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Adherence to antiretroviral therapy (ART) among youth remains low. We piloted an adapted active visualization device that demonstrates how ART works in the body. Youth living with HIV were randomized to: (1) standard care (n = 14) or the (2) adapted active visualization intervention (n = 14) and 71% of the sample (n = 19) were re-assessed on viral load, adherence behaviors, and illness perceptions 2.5months later. Intervention youth had lower viral loads, reported less difficulty in adhering to ART, and more motivation and control over their HIV than standard care at follow-up. Active visualization may be an acceptable tool to address ART adherence among youth.

Background Tenofovir disoproxil fumarate (TDF) decreases bone mineral density (BMD). We hypothesized that vitamin D3 (VITD3) would increase BMD in youth receiving TDF. Methods This was a randomized, double-blind, placebo-controlled trial of directly observed VITD3 vs placebo every 4 weeks for 48 weeks in youth aged 16-24 years with HIV, RNA load

Background Gay, bisexual, transgender, and homeless youth are at risk of sexually transmitted infections. As part of an adolescent human immunodeficiency virus prevention study, we provided same-day Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) testing and treatment. We aimed to evaluate the feasibility and effectiveness of same-day CT and NG treatment on the proportion of participants receiving timely treatment. Methods We recruited adolescents with high sexual risk behaviors aged 12 to 24 years from homeless shelters, lesbian, gay, bisexual, and transgender organizations, and community health centers in Los Angeles, California, and New Orleans, Louisiana from May 2017 to June 2019. Initially, participants were offered point-of-care pharyngeal, rectal, and urethral/vaginal CT and NG testing and referral to another clinic for treatment. After March 2018 in Los Angeles and November 2018 in New Orleans, we provided same-day treatment (and partner treatment packs) for study participants. We measured the proportion of participants who received same-day treatment and the median time to treatment. We collected frequency of partner treatment and any reported adverse treatment-related events. Results The proportion of participants receiving same-day CT and NG treatment increased from 3.6% (5/140) to 21.1% (20/95; Δ17.5%; 95% confidence interval, 9.2%-26.9%) after implementation of same-day testing and treatment. The median time to treatment decreased from 18.5 to 3 days. Overall, 36 participants took a total of 48 partner treatment packs. There were no reported treatment-related adverse events. Conclusions Providing sexually transmitted infection treatment to adolescents at the same visit as testing is feasible and safe, and can increase the proportion of individuals receiving timely treatment.

Author(s): Shannon, Chelsea L; Keizur, Erin M; Fehrenbacher, Anne; Wood-Palmer, Drew; Ramos, Wilson; Koussa, Maryann; Fournier, Jasmine; Lee, Sung-Jae; Patel, Dhara; Akabike, Whitney N; Abdalian, Sue Ellen; Rotheram-Borus, Mary Jane; Klausner, Jeffrey D; Adolescent Trials Network (ATN) CARES Team | Abstract: BackgroundGay, bisexual, and transgender youth and homeless youth are at high risk for sexually transmitted infections (STIs). However, little recent data exist describing STI positivity by anatomical site among those groups. We determined the positivity of Chlamydia trachomatis (CT) infection, Neisseria gonorrhoeae (NG) infection, and syphilis antibody reactivity among lesbian, gay, bisexual, transgender, and homeless youth.MethodsWe recruited 1,264 adolescents with high risk behavior aged 12 to 24 years from homeless shelters, lesbian, gay, bisexual, and transgender organizations, community health centers, and using social media and online dating apps in Los Angeles, California and New Orleans, Louisiana from May 2017 to February 2019. Participants received point-of-care pharyngeal, rectal, and urethral/vaginal CT and NG testing and syphilis antibody testing. We calculated STI positivity by anatomical site and compared positivity by participant subgroups based on human immunodeficiency virus (HIV) status, sex assigned at birth, and gender identity.ResultsCT and NG positivity and syphilis antibody reactivity was higher among HIV-infected adolescent men who have sex with men (MSM) than HIV-uninfected adolescent MSM (40.2% vs. 19%, P l 0.05), particularly CT or NG rectal infection (28% vs. 12.3%, P l 0.05). Of participants with positive CT or NG infections, 65% had extragenital-only infections, 20% had both extragenital and urogenital infections, and 15% had urogenital-only infections.ConclusionsSexually transmitted infection positivity was high, particularly among transgender women and MSM. The high proportion of rectal and pharyngeal infections highlights the importance of both urogenital and extragenital STI screening. More accessible STI testing is necessary for high-risk adolescent populations.

