ClinicalFormThe Clinical Core has been a cornerstone of the UAB CFAR for over two decades, enhancing all aspects of human HIV research. The importance and future direction of the Clinical Core is as dynamic as it has ever been, meeting changing investigator needs, addressing new knowledge gaps and accompanying shifts in the scientific agenda, and studying the evolving HIV epidemic. Enhanced synergies within the Core allows for more timely and seamless service delivery, and for service expansion to allow for “on demand” specimen capture and prospective research recruitment, study coordination and protocol implementation to a record number of investigators.

We provide easy access to comprehensive clinical services, resources and expertise supporting basic science, behavioral, epidemiological, translational, clinical and public health research. Clinical Research Training Services are provided at all levels including the 1917 Clinic Cohort which is an opportunity for investigators from across campus to meet to discuss HIV research. The Clinical Core is rapidly adapting and instituting innovative and expanded services in response to user needs and to support the overarching UAB CFAR scientific mission and pillars of prevention, drug discovery, pathogenesis, and the natural history of HIV in the modern treatment era.


Clinical Core Aims

Aim 1: To provide Computerized Database and Informatics Services along with expertise in management and quality assurance of complex, interactive data derived from multiple electronic data sources, generation of analysis-ready datasets, and development of health informatics software.

Aim 2: To provide a comprehensive and efficient Specimen Repository obtained from well-characterized patients along with expertise in identification of study participants to achieve investigator objectives, and ready provision and processing of existing and ad hoc biological samples.

Aim 3. To provide Study Coordination, Recruitment, and Implementation Services along with the expertise to properly staff and prepare logistics for successful performance of prospective observational and point-of-care interventional studies within the UAB 1917 HIV Clinic.

Aim 4. To provide and coordinate Clinical and Research Education and Training Services along with expertise in matching trainee needs with available services and resources offered by Core C.

Database & Informatics

Database & Informatics Services

The Clinical Core provides a Computerized Database and Informatics Service to store and access complex, interactive data to assist with study design and to conduct appropriate data analysis.
• Assists young and established UAB investigators as well as outside researchers to provide data queries and identification of potential research subjects who meet clinical or scientific criteria for retrospective or prospective translational research studies.
• Collaborates with other CFARs and institutions in the form of computerized informatics and biostatistics expertise to assist with launching their own databases.
• Consults on design of database management plans for individual projects.
• Consults on the operation of project-specific systems.
• Assists or consults in design and creation of data collection instruments and forms.
• Database coordination with other Cores and Centers.
• Prepares datasets suitable for statistical analysis.

Specimen Repository

Specimen Repository Services

The Clinical Core maintains and provides patient samples from a comprehensive and efficient Specimen Repository obtained from well-characterized patients for collaborative investigations involving multiple research disciplines. Contact the Clinical Core to have samples processed or obtain samples for research purposes. The Core also provides samples to other CFARs and outside investigators to aid scientific research.

Types of existing specimens available: :
• Fresh blood,
• Plasma
• Serum
• Peripheral blood mononuclear cells
• Mucosal secretions
• Mucosal biopsies, lymph node biopsies, skin biopsies

Types of services available:
• Provides Identification and collection of clinical samples.
• Provides access to stored samples from well characterized patients..
• Provides access to expertise in the development and implementation of HIV vaccine trials.
• Provides plasmaphoresis and leukophoresis to CFAR members and network organizations in order to provide a greater volume of samples from a few patients with unique characteristics (e.g., long term nonprogressors).

Research Coordination

Research Coordination Services

The Clinical Core offers Research Coordination, Recruitment and Implementation Services including support with recruitment, enrollment, protocol design development and implementation. Core personnel are available to assist with regulatory and study coordinator support, data and specimen collection, web-based tracking and data entry, database design and data management. Ongoing collaborations exist with the CFAR Network of Integrated Clinical Systems and other national and international cohort studies.
• Reviews and critiques existing / draft protocols.
• Collaborates in development of study design (experimental and observational).
• Assists with IRB application.
• Facilitates access to expertise in multiple sub-disciplines of HIV research including hepatology, cardiology, neurology, nephrology, hematology/oncology, obstetrics and gynecology, and psychiatry.
• Consults on study implementation, operations, and monitoring adherence to protocol.
• Assists with data collection or identification and assessment of appropriateness to research hypotheses.
• Develops clinically appropriate analysis plans and strategies.
• Assists with budget planning for grant proposals, estimation of costs.
• Provides letters of support, biosketch, background information, other-support pages.
• Assists with clinical epidemiologic analytic computations.
• Provides interpretive analyses of clinical, laboratory and basic science results.
• Provides collaborative preparation of publications and presentations.
• Progress report check ins with investigators (proactive tracking form)


