Targeted Research Cohorts Working Group
CFAR Targeted Research Cohorts (TRCs): The CFAR Data Repository reflects clinical care. In contrast, each TRC prospectively recruits a cohort to test specific hypotheses, and collect specific data and specimens over defined time periods. Each cohort:
- Targets a research theme
- Includes evaluations beyond clinical care (e.g., PBMCs, DEXAs)
- Favors collaboration through stored data, specimens, and co-enrollment into other studies
- Is led by a principal investigator with relevant expertise
- Is coordinated through regular TRC-WG meetings
Data and specimens collected by TRCs allow new research questions to be quickly addressed, and strengthen other studies that involve these same individuals. Data harmonization across TRCs is facilitated by REDCap (Remote Entry and Data Capture), a system developed by VU DBMI (described below).
Please contact Deborah Sutherland, RN, research manager, for more information.
Patient-related Research Programs
The VM-CFAR strives to increase multidisciplinary research, enhance linkage between multiple programs and investigators and draw on these programs for expertise/collaboration.
Vanderbilt Comprehensive Care Center (VCCC, Stephen Raffanti, Director) is one of the nation’s largest HIV primary care clinics. From 1998 to 2008, 37% of patients were black and 24% female, and household income was <$10,000. In nearly 50%, there was a history of substance abuse in 38%, and mental health diagnosis in 30%. The VCCC is tightly linked with VM-CFAR and the Vanderbilt AIDS Clinical Trials Center. Before 2010 the center was in a doctor’s office building near Vanderbilt. In a major development, VCCC moved in 2010 to Vanderbilt Health One Hundred Oaks with greatly increased and improved space for our HIV clinical and research programs. The benefits of this transition are immense for our entire CFAR, and result from a new $2 million investment by Vanderbilt into HIV care, research and training for acquisition and renovation.
Vanderbilt AIDS Clinical Trials Center (ACTC, David Haas, principal investigator) is the primary site for HIV treatment trials in Tennessee. The ACTC has enrolled >1,300 study volunteers since 1992, has been a Clinical Research Site (CRS) of the NIAID-funded ACTG since 2000, and is primarily supported by NIH. It is consistently a top performing ACTG site (#1 in both accrual and data management among 47 US sites through April 2011).
Vanderbilt HIV Vaccine Program (VHVP, Spyros Kalams, principal investigator) was a founding member of the AIDS Vaccine Evaluation Group, now the HIV Vaccine Trials Network (HVTN). The VHVP has enrolled >1000 volunteers into >50 trials, is adept at studying HIV immune responses, and has robust community outreach. In 2005 ACTG and HVTN joined to form a single Clinical Trials Unit linked with VM-CFAR.
Meharry Center for Health Disparities Research in HIV/AIDS (CHDR, James Hildreth, principal investigator) is an NCRR program awarded in 2003 to strengthen HIV research. The CHDR environment enhances research training and fosters high quality research to compete for funding. Since becoming CHDR's first director in 2005, Dr. Hildreth has markedly improved the infrastructure for research, training and faculty recruitment at MMC.
The VICTR Clinical Research Center (VCRC, David Robertson, principal investigator), one of the nation’s largest CRCs, offers a wide range of resources including around-the-clock nursing and nutritional support. Space and equipment include: cardiovascular physiology, bio-nutrition assessment, assay development, energy balance and PET and fMRI imaging. Many top U.S. clinical investigators trained at VCRC. The Meharry CRC on the Meharry Medical College campus supports outpatient research of MMC investigators.
Tuberculosis clinical research at Vanderbilt has grown markedly in recent years. Tim Sterling is principal investigator of Vanderbilt’s site of the Centers for Disease Control’s TB Trials Consortium (TBTC), and led TBTC Study 26, the largest study of latent M. tuberculosis infection in decades. Dr. Sterling’s 2011 presentation to the ATS International Conference reported the efficacy of a 3-month isoniazid/rifapentime regimen vs. the standard 9-month regimen. This historic discovery will likely increase the proportion of people who finish treatment, helping stop the global spread of TB. Dr. Sterling has also initiated multiple projects in Tennessee, established an electronic database at Metro Health Dept, which he uses for mentoring and research. He studies TB immunogenetics in Tennessee and Brazil, and is co-investigator on the TB Epidemiologic Studies Consortium. His research complements lab work of Doug Kernodle in TB vaccinology. Drs. Kalams and Kernodle collaborate on TB vaccine studies, and Christina Fiske is K23-funded to study TB pathogenesis.
The Vanderbilt Institute for Global Health (VIGH) is a university-wide center initiated in 2005. With a focus on HIV, VIGH has built a program of >$20 million for PEPFAR projects in Mozambique, Zambia and Nigeria as well as NIH and CDC-sponsored research and Fogarty/NIH-supported training. Lead by Dr. Vermund, VIGH is the Fogarty International Clinical Research Scholars and Fellows (FICRS-F) Support Center, an AIDS International Training and Research Program, the IeDEA Coordinating Center for NIH, and recipient of a Methods for Prevention Packages Program (MP3) R01 for ART for Prevention research in China. For six years Dr. Vermund has been principal investigator of the HIV Prevention Trials Network (HPTN) that reported recently the paradigm-shifting 052 trial, documenting a 96% decline in transmission between discordant partners when the HIV+ partner was on ART (tentative acceptance as Cohen MS, et al. NEJM). VIGH members engage in HIV-related research, training, and capacity building in >16 countries, including 8 PEPFAR core partner nations. Work nested in PEPFAR engages traditional healers, clinical outcomes in Mozambique and Nigeria, and poverty and HIV research.
CFAR Specimen Processing and Archiving, overseen by the TRC-WG, strives to assure that the CFAR Specimen Repository is of high quality, complete, and efficiently tracked. Challenges are addressed during TRC-WG meetings. During the previous funding period the TRC-WG:
- Implemented a "point of phlebotomy" cold chain for plasma specimens
- Assigned unique CFAR patient identifiers to each CFAR study participant that track across studies (to allow later linkage of de-identified datasets)
- Optimized specimen storage with tracking via Lab Data Management System (LDMS)
- Scanned consent documents for digital storage
The CFAR Specimen Repository was initiated in 1999 at the CCC, with Vanderbilt's support for renovation, equipment and a technician. The VM-CFAR now handles all IRB approval, sample processing, tracking and distribution. Whenever a CD4 count is ordered on a consented patient, an extra 14 mL whole blood is obtained for -80OC plasma and cell pellet storage. Through May 2011, a total of 3,004 patients had consented to this repository (2,269 under the current version which includes genetic consent). Specimens represent >20,000 visits, with >105,000 total aliquots (>53,000 plasma, >48,000 cell pellets). There are also >1,500 CSF aliquots from Dr. Haas’ projects (33,34,36). This is a rich resource for translational research.
Vanderbilt DNA Resources Core (DNARC) in the Center for Human Genetics Research (CHGR) provides state-of-the-art DNA extraction and banking. Since 1999 Dr. Haas has led the ACTG’s human genomics initiative, including its system for DNA archiving and distribution that protects patient rights and confidentiality. The ACTG DNA Repository at VU DNARC contains DNA from >13,000 ACTG trials participants nationwide, and a growing number from non-US ACTG sites (e.g., South Africa and Peru).