2019–2021, the Adolescent Medicine Trials Network for HIV Interventions 142 study enrolled 225 PrEP users (ages 16–24) throughout the country. Regression models estimated the associations between HIV risk perception (using a modified Perceived HIV Risk Scale), sexual behavior (condomless anal sex in ≤ 3 months), and self-reported oral PrEP adherence (≥4 pills in the past week) at the same time point (baseline) and longitudinally (3 months). ResultsBaseline risk perception (risk ratio [RR]: 0.92, 95% confidence interval [CI]: 0.82, 1.04) and condomless anal sex (RR: 1.10, 95% CI: 0.97, 1.25) were not associated with PrEP adherence at the same time point and did not predict 3-month adherence (RR: 0.97, 95% CI: 0.85, 1.11; RR: 1.05, 95% CI: 0.93, 1.19, respectively). Baseline risk perception was not associated with condomless anal sex at either time point (baseline RR: 1.16, 95% CI: 0.94, 1.43; 3-month RR: 1.07, 95% CI: 0.90, 1.28). DiscussionIn this national trial of YSGM, HIV risk perception and condomless anal sex did not predict PrEP adherence. Targeting individual-level perceptions and behaviors will likely insufficiently address youth's suboptimal PrEP use. Future research should identify YSGM-specific adherence drivers and train providers to recognize such motivations.

Optimal strategies to improve uptake of and adherence to HIV prevention among young people at risk for HIV acquisition in the USA (ATN 149): a randomised, controlled, factorial trial

Pre-exposure prophylaxis (PrEP), condom use, post-exposure prophylaxis (PEP), and sexual partner reduction help to prevent HIV acquisition but have low uptake among young people. We aimed to assess the efficacy of automated text messaging and monitoring, online peer support, and strengths-based telehealth coaching to improve uptake of and adherence to PrEP, condom use, and PEP among adolescents aged 12-24 years at risk of HIV acquisition in Los Angeles, CA, USA, and New Orleans, LA, USA. We conducted a four-arm randomised controlled factorial trial, assessing interventions designed to support uptake and adherence of HIV prevention options (ie, PrEP, PEP, condom use, and sexual partner reduction). We recruited young people aged 12-24 years who were at risk of HIV acquisition from 13 community-based organisations, adolescent medicine clinics, and organisations serving people who are unstably housed, people who were previously incarcerated, and other vulnerable young people, and through dating apps, peer referrals, and social venues and events in Los Angeles, CA, USA, and New Orleans, LA, USA. Young people who tested seronegative and reported being gay, bisexual, or other men who have sex with men, transgender men or women, or gender diverse (eg. non-binary or genderqueer) were eligible for inclusion. Participants were randomly assigned to one of four intervention groups in a factorial design: automated text messaging and monitoring (AMMI) only, AMMI plus peer support via private social media, AMMI plus strengths-based telehealth coaching by near-peer paraprofessionals, or AMMI plus peer support and coaching. Assignment was further stratified by race or ethnicity and sexual orientation within each interviewer's group of participants. Participants were masked to intervention assignment until after baseline interviews when offered their randomly assigned intervention, and interviewers were masked throughout the study. Interventions were available throughout the 24-month follow-up period, and participants completed baseline and follow-up assessments, including rapid diagnostic tests for sexually transmitted infections, HIV, and substance use, at 4-month intervals over 24 months. The primary outcomes were uptake and adherence to HIV prevention options over 24 months, measured by self-reported PrEP use and adherence, consistent condom use with all partners, PEP prescription and adherence, and number of sexual partners in participants with at least one follow-up. We used Bayesian generalised linear modelling to assess changes in outcomes over time comparing the four study groups. This study is registered with ClinicalTrials.gov (NCT03134833) and is completed. We screened 2314 adolescents beginning May 1, 2017, to enrol 1037 participants (45%) aged 16-24 years between May 6, 2017, and Aug 30, 2019, of whom 895 (86%) had follow-up assessments and were included in the analytical sample (313 assigned to AMMI only, 205 assigned to AMMI plus peer support, 196 assigned to AMMI plus coaching, and 181 assigned to AMMI plus peer support and coaching). Follow-up was completed on Nov 8, 2021. Participants were diverse in race and ethnicity (362 [40%] Black or African American, 257 [29%] Latinx or Hispanic, 184 [21%] White, and 53 [6%] Asian or Pacific Islander) and other sociodemographic factors. At baseline, 591 (66%) participants reported anal sex without a condom in the past 12 months. PrEP use matched that in young people nationally, with 101 (11%) participants reporting current PrEP use at baseline, increasing at 4 months to 132 (15%) and continuing to increase in the AMMI plus peer support and coaching group (odds ratio 2·31, 95% CI 1·28-4·14 vs AMMI control). There was no evidence for intervention effect on condom use, PEP use (ie, prescription or adherence), PrEP adherence, or sexual partner numbers. No unanticipated or study-related adverse events occurred. Results are consistent with hypothesised synergistic intervention effects of evidence-based functions of informational, motivational, and reminder messaging; peer support for HIV prevention; and strengths-based, goal-focused, and problem-solving telehealth coaching delivered by near-peer paraprofessionals. These core functions could be flexibly scaled via combinations of technology platforms and front-line or telehealth HIV prevention workers. Adolescent Medicine Trials Network for HIV/AIDS Interventions, US National Institutes of Health.

