Sunday, December 22, 2024
12/22/2024
PROJECT ABSTRACT: GHESKIO is a Haitian organization dedicated to research, service, and training in HIV/AIDS with a 37 year track record of NIH-funded clinical research. GHESKIO has two clinical sites in Port au Prince, Haiti. The Downtown site has large HIV/TB clinics, a maternal child health center, a cardiovascular center, and programs in adjacent slums. The North site has HIV/TB clinics, an MDR-TB hospital, and a BSL3 TB laboratory. The GHESKIO Clinical Trials Unit (CTU) has two clinical research sites (CRSs) enrolling male and female participants across the lifespan, including pregnant women, infants, children, adolescents and adults. The GHESKIO CTU will continue to participate in two networks: Adult HIV/AIDS Therapeutic Trials (ACTG) and Maternal, Adolescent, Pediatric therapeutics (IMPAACT). We propose the following three aims: 1. Operate a single organization (GHESKIO) CTU with two research sites that is integrated, cohesive, and able to respond rapidly to a breadth of emerging research priorities. The CTU will maximize efficiency by having a single research component for administration, communication, evaluation, community liaison, data management, regulatory assurance, quality management, and training program. Each CRS has its own pharmacy. The main laboratory is at GHESKIO-North and the downtown site has a satellite laboratory. 2. Conduct adult HIV/AIDS therapeutic trials at GHESKIO-Downtown and GHESKIO-North - ACTG: Haiti has the highest HIV prevalence in the hemisphere with 2.0% of adults HIV infected. Both GHESKIO sites (Downtown, North) have large HIV-infected adult ART naïve and ART-experienced cohorts available for recruitment into trials. Haiti also has the highest rates of TB with a prevalence of 1,066/100,000 in Port au Prince. GHESKIO treats ~ 2,000 TB patients annually including patients with MDR-TB who are available for enrollment into TB treatment trials. GHESKIO has established a new cardiovascular disease research unit to study the chronic complications of HIV. 3. Conduct maternal, adolescent, and pediatric HIV/AIDS trials at GHESKIO-Downtown- IMPAACT: GHESKIO-Downtown has the expertise, research capacity, and populations for trials of new antiretroviral drugs in children, adolescents and pregnant women. GHESKIO pediatricians identify and enroll HIV-infected newborns for trials of intensive therapy to induce an ART free remission. GHESKIO investigators are leaders in PK studies of TB drugs in children and pregnant women. We will be leading a trial evaluating one month isoniazid/rifapentine prophylaxis in pregnant women. GHESKIO will introduce studies on nutritional interventions in pregnant women and newborns to improve their growth and neurologic development.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).