GHUCCTS

GHUCCTS Programs & Resources

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Hub Liaison Team (Participant Recruitment & Engagement)

Learn more about our Hub Liaison Team.

  • What's It All About

    The GHUCCTS Hub Liaison Team and collaborating service providers across GHUCCTS institutions to provide support to investigators engaged in research at any of the partner institutions. We provide multidisciplinary consultations to facilitate research development and study design, participant recruitment, implementation, retention, and accessing diverse populations in research protocols. We partner with the Trial Innovation Network, a network created to leverage the expertise and resources of the CTSA program, to enhance the speed and efficiency of multi-site clinical trials across all GHUCCTS institutions. The Trial Innovation Network provides opportunities for investigators including: (1) to may propose multicentered clinical trials as a GHUCCTS investigator to leverage the nation-wide Trial Innovation Network – contact us if you are in the planning phase of such a study for additional support; or, (2) to be considered as a site participant for a multicentered clinical trial – be on the lookout for emails from your department related to new opportunities to work with the TIN. Contacts us at ghuccts-hlt@georgetown.edu.

     This is how we work:

    Complete this service request form to schedule a consultation or send us an email ghuccts-hlt@georgetown.edu. Here are some possible areas where we can help:

      • Provide support in recruitment of diverse population and development of recruitment strategies.
      • Development of multicentered studies and identify potential collaborating sites across the nation.
      • Support NIH submissions or resubmissions.
      • Help identify or establish a coordinating center for your multi-site trial.
      • Support requests for EHR data for cohort discovery or research
      • Provide input and feedback on best practices in participant recruitment and retention.
      • Coordinate studio sessions with community and/or participant advisory boards for input on proposed or active studies.
      • Provide guidance on the single IRB model that may be required for your study.
  • Who is Responsible

    Medical Director, GHUCCTS Hub Liaison Team: Seble Kassaye, MD, MS
    Dr. Kassaye, is an Infectious Diseases specialist and epidemiologist, and tenured Associate Professor of Medicine at Georgetown University. Her research spans the translational spectrum, from the molecular epidemiology of HIV including drug resistance; long-term outcomes and comorbidities among persons with HIV, particularly in women; and prevention of HIV including during pregnancy. She has conducted implementation science research globally and supported novel privacy-assured technology initiatives to support clinical services and public health initiatives in HIV and more recently with COVID-19. Dr. Kassaye is the contact PI for the DC MACS/WIHS Combined Cohort Study (MWCCS), and served as the co-chair for the MWCCS executive committee during the formative period of the merger of these two historic multi-site national HIV cohorts. She is also the site PI for the more recently established cohort of younger women living with HIV in the southern U.S. (STAR cohort). She was the site PI for a multi-site national study led by Johns Hopkins University and supported by the CTSA Trial Innovation Network (TIN) to determine the efficacy of convalescent plasma for early treatment and prevention of COVID-19. As part of her role in the GHUCCTS she leads the Hub Liaison Team, and supports investigators in study design, protocol development, and provides her expertise in participant recruitment and retention, community engagement and outreach. She is the point of contact with the CTSA-funded Trial Innovation Network. Dr. Kassaye sees patients at MedStar Georgetown University Hospital covering the general and transplant services on the inpatient service, and maintains an active outpatient clinic practice.

    Expertise: Infectious Diseases, HIV/AIDS, Epidemiology, Medical Education
    Research Techniques: Translational Research, Clinical Trials, Observational Cohorts.
    Interests: Infectious Diseases, Epidemiology, Public Health, Health Outcomes Research, Health Communications, Health Equity, Medical Education
    Language(s): 
    English (Speak Read Write)
    Amharic (Speak Read Write)

     

    Operations Director: Wendy Enriquez 

    Wendy Enriquez manages the overall programmatic and operational responsibilities of the Hub Liaison Team, assigning duties and coordinating with departments within the MedStar Health system and GHUCCTS partner institutions and service providers to ensure synergy and effective service provision. Wendy nurtures our relationship with the Trial Innovation Network and supports investigators’ access to TIN-supported studies. Wendy supports the implementation of participant recruitment strategies to include diverse populations, the adaptation and utilization of social media platforms, and community engagement activities.