Adolescents Living With or at Risk for HIV: A Pooled Descriptive Analysis of Studies From the Adolescent Medicine Trials Network for HIV/AIDS Interventions

PurposeThis study aims to describe the cohort of Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) research program participants and evaluate whether the ATN's recently completed 5-year cycle recruited study participants who parallel the populations most impacted by HIV in the United States. MethodsHarmonized measures across ATN studies collected at baseline were aggregated for participants aged 13–24 years. Pooled means and proportions stratified by HIV status (at risk for or living with HIV) were calculated using unweighted averages of study-specific aggregate data. Medians were estimated using a weighted median of medians method. Public use 2019 Centers for Disease Control and Prevention surveillance data for state-level new HIV diagnoses and HIV prevalence among US youth aged 13–24 years were obtained for use as reference populations for ATN at-risk youth and youth living with HIV (YLWH), respectively. ResultsData from 3,185 youth at-risk for HIV and 542 YLWH were pooled from 21 ATN study phases conducted across the United States. Among ATN studies tailored to at-risk youth, a higher proportion of participants were White and a lower proportion were Black/African American and Hispanic/Latinx compared to youth newly diagnosed with HIV in the United States in 2019. Participants in ATN studies tailored to YLWH were demographically similar to YLWH in the United States. DiscussionThe development of data harmonization guidelines for ATN research activities facilitated this cross-network pooled analysis. These findings suggest the ATN's YLWH are representative, but that future studies of at-risk youth should prioritize recruitment strategies to enroll more participants from African American and Hispanic/Latinx populations.

Rates of Sexually Transmitted Infection Diagnoses Among US Youth With Perinatally and Nonperinatally Acquired HIV.