Education and Training Services

The Clinical Core provides Clinical and Research Education and Training Services providing coordination of training sessions including 1917 Clinic Cohort Meetings and 1917 Clinic Provider meetings. Additional services including research consultation and regulatory training are provided to a wide range of trainees.
• Training ID Fellows
• IPE (inter-professional education)
• Weekly Cohort Research Roundtable Interactive Discussions
• Monthly Provider meetings
• Monthly 1917 Clinic meetings
• 1917 CQI and AL Regional Quality Group
• Community Partner Collaborative Education
• Clinical Care Team Education Services


Publications Describing New Work Supported by the Core

1.         Achenbach CJ, Buchanan AL, Cole SR, Hou L, Mugavero MJ, Crane HM, Moore RD, Haubrich RH, Gopal S, Eron JJ, Hunt PW, Rodriguez B, Mayer K, Saag MS, Kitahata MM. HIV viremia and incidence of non-Hodgkin lymphoma in patients successfully treated with antiretroviral therapy. Clin Infect Dis 2014;58(11):1599-606.
PMID number: 24523217
PMCID number: PMC4017888

2.         Aweeka F, Hu C, Huang L, Best B, Stek A, Lizak P, Burchett S, Read J, Watts H, Mirochnick M, Capparelli E. Alteration in cytochrome p450 3a4 activity as measured by a urine cortisol assay in HIV-1-infected pregnant women and relationship to antiretroviral pharmacokinetics. HIV Med 2015;16(3):176-83.
PMID number: 25407158
PMCID number: PMC4320673

3.         Bachmann LH, Grimley DM, Gao H, Aban I, Chen H, Raper JL, Saag MS, Rhodes SD, Hook EW, 3rd. Impact of a computer-assisted, provider-delivered intervention on sexual risk behaviors in HIV-positive men who have sex with men (MSM) in a primary care setting. AIDS Educ Prev 2013;25(2):87-101.
PMID number: 23514077

4.         Baheti G, King JR, Acosta EP, Fletcher CV. Age-related differences in plasma and intracellular tenofovir concentrations in HIV-1-infected children, adolescents and adults. AIDS 2013;27(2):221-25.
PMID number: 23032419
PMCID number: PMC3586236

5.         Bengtson AM, Pence BW, O'Donnell J, Thielman N, Heine A, Zinski A, Modi R, McGuinness T, Gaynes B. Improvements in depression and changes in quality of life among HIV-infected adults. AIDS Care 2015;27(1):47-53.
PMID number: 25105320

6.         Bess KD, Adams J, Watt MH, O'Donnell JK, Gaynes BN, Thielman NM, Heine A, Zinski A, Raper JL, Pence BW. Providers' attitudes towards treating depression and self-reported depression treatment practices in HIV outpatient care. AIDS Patient Care STDS 2013;27(3):171-80.
PMID number: 23442030
PMCID number: PMC3595951

7.         Bet A, Sterrett S, Sato A, Bansal A, Goepfert PA. Characterization of t-cell responses to cryptic epitopes in recipients of a noncodon-optimized HIV-1 vaccine. J Acquir Immune Defic Syndr 2014;65(2):142-50.
PMID number: 24442221
PMCID number: PMC3896890

8.         Bharaj P, Chahar HS, Alozie OK, Rodarte L, Bansal A, Goepfert PA, Dwivedi A, Manjunath N, Shankar P. Characterization of programmed death-1 homologue-1 (pd-1h) expression and function in normal and HIV infected individuals. PLoS One 2014;9(10):e109103.
PMID number: 25279955
PMCID number: PMC4184823

