CLINICAL CORE MISSION AND SERVICES: The mission of the Duke CFAR Clinical Core is to promote research excellence, innovation, and increase impact in the prevention and control of HIV/AIDS domestically and globally. We achieve this mission by providing outstanding service, resources, and mentorship to mentees, early-stage investigators (ESIs), and established investigators new to HIV/AIDS research.  

• Clinical Core Consultation: Our five faculty leaders provide consultation on HIV study concept, design, human subject research, and protocol implementation with domestic and international expertise at any stage of research development. The diverse expertise of the Clinical Core faculty allows us to support a broad breath of research topics and to be nimble in identifying new scientific opportunities based upon novel clinical observations and contemporary health challenges consistent with the NIH’s HIV research priorities. We work closely with the Development Core and the Social Behavioral Sciences Core to provide grant review (specifically assessment of study feasibility, design considerations, and implementation strategies), post-award consultation, and community engagement for ESIs during grant application development. We strongly promote an interdisciplinary team science approach to problem solving as we believe team science increases research quality and impact.
• Regulatory and coordination services: Kathy Link, Stuart Carr, and Tina Watkins, with a collective 38-year knowledge of the Duke Health system and domestic and international HIV research, provide comprehensive regulatory support for HIV clinical studies. This includes support in the development of informed consent, IRB protocol development and submission, providing yearly research updates and responding to regulatory queries, human subject research training offered at the School of Medicine, connecting investigators to the myriad of resources available for clinical research at Duke ranging from electronic health record recruitment tools to REDCap Database support. For ESIs who have a CFAR pilot grant, we additionally can offer support in study coordination, helping them to efficiently recruit and enroll participants in clinical studies to ensure projects meet their timelines and milestones and generate sound preliminary data to support larger grant applications.
• Clinical Core Resources: We accelerate HIV translational and clinical research by providing direct interaction with research participants for enrollment into research protocols, including those from underserved and marginalized populations with HIV and at increased risk of HIV acquisition locally at Duke (over 2,000 PWH and PrEP patients combined), at our international sites in Tanzania (over 10,000 PWH), in Kenya, South Africa, and Botswana (over 10,000 PWH combined), and in Vietnam, Thailand, and southern China (over 20,000 PWH combined). We connect trainees to mentors, investigators to investigators, and all individuals to resources offered at our extensive network of Duke partners, centers, programs and institutes, in the U.S. South, in sub-Saharan Africa and in Southeast Asia, to foster robust and excellent interdisciplinary team science. 

A distinguished resource of the Clinical Core is access to the Duke HIV Research Database and Repository  which houses over 70,000 plasma samples from PWH with well-characterized clinical phenotypes and longitudinal follow up (median 17 years).  This includes plasma, serum, urine, and PBMC samples from over 3,000 adults with advanced HIV disease in Vietnam. The repository has supported numerous clinical investigators from multiple disciplines across Duke to obtain NIH grants to advance diagnostics and biomarker research programs.

• Clinical Core Mentorship: We foster a vibrant mentor/mentee community and camaraderie around ESIs and trainees through intentional outreach/recruitment activities, social engagement, and supportive mentorship. This includes grassroot engagement events with prospective medical students, residents, and postdoctoral clinical fellow scientists interested in ID and HIV and engaging them in our biannual Clinical Core Social Mixer events and biannual research-in-progress seminars presented and organized by ESIs. The Clinical Core also host individual ESI for a 30-minute Think Tank session during our Clinical Core monthly meetings, which has been a useful platform for ESIs to receive focused feedback on new research ideas, grant management, or trouble shooting challenges.
• Community engagement: We emphasize bidirectional communication and engagement with communities of researchers and PWH in North Carolina through the Duke Collaboratory Community Council (D3C) and in Tanzania through the Adult and Youth Community Advisory Boards (CABs).