Of new sexually transmitted infections (STIs) in the United States, 50% occur among youth aged 15 to 24 years. Previous studies among youth with HIV (YHIV) do not distinguish STI trends among individuals with perinatally (YPHIV) and nonperinatally (YNPHIV) acquired HIV. Among 3 Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) studies conducted between 2009 and 2015, we estimated incident diagnoses of trichomonal, bacterial, viral, and overall STIs stratified by sex assigned at birth, mode of HIV acquisition (perinatal [YPHIV] and nonperinatal [YNPHIV]), age (13-17 and 18-24 years), CD4 count (<200, 200-499, and ≥500/μL), and HIV viral load (VL) (<400 and ≥400 copies/mL). Among 3131 YHIV, across the 3 studies, mean (SD) age was 20.6 (2.6) years, 888 (28%) were female, 2498 (80%) had nonperinatal HIV acquisition recorded, and 2298 (73%) were African American/Black. Mean follow-up was 0.9 (0.3) years. Compared with YPHIV, YNPHIV spent less person-time with VL <400 copies/mL (47% vs. 53%) and more time off antiretroviral therapy (49% vs. 15%), and had higher overall STI rates (males, 65.9 vs. 8.5/100 person-years [PY]; females, 54.7 vs. 17.2/100 PY). Among YPHIV, bacterial STIs were higher during person-time spent with VL ≥400 vs. <400 copies/mL (male YPHIV, 10.9 vs. 0.6/100 PY; female YPHIV, 11.2 vs. 2.9/100 PY); no difference was observed among YNPHIV, which may be due to concurrent acquisition of HIV and other STIs and limited follow-up. Compared with YPHIV, YNPHIV spent less time on antiretroviral therapy and virologically suppressed; YNPHIV also had higher STI diagnosis rates. Very high STI diagnosis rates among YHIV, including among those without virologic suppression, highlight the importance of youth-focused efforts to support durable virologic suppression and identify and treat STIs.

Engaging Sexual and Gender Minority Youth in HIV Interventions Through Gay Dating Apps: Recruitment Protocol.

BackgroundHIV continues to disproportionately impact sexual and gender minority youth (SGMY) in the United States. Public health efforts have increasingly focused on developing efficacious interventions to curb the spread of HIV among SGMY and help those living with HIV achieve and sustain viral suppression. However, recruiting and engaging SGMY in prevention and care interventions is challenging.ObjectiveDuring the past decade, gay dating apps have quickly emerged as popular web-based spaces in which SGMY congregate. Although the recruitment of SGMY through these apps has been commonly reported, advertisement is the typical modality used, and direct recruitment approaches are not adequately described. This study aims to describe the process for developing a direct recruitment protocol for use in gay dating apps.MethodsThe Adolescent Medicine Trials Network Comprehensive Adolescent Research and Engagement Studies is a community-based research program consisting of 3 interrelated studies testing scalable behavioral interventions to improve HIV prevention and care engagement among youth aged 12-24 years in Los Angeles and New Orleans. To supplement our in-person recruitment approaches for Comprehensive Adolescent Research and Engagement Studies, the New Orleans site formed a gay dating app recruitment team. In April 2018, the team developed a loosely structured protocol that included study-specific profiles and sample language to guide initial recruitment efforts. Two self-identified Black, gay cisgender male field recruiters field-tested the protocol on the popular gay dating app Jack’d. During the field test, the recruitment team met weekly to discuss the recruiters’ experiences and user reactions. For example, we learned the importance of addressing concerns about study legitimacy and identifying appropriate ways to describe the study. We iteratively incorporated these lessons learned into the final protocol and developed a training program and tracking procedures before moving to full-scale implementation at both sites.ResultsAdhering to this protocol yielded 162 enrollments in New Orleans (332 total enrollments across the two sites) throughout the recruitment period (April 2018 to August 2019). Most of these participants were sexual minority cisgender males (91%), and the remainder were identified as members of gender minority groups. We outlined step-by-step instructions on training staff, engaging users, and scheduling and tracking recruitment activities.ConclusionsThis paper provides a practical guide for researchers and community-based providers to implement a gay dating app recruitment protocol. Our experience indicates that gay dating app recruitment is feasible and fruitful when the staff members are knowledgeable, flexible, honest, and respectful to the user. Perhaps the most salient lesson we learned in approaching gay dating app users is the importance of setting clear and transparent intentions without judgment. As gay dating apps continue to increase in popularity, researchers need to stay vigilant to changing formats and develop systematic approaches to harness their potential as invaluable recruitment strategies for SGMY.International Registered Report Identifier (IRRID)RR1-10.2196/28864

Barriers and Facilitators to the Collection and Aggregation of Electronic Health Record HIV Data: An Analysis of Study Recruitment Venues Within the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN).

