The specific aim of the applicant is to serve as the Data and Operations Center (DOC) for the Adolescent Medicine Trials Network for HIV/AIDS Intervention (ATN). The primary focus of the ATN will be evaluation of behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in HIV-infected adolescents and adolescents at risk for acquiring HIV. As the DOC, Westat aims to work collaboratively with the ATN clinical sites, leadership groups, and the National Institute of Child Health and Human Development (NICHD) program staff, as well as other HIV research networks to develop and conduct studies that are responsive to the scientific agenda. Westat will: (1) maintain the ATN protocol disbursement fund and execute all necessary agreements with sites to support study and subject accrual costs reconciling reimbursement to site performance with NICHD approval;(2) collaboratively plan and conduct all Adolescent Medicine Leadership Group (AMLG) and ATN meetings;(3) provide methodologic and analytic support to the development of independent research projects, design the corresponding data collection forms and database(s), maintain the database(s) and supply the required analytic capacity;(4) supervise all data collection procedures;(5) provide for the most efficient transfer of study data generated by collaborative research;(6) conduct protocol and site registration and other regulatory duties;(7) establish and support Data and Safety Monitoring Boards (DSMB);(8) provide training to all site personnel related to acceptable quality control and quality assurance procedures;(9) provide on-site monitoring;(10) recruit and support the Community Advisory Board (CAB) staff person and provide logistical support to any CAB-associated meetings if requested by NICHD;(11) participate in regular conference calls and attend AMLG meetings;and (12) provide the NICHD an itemized account of all internal expenditures associated with operational, data management, analytic and other supportive activities. Additional tasks related to the management of a specimen repository, drug management, reporting of site performance, and Serious Adverse Event (SAE) reporting will also be performed if requested by NICHD.

Public Health Relevance

Our goal is to provide the appropriate technical expertise and resources to efficiently design, implement, and manage a broad portfolio of therapeutic, behavioral and community studies. Information obtained from these studies will ultimately be used to develop programs and policies for reducing the incidence of new HIV infections, and for improving methods for addressing clinical, behavioral, and social issues faced by HIV- infected adolescents.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
3U01HD040474-13S1
Application #
8741313
Study Section
Special Emphasis Panel (ZHD1-DSR-A (15))
Program Officer
Russo, Denise
Project Start
2001-05-15
Project End
2016-02-29
Budget Start
2013-09-25
Budget End
2014-02-28
Support Year
13
Fiscal Year
2013
Total Cost
$597,000
Indirect Cost
Name
Westat, Inc.
Department
Type
DUNS #
049508120
City
Rockville
State
MD
Country
United States
Zip Code
20850
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Philbin, Morgan M; Tanner, Amanda E; Ma, Alice et al. (2017) Adolescent and Adult HIV Providers' Definitions of HIV-Infected Youths' Successful Transition to Adult Care in the United States. AIDS Patient Care STDS 31:421-427
Philbin, Morgan M; Tanner, Amanda E; DuVal, Anna et al. (2017) Understanding Care Linkage and Engagement Across 15 Adolescent Clinics: Provider Perspectives and Implications for Newly HIV-Infected Youth. AIDS Educ Prev 29:93-104
Miller, Robin Lin; Reed, Sarah J; Chiaramonte, Danielle et al. (2017) Structural and Community Change Outcomes of the Connect-to-Protect Coalitions: Trials and Triumphs Securing Adolescent Access to HIV Prevention, Testing, and Medical Care. Am J Community Psychol 60:199-214
Kahn, Jessica A; Lee, Jeannette; Belzer, Marvin et al. (2017) HIV-Infected Young Men Demonstrate Appropriate Risk Perceptions and Beliefs about Safer Sexual Behaviors after Human Papillomavirus Vaccination. AIDS Behav :
van den Berg, Jacob J; Isabel Fernández, M; Fava, Joseph L et al. (2017) Using Syndemics Theory to Investigate Risk and Protective Factors Associated with Condomless Sex Among Youth Living with HIV in 17 U.S. Cities. AIDS Behav 21:833-844

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