Patrick G. Clay, PharmD

Professor of Pharmacotherapy   

Cathleen Kearns

 

Education & Experience:

I received formal training in the field of pharmacy with a BPharm from the University of Louisiana-Monroe and a PharmD from the University of Oklahoma. I completed an Infectious Diseases Residency and a Fellowship in Pharmacotherapy of Infectious Diseases & Clinical Research through the University of Oklahoma Health Science Center’s Colleges of Pharmacy and Medicine. Prior to joining the System College of Pharmacy, I held the positions of Associate Professor of Pharmacology/Microbiology and Director of Clinical Research at Kansas City University of Medicine and Biosciences. I have also had academic experience as an Assistant Professor of Pharmacy Practice at University of Missouri – Kansas City School of Pharmacy. I have held adjunct academic appointments with University of Kansas, St. Louis University and Creighton University schools of pharmacy.

Teaching Areas & Interests:

Teaching areas include infectious diseases, HIV, clinical trials, clinical research.  Dr. Clay is also involved in HIV clinical outcomes, investigational medicines (primarily anti-viral), and community pharmacy clinical services.

Current Funding:

1S21 MD012472-01Vishwantha (PI)2017 – 2022
National Institutes of Health (NIMHD)Role: Co-investigator (0.6 calendar months)
Goals: The long term objective of the Texas Minority Health, Education, Research and Outreach (Texas MiHERO) is to expand the capacity of  University of North Texas Health Science Center (UNTHSC) to enhance research and research training in minority health and health disparities by increasing the number of under-represented students in health disparity research, providing interdisciplinary  research and leadership training to junior faculty, and increasing the number of health professional faculty involved in health disparity research.

2U54 MD006882-06Clay (Co-Investigator)2017 – 2022
National Institutes of Health (MINHD)Role: Project Lead
Goal: The overarching goal for Project 2 of this U54 funding is to conduct a randomized, prospective, clinical trial designed to test for improvement in health outcomes using community pharmacy based Medication Optimization Management that proactively acquires all medical records in adult, HIV-positive men and women with either diabetes, hypertension or both. Dr. Clay serves as Principal Investigator for this project.

PS315-15Clay (PI)2013 – 2017
CDC/National Minority AIDS Council
Goals: Determining and describing optimal features (in a model) of collaborative relationships between community pharmacies and HIV primary care providers in a patient centered care model to obtain maximal impact on individual and community health outcomes

Merck & Co., Inc, MK-1459-018Clay (Site PI)2013 – 2019
Goals: A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination With TRUVADA™ or EPZICOM®/KIVEXA®, in Treatment-Naïve HIV-1 Infected Subjects.

Professional Activities & Awards:

State
2016 – 2018 Texas Department of Health and Senior Services Medicaid Drug Utilization Review Board (voting member)

Federal
1987 – 1993 Louisiana Army National Guard 256th Mechanized and Light Infantry Brigade (Tactical operations center operations specialist; security detachment, Battalion S-3, deployment – Operation Desert Storm, 1991)
2008 – 2011 United States Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) Center for Drug Evaluation and Research’s (CDER) Antiviral Advisory Committee (voting member), Silver Springs, Maryland.
2011 – 2014 DHHS FDA CDER, Pharmacology consultant (all committees), Silver Springs, Maryland.
2012 DHHS NIH NIAID Special Emphasis Panel, Integrated Preclinical/Clinical Program Review Panel (ZAI1 EC-A (S1))
2013 CMMI Healthcare Innovations Awards Round Two reviewer (panel 36)
2013 DHHS NIH NIAID Special Emphasis Panel (R01, RFA-AI-13-008)
2013 DHHS NIH NIAID Special Emphasis Panel (UM1, RFA-AI-05-002)
2013 DHHS NIH NIAID Preclinical Innovation Program Panel (R01, AZI1 JKB-A)
2014 DHHS NIH NIAID Preclinical Innovation Program Panel (U19, ZAI1 BP-A(M2)
2018 DHHS NIH NICHD Special Emphasis Panel (ZHD1 DSR-K 501)
2018 DHHS NIH NIAID / NIMH Preclinical Innovation Program Panel (R61/R33 – Next Generation Multipurpose Prevention Technology Clinical Trial Optional)

Promotion and Tenure External Reviewer

2012 University of Louisiana – Monroe, College of Pharmacy
2013 West Virginia University College of Pharmacy
2014 St. Louis College of Pharmacy
2015 University of California – San Francisco, College of Pharmacy
2015 UNTHSC School of Public Health
2016 UNTHSC School of Public Health
2016 Albany College of Pharmacy
2016 University of New Mexico College of Pharmacy
2017 UNTHSC School of Public Health
2018 St. Louis College of Pharmacy

Professional Organizations (only those with offices held or leadership roles listed):

