Leading investigators in the area of HIV research from Johns Hopkins (JHU) and Makerere Universities (MU) propose to establish the Makerere University-Johns Hopkins University HIV Clinical Trials Unit-Kampala, Uganda to conduct critical HIV prevention and treatment research. This Clinical Trials Unit (CTU) consists of an administrative base at JHU and two Kampala clinical research sites (CRS). The MU-JHU Research Collaboration site will be affiliated with both the IMPAACT and the Microbicide Network applications, focusing on HIV prevention and treatment in women and children. The Infectious Diseases Institute site will be affiliated with the HPTN Network application with a focus on HIV prevention in adults. Both sites also have the capacity to expand to other network areas such as HIV vaccine end treatment studies. The clinical, data management, laboratory, and administrative resources and expertise necessary to screen, enroll, and retain HIV infected and uninfected participants in HIV prevention and treatment trials are currently available. The presence of the shared CAP-certified laboratory, community advisory boards, strong regulatory/QC sections, and local Ugandan IRB oversight coupled with extensive clinical trials experience will insure that all research is conducted to the highest scientific and ethical standards. The longstanding (>17 yr) relationship between JHU and MU investigators and support of the Uganda Ministry of Health has created a strong, productive, and mutually beneficial international center for HIV research that will be able to continue and expand through the funding of this application. Uganda has been at the forefront in HIV education, programs, and research in response to their devastating epidemic. However, rates of HIV infection in the 45,000 women in the Mulago hospital antenatal clinics yearly remain high (~11%), with transmission to neonates during pregnancy and breastfeeding. Women are economically and socially disadvantaged with limited capacity to protect themselves against infection. Access to HIV therapy is expanding, but lack of medical infrastructure and human capacity presents an ongoing challenge. Preventing HIV infection in adults and children and providing access to care to those infected is a worldwide public health crisis. The goal of this research unit is to find practical and affordable ways to accomplish this in a setting with limited resources. ADMINISTRATIVE COMPONENT:

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
5UM1AI069530-06
Application #
8215694
Study Section
Special Emphasis Panel (ZAI1-MH-A (M1))
Program Officer
Welsch, Sue A
Project Start
2007-02-05
Project End
2014-01-31
Budget Start
2012-02-01
Budget End
2013-01-31
Support Year
6
Fiscal Year
2012
Total Cost
$1,577,922
Indirect Cost
$180,010
Name
Johns Hopkins University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218
RuiseƱor-Escudero, Horacio; Familiar, Itziar; Nyakato, Mary et al. (2018) Building capacity in neurodevelopment assessment of children in sub-Saharan Africa: A quality assurance model to implement standardized neurodevelopment testing. Child Neuropsychol :1-16
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
Chernoff, Miriam C; Laughton, Barbara; Ratswana, Mmule et al. (2018) Validity of Neuropsychological Testing in Young African Children Affected by HIV. J Pediatr Infect Dis 13:185-201
Boivin, Michael J; Barlow-Mosha, Linda; Chernoff, Miriam C et al. (2018) Neuropsychological performance in African children with HIV enrolled in a multisite antiretroviral clinical trial. AIDS 32:189-204
Fowler, Mary G; Flynn, Patricia; Aizire, Jim (2018) What is new in perinatal HIV prevention? Curr Opin Pediatr 30:144-151
Balkus, Jennifer E; Palanee-Phillips, Thesla; Reddy, Krishnaveni et al. (2017) Brief Report: Dapivirine Vaginal Ring Use Does Not Diminish the Effectiveness of Hormonal Contraception. J Acquir Immune Defic Syndr 76:e47-e51
Currier, Judith S; Britto, Paula; Hoffman, Risa M et al. (2017) Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ? 400 cells/mm3. PLoS One 12:e0176009
Hobbs, Charlotte V; Gabriel, Erin E; Kamthunzi, Portia et al. (2016) Malaria in HIV-Infected Children Receiving HIV Protease-Inhibitor- Compared with Non-Nucleoside Reverse Transcriptase Inhibitor-Based Antiretroviral Therapy, IMPAACT P1068s, Substudy to P1060. PLoS One 11:e0165140
Mirembe, Brenda G; Kelly, Clifton W; Mgodi, Nyaradzo et al. (2016) Bone Mineral Density Changes Among Young, Healthy African Women Receiving Oral Tenofovir for HIV Preexposure Prophylaxis. J Acquir Immune Defic Syndr 71:287-94
Luecke, Ellen H; Cheng, Helen; Woeber, Kubashni et al. (2016) Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study. J Int AIDS Soc 19:20875

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