9.         Blashill AJ, Mayer KH, Crane HM, Baker JS, Willig JH, Willig AL, Grasso C, O'Cleirigh C, Safren SA. Body mass index, depression, and condom use among HIV-infected men who have sex with men: A longitudinal moderation analysis. Arch Sex Behav 2014;43(4):729-34.
PMID number: 23979782
PMCID number: PMC3933471

10.      Boehme AK, Davies SL, Moneyham L, Shrestha S, Schumacher J, Kempf MC. A qualitative study on factors impacting HIV care adherence among postpartum HIV-infected women in the rural southeastern USA. AIDS Care 2014;26(5):574-81.
PMID number: 24116662

11.      Bowers NL, Helton ES, Huijbregts RP, Goepfert PA, Heath SL, Hel Z. Immune suppression by neutrophils in HIV-1 infection: Role of PD-L1/PD-1 pathway. PLoS Pathog 2014;10(3):e1003993.
PMID number: 24626392
PMCID number: 3953441

12.      Burkholder GA, Tamhane AR, Appell LE, Willig JH, Saag MS, Raper JL, Westfall AO, Mugavero MJ. Viral suppression is associated with increased likelihood of colorectal cancer screening among persons living with HIV/AIDS. AIDS Res Hum Retroviruses 2014. [Epub ahead of print]
PMID number: 25435340

13.      Buscher A, Mugavero M, Westfall AO, Keruly J, Moore R, Drainoni ML, Sullivan M, Wilson TE, Rodriguez A, Metsch L, Gardner L, Marks G, Malitz F, Giordano TP. The association of clinical follow-up intervals in HIV-infected persons with viral suppression on subsequent viral suppression. AIDS Patient Care STDS 2013;27(8):459-66.
PMID number: 23886048
PMCID number: PMC3739946

14.      Cole SR, Lau B, Eron JJ, Brookhart MA, Kitahata MM, Martin JN, Mathews WC, Mugavero MJ. Estimation of the standardized risk difference and ratio in a competing risks framework: Application to injection drug use and progression to AIDS after initiation of antiretroviral therapy. Am J Epidemiol 2015;181(4):238-45.
PMID number: 24966220
PMCID number: PMC4325676

15.      Cressey TR, Best BM, Achalapong J, Stek A, Wang J, Chotivanich N, Yuthavisuthi P, Suriyachai P, Prommas S, Shapiro DE, Watts DH, Smith E, Capparelli E, Kreitchmann R, Mirochnick M. Reduced indinavir exposure during pregnancy. Br J Clin Pharmacol 2013;76(3):475-83.
PMID number: 23305215
PMCID number: PMC3769674

16.      Cropsey KL, Hendricks PS, Jardin B, Clark CB, Katiyar N, Willig J, Mugavero M, Raper JL, Saag M, Carpenter MJ. A pilot study of screening, brief intervention, and referral for treatment (SBIRT) in non-treatment seeking smokers with HIV. Addict Behav 2013;38(10):2541-46.
PMID number: 23787030
PMCID number: PMC3725186

17.      Crowell CS, Huo Y, Tassiopoulos K, Malee KM, Yogev R, Hazra R, Rutstein RM, Nichols SL, Smith RA, Williams PL, Oleske J, Muller WJ. Early viral suppression improves neurocognitive outcomes in HIV-infected children. AIDS 2015;29(3):295-304.
PMID number: 25686678
PMCID number: PMC4332557

18.      Dombrowski JC, Kitahata MM, Van Rompaey SE, Crane HM, Mugavero MJ, Eron JJ, Boswell SL, Rodriguez B, Mathews WC, Martin JN, Moore RD, Golden MR. High levels of antiretroviral use and viral suppression among persons in HIV care in the United States, 2010. J Acquir Immune Defic Syndr 2013;63(3):299-306.
PMID number: 23572013
PMCID number: PMC3691075

19.      Duverger A, Wolschendorf F, Zhang M, Wagner F, Hatcher B, Jones J, Cron RQ, van der Sluis RM, Jeeninga RE, Berkhout B, Kutsch O. An ap-1 binding site in the enhancer/core element of the HIV-1 promoter controls the ability of HIV-1 to establish latent infection. J Virol 2013;87(4):2264-77.
PMID number: 23236059
PMCID number: PMC3571467

