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Proposing a Network Behavioral Study Affiliated Research Groups and General Resources
This page is for current and future network behavioral and social science researchers as they propose new studies, request data sets for additional analyses, apply for scholar programs, and liaise with colleagues.
 
Below, please find information on the steps required to propose a NIH HIV/AIDS Clinical Trials Network study. Included are links to web pages offering details on proposing a study to the various NIH networks and committees addressing behavioral and social science questions.
 
Click on the name of the Network to view the information below.
  
 

 Networks

 

ACTG                                                  

HPTN                                                   MTN

HVTN                                                   Affiliated Research Groups

IMPAACT                                              General Resources

ATN Network Background & Scientific Priorities:
 
The primary mission of the ATN is to conduct U.S.-based research, both independently and in collaboration with existing research networks and individual investigators, in HIV-infected and HIV-at-risk pre-adolescents, adolescents, and young adults up to age 25 years. Prevention research, not the development of antiretroviral therapy trials, remains a large focus of research for pre-adolescents. Much of the research activity of the ATN focuses on collaboration with the Clinical Trials Networks supported by other institutes of the NIH, including but not limited to NIAID and the National Cancer Institute (NCI) through coordination of research. The ATN has the capacity for developing and conducting selected behavioral, community-based translational, prophylactic, therapeutic, microbicide and vaccine trials based on and adding to the information developed through the Adolescent Medicine HIV/AIDS Research Network (1994-2001) and the earlier years of the Adolescent Medicine Trials Network (2001-2011). The ATN is funded by the National Institute of Child Health and Human Development.
 
The ATN brings expertise and resources to collaborative protocol development that ensures feasible and acceptable study design as well as experience in recruiting and retaining this unique population. This initiative calls for a broad array of intervention studies aimed at the primary, secondary, and tertiary prevention of HIV infection in pre-adolescents, adolescents, and young adults at clinical sites and in their surrounding communities. These include pilot phase and formative studies as well as selected larger efficacy level interventions, with appropriate collaboration from other networks when needed. Comparative effectiveness and operational research, including program evaluation research, may also be conducted when necessary and feasible. This network designs, develops, and conducts multiple common clinical trials as well as pertinent formative and translational research studies collaboratively or independently when needed. The ATN strives to bring the required numbers of subjects into rigorously designed common protocols and thus address pressing research questions in youth more quickly than individual centers acting alone.
 
The ATN offers expertise and infrastructure to collaborative protocol development that will ensure feasible and acceptable study design as well as experience in recruiting and retaining this unique population. The network investigators are strongly committed to developing the best scientific knowledge possible and are committed as individual professionals and as a group to improving the health and quality of life of HIV-infected and other high-risk adolescents. The network welcomes the opportunity to consider collaborative proposals from other basic science and clinical investigators.
 
The ATN offers three key features to collaborators in the field of adolescence and HIV infection:
  • Leadership by experts with behavioral, clinical, therapeutic, epidemiologic, laboratory, and statistical expertise to set research priorities;
  • Resources for collaborative protocol development to ensure feasible and acceptable study design; and
  • Experience in recruiting and retaining the adolescent population in clinical trials.
Opportunities & Proposal Process:
  • Investigators interested in collaborating with the ATN will develop a brief description of the proposed study in a short encapsulated format, i.e., a Protocol Concept Capsule (PCC), following the development procedure in Step One, Initiation of a Protocol Concept, of the ATN Policy for Study Concept Plan Development. Additionally, the investigators will identify who will collect the data, manage the data, and be responsible for providing the Executive Committee with data analysis. The collaboration supports the overall purpose of the Network and is within the prioritized scientific agenda as established by the Executive Committee. 
ClinicalTrials.gov 
ClinicalTrials.gov: Searchable clinical trials database that includes results from many recent trials (e.g., A5202).
 
 
 
