Contents
- 1 Working Groups
- 1.0.1 Aging Working Group
- 1.0.2 Cardiovascular (CVD) Working Group
- 1.0.3 Clinical Outcomes/Epidemiology Working Group
- 1.0.4 Genomics Working Group
- 1.0.5 Human Papilloma Virus (HPV) Working Group
- 1.0.6 Liver Working Group
- 1.0.7 Malignancy Working Group
- 1.0.8 Metabolic Working Group
- 1.0.9 Neuropsychology Working Group
- 1.0.10 Pharmacology Working Group
- 1.0.11 Psychosocial Behavioral Working Group
- 1.0.12 Pulmonary Working Group
- 1.0.13 Sleep Working Group
- 1.0.14 Viral and Immune Pathogenesis Working Group
- 1.0.15 CCS Specimen Allocation Committee (CSAC)
- 1.0.16 Core Laboratory Working Group
- 1.0.17 Data Management Working Group
- 1.0.18 Project Directors Working Group
- 1.0.19 Medical Record Abstraction Working Group
- 1.0.20 Communications and Dissemination Committee (CDC)
- 1.0.21 Investigator Developmental Awards Committee (IDAC)
- 1.0.22 Quality Assurance Advisory Committee (QAAC)
- 1.0.23 Biomarkers Working Group
- 1.0.24 Data Analysis/Methods Working Group
- 1.0.25 Gynecology & Pregnancy Working Group
- 1.0.26 Microbiome Working Group
- 1.0.27 Renal Working Group
Working Groups
Aging Working Group
Studies complex characteristics of aging, to include both aging-related diseases and non-organ-specific events that are associated with age, in multi ethnoracial HIV- and HIV+ men and women comprising the CCS. Studies the epidemiology of complex aging-related processes including physical/functional status (frailty, walking speed, balance, falls, fractures, endocrine status), mental health (depressive symptoms), the interaction between physical/functional and mental health, and healthy aging and resilience. Studies mechanisms of complex systemic aging processes comprised of the four proposed domains of the aging phenotype (body composition changes, energy balance changes and impairments, alterations in homeostasis, and peripheral and central neurodegeneration).
UAB-UMMC: Sonya Heath, Elizabeth Jackson
Chairs: Deborah Gustafson (deborahrgustafson@gmail.com), Joseph Margolick (jmargol1@jhu.edu)
Cardiovascular (CVD) Working Group
Leads the CCS agenda of research on heart and vascular disease, stroke, and subclinical markers of cardiovascular disease. Assists with development of manuscripts and ancillary studies to understand the relationship of CVD and its risk factors with HIV infection, important comorbidities, such as Hepatitis C, and exposure to antiretroviral medications. Serves as a source of information about the design of cardiovascular studies in the CCS and related data on major CVD risk factors (e.g., lipids, blood pressure), blood, urine, and cellular makers, ‘omics data (e.g., metabolome, microbiome, genome), vascular imaging, and clinical CVD events. Monitors CVD measurement protocols in the CCS and oversees the adjudication of CVD events.
UAB-UMMC: Ervin Fox, Elizabeth Jackson, Saurabh Aggarwal, Julian Booker, Lisa Jackson
Chairs: Robert Kaplan (Robert.Kaplan@einstein.yu.edu), Wendy Post (wpost@jhmi.edu)
Clinical Outcomes/Epidemiology Working Group
Reviews and adjudicates deaths and important clinical events using source medical record documentation which is aggregated at the sites and submitted as de-identified “packets for review.” Reviews submitted concept sheets for which clinical expertise is needed. Provides ongoing review and makes recommendations regarding activities performed at semi-annual study visits.
UAB-UMMC: Jodie Dionne-Odom, Leandro Mena, Mirjam-Colette Kempf, Turner Overton, Paul Burns, Karen Fowler
Chairs: Frank Palella (f-palella@northwestern.edu), Adaora Adimora (adimora@med.unc.edu)
Clinical Outcomes/Epidemiology Working Group Directory
Genomics Working Group
Oversees the study of host genomic (e.g., genetic, epigenetic, gene expression) data of CCS study participants. Provides expert feedback on proposed and in-progress scientific genomic-related activities.
