This application is submitted on behalf of the ongoing HIV Malawi HIV Research Consortium (HRC) which includes the College of Medicine (COM) in Malawi, the University of North Carolina (UNC) at Chapel Hill, NC and the Johns Hopkins University (JHU) Bloomberg School of Public Health in Baltimore, MD. In recognition of the long history of these collaborations, JHU will continue to serve as the primary grantee institution and lead the Administrative Component of the proposed Clinical Trials Unit (CTU). This country-wide consortium includes the resources of the two main medical facilities in Malawi, the Queen Elizabeth Central Hospital in Blantyre and the Kamuzu Central Hospital in Lilongwe (they will represent the Clinical Research Sites). The HIV/AIDS epidemic is severely impacting the health of children, adolescents, men and women in Malawi. In some of these populations, the HIV prevalence is more than 30% and HIV incidence is more than 4 per 100 person-years. The Malawi HRC has developed a long-term collaboration focused on a wide spectrum of HIV research that includes most aspects of HIV prevention, HIV treatment and care and nascent vaccine efforts. This consortium has inspired several cutting-edge research projects and very extensive training and technology transfers. Each participating institution brings essential resources to this collaboration: the COM in Malawi provides a critical ink to all aspects of the health care infrastructure, appropriate patient populations, and in-country personnel required for a successful research program;Johns Hopkins University has provided leadership, training, clinical and laboratory resources, and a diverse scientific research agenda that led to innovative interventions;and UNC has provided access to new populations, increased capacity for biological research, pioneered research on sexually transmitted infections, and increased focus on issues of HIV treatment.
The Aims of this Proposal are I) To implement clinical trials that assess safety, efficacy and acceptability of appropriate interventions in all high priority research areas;II) To expand as needed to additional populations to further investigate HIV pathogenesis, evaluate the development of treatment and prevention strategies that are applicable to populations in resource-constrained settings, and respond to emerging scientific opportunities;and III) To work collaboratively with the Clinical Trials Networks Leadership to contribute to the scientific agenda. ADMINISTRATIVE COMPONENT:

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
Program Officer
Potter, Dara G
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Johns Hopkins University
Public Health & Prev Medicine
Schools of Public Health
United States
Zip Code
Palanee-Phillips, Thesla; Roberts, Sarah T; Reddy, Krishnaveni et al. (2018) Impact of Partner-Related Social Harms on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III Trial. J Acquir Immune Defic Syndr 79:580-589
Hosseinipour, Mina C; Kang, Minhee; Krown, Susan E et al. (2018) As-Needed Vs Immediate Etoposide Chemotherapy in Combination With Antiretroviral Therapy for Mild-to-Moderate AIDS-Associated Kaposi Sarcoma in Resource-Limited Settings: A5264/AMC-067 Randomized Clinical Trial. Clin Infect Dis 67:251-260
Robertson, K; Oladeji, B; Jiang, H et al. (2018) HIV-1 and TB Co-infection in Multinational Resource Limited Settings: Increased neurological dysfunction. Clin Infect Dis :
Ngongondo, McNeil; Miyahara, Sachiko; Hughes, Michael D et al. (2018) Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. J Acquir Immune Defic Syndr 78:54-61
Flynn, Patricia M; Taha, Taha E; Cababasay, Mae et al. (2018) Prevention of HIV-1 Transmission Through Breastfeeding: Efficacy and Safety of Maternal Antiretroviral Therapy Versus Infant Nevirapine Prophylaxis for Duration of Breastfeeding in HIV-1-Infected Women With High CD4 Cell Count (IMPAACT PROMISE): A Randomi J Acquir Immune Defic Syndr 77:383-392
Robertson, Kevin R; Jiang, Hongyu; Kumwenda, Johnstone et al. (2018) HIV Associated Neurocognitive Impairment in Diverse Resource Limited Settings. Clin Infect Dis :
Fowler, Mary G; Flynn, Patricia; Aizire, Jim (2018) What is new in perinatal HIV prevention? Curr Opin Pediatr 30:144-151
Palumbo, Philip J; Fogel, Jessica M; Hudelson, Sarah E et al. (2018) HIV Drug Resistance in Adults Receiving Early vs. Delayed Antiretroviral Therapy: HPTN 052. J Acquir Immune Defic Syndr 77:484-491
Greer, Amy E; Ou, San-San; Wilson, Ethan et al. (2017) Comparison of Hepatitis B Virus Infection in HIV-Infected and HIV-Uninfected Participants Enrolled in a Multinational Clinical Trial: HPTN 052. J Acquir Immune Defic Syndr 76:388-393
Bisson, Gregory P; Ramchandani, Ritesh; Miyahara, Sachiko et al. (2017) Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults. AIDS 31:2217-2225

Showing the most recent 10 out of 50 publications