Background Human Papillomavirus (HPV) is common and is linked to cancer in both males and females. Efforts are underway to increase uptake of the vaccine (Gardasil) that is now recommended for youth and adults up to age 45. However, little is known about the role of gender identify on vaccination, particularly among youth at increased risk for contracting and spreading the virus. Methods We analyzed data (N=1070) from a longitudinal study of high-risk HIV negative youth and youth living with HIV aged 12–24. Data were collected in Los Angeles, CA and New Orleans, LA from clinic and community settings. We examined self-reports of HPV vaccination as well as predictors of vaccination. Results Cis-gender females (CGFs) had the highest proportion of youth reporting vaccination (52.7%) followed by transgender youth (45.9%), gender non-conforming youth (44.2%), and MSM (39.0%). Cis-gendered, heterosexual males (CGHMs) reported the lowest proportion (32.9%). However, 18.8% of youth did not know if they had received the vaccine. In our multivariate logistic model examining predictors of vaccination, gender identity was only significant for CGHMs. Other significant variables included age, some education higher than a high school diploma or completing higher education compared to less than high school, ever being tested for Hepatitis C, currently having a healthcare provider, always using condoms, and Latino or other race/ethnicity compared to African-American. Conclusion Results suggest that despite national efforts to increase the uptake of the vaccine, many youth at high-risk for HPV have not received it or did not know if they had. CGFs appear to have the highest uptake, but CGMs are a group for whom increased efforts targeting vaccination are needed. Demographic and health care factors may also impact vaccination rates. Research is needed on barriers to vaccination and new interventions that go beyond education and promotion such as policy initiatives. Disclosure No significant relationships.

Background Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) disproportionately affect adolescents, however, many adolescents receive infrequent sexually transmitted infection (STI) testing. Gay, bisexual, transgender, and homeless youth are at increased risk for STIs. Currently, the Centers for Disease Control and Prevention recommend only annual screening of CT/NG for all sexually active gay, bisexual, and other men who have sex with men (MSM). Methods We recruited adolescents aged 12–24 years from homeless shelters, lesbian, gay, bisexual, transgender, and queer (LGBTQ) organizations, and community health centers in Los Angeles, California and New Orleans, Louisiana from May 2017-January 2019. All participants received point-of-care pharyngeal, rectal, and urethral/vaginal CT/NG testing using the Cepheid GeneXpert (Sunnyvale, CA). We measured the proportion of participants with CT/NG infections every 4 months for 12 months. We compared the proportion of STI positivity at each time point to the baseline visit using a McNemar’s test. Results Overall, 156 participants received testing (53 MSM/transgender women, 56 heterosexual men, 47 heterosexual women). Baseline prevalence of CT/NG among MSM and transgender women was 18.9%. At the 4 month visit, prevalence was 5.7% (Δ = 13.2%, P-value = 0.04). At the 8 month visit, prevalence was 15.1% (Δ = 3.8%, P-value = 0.99). At the 12 month visit, prevalence of CT/NG was 3.8%, a 15.1% decrease from baseline (P-value = 0.02). There was no significant difference in prevalence among heterosexual men between their baseline visit (5.4%) and their 12-month visit (8.9%) (Δ = 3.5%, P-value = 0.82). There was no significant difference in prevalence among heterosexual women between their baseline visit (10.6%) and their 12-month visit (8.5%) (Δ = 2.1%, P-value = 0.99). Conclusion Providing regular testing among adolescent MSM and transgender women may be beneficial in reducing the prevalence of CT/NG infections. Reasons for failure to reduce prevalence among heterosexual men and women require further study. Disclosure No significant relationships.

