NIH U-01 Application

1. NIH U-01 Application Limited Competition: Women’s Interagency HIV Study (WIHS-V) http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-002.html

2. NIH U-01 Application Components of Participating Organizations: National Cancer Institute (NCI): http://www.cancer.gov/ National Institute of Allergy and Infectious Diseases (NIAID): http://www.niaid.nih.gov/ Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): http://www.nichd.nih.gov/ National Institute on Drug Abuse (NIDA): http://www.nida.nih.gov/nidahome.html National Institute of Mental Health (NIMH): http://www.nimh.nih.gov/

3. NIH U-01 Application • Release Date:  November 29, 2011 • Letters of Intent Due Date: January 22, 2012 • Application Due Date: February 22, 2012, by 5:00PM • Scientific Merit Review: June 2012 • Advisory Council Review Date: October 2012 • Earliest Anticipated Start Date: January 2013 • Expiration Date: February 23, 2012

4. NIH U-01 Application Overall Purpose of WIHS V: • The purpose is to continue support for clinical, epidemiologic and basic research on an HIV cohort of women who are representative of the U.S. HIV-1 epidemic. • The purpose of the Women’s Interagency HIV Study V (WIHS-V) is to characterize the long-term, natural and treated history of HIV infection in the current cohort of women, and recruit and retain new women into the cohort to provide insight into the changing demographics of the HIV epidemic among women in the U.S.  T • This Limited Competition Funding Opportunity Announcement (FOA) encourages applications from : • 1) current Clinical Research Sites (CRS), • 2) the current Data Management and Analysis Center (WDMAC), and • 3) 1 new Clinical Research Site with capacity to enroll targeted populations of women from a geographically limited region of the U.S. (Alabama, Arkansas, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, or Texas only).  • All cooperative agreement awards funded under this FOA will comprise the WIHS – V epidemiologic cohort.

5. NIH U-01 Application Award Information • Award Budget: $3.5 million (maximum) of total cost per clinical research site. • Project Duration: 5 years • # of Expected Awards: 6-8 awards, totaling $23.9M • 7 awards are expected for the existing sites; 1 award to a new site located in the South.

6. NIH U-01 Application Concept of WIHS-V • The approved concept for WIHS plans to continue the program, whereby seeking applications from the existing 6 HIHS clinical sites and 1 data management center as well as competitive applications from sites in the southern U.S.: • North and South Carolina • Tennessee • Georgia • Florida • Alabama • Mississippi • Arkansas • Kentucky • Louisiana • Texas

7. NIH U-01 Application WIHS-V • Seeks applications to fund seven US institutions to enroll and follow HIV-positive and at-risk women and conduct observational clinical research on these women. • WIHS supports clinical personnel, epidemiologists, data management specialists, and statisticians to conduct research on collected clinical data and specimens and to store and provide these specimens and data to investigators worldwide. This renewal also supports replenishment of the cohort, through both the addition of a southern site and adding 200 women per site to ensure that WIHS remains representative of women with HIV in the U.S. and maintains sufficient statistical power to address key questions across the full age spectrum. WIHS will facilitate research in the new NIH priority area of comparative effectiveness, including clinical trials to study the effectiveness of clinical and behavioral interventions already in use in HIV-positive or HIV-negative patient populations.

8. NIH U-01 Application Eligible Individuals (Principal Director/Principle Investigator): • Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD(s)/PI(s) is invited to work with his/her organization to develop an application for support. • Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.For institutions/organizations proposing multiple PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide. • Applications proposing Multiple PD(s)/PI(s) are particularly appropriate for this program, including those with diverse expertise in clinical infectious diseases and HIV epidemiologic research.   

9. NIH U-01 Application Applicants for New Clinical Research Sites should: • Describe their ability to recruit and retain the targeted participant population, follow the WIHS standard data and specimen collection protocols, maintain a local scientific agenda related to WIHS goals, and contribute to an overall WIHS Scientific Research Agenda.  • Propose research at the site level in addition to work which could be conducted across multiple WIHS CRSs. • Demonstrate capacity to recruit at least 200 women (but no more than 300) who are representative of the local epidemic, which would include women who are and women who are not engaged consistently in HIV care. This is to ensure sufficient statistical power and meet the goals of WIHS-V. • Given that the WIHS cohort should represent women across the spectrum of care, receiving HIV care should not be a requirement for enrolling in the WIHS.  The disassociation of WIHS participation from care is a key element to understanding the true epidemiology of HIV among women. However, WIHS CRSs should describe how they facilitate access to care.  While applicants should describe their enrollment plans in their applications, the final determination of the enrollment criteria for the new CRS will be determined by the WIHS-V Executive Committee and NIH, in consultation with the WIHS External Advisory Board.

10. Research Scope Scientific agenda of WIHS awardees may include, but not limited to: • Antiretroviral treatment • Therapeutics • Comorbidities • Substance use • Pathogenesis • Cancer • Epidemiologic and statistical methods • Through this FOA, NIAID will support epidemiology of HIV infection and its treatment including the range of acute and chronic pathologies in women over the full course of their adult life with HIV.  The FOA also supports research on behavioral components of HIV care including how women access care, remain in care, initiate HIV therapy, suppress virus, and maintain viral suppression.  Research on these components, but within the context of treatment as prevention, is particularly encouraged.  • It is also expected that the WIHS consortium will continue to provide a platform for collaborations that lead to independent, investigator-initiated research projects.  In the past,  administrative supplements have been used to supplement WIHS-funded grantees in order to address high priority questions, such as the association of race and gender in response to potent ARV therapy, alternative methods of measuring ARV exposure (hair analysis), and most recently the potential impact of abacavir use on HIV- and cardiac-related inflammation. These additional investigations have resulted in numerous important publications for the field of HIV/AIDS research.