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CORE STAFF CONTACTS:

The HIV Center or Excellence (COE) was established in August 2023 as a new Department of Medicine level Center led by Core Associate Directors Lance Okeke and Mehri McKellar to align Duke’s HIV clinical activities with contemporary HIV best practices, and to inform the Duke CFAR’s clinical research mission.  The Duke HIV COE is guided by cross-cutting principles of i) Addressing inequity in HIV care and ii) Leveraging practice-generated performance data to develop novel strategies to optimize HIV care and prevent new HIV infections. The Center’s operations are organized into four sections: Research, Education and Outreach, Care Quality Improvement, and Informatics. The Center currently administers two innovative HIV practice-informed clinical initiatives: Duke ID Fellowship HIV Clinical Practice Quality Improvement Program and the HIV Rapid Response Re-engagement Team (H3RT). COE leadership meets quarterly with Duke’s Health Services Research Scientific Working Group co-directors to identify emerging trends in Duke’s HIV clinical practice that can inspire new CFAR research initiatives or inform ongoing research efforts.  

Early Stage Investigator Mixer activities

• June 18, 2024 inaugural meeting introducing the clinical core to the broader HIV research community and setting our agenda
   
  
  
   
• October 22, 2024, led by ESIs Nassem Alavian, Emily Neihause, and Haley Cunningham, with presentations by
  • Suur Ayangeakaa - https://populationhealth.duke.edu/profile/suur-debrah-ayangeakaa 
  • Carl Mhina - https://populationhealth.duke.edu/personnel/carl-mhina 

Global HIV Initiative in partnership with the Duke Global Health Institute

The Global HIV Initiative is jointly coordinated by the Clinical Core Directors and DGHI Director and CFAR Associate Director for Global HIV Chris Beyrer, to work across all Cores, Institutes and Centers to serve as a resource for Duke investigators and our international partners to deepen our partnerships in Africa and Asia and provide global network opportunities for ESIs and trainees through training, capacity development, and research, and foster a new generation of global HIV researchers at Duke. 

• International Conference events mixers highlighting HIV clinical research from trainees
  • CROI 2024

    

  • AIDS 2024
    
  • ID WEEK 2024 (Coming soon)
  • R4P 2024 pics (Coming soon)

Tropical Medicine Research Center for Talaromycosis in Vietnam (TMRC-Vietnam): The TMRC was established in May 2022, is a newly NIH-sponsored Center hosted by Pham Ngoc Thach University of Medicine (PNTU) in Ho Chi Minh City, Vietnam, led by Co-Directors Thuy Le and Vietnamese PhD scientist Ngo Thi Hoa (Head of Department of Microbiology and Parasitology at PNTU) (NIH U01AI169358). The TMRC research focuses on reducing advanced HIV disease mortality through innovative diagnostics and treatment strategies of AIDS-associated mycoses. The Clinical Core collaborates across CFAR Cores to support this NIH program by providing training and mentorship to ESIs and trainees in Vietnam. Between January and March 2024, the TMRC held an  8-week online R programing course, followed by a 2-day in-person Biostatistics Workshop led by the Quantitative Sciences (QS) Core (Rishi Chakraborty), and a 2-day in-person Qualitative Science Methodology Workshop from the Social and Behavioral Sciences Core (SBS) (Amy Corneli, via a travel grant from the DGHI)

Kilimanjaro Christian Medical Centre-Duke Collaboration is located in Moshi, Tanzania, founded by former CFAR Co-Director John Bartlett.  The collaboration is a longstanding deeply-rooted bi-directional partnership spanning over twenty years. The KCMC-Duke partnership thrives with Core mentorship, consultation, regulatory assistance, and community outreach. The value of this partnership is an outstanding global research base for Duke and Tanzanian investigators, ESIs, and trainees to conduct collaborative HIV global health research. Clinical investigators Dorothy Dow (Co-Director; KCMC site co-leader), Nathan Thielman, Matthew Rubach, and Catherine Staton received Core support to run their independent NIH-funded research programs at KCMC. Two ESIs Julian Hertz and Brandon Knettel received CFAR pilot awards leading to successful K awards over the current cycle to conduct HIV research at KCMC. James Ngocho (Mentors: Rubach/Bartlett) received the first K43 awarded to KCMC. Numerous Duke trainees have engaged in HIV research at KCMC through the Duke Global Health Pathway, the Duke Global Health Master’s Program, and Fogarty Fellowships including the Sociobehavioral Sciences HIV Research and Training Grant (D43TW009595).