UAB-UMMC: Brahim Aissani, Sadeep Shrestha
Chairs: Bradley Aouizerat (bea4@nyu.edu), Jeremy Martinson (jmartins@pitt.edu)
Human Papilloma Virus (HPV) Working Group
Specializes in cervical, oral and anal HPV infection and disease. Monitors progress of HPV-related R01s in the CCS and shares results.
UAB-UMMC: Jermaine Gray, Louise Chow, Leandro Mena, Sadeep Shrestha, Sanjib Banerjee
Chair: Howard Strickler (howard.strickler@einstein.yu.edu)
Liver Working Group
Assesses the interplay of HIV and liver disease from viral hepatitis and fatty liver on various outcomes including HIV, liver, cardiovascular, behavioral, metabolic, neurocognition, pulmonary, and renal.
UAB-UMMC: Svenja Albrecht, Turner Overton, Ricardo Franco
Chairs: Chloe Thio (cthio@jhmi.edu), Jennifer Price (Jennifer.price@ucsf.edu )
Malignancy Working Group
Oversees the identification, tissue collection, adjudication, and analysis of cancers that occur in the CCS study participants. Provides expert feedback on proposed and in-progress scientific cancer-related activities.
UAB-UMMC: Sadeep Shrestha, Sanjib Banerjee, Zenoria Causey Pruitt, Jesus Monico
Chairs: Minhly Nguyen (mnguye3@emory.edu), Chia-Ching Wang (Chia-Ching.Wang@ucsf.edu), Nancy Hessol (Nancy.Hessol@ucsf.edu), Shehnaz Hussain (Shehnaz.Hussain@cshs.org)
Metabolic Working Group
Supports research and provides expertise in areas relating to and affected by endocrine and metabolic disorders in adults living with and at risk for HIV infection. Areas falling under the primary purview of the Metabolic Working Group include dyslipidemia, disorders of insulin and glucose homeostasis, body composition (including obesity, lipodystrophy, and visceral adiposity), bone metabolism and fractures, and sex hormone disturbances (including menopause and male hypogonadism). Strives to provide support and expertise to the other working groups that advance the Unified Scientific Agenda, for whom metabolic issues play a critical role in the development or progression of disease. Examples include, but are not limited to, hepatic steatosis, cardiovascular disease, aging, cognitive function, cancer, and the psychosocial determinants and effects of these comorbid conditions. Supports development of guidelines for ascertainment of clinical events and the mentoring of junior investigators.
UAB-UMMC: Amanda Willig, Amy Warriner, Turner Overton
Chairs: Jordan Lake (jordan.e.lake@uth.tmc.edu), Anjali Sharma (anjali.sharma@einstein.yu.edu)
Neuropsychology Working Group
Assesses the interaction between HIV status, psychosocial moderators, medical comorbidities, and biomarkers on brain structure and cognition and its impact on everyday function.
UAB-UMMC: David Vance, Jebediah Clark, Joy Clark, Jemma Cook
Chairs: David Vance (devance@uab.edu), James Becker (beckerjt@upmc.edu)
Pharmacology Working Group
Studies the pharmacokinetics, adverse events, and utilization of antiretroviral drugs in CCS participants, including measuring hair concentrations as markers of viral suppression and adherence. Advises related working groups with interest in drug disposition on analytical methods and data analysis techniques, and provides feedback and suggestions to investigators looking to use the CCS sample repository to answer relevant pharmacology questions in men and women. Working group members have expertise in measuring drug concentrations in plasma, peripheral blood mononuclear cells, hair, and the male and female genital tracts, and are well-versed in noncompartmental and population pharmacokinetic analyses.
UAB-UMMC: Forthcoming
Chairs: Cecile Delille Lahiri (cdelill@emory.edu), Julie Dumond (jdumond@unc.edu)
Provides guidance into research utilizing psychosocial and behavioral aims, including drug use, ARV adherence, depression and other psychological diagnoses, quality of life, sexual behavior, and successful aging with HIV.
UAB-UMMC: Janet Turan, Bulent Turan, Deborah Konkle-Parker, Latesha Elopre, Mirjam-Colette Kempf, Lori Ward
Chairs: Mackey Friedman (mrf9@pitt.edu), Deborah Konkle-Parker (dkparker@umc.edu )
Pulmonary Working Group
Investigates factors that impact pulmonary function and sleep in HIV-seropositive and HIV-seronegative individuals in the CCS. Performs research defining changes in pulmonary function and respiratory symptoms that are associated with HIV, its co-morbidities, and its treatment.
