The Clinical Research Site at Johns Hopkins, directed by Yukari Manabe, MD, occupies space on the East Baltimore Medical Campus. The JHU CRS takes advantage of the many units available within Johns Hopkins Hospital, including Inpatient/Overnight Services for adult research participants, the Outpatient Research Unit, Inpatient/Outpatient Service for pediatric research participants, research nutrition services, and the Drug Development and Analysis Unit.
The HIV Care Program serves as the most important resource for patient referrals to ACTG clinical trials, and is also an important referral source for HPTN trials. The Service is directed by Dr. Manabe, and was founded in 1983. The principal components are summarized below:
- The John G Bartlett Speciality Practice: The centerpiece of the clinical care program, operated by the Division of Infectious Diseases, is housed within Johns Hopkins Hospital and is designated for HIV care. The clinic is 16,000 square feet with 24 examining rooms and provides a complete range of outpatient services including primary care, medical specialties, social work programs, drug rehabilitation, adherence programs, mental health care, infusion services, induced sputum facilities, phlebotomy, pharmacy, on-site laboratory, and several specialty services. Primary care is currently provided for 3,500 patients with HIV infection, viral hepatitis (B and C), transplant and general infectious diseases, and there are >30,000 patient-visits/year. The HIV primary care clinical practice consists of physician faculty (Infectious Diseases and General Internal Medicine), ID fellows, nurse practitioners, and physician's assistants. There are 84 care providers. Treatment is provided in accordance with the manual, Medical Management of HIV Infection (JG Bartlett ed) and national consensus guidelines.
- The HIV Inpatient Service: The HIV/AIDS service (Polk Unit) is a 24-bed ward located in The Johns Hopkins Hospital. This service opened in 1986 as the second designated AIDS inpatient facility in the US. The unit is managed by the Johns Hopkins HIV Care Program. This unit primarily serves the patients enrolled in the John G Bartlett Specialty Practice.
- Outpatient Clinical Research Unit: The Outpatient CRU operates its facility immediately in the Carnegie building and operates a 14-bed inpatient facility within Johns Hopkins Hospital on Osler 5.
- HIV County Program: The county program is operated within the HIV Care Program and includes 9 clinics and nearly 900 patients throughout Maryland. On-site primary care is provided by Moore Clinic providers, and specialty/hospitalization referral to the Bartlett Specialty Practice and the Johns Hopkins Hospital Inpatient AIDS Unit.
- HIV Subspecialty Care: Subspecialty services that provide care on-site within the HIV Clinic include neurology, psychiatry, obstetrics-gynecology, dermatology, nephrology, metabolic diseases, clinical pharmacology, psychology, social services, and nutrition. Other services—including pulmonary, ophthalmology, cardiology, and endocrinology—are coordinated with the AIDS Service.
All sample processing for virology assays for the CRS will be performed in the HIV Specialty Lab and includes a tissue culture room, specimen prep room, a PCR amplification room, a room for HIV antibody testing and a PCR detection room. The HIV/STD Research Laboratory is recognized internationally for expertise as a reference laboratory for all STDs, especially gonorrhea and chlamydia testing. Both the gonococcal and chlamydial sections of this laboratory are licensed by the State of Maryland and Clinical Laboratory Improvement Amendments (CLIA; ID # 21D0680509; State of Maryland laboratory permit #008 and 940247, respectively) for STD diagnostic evaluations, and are recognized as leading diagnostic labs in the United States.