Author(s): Nielsen-Saines, Karin; Mitchell, Kate; Kerin, Tara; Fournier, Jasmine; Kozina, Leslie; Andrews, Brenda; Cortado, Ruth; Bolan, Robert; Flynn, Risa; Rotheram, Mary Jane; Abdalian, Sue Ellen; Bryson, Yvonne; Adolescent Medicine Trials Network (ATN) CARES Team; Mobilizing Minds Research Group | Abstract: BackgroundEarly treatment studies have shown that prompt treatment of HIV with combination antiretroviral therapy (cART) can limit the size of latent viral reservoirs, thereby providing clinical and public health benefits. Studies have demonstrated that adolescents have a greater capacity for immune reconstitution than adults. Nevertheless, adolescents who acquired HIV through sexual transmission have not been included in early treatment studies because of challenges in identification and adherence to cART.ObjectiveThis study aimed to identify and promptly treat with cART youth aged 12 to 24 years in Los Angeles and New Orleans who have acute, recent, or established HIV infection, as determined by Fiebig stages 1 to 6 determined by viral RNA polymerase chain reaction, p24 antigen presence, and HIV-1 antigen Western blot. The protocol recommends treatment on the day of diagnosis when feasible. Surveillance and dedicated behavioral strategies are used to retain them in care and optimize adherence. Through serial follow-up, HIV biomarkers and response to antiretroviral therapy (ART) are assessed. The study aims to assess viral dynamics, decay and persistence of viral reservoirs over time, and correlate these data with the duration of viral suppression.MethodsA total of 72 youth (36 acutely infected and 36 treatment naive controls) are enrolled across clinical sites using a current community-based strategy and direct referrals. Youth are prescribed ART according to the standard of care HIV-1 management guidelines and followed for a period of 2 years. Assessments are conducted at specific time points throughout these 2 years of follow-up for monitoring of adherence to ART, viral load, magnitude of HIV reservoirs, and presence of coinfections.ResultsThe study began enrolling youth in July 2017 across study sites in Los Angeles and New Orleans. As of September 30, 2018, a total of 37 youth were enrolled, 12 with recently acquired, 16 with established HIV infection as determined by Fiebig staging, and 9 pending determination of Fiebig status. Recruitment and enrollment are ongoing.ConclusionsWe hypothesize that the size of the HIV reservoir and immune activation markers will be different across groups treated with cART, that is, those with acute or recent HIV infection and those with established infection. Adolescents treated early who are virally suppressed will have diminished HIV reservoirs than those with established infection. These youth may be potential candidates for a possible HIV vaccine and additional HIV remission intervention trials. Our study will inform future studies of viral remission strategies.International registered report identifier (irrid)DERR1-10.2196/10807.