UAB-UMMC: Surya Bhatt, Zenoria Causey Pruitt
Chairs: M. Bradley Drummond (brad_drummond@med.unc.edu), Alison Morris (morrisa@upmc.edu), Ken Kunisaki (kunis001@umn.edu)
Sleep Working Group
Sleepiness and fatigue are recognized as a major source of morbidity in those with HIV infection, and can impair quality of life and functional status. This working group explores the effects of sleep quality and/or duration among HIV infected individuals and those without HIV differ.
Chairs: Audrey French (afrench@cookcountyhhs.org), Naresh Punjabi (npunjabi@jhmi.edu)
Viral and Immune Pathogenesis Working Group
Supports basic and translational research in broad areas relating to HIV pathogenesis, virology, and immunology. Specific areas of research in this Working Group include HIV persistence, latency, and reservoirs; mucosal and systemic factors affecting HIV transmission, acquisition, and diseases progression; and the pathogenesis of HIV-associated inflammation. This Working Group works with other relevant working groups to provide support and expertise for development of procedures related to specimen collection and testing for blood and tissue studies. Provides feedback to investigators seeking to utilize CCS for the above scientific areas, including mentoring of junior investigators.
UAB-UMMC: Christina Ochsenbauer, Steffanie Sabbaj, Kristal Aaron
Chairs: Nadia Roan (nadia.roan@ucsf.edu), Bernard Macatangay (macatangaybj@upmc.edu )
MWCCS Operational Working Groups
CCS Specimen Allocation Committee (CSAC)
Assists in the allocation of high-value repository specimens. Reviews all requests for the release of samples from individuals who contribute significant or unique outcomes to overall CCS research aims and will determine whether or not the restricted samples should be released to the requesting investigator.
UAB-UMMC: Steffanie Sabbaj, Stephanie Tanner
Chairs: Forthcoming
CCS Specimen Allocation Committee (CSAC) Working Group Directory
Core Laboratory Working Group
Ensures standardization across all sites for sample collection, laboratory processing, sample analysis, and storage. Ensures assays are state-of-the-art, while maintaining consistency through time. Maintains rigorous quality control on all laboratory protocols through Quality Assurance protocols and programs. Provides interface between the DACC and all laboratories. Assists investigators with laboratory aspects of multi-site sub-studies. Conducts original laboratory-based research that fulfills and advances the specific aims of the CCS. Assists site laboratories with sample collection, processing, analysis, and storage related questions and concerns. Provides expert recommendations to the EC on laboratory aspects on all projects.
UAB-UMMC: Kamellia Safavy, Michelene Brock, Sonya Heath, Steffanie Sabbaj, Tina Barnes, Venetra McKinney, Zenoria Causey Pruitt, Clifford Chalfant, Sarika Jain, Jesus Monico, Stephanie Tanner, S. Michelle Barfield, Ashley Dawson, Kwamie Harris, Amy Tubbs, Dannielle Freeman
Chairs: Najib Aziz (naziz@ucla.edu), Beth Jamieson (bjamieso@ucla.edu), Kehmia Titanji (ktitanj@emory.edu)
Data Management Working Group
Oversees all aspects of data collection and editing, ensuring that data collection standards are upheld across all sites. Typical discussion topics include data freezes and edits, summary file updates, central data transfers, and Apollo reports.
UAB-UMMC: Margaret McDonald, Deborah Konkle-Parker, Michelene Brock, Ilene Brill, Venetra McKinney, Zenoria Causey Pruitt, Karen Fowler, Crystal Thomas, Jemma Cook, Kwamie Harris, Henry R. Jones
Chairs: Andrew Edmonds (aedmonds@email.unc.edu), Alison Abraham (alison.abraham@jhu.edu)
Data Management Working Group Directory
Project Directors Working Group
Discusses operational aspects of the MACS and WIHS, such as form and protocol revisions, sub-study feasibility and implementation, registry match status, budgets, certification and quality assurance, and the activities of the scientific research groups and their impact on clinical operations.
