Potential Study Subject Populations
If you would like to propose a study involving any of these potential subject populations, please complete a Concept Sheet (available on the CFAR Website, Clinical Research Core page), and submit this for review to the CFAR Core leaders.
A. Local Patient Populations
- Adult HIV Population at Thomas Street Health Center (TSHC). In 2013, the Harris Health System HIV/AIDS Services and TSHC cared for over 5500 unique HIV-infected patients who completed about 22,000 physicians visits. About a third were female, 61% were African-American or black, and 27% were Hispanic or Latine, making the site an excellent venue for recruiting women and racial/ethnic minority patients. Patients at TSHC can access federally funded, industry funded, and locally funded research studies. Under the leadership of UTHouston, TSHC offers patients access to clinical trials run by the ACTG network (Site Director Roberto C. Adruino, MD). Robust data sources include (1) electronic medical records (Epic) that include laboratory data, prescription data, informed consent data, and all office, hospitalization and emergency room visits. In 2013, a TSHC behavioral screen was implemented for all routine patient care; it includes screening in Epic on Mental Health (PHQ-2) that provides information on many risk behaviors. The TSHC Ryan White databases link to the regional Centralized Patient Care Data Management System, a real time, de-identified client-level computer database application. Contact: Thomas P. Giordano, MD/MPH or Roberto Arduino, MD.
- Pediatric HIV Patients at Texas Children’s Hospital. In November 2012 there were an estimated 629 HIV-infected infants, children, adolescents, and young adults in Houston. The racial distribution of this cohort is African American (~69–75%), Hispanic (~17–24%), and non-Hispanic Whites (~6–7%). The cohort at Texas Children’s Hospital are predominantly perinatally infected and are more female (56%) than male (44%). The TSHC cohort, who were predominantly infected through high-risk sexual behavior are 73% male and 27% female. Most of the children’s CD4+ T cell counts are greater than that which defines Centers for Disease Control and Prevention classification as severe immunosuppression (i.e., <15%), but their viral load values vary broadly despite instruction on adherence in clinic visits scheduled every 3 months. The robust data sources include (i) the electronic medical records system (Epic), (ii) connection to the IMPAACT database at Frontier Science and Technology Research Foundation, Amherst, NY, and (iii) connection to the PHACS database at the Harvard School of Public Health, Boston, MA.
- Michael E. DeBakey VA Medical Center HIV Clinic. The Houston VA’s HIV clinic cares for about 900 unique patients annually. The clinic is staffed by Infectious Disease faculty and fellows, as well as a clinical pharmacist, a clinical psychologist, and HIV worker and case workers. Because this is a veteran population, the average age of patients is 54 years and only about 3% are women. The patients are predominanly African-American (60%) or Hispanic (10%). The clinic sees between 50 and 100 new patients annually, most of whom are transferring into the VA after having been diagnosed elsewhere. Access to this patient population is facilitated through Thomas Giordano, MD/MPH. The VA system has databases, such as HIV Clinical Case Registry and VA Immunologic Case Registry. Contact:Maria Rodriguez-Barradas, MD, Medical Director of the clinic
- National HIV Networks. The CFAR leaders will use their established connections with national and international HIV Networks (ACTG, IMPAACT, PHACS, PREDICT) to increase the Baylor–UTHouston CFAR’s participation in large-scale studies. The Core will provide concepts and protocols, patient populations, or both for large-scale and smaller individual studies.
B. International Clinical Sites- Pediatric patients
Clinical research sites include eight Baylor College of Medicine Children’s Clinical Centers of Excellence (COE) in Gaborone, Botswana; Maseru, Lesotho; Mbabane, Swaziland; Lilongwe, Malawi; Kampala, Uganda; and Mbeya and Mwanza, Tanzania; as well as the Romanian-American Children’s Center in Constanta, Romania. Each COE is well equipped with computers with Internet access and offers housing for trainees and visiting collaborators. Baylor College of Medicine employs 30 or more individuals at each center, including faculty physicians and full-time training coordinators.
Over 200,000 HIV-infected patients are linked in the international Electronic Medical Records (EMR) system, and are available to CFAR investigators for epidemiologic, operational, and clinical research.
If you would like to propose a study involving any of these potential subject populations, please contact Dr. Mark Kline at
Updated October 2014