In its first 11 years, the program has successfully partnered with Alan Greenberg of the George Washington University School of Public Health and Health Policy and formed a network of the 15 largest HIV providers in the District of Columbia The project has created a common data base for the 15 providers, linking key HIV related information for patients being seen at all sites who agree to participate in the observational cohort that has been created. The DC Cohort is overseen by the DC PFAP Steering Committee but managed by Alan Greenberg, Amanda Castel, and Anne Munroe of GW School of Public Health. The Cohort now has more than 10,000 HIV positive volunteers among DC's 14000 persons with HIV. This is the largest urban HIV cohort in the nation. It is being analyzed to cross sectional and longitudinal observational data about the DC epidemic, which has led to numerous presentations and manuscripts. The cohort has launched a real time desk top scoreboard so that clinics and providers can determine if they are meeting important HIV related benchmarks. This tool is also being used to drive quality assurance and quality improvement. The DC PFAP Subspecialty Clinics were established as a distinct pillar of DC PFAP in order to address the increasing prevalence of medical co-morbidities that are affecting the health of people living with HIV/AIDS (PLWHA), targeting underinsured and disenfranchised populations. Medical co-morbidities have become a major concern among the PLWHA community as people are living longer with HIV infection as a direct result of improved antiretroviral medications. Unfortunately, morbidity and mortality rates have now become a result of problems such as liver disease, renal disease, cardiovascular disease, metabolic disorders and malignancies, which may be related to HIV, to concurrent infections, or to non-infectious co-morbidities. Since June 1, 2009, the Subspecialty Clinics have been created and the providers have started to engage patients in the medical care of hepatitis C viral infections. It is crucial to the DC PFAP mission that these programs become integral components of the health care community in DC, and embed their services within the existing community HIV and Primary care medical clinics. Over 1600 patients with HCV have been evaluated for studies at community-based sites. This program is the leading clinical research program in the US focusing on the development of new HCV therapeutics and the delivery of such drugs. DC PFAP leaders appear at many national meetings, and were founding leaders and members of the AASLD-IDSA national guidance on HCV Management, the gold standard for management in the US. The Program has also focused on the role of marginalized patients in propagating the epidemic. Clinical sites in northeast and southeast DC have been designed to assess the characteristics and molecular viral sequences of HIV and HCV in these populations, and compare them to new case isolates to determine which subgroups are most important regarding new cases of HIV and HCV. The GRAVITY study has enrolled 500 marginalized persons to determine their incidence and prevalence of HIV and HCV. Molecular epidemiologic analysis is underway to determine their link to new cases in DC. HCV therapy is very popular among persons with and without HIV in DC. Thus, providing access to such therapy is being assessed as a bridge to HIV services (ART and PREP) and to opioid use disorder services. Given the importance of opioid use disorder in contributing to risky behavior that promotes HIV and HCV transmission, and given the importance of opioid sue disorder in interfering with adherence to PREP and ART, DC PFAP has been funded by NIH OD to collaborate with pharmaceutical companies on the development of new strategies for dealing with OUD. This developing project is being performed with the Clinical Directors of NIDA, NIMH, NIAA, and NINDS. In 2019 a phase I study of ANS 6697 was completed at the CC to meet FDA requirements for drug development for a novel compound that reduces cravings. The project includes collaborations with NIAID, NIMH, NIDA and NINDS. A phase II study should launch in the 4th quarter of 2019 or first quarter of 2020.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Investigator-Initiated Intramural Research Projects (ZIA)
Project #
1ZIACL009010-10
Application #
10017611
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
10
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
Zip Code
Emmanuel, Benjamin; Masur, Henry; Kottilil, Shyam et al. (2018) Expansion of Treatment for Hepatitis C Virus Infection. Ann Intern Med 168:457-459
Lucar, Jose; Hart, Rachel; Rayeed, Nabil et al. (2018) Sexually Transmitted Infections Among HIV-Infected Individuals in the District of Columbia and Estimated HIV Transmission Risk: Data From the DC Cohort. Open Forum Infect Dis 5:ofy017
Chaudhury, Chloe S; Sheehan, Julia; Chairez, Cheryl et al. (2017) No Improvement in Hemoglobin A1c Following Hepatitis C Viral Clearance in Patients With and Without HIV. J Infect Dis 217:47-50
Aldous, Annette M; Castel, Amanda D; Parenti, David M et al. (2017) Prevalence and trends in transmitted and acquired antiretroviral drug resistance, Washington, DC, 1999-2014. BMC Res Notes 10:474
Levy, M E; Greenberg, A E; Hart, R et al. (2017) High burden of metabolic comorbidities in a citywide cohort of HIV outpatients: evolving health care needs of people aging with HIV in Washington, DC. HIV Med 18:724-735
Castel, Amanda D; Kalmin, Mariah M; Hart, Rachel L D et al. (2016) Disparities in achieving and sustaining viral suppression among a large cohort of HIV-infected persons in care - Washington, DC. AIDS Care 28:1355-64
Townsend, Kerry; Meissner, Eric G; Sidharthan, Sreetha et al. (2016) Interferon-Free Treatment of Hepatitis C Virus in HIV/Hepatitis C Virus-Coinfected Subjects Results in Increased Serum Low-Density Lipoprotein Concentration. AIDS Res Hum Retroviruses 32:456-62
Meissner, Eric G; McLaughlin, Mary; Matthews, Lindsay et al. (2016) Simtuzumab treatment of advanced liver fibrosis in HIV and HCV-infected adults: results of a 6-month open-label safety trial. Liver Int 36:1783-1792
Petersen, Tess; Townsend, Kerry; Gordon, Lori A et al. (2016) High adherence to all-oral directly acting antiviral HCV therapy among an inner-city patient population in a phase 2a study. Hepatol Int 10:310-9
Wilson, Eleanor M; Kattakuzhy, Sarah; Sidharthan, Sreetha et al. (2016) Successful Retreatment of Chronic HCV Genotype-1 Infection With Ledipasvir and Sofosbuvir After Initial Short Course Therapy With Direct-Acting Antiviral Regimens. Clin Infect Dis 62:280-8

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