American Academy of HIV Medicine
2011 – ONGMember
2013 – 2018AAHIVM Pharmacist Taskforce
2013 – ONGAAHIVM Certified HIV Pharmacist

American Pharmacists Association
2011 – ONGScience Officer
2011 – 2012 Immediate past-chair, APRS Section on Clinical Sciences
2013 – Present Chair, Expert Panel on Pharmacist Direct Patient Care Services

Society of Infectious Disease Pharmacists:
2012 Member, Recognition Committee
2013 Member, Recognition Committee
2015 Member, Grants Committee
2016 Member, Elections Committee
2017 Member, Interprofessional Engagement Committee
2017 Member, Elections Committee

Scholarly Interests:

Primarily interested in clinical trials / research involving humans but also database and literature analyses of outcomes of other’s work in human research.

Recent Publications:

Byrd K, Clay PG, Delpino A, et al., Retention in HIV care among participants in the Patient-centered HIV Care Model project—a collaboration between community pharmacists and primary medical providers. ACCEPTED, AIDS Patient Care and STDS (September 2018)

Narayanan S, Clay PG. Adherence, Healthcare Resource Use (HRU) And Costs: A Comparison Of Single-Tablet Regimen (STR) Versus Multi-Tablet Regimen (MTR) Containing Fixed Dose Combination (Fdc) Regimens. Value Health 2015;18:A577. doi: 10.1016/j.jval.2015.09.1918

Clay PG*, Nag S, Graham CM, Narayanan S. Meta-Analysis of Studies Comparing Single and Multi-Tablet Fixed Dose Combination HIV Treatment Regimens. Medicine 2015;94:e1677. doi: 10.1097/MD.0000000000001677

MacArthur RD, Hawkins TN, Brown SJ, Lamarca A, Clay PG, Barrett AC, Bortey E, Paterson C, Forbes WP. Efficacy and safety of crofelemer for noninfectious diarrhea in HIV-seropositive individuals (ADVENT trial): a randomized, double-blind, placebo-controlled, two-stage study. HIV Clin Trials 2013;14:261-73. DOI: 10.1310/hct1406-261.

Hicks C, Clay PG, Redfield R, Lelezari J, Liporace R, Schneider S, Sension M, McRae MP, Laurent JP. Safety, tolerability and efficacy of KP—1461 as monotherapy for 124 days in antiretroviral experienced, HIV-1 infected subjects. AIDS Res Human Retroviruses 2013;29:250-5. DOI: 10.1089/aid.2012.0093.

Conference Presentations / Posters:

2018

Clay PG, Suzuki S, Chaturvedi P, MacFarlane K. Patient outcomes are not just viral loads and CD counts: quality of life and work productivity changes resulting from addressing HIV-associated diarrhea. 13th Annual Conference on HIV Treatment and Adherence. June 7-10, 2018. Miami, FL. Poster #233.

Rivera M, Clay PG, Hall B, Thomas D, Suzuki S. Geo-Mapping HIV-Specialty Pharmacists in the US: Phase 1. 13th Annual Conference on HIV Treatment and Adherence. June 7-10, 2018. Miami, FL. Poster #95.

Byrd K, Clay PG, Delpino A, et al. Retention in care among participants in the Patient-centered HIV Care Model project—a collaboration between community pharmacists and primary medical providers. ID Week 2018, October 6, 2018. San Francisco, CA. Abstract 69754 (oral platform)

Asmuth DA, Blick G, Clay PG, et al. Prevalence of Diarrhea in HIV Clinical Trials in the Recent Post-Combined Antiretroviral Therapy (cART) Era: Analysis of Data from 39 Clinical Trials from 2008-2017 in Over 20,000 Patients. AIDS 2018. July 23-27, 2018. Amsterdam, Netherlands. Abstract B30.

2017

McArthur R, Clay PG, Blick G, Waltzman R, Bell M. Long-term crofelemer use gives clinically relevant reductions in HIV-related diarrhea. 9th IAS Conference on HIV Science. Paris, France. 23-26 July 2017. Abstract: A-854-01010-01472

Mukasa K, Torres O, Clay PG, Baskaran K. Retrospective analysis to map student engagement in research design in required curriculum offered by the college of pharmacy at University of North Texas Health Science Center at Fort Worth: stage 1 of 3. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017.

Rybalchenko A, Hall B, Huang J, Clay PG.  Identifying deserts of HIV provider training: part 1, PharmD students. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017.

Abebe B, Huang J, Clay PG. Development of a manuscript checklist for use by peer-reviewed journals to evaluate pharmacist direct patient care services manuscript submissions. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017

Ma AB, Clay PG. Oxidized low density lipoprotein for the early detection of atherosclerosis in human immunodeficiency virus patients on antiretroviral therapy. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017

Troung D, Clay PG, Elrod S. Adherence rates of antibiotic use during antiretroviral therapy in people living with HIV/AIDS. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017.