Electronic health record (EHR) data can be leveraged for prospective cohort studies and pragmatic clinical trials, targeting youth living with HIV (YLH). Using EHRs in this manner may minimize the need for costly research infrastructure in service to lowering disease burden. This study characterizes HIV prevention and care continua variables and identifies factors likely to impede or facilitate EHR use for research and interventions. We conducted telephone-based qualitative interviews with National Experts (n = 10) and Key Stakeholders (n = 19) from subject recruitment venues (SRVs), providing care services to YLH and youth at risk for HIV. We found 17 different EHR systems being used for various purposes (e.g., workflow management and billing). Thematic content analysis of interviews highlighted six broad categories of perspectives on barriers to and facilitators of EHR use: specific variable collection, general use barriers, and facilitators, general data collection barriers and facilitators, EHRs for surveillance and research, EHRs for personnel and resource management and capture of HIV specific variables. These findings may inform implementation strategies of future studies, in which we conduct routine monitoring of the youth HIV prevention and care continua using EHRs and test an eHealth intervention.

Modeling Adherence Interventions Among Youth with HIV in the United States: Clinical and Economic Projections

The Adolescent Medicine Trials Network for HIV/AIDS Interventions is evaluating treatment adherence interventions (AI) to improve virologic suppression (VS) among youth with HIV (YWH). Using a microsimulation model, we compared two strategies: standard-of-care (SOC) and a hypothetical 12-month AI that increased cohort-level VS in YWH in care by an absolute ten percentage points and cost $100/month/person. Projected outcomes included primary HIV transmissions, deaths and life-expectancy, lifetime HIV-related costs, and incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year [QALY]). Compared to SOC, AI would reduce HIV transmissions by 15% and deaths by 12% at 12 months. AI would improve discounted life expectancy/person by 8 months at an added lifetime cost/person of $5,300, resulting in an ICER of $7,900/QALY. AI would be cost-effective at $2,000/month/person or with efficacies as low as a 1 percentage point increase in VS. YWH-targeted adherence interventions with even modest efficacy could improve life expectancy, prevent onward HIV transmissions, and be cost-effective.

Research Priorities to End the Adolescent HIV Epidemic in the United States: Viewpoint.

Youth represent 21% of new HIV diagnoses in the United States. Gay, bisexual, and transgender (GBT) youth, particularly those from communities of color, and youth who are homeless, incarcerated, in institutional settings, or engaging in transactional sex are most greatly impacted. Compared with adults, youth have lower levels of HIV serostatus awareness, uptake of antiretroviral therapy (ART), and adherence. Widespread availability of ART has revolutionized prevention and treatment for both youth at high risk for HIV acquisition and youth living with HIV, increasing the need to integrate behavioral interventions with biomedical strategies. The investigators of the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) completed a research prioritization process in 2019, focusing on research gaps to be addressed to effectively control HIV spread among American youth. The investigators prioritized research in the following areas: (1) innovative interventions for youth to increase screening, uptake, engagement, and retention in HIV prevention (eg, pre-exposure prophylaxis) and treatment services; (2) structural changes in health systems to facilitate routine delivery of HIV services; (3) biomedical strategies to increase ART impact, prevent HIV transmission, and cure HIV; (4) mobile technologies to reduce implementation costs and increase acceptability of HIV interventions; and (5) data-informed policies to reduce HIV-related disparities and increase support and services for GBT youth and youth living with HIV. ATN’s research priorities provide a roadmap for addressing the HIV epidemic among youth. To reach this goal, researchers, policy makers, and health care providers must work together to develop, test, and disseminate novel biobehavioral interventions for youth.

Healthy Choices Intervention is Associated with Reductions in Stigma Among Youth Living with HIV in the United States (ATN 129).