Background: Sexually transmitted infection (STI) rates are increasing in the United States, with approximately half of new infections occurring among adolescents aged 15-24 years. Gay, bisexual, and transgender youth (GBTY), homeless youth, and youth with histories of drug use, mental health disorders, and incarceration are all at uniquely high risk for STIs. However, these adolescents often lack access to sexual health services. Objective: This study aims to use point-of-care STI tests in community-based settings to screen for and treat STIs in adolescents. Methods: We are recruiting 1500 HIV-uninfected youth and 220 HIV-infected youth from homeless shelters, GBTY organizations, and community health centers in Los Angeles, California and New Orleans, Louisiana. Study participants will receive STI screening every 4 months for 24 months. STI screening includes rapid HIV, syphilis, Chlamydia trachomatis, Neisseria gonorrhoeae, and Hepatitis C virus testing. Trained paraprofessionals will conduct all STI testing. When a participant screens positive for an STI, they are either linked to a partner medical clinic or provided with same-day antibiotic therapy and expedited partner therapy. We will monitor STI prevalence among study participants as well as point-of-care test performance, linkage to care, and treatment outcomes. Results: The project was funded in 2016, and enrollment will be completed in 2019. Preliminary data analysis is currently underway. Conclusions: As STI rates continue to rise, it is important to improve access to screening and treatment services, particularly for high-risk adolescents. In this study, we aim to evaluate the use of point-of-care STI diagnostic tests in community-based organizations. We hope to determine the prevalence of STIs among these adolescents and evaluate the acceptability and feasibility of community-based STI screening and treatment. Trial Registration: ClinicalTrials.gov NCT03134833; https://clinicaltrials.gov/ct2/show/NCT03134833 International Registered Report Identifier (IRRID): DERR1-10.2196/10795

Background: Over 20% of HIV diagnoses in the United States are among youth aged 12-24 years. Furthermore, youth have the lowest rates of uptake and adherence to antiretroviral (ARV) medications and are least aware of their HIV status. Objective: Our objective was to design a set of interrelated studies to promote completion of each step of the HIV Prevention Continuum by uninfected youth at high risk (YHR), as well as completion of steps in the Treatment Continuum by youth living with HIV (YLH). Methods: Gay, bisexual, and transgender youth; homeless youth; substance-abusing youth; youth with criminal justice contact; and youth with significant mental health challenges, particularly black and Latino individuals, are being recruited from 13 community-based organizations, clinics, drop-in centers, and shelters in Los Angeles and New Orleans. Youth are screened on the basis of self-reports and rapid diagnostic tests for HIV, drug use, and sexually transmitted infections and, then, triaged into one of 3 studies: (1) an observational cohort of YLH who have never received ARV medications and are then treated—half initially are in the acute infection period (n=36) and half with established HIV infection (n=36); (2) a randomized controlled trial (RCT) for YLH (N=220); and (3) an RCT for YHR (N=1340). Each study contrasts efficacy and costs of 3 interventions: an automated messaging and weekly monitoring program delivered via text messages (short message service, SMS); a peer support intervention delivered via social media forums; and coaching, delivered via text message (SMS), phone, and in-person or telehealth contacts. The primary outcomes are assessing youths’ uptake and retention of and adherence to the HIV Prevention or Treatment Continua. Repeat assessments are conducted every 4 months over 24 months to engage and retain youth and to monitor their status. Results: The project is funded from September 2016 through May 2021. Recruitment began in May 2017 and is expected to be completed by June 2019. We expect to submit the first results for publication by fall 2019. Conclusions: Using similar, flexible, and adaptable intervention approaches for YLH and YHR, this set of studies may provide a roadmap for communities to broadly address HIV risk among youth. We will evaluate whether the interventions are cost-efficient strategies that can be leveraged to help youth adhere to the actions in the HIV Prevention and Treatment Continua. International Registered Report Identifier (IRRID): DERR1-10.2196/10759

Introduction Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general. Methods Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative. Results 123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly. Conclusions Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.

Future HIV vaccine efficacy trials with adolescents will need to ensure that participants comprehend study concepts in order to confer true informed assent. A Hepatitis B vaccine trial with adolescents offers valuable opportunity to test youth understanding of vaccine trial requirements in general.Youth reviewed a simplified assent form with study investigators and then completed a comprehension questionnaire. Once enrolled, all youth were tested for HIV and confirmed to be HIV-negative.123 youth completed the questionnaire (mean age=15 years; 63% male; 70% Hispanic). Overall, only 69 (56%) youth answered all six questions correctly.Youth enrolled in a Hepatitis B vaccine trial demonstrated variable comprehension of the study design and various methodological concepts, such as treatment group masking.