20.      Edwards JK, Cole SR, Westreich D, Moore R, Mathews C, Geng E, Eron JJ, Mugavero MJ. Loss to clinic and five-year mortality among HIV-infected antiretroviral therapy initiators. PLoS One 2014;9(7):e102305.
PMID number: 25010739
PMCID number: PMC4092142

21.      Edwards M, Quinlivan EB, Bess K, Gaynes BN, Heine A, Zinski A, Modi R, Pence BW. Implementation of phq-9 depression screening for HIV-infected patients in a real-world setting. J Assoc Nurses AIDS Care 2014;25(3):243-52.
PMID number: 24103743
PMCID number: PMC3976873

22.      Elias JA, Rossman MD, Zurier RB, Daniele RP. Human alveolar macrophage inhibition of lung fibroblast growth. A prostaglandin-dependent process. Am Rev Respir Dis 1985;131(1):94-99.
PMID number: 3966717

23.      Engsig FN, Zangerle R, Katsarou O, Dabis F, Reiss P, Gill J, Porter K, Sabin C, Riordan A, Fatkenheuer G, Gutierrez F, Raffi F, Kirk O, Mary-Krause M, Stephan C, de Olalla PG, Guest J, Samji H, Castagna A, d'Arminio Monforte A, Skaletz-Rorowski A, Ramos J, Lapadula G, MUSsini C, Force L, Meyer L, Lampe F, Boufassa F, Bucher HC, De Wit S, Burkholder GA, Teira R, JUStice AC, Sterling TR, H MC, Gerstoft J, Grarup J, May M, Chene G, Ingle SM, Sterne J, Obel N. Long-term mortality in HIV-positive individuals virally suppressed for >3 years with incomplete CD4 recovery. Clin Infect Dis 2014;58(9):1312-21.
PMID number: 24457342

24.      Fletcher FE, Buchberg M, Schover LR, Basen-Engquist K, Kempf MC, Arduino RC, Vidrine DJ. Perceptions of barriers and facilitators to cervical cancer screening among low-income, HIV-infected women from an integrated HIV clinic. AIDS Care 2014;26(10):1229-35.
PMID number: 24635664
PMCID number: PMC4087052

25.      Franco RA, Saag MS. When to start antiretroviral therapy: As soon as possible. BMC Med 2013;11:147.
PMID number: 23767762
PMCID number: PMC3682940

26.      Franco RA, Tamhane A, Overton ET. Impact of poor retention in HIV medical care on hepatitis b vaccination. J Int Assoc Provid AIDS Care 2014. [Epub ahead of print]
PMID number: 25301284

27.      Gakumo CA, Enah CC, Vance DE, Sahinoglu E, Raper JL. "Keep it simple": Older African Americans' preferences for a health literacy intervention in HIV management. Patient Prefer Adherence 2015;9:217-23.
PMID number: 25678780
PMCID number: PMC4319466

28.      Galbraith JW, Donnelly JP, Franco RA, Overton ET, Rodgers JB, Wang HE. National estimates of healthcare utilization by individuals with Hepatitis C virus infection in the United States. Clin Infect Dis 2014;59(6):755-64.
PMID number: 24917659
PMCID number: PMC4200046

29.      Galbraith JW, Franco RA, Donnelly JP, Rodgers JB, Morgan JM, Viles AF, Overton ET, Saag MS, Wang HE. Unrecognized chronic Hepatitis C virus infection among baby boomers in the emergency department. Hepatology 2015;61(3):776-82.
PMID number: 25179527

30.      Goepfert PA, Elizaga ML, Seaton K, Tomaras GD, Montefiori DC, Sato A, Hural J, DeRosa SC, Kalams SA, McElrath MJ, Keefer MC, Baden LR, Lama JR, Sanchez J, Mulligan MJ, Buchbinder SP, Hammer SM, Koblin BA, Pensiero M, Butler C, Moss B, Robinson HL. Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 2014;210(1):99-110.
PMID number: 24403557
PMCID number: PMC4072895