Considering the lack of validated stigma reduction interventions for youth living with HIV (YLWH), we evaluated effects of the Healthy Choices intervention on HIV-related stigma among YLWH. We analyzed data from the Adolescent Medicine Trials Network protocol 129, multi-site randomized controlled trial, applying latent growth curve modeling with two linear slopes estimating changes in Berger's Stigma Scale pre-intervention, 16, 28, and 52weeks post-intervention, as well as the trajectory of stigma scores over the follow-up period (N = 183). Expected value for the growth intercept was statistically significant (Bintercept = 2.53; 95% CI 2.32, 2.73; p < 0.001), as were differences in the change from baseline to 16-week follow-up (Bintercept slope1 = - 0.02; 95% CI - 0.04, 0.01; p = 0.034). Expected value of the slope factor measuring growth over the follow-up period was non-significant suggesting that stigma scores were stable from 28 to 52weeks. Our findings warrant replication and additional research comparing effects of this intervention to counterfactual controls.

Pre-Exposure Prophylaxis Integration Into Family Planning Services at Title X Clinics in the Southeastern United States: Protocol for a Mixed Methods Hybrid Type I Effectiveness Implementation Study (Phase 2 ATN 155).

BackgroundAdolescent and young adult women (AYAW), particularly racial and ethnic minorities, in the Southern United States are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) is an effective, scalable, individual-controlled HIV prevention strategy that is grossly underutilized among women of all ages and requires innovative delivery approaches to optimize its benefit. Anchoring PrEP delivery to family planning (FP) services that AYAW already trust, access routinely, and deem useful for their sexual health may offer an ideal opportunity to reach women at risk for HIV and to enhance their PrEP uptake and adherence. However, PrEP has not been widely integrated into FP services, including Title X–funded FP clinics that provide safety net sources of care for AYAW. To overcome potential implementation challenges for AYAW, Title X clinics in the Southern United States are uniquely positioned to be focal sites for conceptually informed and thoroughly evaluated PrEP implementation science studies.ObjectiveThe objective of this study is two-fold: to evaluate multilevel factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics and to evaluate PrEP uptake, persistence, and adherence among female patients in these clinics over a 6-month follow-up period.MethodsPhase 2 of Planning4PrEP (Adolescent Medicine Trials Network for HIV/AIDS Interventions 155) is a mixed methods hybrid type 1 effectiveness implementation study to be conducted in three clinics in Metro Atlanta, Georgia, United States. Guided by the Exploration, Preparation, Implementation, and Sustainment framework, this study will prepare clinics for PrEP integration via clinic-wide trainings and technical assistance and will develop clinic-specific PrEP implementation plans. We will monitor and evaluate PrEP implementation as well as female patient PrEP uptake, persistence, and adherence over a 6-month follow-up period.ResultsPhase 2 of Planning4PrEP research activities began in February 2018 and are ongoing. Qualitative data analysis is scheduled to begin in Fall 2020.ConclusionsThis study seeks to evaluate factors associated with the level of PrEP adoption and implementation (eg, PrEP screening, counseling, and prescription) within and across 3 FP clinics following training and implementation planning and to evaluate PrEP uptake, persistence, and adherence among female patients over a 6-month follow-up period. This will guide future strategies to support PrEP integration in Title X–funded clinics across the Southern United States.Trial RegistrationClinicalTrials.gov NCT04097834; https://clinicaltrials.gov/ct2/show/NCT04097834International Registered Report Identifier (IRRID)DERR1-10.2196/18784

Technology-Based Stepped Care to Stem Transgender Adolescent Risk Transmission: Protocol for a Randomized Controlled Trial (TechStep).

