Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) Technical Assistance Webinar
For Research Program Grants (U19) and Data Coordinating Center (U24)
The ATN is the only national, multicenter research network devoted to the health and well-being of HIV-infected and at-risk adolescents and young adults. The Network was started by the
Maternal and Pediatric Infectious Disease Branch (MPIDB) (formerly the Pediatric, Adolescent, and Maternal AIDS [PAMA] Branch) in 2001 through a cooperative agreement mechanism with co-funding from the National Institute on Drug Abuse and the National Institute of Mental Health. The Branch created the ATN after the Adolescent Medicine HIV/AIDS Research Network external scientific advisory panel stated that interventional studies in adolescents were needed. The first and second funding cycles ended in February 2006 and 2011, respectively; the ATN was re-competed in 2010 and was funded in 2011 for a third five-year period. The ATN has extensive experience in recruiting and retaining understudied youth populations in the United States. Over the past 10 years (2003-2013), they have had over 26,000 enrollments among 88 ATN studies, with enrollment and retention rates among completed studies over 90%. Among 32 studies with completed analyses, there have been 134 manuscripts published with 18 more in review, and 112 abstracts presented, with 8 more in review. Additionally, the ATN has successfully forged collaborations with the CDC, HRSA, ACTG, HVTN, IMPAACT and MTN, as evidenced by 12 co-endorsed collaborating protocols.
The primary mission of the ATN is to conduct both independent and collaborative research that explores promising behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected and at-risk adolescents, ages 12 years through 24 years. ATN activities encompass the full spectrum of research needs for youth, from primary prevention—including HIV preventive vaccine, microbicide, and pre-exposure prophylaxis trials—for HIV at-risk youth in the community to secondary and tertiary prevention with clinical management of HIV infection among youth along the entire HIV care continuum. Secondary and tertiary prevention research investigates novel treatment strategies and regimens, drug adherence, risk reduction interventions, and linkage and engagement to care strategies that can lead to optimal antiretroviral therapy initiation and virologic suppression outcomes.
The overall research agenda of the ATN includes three broad areas:
Therapeutics—The ATN seeks to improve understanding of HIV immunopathogenesis, optimize diagnosis and management, and improve HIV-related co-morbidities in HIV-infected youth. The network also seeks to understand how to best prevent new infections using biomedical modalities such as oral and topical pre-exposure prophylaxis (PrEP) and HIV vaccines, in close collaboration with the community prevention agenda.
Behavior—The behavioral research agenda of the ATN is broadly defined to include the development, adaptation, implementation, and evaluation of culturally appropriate, theory-driven behavioral preventive interventions for HIV and other sexually transmitted diseases in at-risk youth. The behavioral research agenda also is aimed at examining interventions that preserve and improve the well-being of HIV-infected adolescents and young people.
Community Prevention—Community consultations conducted at the beginning of the ATN revealed that the responsibility for decision making about an HIV research agenda for youth should rest with communities. To address this issue, studies within the ATN include community prevention protocols, such as Connect-to-Protect® (C2P). The C2P program has built and continues to foster community trust and engagement, established an extensive and expanding primary prevention research infrastructure, and tested a model of community mobilization that used structural change to produce measurable improved-health outcomes in community youth. The completed work and new protocols in this area are critical to creating lasting behavior change with the ultimate hope of reducing risk for HIV acquisition among youth. Secondary prevention is another burgeoning area of urgent need to address the domestic youth HIV epidemic, and it is part of the ATN's commitment to improving individual treatment outcomes among infected youth along the entire continuum of HIV care by enhancing the identification and linkage to care of those who were previously unaware they were infected. Studies will also address youth retention in care, the prompt initiation of antiretroviral therapy, and barriers to adherence, leading to durable virologic suppression, reduce secondary transmission events, and improve youth health outcomes. The primary prevention infrastructure established under C2P has expanded to undertake the additional secondary prevention objectives of enhancing health outcomes by reducing to structural barriers to linkage, engagement, and retention in care for our nation's HIV-infected youth. This activity is being conducted in collaboration with sister agencies the Centers for Disease Control and Prevention and the Health Resources and Services Administration. The SMILE (Strategic Multisite Initiative for the Identification, Linkage and Engagement in Care of Youth with Undiagnosed HIV Infection) collaboration between the ATN, CDC and HRSA established the first-of-its- kind clinical trials site-health department partnership between US ATN sites and their local health departments to improve the identification of youth with undiagnosed HIV infection, and through an ATN outreach expert, link them to youth-friendly clinical care. Since 2010 when SMILE was implemented, it has led to the identification of over 3,300 youth and linked approximately 2/3 to care across all ATN sites nationally.
Adolescent Medicine Trials Units
There are currently 14 NICHD-funded clinical research sites within the ATN where interested youth can join clinical protocols:
- Baylor College of Medicine (Houston, TX)
- Children's Hospital of Los Angeles (Los Angeles, CA)
- Children's Hospital of Philadelphia (Philadelphia, PA)
- Children's National Medical Center (Washington, DC)
- John H. Stroger, Jr. Hospital of Cook County (Chicago, IL)
- Fenway Health (Boston, MA)
- Johns Hopkins University (Baltimore, MD)
- Montefiore Medical Center (Bronx, NY)
- St. Jude Children's Research Hospital (Memphis, TN)
- Tulane University Medical Center (New Orleans, LA)
- University of Colorado, Denver (Denver, CO)
- University of Miami (Miami, FL)
- University of South Florida (Tampa, FL)
- Wayne State University (Detroit, MI)
ATN Leadership and Operations
The NICHD funds the ATN Coordinating Center, which is responsible for creating the ATN's scientific agenda, and the ATN Data and Operations Center, which is responsible for managing the data and operational aspects of the research conducted in the network:
ATN Coordinating Center (ACC) provides scientific leadership and infrastructure support for the ATN. The ACC principal investigator assembles a multidisciplinary team of established investigators from across the United States to set the research agenda for the network and outlines the priority areas, plans, processes, and timelines for implementing the proposed agenda.
ATN Data and Operations Center (DOC) provides the ATN's infrastructure and organizational support. This includes the funding of study needs and subject enrollment to protocols at the clinical sites, staff and site training, and quality assurance procedures, including site monitoring. The DOC also provides support for ATN study development and conduct, management of the study databases, analytic capacity, and regulatory adherence.