We propose a clinical trials unit (CTU) with a single integrated research site (CRS) at GHESKIO in Port-au-Prince, Haiti. GHESKIO is the acronym for Groupe Haitian d'Etude du Sarcoma da Kaposi at des Infections Opportunistas. The CTU/CRS will focus on the rapid implementation of clinical research sponsored by three of the NIAID Networks - Adult HIV Therapeutic strategies (ACTG), HIV vaccines (HVTN), and the International Maternal-Pediatric-Adolescent AIDS Clinical Trials Network (IMPAACT). The CTU will also contribute new ideas for Network clinical trials. GHESKIO has consistently been ranked among the top several sites in recruitment to both the ACTG and HVTN Networks, and is also a leader in maternal-child-adolescent study enrollment. The GHESKIO tripartite mission of research, patient care and training provides the patient populations, cohorts, and experienced research teams to conduct intensive Phase I to Phase IV studies. GHESKIO provides free health care to over 100,000 persons/year. In 2012 GHESKIO tested over 40,000 parsons for HIV, with 9.6% seroprevalence. Sixty percent of the new HIV infections diagnosed at GHESKIO in 2012 were women, including 485 pregnant women. Haiti has the highest prevalence of HIV infection in this hemisphere with an incidence of 2.0% in high-risk heterosexual populations and a clade B strain. GHESKIO currently has over 15,000 patients receiving ART and follows several thousand children and adolescents. Tuberculosis research capitalizes on GHESKIO's unique resources - a BSL-3 laboratory, a 30-bed MDR-TB research hospital under construction, and a local TB incidence of 768 cases/100,000 persons. GHESKIO diagnosed and treated 1,666 new TB cases in 2012. The capacity of GHESKIO to rapidly adapt was demonstrated by its response to the 2010 earthquake and the subsequent cholera epidemic. In 2012, GHESKIO also successfully immunized 50,000 high-risk persons for cholera in the slums adjacent to its clinics. This record of productivity and the breadth of GHESKIO's clinical, laboratory, and staff resources assure significant contributions will continue to be made in the Networks.
The GHESKIO CTU/CRS will conduct research in the areas of adult HIV therapeutic strategies (ACTG), HIV vaccines (HVTN), and on HIV infection in pediatric and maternal populations (IMPAACT). The goal is to increase our ability to prevent and to treat HIV/AIDS and its associated conditions.
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