BackgroundTransgender youth demonstrate significantly higher rates of engagement in sexual risk behaviors relative to their cisgender or gender-conforming counterparts, including high rates of condomless anal intercourse and engagement in sex work. In addition, transgender youth experience increased physical or sexual abuse, victimization, substance use, mental health disorders, incarceration, and homelessness. Owing to these syndemic health disparities, transgender youth are at substantially increased risk of HIV infection.ObjectiveThis protocol aims to describe a randomized controlled trial (RCT), Adolescent Medicine Trials Network 160 TechStep (N=250), which assesses the differential immediate and sustained effects of each of 3 conditions (text messaging, WebApp, or information-only control) for reducing sexual risk behaviors and increasing pre-exposure prophylaxis (PrEP) uptake among high-risk, HIV-negative transgender youth and young adults (aged 15-24 years).MethodsParticipants will be recruited through web-based (targeted social media sites and apps) and offline (print ads and flyers) advertisements, peer and clinic referrals, and street- and venue-based outreach, and by contacting potential participants who have requested contact for future studies. Participants will be randomized into 1 of the 3 conditions: (1) text messaging, (2) WebApp, or (3) information-only control for 6 months. Assessments will occur at baseline and at 3, 6, and 9 months. Participants who do not show improvements in sexual risk or PrEP uptake at the 3-month assessment will be rerandomized to receive weekly electronic coaching (eCoaching) sessions in addition to their assigned text messaging or WebApp intervention, or remain in the original text messaging or WebApp intervention using a 2:1 ratio. Participants originally assigned to the information-only condition are not eligible for rerandomization.ResultsFunding for TechStep was awarded in June 2017. Phase 1 was approved by the Institutional Review Board (IRB) in April 2018. Recruitment began in November 2018 for phase 1, the formative phase. Initial phase 2 IRB approval came in June 2019. The data collection for phase 2, the RCT, is expected to be completed in April 2021. As of March 2020, 54 participants have been enrolled in TechStep. The final results are anticipated in May 2021.ConclusionsBy providing culturally responsive, technology-based interventions, TechStep aims to improve sexual health outcomes among HIV-negative transgender youth and young adults at high risk of HIV. TechStep will evaluate the efficacy of technology-based interventions for reducing HIV sexual risk behaviors and increasing PrEP initiation, adherence, and persistence. The suite of technology-based interventions developed in TechStep, and assessed for efficacy in a 3-condition RCT, represents an important advancement in intervention science toward developing tailored and scalable interventions for transgender youth and young adults.Trial RegistrationClinicalTrials.gov NCT04000724; http://clinicaltrials.gov/ct2/show/NCT04000724International Registered Report Identifier (IRRID)DERR1-10.2196/18326

Cost-effectiveness of Frequent HIV Screening Among High-risk Young Men Who Have Sex With Men in the United States.

Of new HIV infections in the US, 20% occur among young men who have sex with men (YMSM, ages 13-24), but >50% of YMSM with HIV are unaware of their status. Using Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) data, we projected the clinical benefit and cost-effectiveness of frequent HIV screening among high-risk YMSM from age 15. Using a mathematical simulation, we examined 3 screening strategies: Yearly, 6-monthly, and 3-monthly, each in addition to the Status quo (SQ, 0.7-10.3% screened/year, stratified by age). We used published data (YMSM-specific when available) including: HIV incidences (0.91-6.41/100PY); screen acceptance (80%), linkage-to-care/antiretroviral therapy (ART) initiation (76%), HIV transmission (0.3-86.1/100PY, by HIV RNA), monthly ART costs ($2290-$3780), and HIV per-screen costs ($38). Projected outcomes included CD4 count at diagnosis, primary HIV transmissions from ages 15-30, quality-adjusted life expectancy, costs, and incremental cost-effectiveness ratios (ICERs, $/quality-adjusted life-year saved [QALY]; threshold ≤$100 000/QALY). Compared to SQ, all strategies increased projected CD4 at diagnosis (296 to 477-515 cells/µL) and quality-adjusted life expectancy from age 15 (44.4 to 48.3-48.7 years) among YMSM acquiring HIV. Compared to SQ, all strategies increased discounted lifetime cost for the entire population ($170 800 to $178 100-$185 000/person). Screening 3-monthly was cost-effective (ICER: $4500/QALY) compared to SQ and reduced primary transmissions through age 30 by 40%. Results were most sensitive to transmission rates; excluding the impact of transmissions, screening Yearly was ≤$100 000/QALY (ICER: $70 900/QALY). For high-risk YMSM in the US, HIV screening 3-monthly compared to less frequent screening will improve clinical outcomes and be cost-effective.