UAB-UMMC: Venetra McKinney, Zenoria Causey Pruitt
Chairs: Susan Holman (susan.holman@downstate.edu), Jacquett Johnson (jjohns20@jhu.edu )
Project Directors Working Group Directory
Medical Record Abstraction Working Group
description forthcoming.
UAB-UMMC: Amy Tubbs, Zenoria Causey Pruitt, Ashley Dawson, Crystal Thomas, Dannielle Freeman
Chairs: Forthcoming
Communications and Dissemination Committee (CDC)
Develop and help to implement strategies to communicate study findings to study participants, lay community, and scientific community, which may include website development, social media, press releases, etc. In addition, develop CCS‐wide strategies for recruitment and retention.
UAB-UMMC: Zenoria Causey Pruitt
Chairs: Forthcoming
Communications and Dissemination Committee (CDC) Working Group Directory – Forthcoming
Investigator Developmental Awards Committee (IDAC)
Review how sites are allocating developmental funds (1% of site budget) in the first two years of the funding period. Provide advice on concept sheets funded by developmental funds re: scope, methodology, approach, investigative team that are value‐added and geared towards career enhancement and forging of new collaborations. Develop a more formal plan for solicitation of proposals at sites to be funded by developmental funds in Y3‐7 with EC review re: scope, methodology, approach, investigative team that are value‐added and geared towards career enhancement and forging of new collaborations.
UAB-UMMC: Mirjam-Colette Kempf
Chairs: Mirjam-Colette Kempf (mkempf@uab.edu) , Shehnaz Hussein ( Shehnaz.hussain@cshs.org)
Investigator Developmental Awards Committee (IDAC) Working Group Directory – Forthcoming
Quality Assurance Advisory Committee (QAAC)
Provide advice to the DACC regarding data quality issues. Help develop priority list for QA/QC efforts. Review site monitoring reports. Help advise DACC about any performance issues identified at a site and help sites develop a corrective action plan.
UAB-UMMC: Forthcoming
Chairs: Forthcoming
Quality Assurance Advisory Committee (QAAC) Working Group Directory – Forthcoming
MWCCS Interests Groups
Biomarkers Working Group
Provides intellectual and technical advice on biomarker-related efforts by CCS investigators. Evaluates proposals from outside investigators requesting access to CCS specimens and/or biomarker data for soundness and overlap with existing biomarker-related projects.
UAB-UMMC: Forthcoming
Chair: Jay Bream (jbream1@jhu.edu)
Data Analysis/Methods Working Group
Advises on maximizing data quality, decides on standardized summary metrics, monitors and maintains study design and analytic appropriateness for proposed research, disseminates analytic/methodologic best practices, and leads methodological development.
UAB-UMMC: Ilene Brill
Chairs: Andrew Edmonds (aedmonds@email.unc.edu), Alison Abraham (alison.abraham@jhu.edu)
Data Analysis/Methods Working Group Directory
Gynecology & Pregnancy Working Group
Coordinates studies assessing the effect of menopause. Evaluates the effect of effective contraception. Assesses the association of pregnancy outcomes with maternal health markers and studies the interaction between mental health and substance abuse with pregnancy outcomes, maternal health markers, immunologic and virologic response to HAART, and quality of life/post-partum mental health/functional status.
UAB-UMMC: Forthcoming
Chairs: Lisa Rahangdale (lisa_rahangdale@med.unc.edu), Elizabeth Topper Golub (egolub@jhu.edu)
Microbiome Working Group
Develops SOPs for collection and processing of stool, oral, and cervicovaginal samples for microbiome analysis and bioinformatics approaches for data analysis. Responsible for the evaluation of proposed microbiome studies in the CCS cohort. Works to develop new concepts and scientific/health aims that utilize stored microbiome samples.
UAB-UMMC: Amanda Willig, Steffanie Sabbaj, Christina Muzny
Chairs: Robert Burk (Robert.Burk@einstein.yu.edu), Alan Landay (Alan_Landay@rush.edu)
Renal Working Group
Spearheads projects, provides guidance to investigators, and fosters collaboration for research focused on kidney disease and its related complications in persons living with or at risk for HIV.
UAB-UMMC: Forthcoming
Chairs: Michelle Estrella (michelle.estrella@ucsf.edu)