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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