    Language(s):
    English (Speak Read Write)
    Spanish (Speak Read Write)


    Informatics Lead

    Stephen Fernandez, MPH: As the Informatics Lead for the Trial Innovation Network, Stephen Fernandez, MPH provides services for PI’s and MHRI investigators by providing data through various EMR Systems within MedStar.

    As the manager of MedStar Health Research Institute’s Biomedical Informatics team, he develops and oversees the implementation of site management and monitoring functions, including developing data management plans, creating databases, assigning project tasks, ensuring the sites are monitored and contacted as outlined in the site monitoring plan, reviewing and approving visit reports, and providing feedback to the Clinical Research Associates at each site regarding site performance and/or additional training needs.


    Additional Team Members

      • Finie Richardson, PhD, MPH (HU)
      • Florencia Gonzales (HU)
      • Chad League, JD (MHRI)
      • Marie Therese (Terry) Jeffs, RN (GU, CRU)
      • Yejide Obisesan (HU)
      • Justin Hughes (MHRI)
      • Claudia Gunawan (DAVAMC)
      • Tolu Ijayekunle (DCVAMC)
      • Angie Wilkis (GU)
      • Tonya Bishop (MHRI)
      • Marjorie Gondre-Lewis (HU)
      • Thomas Mellman, MD (HU)
      • Neil Weissman, MD (MHRI)
      • Marc Blackman, MD (DCVAMC)
      • Joseph Verbalis, MD (GU)
  • Tell Me More

    Hub Liaison Team Study Start Up

    Our number one goal is to help investigators implement their TIN multi-site study as quickly and simply as possible. How? After years of planning and strategizing with contract offices at Georgetown University, Howard University, MedStar Health Research Institute, and the Washington VA Medical Center, we’ve established a collaborative infrastructure to help implement multi-site contracts and quickly as possible. We have contract facilitators, one at each institution, who know their contracting environment, are aware of potential barriers and can help facilitate study start up, including contract execution and IRB. Essentially, they know the right people and the resources we have in place to get the job done. Contact us today to learn more!

    Standard Agreement: To improve the efficiency of the process for review and negotiation process for research agreements, the CTSA Program hubs and the Federal Demonstration Partnership (FDP) have developed a toolkit of standardized agreements and FAQs for use by the TIN. | Learn More

    Single IRB: The goal of the Trial Innovation Network (TIN) single IRB (SIRB) is to create a comprehensive, cohesive central IRB process and operating system that will support multi-center studies on a national level. | Learn More

    Hub Liaison Team chart showing that the TIN has supported trials at Johns Hopkins, Vanderbilt, and the University of Utah

    To learn more about how our team can support your research study email us at: ghuccts-hlt@georgetown.edu or submit a services request to meet with our team: submit a service request form

  • Services & Resources

    Participant Recruitment & Engagement

    The HLT Participant Recruitment & Engagement team is here to help investigators engage with the community. As the liaison to the national Recruitment Innovation Center, funded by the National Center for Advancing Translational Sciences, we provide a variety of services to support research teams with participant recruitment.

    Recruitment services include:

    Schedule a free consultation call with our team: submit a service request form

    Hub Liaison Team/ Study Start Up

    We guide investigators to rapidly and successfully implement their TIN- supported multi-site studies. After years of planning and strategizing with contract offices at Georgetown University, Howard University, MedStar Health Research Institute, and the Washington VA Medical Center, we’ve established a collaborative infrastructure to facilitate timely execution of multi-site contracts. We have points of contact at each institution to guide and expedite institutional agreements for rapid study start up. The GHUCCTS IRB serves as a single IRB (sIRB) for partner institutions, and has the requisite expertise and staffing to engage with external sIRBs for multi-site studies. Contact us today to learn more! You can find additional information about TIN resources here

    How does can the Trial Innovation Network Support your study?

Trial Innovation Network

The network will leverage the expertise, skills and knowledge of NCATS and the CTSA participants to provide consultation and resources for multi-site clinical trials.

Learn More

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