Document text
Principal Investigator: JACKY M JENNINGS
Organization: JOHNS HOPKINS UNIVERSITY
Fiscal Year: 2024
Award: $1,755,125
Funding agency: National Institute of Allergy and Infectious Diseases
Project Summary
Sub-Saharan Africa continues to bear a disproportionate burden of the global HIV epidemic. Conducting
studies in the most affected areas of the world is critical to the international HIV research agenda. The Johns
Hopkins University-Blantyre, Malawi Clinical Trials Unit (JHU Blantyre-CTU) and its clinical research site (CRS)
in Malawi, located in one of the most affected regions of the world, propose to continue and expand high-
impact research collaborations with four NIAID Clinical Research Networks in order to prevent, treat, manage
and potentially cure HIV and AIDS in adults, key populations, and children. With more than 30 years of HIV
research experience and the strong backing of the host institutions (Johns Hopkins University and College of
Medicine, University of Malawi), the CTU and CRS leadership will be responsible for the conduct and
management of clinical trials at the Blantyre, CRS in accordance with the Research Networks and NIAID
policies. The CTU aims to advance the scientific agenda of the proposed Clinical Research Networks for HIV
prevention, treatment and vaccine research among adults and children by generating hypotheses and
developing new scientific concepts; continuing implementation of active study protocols at the Blantyre CRS
under the current CTU; making available the efficient and flexible local research infrastructure to quickly
respond to emerging needs of the Networks; and by engaging protocol-specific populations. The CTU will
emphasize quality, oversight, cohesiveness and efficiency in all operations as it works to achieve these aims.
During the current CTU cycle (2013 to present), the Blantyre CRS has been involved in 35 studies at various
stages, from initiation to completion, for four existing Division of AIDS/NIAID Clinical Research Networks. The
CRS has established effective institutional and community collaborations and has been responsive to both the
Network agendas and the national health research agenda for Malawi. The goal of this application is to
describe scientific, leadership and administrative strengths of the proposed JHU-Blantyre CTU and its CRS in
Blantyre, Malawi, which will ensure successful implementation of the NIAID international clinical research
agenda. The sub-sections (A-L) of this application provide a scientific overview of the proposed CTU and
describe its administrative and financial management structures; plans for communication, evaluation and
training; and the roles, responsibilities and resources of each CTU element and CRS technical department,
including community engagement, pharmacy, laboratory, quality and regulatory assurance, and data
management. Our CTU arrangement that encompasses a single CRS has demonstrated capacity and
promotes efficiency.
Terms: <0-11 years old><21+ years old><AIDS><AIDS Virus><AIDS prevention><AIDS/HIV><Acquired Immune Deficiency><Acquired Immune Deficiency Syndrome><Acquired Immune Deficiency Syndrome Virus><Acquired Immunodeficiency Syndrome><Acquired Immunodeficiency Syndrome Virus><Administrative Management><Adolescent><Adolescent Youth><Adult><Adult Human><Affect><Africa><Africa South of the Sahara><Anti-HIV Positivity><Area><Basic Research><Basic Science><Behavior Conditioning Therapy><Behavior Modification><Behavior Therapy><Behavior Treatment><Behavioral Conditioning Therapy><Behavioral Modification><Behavioral Therapy><Behavioral Treatment><Child><Child Youth><Childhood><Children (0-21)><Cities><Clinical><Clinical Cooperative Groups><Clinical Management><Clinical Research><Clinical Study><Clinical Trial Groups><Clinical Trials><Clinical Trials Cooperative Group><Clinical Trials Network><Clinical Trials Unit><Collaborations><Communication><Communities><Conditioning Therapy><Country><Data><Development><Elements><Ensure><Epidemic><Ethics><Evaluation><Financial Management><Generations><Goals><HIV><HIV Infections><HIV Positive><HIV Positivity><HIV Prevention><HIV Seroconversion><HIV Seronegativities><HIV Seronegativity><HIV Seropositivity><HIV Vaccine Trials Network><HIV antibody positive><HIV negative><HIV prevention trials network><HIV-1><HIV-I><HIV/AIDS><HIV/AIDS prevention><HIV1><HTLV-III Infections><HTLV-III Seroconversion><HTLV-III Seronegativities><HTLV-III Seronegativity><HTLV-III Seropositivity><HTLV-III-LAV Infections><HVTN><Health><Human Immunodeficiency Virus Type 1><Human Immunodeficiency Viruses><Human T-Lymphotropic Virus Type III Infections><Human immunodeficiency virus 1><Individual><Information Technology><Infrastructure><Institution><International><LAV-HTLV-III><Laboratories><Leadership><Lymphadenopathy-Associated Virus><Malawi><Medicine><Mentors><Microbicide Treatment Network><Microbicide Trials Network><Modality><NIAID><NIH><National Institute of Allergy and Infectious Disease><National Institutes of Health><Nyasaland><Occupational activity of managing finances><Office of Administrative Management><Patient Self-Report><Persons><Pharmacies><Pharmacy facility><Policies><Population><Prevalence><Prevention><Prevention Research><Preventive><Principal Investigator><Prophylactic treatment><Prophylaxis><Protocol><Protocols documentation><Regimen><Research><Research Infrastructure><Research Priority><Research Resources><Resources><Risk><Role><Scientific Advances and Accomplishments><Self-Report><Site><Structure><Sub-Saharan Africa><Subsaharan Africa><Survey Instrument><Surveys><Testing><Therapeutic Clinical Trial><Training><United States National Institutes of Health><Universities><Vaccine Research><Vaccines><Viral Burden><Viral Load><Viral Load result><Virus-HIV><Work><adulthood><age group><behavior intervention><behavioral intervention><clinical research site><clinical site><collaboration with communities><college><collegiate><community collaboration><community engagement><community-based collaboration><data management><developmental><engagement with communities><ethical><experience><flexibility><flexible><high standard><juvenile><juvenile human><kids><operation><operations><pediatric><prevent><preventing><programs><research study><scientific accomplishments><scientific advances><social interventions><social role><statistics><support network><treatment research><vaccination study><vaccination trial><vaccine study><vaccine trial><vaccine-related research><youngster>