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March 21, 2019 - ATN Protocol Concept Capsule (PCC) Announcement

Introduction

The U.S. National Institutes of Health (NIH)-sponsored Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) aims to develop and conduct innovative behavioral, community- based, translational, therapeutic, microbicide and vaccine trials in HIV-at-risk and HIV-infected youth ages 12 to 24 years, with a focus on the inclusion of minors. The objectives and overarching goals of the ATN are to increase the numbers of at-risk youth who are aware of their serostatus, and for those who are diagnosed with HIV, to increase the numbers in each segment of the care continuum to 95% and to bend the infection rate curve downward toward zero. The ATN currently includes three research program projects (CARES, iTech, Scale It Up) and a coordinating center (CC). A description of the ATN structure and current studies are available at http://atnweb.org. A list of ATN study sites is provided in Appendix A.

Purpose

The ATN welcomes ideas from the scientific community in the form of proposals for new studies which are consistent with the Network's mission and are not currently being planned or pursued elsewhere. The ATN also welcomes proposals from investigators who would like to use existing data and/or specimens collected during ATN studies to answer questions related to the HIV epidemic among US adolescents and young adults. The ATN does not accept concepts that are duplicate or highly overlapping with applications under review at the same time by other funding sources.

Investigators interested in proposing an ATN study should submit a protocol concept capsule (PCC) as described below. Concept capsules are reviewed by the ATN twice per year, with the next deadline for review April 1, 2019.

Scope of Work

PCCs should describe potential R01-like research projects that focus on feasibility, uptake and effectiveness of prevention services, including HIV testing and PrEP among youth at risk of HIV infection, and projects to improve early diagnosis, linkage, retention and viral suppression outcomes for youth with HIV, especially those with sporadic engagement. The planned research projects should be conducted within the U.S. and leverage existing ATN infrastructure to address an important research area. Current areas of particular interest are studies focused on the following research topics:

  • - Evaluation and optimization of community level interventions and programs in collaboration with federal, state or local authorities (e.g., public health authorities) for youth with undiagnosed infection, to improve early diagnosis and linkage/retention in care
     
  • - Evaluation of safety, PK/PD, acceptability, usability and desirability of novel HIV biomedical product methods and delivery systems to prevent or treat HIV infection that strategically align and maintain pace with youth and provider demands
     
  • - Assessment and evaluation of integrated treatment approaches on HIV infection and its therapy, with focus on mental health issues, including depression, trauma, and PTSD
     
  • - HIV risk reduction tools, services and interventions that are delivered by health care providers
     
  • - Evaluation of novel approaches to identifying youth with undiagnosed HIV infection (e.g., technology-based methods, point-of-care/home testing or testing at other settings outside of traditional healthcare venues, behavioral economics, social and sexual networks, and risk venue testing) focused on health disparity populations

Protocol Concept Capsule Requirements

A PCC, no longer than two-pages, should provide a brief description of the proposed study and includes the following:

  • - Study title
  • - Lead investigator(s)
  • - Overall study goal and specific study objectives
  • - Scientific significance
  • - Relevance to overall mission and scientific agenda of the ATN
  • - Study population
  • - Study design and methods
  • - Outcome measures
  • - Approximate sample size (formal sample size calculation not required)
  • - Estimate of total cost of proposed study

The PCC should be submitted to the CC via email to ATNadmin@unc.edu. Questions regarding PCC development and submission should be sent to ATNadmin@unc.edu. The proposing investigator(s) will receive notification of receipt of the PCC from the CC.

Review Process and Prioritization

Submitted PCCs are reviewed by the ATN according to the following criteria:

  • - Relevance: Does the project have relevance to the overall mission and research agenda of the ATN?
     
  • - Resources: What resources will be utilized, both within and outside of the network?
     
  • - Rationale: What is the rationale for including the protocol concept within the network as opposed to a free-standing research effort? Is the proposed study duplicative relative to current ATN studies?

The PCCs are then prioritized based on overall impact, taking into account: Significance, Investigator(s), Innovation, Approach, Environment, and Protections for Human Subjects.

Based on review and prioritization of each PCC, the ATN Executive Committee (EC) will decide to: 1) decline further consideration, 2) invite submission of a full protocol proposal, or 3) request that a representative from the research team proposing the PCC respond to EC questions to aid in the final determination.

Contact Information

PCCs Submission: ATNadmin@unc.edu

Submission Contact: ATNadmin@unc.edu

Scientific/Research Contact: Sonia Lee, Ph.D. (sonia.lee@nih.gov)

 

Appendix A

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ATN Study Sites

iTech

  • Atlanta
  • Boston
  • Bronx
  • Chapel Hill
  • Chicago
  • Houston
  • Jackson
  • Los Angeles
  • Philadelphia
  • Tampa

CARES

  • Los Angeles
  • New Orleans

Scale It Up

  • Baltimore
  • Birmingham
  • Detroit
  • Los Angeles
  • Memphis
  • Miami
  • New York City
  • Philadelphia
  • San Diego
  • Tampa

CC Projects

  • Atlanta
  • Baltimore
  • Bronx
  • Chicago
  • Denver
  • Detroit
  • Ft. Lauderdale
  • Jacksonville
  • Memphis
  • Tampa
  • Washington DC