HANC offers various resources for behavioral and social scientists (BSS) interested in collaborating with the NIH HIV/AIDS Clinical Trials Networks:
  • Behavioral Science Interest Group (BSIG): The BSIG is a listserv connecting BSS, Network Leaders, protocol team members, community members, and advocates.  HANC circulates a weekly digest noting funding announcements, relevant presentations, tools and measures, and articles of interest saved to the BSIG Resource Center.
  • BSIG Resource Center and Document Library: A password protected forum to share ideas; post relevant articles; house network CRFs and behavioral measures; gather and address BSS needs; and collaborate on related topics. PDFs of articles etc. are available to all BSIG members.
  • BSIG Rx Connect: Investigators pose research and technical questions to one another using the BSIG listserv.  HANC facilitates the discussions and documents the suggestions for future queries.
  • BSIG Topics of Interest Webinar Series: HANC curates a webinar series addressing BSS research concerns. Recent presentations included the HIV epidemic in the U.S. MSM population, conducting research using social media
  • Behavioral Science Working Group: The overarching goal is to ensure that the networks benefit from state-of-the-science methods and procedures that optimize adherence to product and risk reduction counseling and minimize the risk of confounding user- and product failures. Further, the BSWG endeavors to maximize fiscal and scientific resources, reduce redundancies, improve cross-network communication and collaboration, and ensure that the best quality behavioral science is integrated into clinical trials.  The BSWG features representatives from each participating network, as well as the relevant data coordinating and operations centers, community partners and key NIH staff. These representatives serve as liaisons to their respective entities and enlist assistance from additional staff for specific BSWG tasks as indicated.
  • BSWG Report Library:  Recommendations, guidance, and detailed reports emerging from annual BSWG meetings as well as focus groups considering risk assessment, neurocognitive assessments, and behavioral data capture technologies.
  • Public BSS Publications Library Page Content: An important resource for behavioral and social scientists as well as those interested in relevant topics in HIV social and behavioral research. Each entry includes PubMed IDs, article abstract, and a link to the full text (if available).
  • Youth Prevention Working Group (YPRWG): The cross-network/trans-Institute was formed in the winter of 2012.  The group consists of representatives from the networks, the Adolescent Trials Network (ATN), DAIDS, NIAID, NIMH, NIDA, and NICHD. The group is interested in coordinating sharing of network adolescent research agendas; addressing the challenge of conducting trials across multiple networks, considering tangible outcomes such as dropping the mean age of network volunteers, validating existing tools, considering adolescent issues early on in design process, reviewing relevant informed consent documents, and collating a set of core competencies.
  • Other HANC projects addressing behavioral research concerns follow:
    • Community Partners is made up of community representatives from the NIH Networks community groups and network staff, and other external community advisors. Community Partners represents community research needs and priorities to the HIV/AIDS Clinical Trials Network Leadership Operations Group (NLOG) and Strategic Working Group (SWG) and other advisory groups or committees as needed/requested. CP provides input to NIH research plans as they relate to scientific agendas, ethical conduct of clinical trials, community education, community training and communication/information dissemination in a manner that ensures respect for community priorities and continued community participation.
    • The Legacy Project works nationally to increase awareness of and build support for HIV prevention and treatment clinical and behavioral research by addressing factors that influence participation of historically underrepresented communities.  The Legacy Project achieves its core mission through ongoing and strategic engagement, collaboration, education, and scientific investigation. With a team of diverse, skilled and devoted staff, the Legacy Project works to cultivate and enhance partnerships and relationships among the NIH HIV/AIDS Clinical Trials Networks and research sites, research and academic institutions, governmental agencies, community-based organizations and affiliates, while ensuring a commitment to capacity building for communities and populations most impacted by the HIV epidemic in the United States.
 
 
The PHACS network was established in 2006 to address two critical pediatric HIV research questions: the long-term safety of fetal and infant exposure to prophylactic antiretroviral (ART) chemotherapy, and the effects of perinatally acquired HIV infection in adolescents. The goals of this network are to: create a body of data to understand more fully the effect of HIV on sexual maturation, pubertal development, and socialization of perinatally HIV-infected pre-adolescents and adolescents; acquire more definitive information regarding long-term safety of ARV agents when used during pregnancy and in newborns; ensure a mechanism is in place to estimate the upper bounds of risk for children associated with the use of ARVs in their HIV-infected pregnant mothers as recommended in the Public Health Service Guidelines to prevent perinatal HIV transmission; and ensure that the follow-up of these populations continues.
 
Opportunities & Proposal Process:
  • Guidelines for development of a sub-study or data analysis capsule can be found here.
  • Please contact the Behavioral and Neurological Disease Working group through the PHACS Coordinating Center at phacscc@tulane.edu ophacscc@fstrf.org.
 

Collaboration

Collaboration and data sharing are critical to PHACS and will lead to better treatments not only for HIV/AIDS, but also for other infections and health conditions. Our protocols are structured to accommodate focused sub-studies, and we welcome collaboration with researchers from a range of fields and institutions. Many of our substudies have led to advancement in knowledge around best practices in pediatric HIV. For example, a collaboration between PHACS and the Centers for Disease Control and Prevention led to the recommendation from the Advisory Committee on Immunization Practices that HIV-infected youth be re-immunized for measles after receiving combination ART.
Typically, people in the following categories identify topics for our substudies:
  • The PHACS Scientific Leadership Group
  • PHACS clinical sites
  • NIH program scientists
  • HIV clinical research networks supported by NICHD and the collaborators listed above
  • Independent investigators conducting HIV-related research funded by NIH Institutes and Centers
Are you interested in collaborating with PHACS on a study? Email Us to inquire. 
 
 
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