Higher soluble CD14 levels are associated with lower visuospatial memory performance in youth with HIV.

HIV-associated neurocognitive disorders persist despite early antiretroviral therapy (ART) and optimal viral suppression. We examined the relationship between immunopathogenesis driven by various pathways of immune activation and discrete neurocognitive performance domains in youth with HIV (YWH). Observational cross-sectional study. YWH, ages 20-28 years, enrolled in Adolescent Medicine Trials Network 071/101 were assessed for biomarkers of macrophage, lymphocyte activation, and vascular inflammation using ELISA/multiplex assays. Standardized neurocognitive tests were performed, and demographically adjusted z-scores were combined to form indices of attention, motor, executive function, verbal, and visuospatial memory. Cross-sectional analysis of the relationship between 18 plasma inflammatory biomarkers and each neurocognitive domain was performed. Linear regression models were fit for each combination of log-transformed biomarker value and neurocognitive domain score, and were adjusted for demographics, socioeconomic status, substance use, depression, CD4 T-cell count, HIV viral load, and ART status. Study included 128 YWH [mean age 23.8 (SD 1.7) years, 86% men, 68% African American]. Verbal and visuospatial memory domains were most significantly impaired in the cohort (z = -1.59 and -1.0, respectively). Higher sCD14 was associated with impaired visuospatial memory, which remained robust after adjusting for other biomarkers, demographics, and HIV-associated covariates. Among biomarkers of vascular inflammation, sICAM-1 was negatively associated with verbal memory and attention, whereas sVCAM-1 was positively associated with executive function and visuospatial memory. Specific neurocognitive domains were not associated with sCD163, LPS, or CCL2 levels. Impaired visuospatial memory in YWH is associated with immune activation, as reflected by higher sCD14.

1277. Retention Among Adolescents with Mental Health Diagnoses on Pre-Exposure Prophylaxis (RAMP) Study

BackgroundThe CDC reported in 2017 that 21% of new HIV diagnoses were composed of persons 13–24 years old. New York State (NYS) is addressing this with the Ending the Epidemic initiative, started in 2014, which emphasized pre-exposure prophylaxis (PrEP) for persons at risk of acquiring HIV. Though PrEP can effectively prevent HIV transmission, NYS minors were only granted capacity to accept PrEP in 2017. The Adolescent Medicine Trials Network found clinicians had varying perceptions on whether mental health diagnoses (MHD) were a barrier to adolescent PrEP utilization. This study aims to test the hypothesis that patients with MHD do not differ in PrEP retention length when compared with adolescents without MHD.MethodsThis is a retrospective single-center study analyzing self-reported visit data for adolescent enrolled on PrEP (n = 27) in the Capital District, NY. MHD were confirmed with clinician notes and retention to PrEP was defined as attending appointments. Between-group differences were compared using Fisher’s Exact Test (FET). Kaplan–Meier curves were compared using the log-rank test.ResultsOf the 27 adolescents enrolled on PrEP between Sep 2015-March 2019, most self-identified as males (93%), MSM (85%), white (74%), and 13 (48%) had a MH diagnosis. Anxiety was the most common MHD (69%), followed by depression (38%). The mean age was 20.3 years (16–24). The average PrEP retention for patients with and without MHD were 262±136 and 292±138 days, respectively (P = 0.575). For patients with MHD, follow-up at 1-month, 3-months and 1-year was 10 (77%), 8 (62%), and 5 (39%), respectively. For patients without MHD, follow-up at 1-month, 3-months, and 1-year was 11 (79%), 10 (71%), 5 (36%), respectively. Follow-up between adolescents with and without MHD was compared at 1-month (P = 0.086, FET), 3-months (P = 0.695, FET), and 1-year (P = 1.0, FET). Adolescents’ retention on PrEP was depicted on Kaplan–Meier curves (Figure 1). Log-rank test indicated that PrEP retention is not significantly associated with MHD (χ2(1) = 0.1, P = 0.727).ConclusionAdolescents with and without MHD did not significantly differ in PrEP retention outcomes. The RAMP study elucidates a potentially incorrect provider bias regarding PrEP retention and MHD. Future investigation should be done prospectively with larger sample size. Disclosures All authors: No reported disclosures.