Liu Z, Clay PG, Elrod S. Medication adherence in people living with HIV/AIDS with concomitant diabetes. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017.

2016

Gehrig M, Clay PG, Perry R, Suzuki S, Liu J. Actual versus perceived use of pharmacokinetic (primarily absorption) influential OTC agents and ART tolerability in a nationwide matched cohort of HIV patients and their healthcare providers. ID Week 2016, New Orleans, LA. October 28, 2016. Poster 59190. (Encore presentation at UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017)

Clay PG, Uberu J, Silva H, Carlson E. Health literacy: assessing the health literacy assessment tool using talking touchscreen technology (HealthLiTT) survey in HIV participants. ID Week 2016, New Orleans, LA. October 28, 2016. Poster 60421. (Encore presentation: UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2017)

Gilman J, Clay PG, Liu J, Suzuki S, Sinclair G. Hepatitis C treatment outcomes in people actively using drugs in Dallas, Texas. ID Week 2016, New Orleans, LA. October 30, 2016. Poster # 444.

Carlson E, Mudasiru O, Proeitti M, Clay PG. A qualitative assessment of health literacy to improve pharmacy services for HIV patients in north Texas. American Public Health Association 2016 Annual Meeting & Expo, Denver, CO. October 30, 2016. Poster 348619.

Voskuhl G, Gilman J, Clay PG, Liu J, Suzuki S. Real world hepatitis C treatment outcomes in Dallas, Texas. 2016 National Ryan White Conference on HIV Care and Treatment, Washington, DC. August 23, 2016. Poster # 6208.

Mudasiru O, Carlson E, Proeitti M, Clay PG. An assessment of HIV patient feedback on customer service in the pharmacy: a comparison between urban and rural locations. 2016 National Student Research Forum, Galveston, Texas. July 12, 2016. Poster # 215.

2015

Moncus T, Darin KM, Clay PG. Lessons learned from implementation of a patient-centered HIV care model to optimize HIV outcomes through improved communication between pharmacists and providers. Rural HIV Conference 2015. Savannah, GA. September 30, 2015. (platform)

Darin KM, Clay PG. Implementation of a patient-centered HIV care model to optimize HIV outcomes through improved communication between pharmacists and providers. 10th International Conference on HIV Treatment and Prevention. Miami, FL. June 28, 2016.

Clay PG, Surles T, Barrett A, Perry R, Hadfield A. Characterizing gastrointestinal symptoms in HIV patients taking antiretroviral therapy. American Conference for the Treatment of HIV, Dallas, TX. May 1, 2015. Poster # ACTHIV3.

Abebe B, Dokpesi P, Clay PG. Comprehensive literature examination to derive terminology currently used to describe pharmacist provided medication therapy management. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2015.

Bavafa A, Killam-Worrall L, Clay PG.  Methods to determine the true rate of side effects caused by medications: a case study with antiretroviral medications and diarrhea. UNTHSC Research Appreciation Day, Fort Worth, Texas. March 2015.

2013

Hawkins TN, McArthur RD, Brown SJ, Clay PG, Waldman L, Barrett AC, Bortey E, Paterson C, Forbes WP. Safety and tolerability of crofelemer 125 mg twice daily in the treatment of non-infectious diarrhea in HIV-seropositive patients on antiretroviral therapy: results from a Phase 3, 48-week open-label study. ID Week 2013, San Francisco, CA. October 5, 2013. Poster #1505.

McArthur RD, Clay PG,  Barrett AC, Golden PL, Bortey E, Paterson C, Forbes WP. Identifying high responder populations to crofelemer for treatment of non-infectious diarrhea in HIV(+) individuals. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Denver, Colorado. September 13, 2013. Poster #H-1264.

Golden PL, Mathis A, Chu HM, Ette E, Clay PG, Paterson C, Rolleri R, Bortey E, Forbes WP. Population pharmacokinetic (PK) analysis demonstrates no drug-drug interactions between crofelemer, a novel treatment for non-infectious diarrhea in HIV(+) individuals, and antiretroviral therapy. 53rd Interscience Conference on Antimicrobial Agents and Chemotherapy, Denver, Colorado. September 12, 2013. Poster #A-1577.

Clay PG, Williams CR, Erickson KD, Piepergerdes A. A site level quality assurance program outcome: identification of sponsor-provided source documents with greatest prevalence of errors. 49th Annual Drug Information Association Meeting, June 25, 2013. Poster #52432.

Clay PG, Barrett A, Golden P, Paterson C, Bortey E, Forbes W. Crofelemer for HIV-associated diarrhea: sustained efficacy, safety and adherence during a 6-months randomized, placebo controlled trial. 8th International Conference on HIV Treatment and Prevention Adherence. Miami, FL. June 5, 2013. Poster #140.

Link to Dr. Clay’s University Profile

 

This page was last modified on October 18, 2018