31.      Gopal S, Patel MR, Achenbach CJ, Yanik EL, Cole SR, Napravnik S, Burkholder GA, Mathews WC, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Richards KL, Eron JJ. Lymphoma immune reconstitution inflammatory syndrome in the Center for AIDS Research Network of Integrated Clinical Systems Cohort. Clin Infect Dis 2014;59(2):279-86.
PMID number: 24755860
PMCID number: PMC4102912

32.      Gopal S, Patel MR, Yanik EL, Cole SR, Achenbach CJ, Napravnik S, Burkholder GA, Reid EG, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Eron JJ, Richards KL. Temporal trends in presentation and survival for HIV-associated lymphoma in the antiretroviral therapy era. J Natl Cancer Inst 2013;105(16):1221-59.
PMID number: 23892362
PMCID number: PMC3748003

33.      Gopal S, Patel MR, Yanik EL, Cole SR, Achenbach CJ, Napravnik S, Burkholder GA, Reid EG, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Richards KL, Eron JJ. Association of early HIV viremia with mortality after HIV-associated lymphoma. AIDS 2013;27(15):2365-73.
PMID number: 23736149
PMCID number: PMC3773290

34.      Grant JS, Vance DE, Keltner NL, White W, Raper JL. Reasons why persons living with HIV include individuals in their chosen families. J Assoc Nurses AIDS Care 2013;24(1):50-60.
PMID number: 22853884

35.      Hall HI, Tang T, Westfall AO, Mugavero MJ. HIV care visits and time to viral suppression, 19 U.S. Jurisdictions, and implications for treatment, prevention and the national HIV/AIDS strategy. PLoS One 2013;8(12):e84318.
PMID number: 24391937
PMCID number: PMC3877252

36.      Hanna DB, Buchacz K, Gebo KA, Hessol NA, Horberg MA, Jacobson LP, Kirk GD, Kitahata MM, Korthuis PT, Moore RD, Napravnik S, Patel P, Silverberg MJ, Sterling TR, Willig JH, Collier A, Samji H, Thorne JE, Althoff KN, Martin JN, Rodriguez B, Stuart EA, Gange SJ. Association between U.S. State AIDS Drug Assistance Program (ADAP) features and HIV antiretroviral therapy initiation, 2001-2009. PLoS One 2013;8(11):e78952.
PMID number: 24260137
PMCID number: PMC3832515

37.      Himes SK, Scheidweiler KB, Tassiopoulos K, Kacanek D, Hazra R, Rich K, Huestis MA. Development and validation of the first liquid chromatography-tandem mass spectrometry assay for simultaneoUS quantification of multiple antiretrovirals in meconium. Anal Chem 2013;85(3):1896-904.
PMID number: 23256731
PMCID number: PMC3638039

38.      Horberg MA, Hurley LB, Silverberg MJ, Klein DB, Quesenberry CP, Mugavero MJ. Missed office visits and risk of mortality among HIV-infected subjects in a large healthcare system in the United States. AIDS Patient Care STDS 2013;27(8):442-49.
PMID number: 23869466
PMCID number: PMC3739947

39.      Howe CJ, Cole SR, Napravnik S, Kaufman JS, Adimora AA, Elston B, Eron JJ, Jr., Mugavero MJ. The role of at-risk alcohol/drug use and treatment in appointment attendance and virologic suppression among HIV(+) African Americans. AIDS Res Hum Retroviruses 2014;30(3):233-40.
PMID number: 24325326
PMCID number: PMC3938941

40.      Howe CJ, Napravnik S, Cole SR, Kaufman JS, Adimora AA, Elston B, Eron JJ, Jr., Mugavero MJ. African american race and HIV virological suppression: Beyond disparities in clinic attendance. Am J Epidemiol 2014;179(12):1484-92.

*CFAR members are bolded

Contact Information

                                              Pictured: Drs. Turner Overton, Greer Burkholder and Michael Mugavero

Michael Mugavero, MD, MHSC
Email: mmugavero@uab.edu 

Greer A. Burkholder, MD, MSPH (Database and Informatics)
Email: gburkhol@uab.edu

Sonya L. Heath, MD (Specimen Repository)
Email: heaths@uab.edu

E. Turner Overton, MD (Education and Training)
Email: toverton@uab.edu 

University of Alabama at Birmingham
Community Care Building (CCB)
908 20th Street South
Birmingham AL 35294-2050