Improving the Youth HIV Prevention and Care Cascades: Innovative Designs in the Adolescent Trials Network for HIV/AIDS Interventions

Dramatic decreases in HIV transmission are achievable with currently available biomedical and behavioral interventions, including antiretroviral therapy and pre-exposure prophylaxis. However, such decreases have not yet been realized among adolescents and young adults. The Adolescent Medicine Trials Network (ATN) for HIV/AIDS interventions is dedicated to research addressing the needs of youth at high risk for HIV acquisition as well as youth living with HIV. This article provides an overview of an array of efficient and effective designs across the translational spectrum that are utilized within the ATN. These designs maximize methodological rigor and real-world applicability of findings while minimizing resource use. Implementation science and cost-effectiveness methods are included. Utilizing protocol examples, we demonstrate the feasibility of such designs to balance rigor and relevance to shorten the science-to-practice gap and improve the youth HIV prevention and care continua.

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

BackgroundMotivational 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.ObjectiveThis 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.MethodsThis 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.ResultsParticipant recruitment began in August 2017 and is ongoing. As of mid-May 2018, TMI has 150 active participants.ConclusionsThis 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 RegistrationClinicalTrials.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.

BackgroundPast 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.ObjectiveThe 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.MethodsDeidentified 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.ResultsThis 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.ConclusionsThis 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

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.

BackgroundThe 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.ObjectiveThis 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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

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.

BackgroundYoung 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.ObjectiveThis 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.MethodsThis 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.ResultsPhase 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.ConclusionsWe 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 RegistrationClinicalTrials.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

Model-Based Methods to Translate Adolescent Medicine Trials Network for HIV/AIDS Interventions Findings Into Policy Recommendations: Rationale and Protocol for a Modeling Core (ATN 161).

BackgroundThe United States Centers for Disease Control and Prevention estimates that approximately 60,000 US youth are living with HIV. US youth living with HIV (YLWH) have poorer outcomes compared with adults, including lower rates of diagnosis, engagement, retention, and virologic suppression. With Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) support, new trials of youth-centered interventions to improve retention in care and medication adherence among YLWH are underway.ObjectiveThis study aimed to use a computer simulation model, the Cost-Effectiveness of Preventing AIDS Complications (CEPAC)-Adolescent Model, to evaluate selected ongoing and forthcoming ATN interventions to improve viral load suppression among YLWH and to define the benchmarks for uptake, effectiveness, durability of effect, and cost that will make these interventions clinically beneficial and cost-effective.MethodsThis protocol, ATN 161, establishes the ATN Modeling Core. The Modeling Core leverages extensive data—already collected by successfully completed National Institutes of Health–supported studies—to develop novel approaches for modeling critical components of HIV disease and care in YLWH. As new data emerge from ongoing ATN trials during the award period about the effectiveness of novel interventions, the CEPAC-Adolescent simulation model will serve as a flexible tool to project their long-term clinical impact and cost-effectiveness. The Modeling Core will derive model input parameters and create a model structure that reflects key aspects of HIV acquisition, progression, and treatment in YLWH. The ATN Modeling Core Steering Committee, with guidance from ATN leadership and scientific experts, will select and prioritize specific model-based analyses as well as provide feedback on derivation of model input parameters and model assumptions. Project-specific teams will help frame research questions for model-based analyses as well as provide feedback regarding project-specific inputs, results, sensitivity analyses, and policy conclusions.ResultsThis project was funded as of September 2017.ConclusionsThe ATN Modeling Core will provide critical information to guide the scale-up of ATN interventions and the translation of ATN data into policy recommendations for YLWH in the United States.