We propose to establish a Johns Hopkins (JHU) Clinical Trial Unit (CTU) with three affiliated Clinical Research sites (CRS): two in Kampala, Uganda, and one in Manning, China. The proposed CTU structure includes joining of two CTU leaderships and clinical research sites with outstanding performance over the past grant cycle. The successful performance includes high enrollment of over 3700 participants and retention rates between 83% and 97%;a consistent track record as the leader of network scientific contributions;and successful conduct of high priority HIV Prevention and Therapeutic clinical trials within three of the current NIH HIV Clinical Trial Networks. The Johns Hopkins Kampala -Nanning (K-N) CTU proposal will be led by two PD/PIs, Professors Mary Glenn Fowler and Brooks Jackson, who have worked collaboratively in various roles over the past 22 years to conduct clinical trials on HIV prevention and HIV therapeutics and its complications. This CTU will have its central administrative base at JHU in Baltimore, MD and will conduct the network HIV clinical protocols at two CRSs in Kampala, Uganda and one CRS in Nanning, China. 1. The Makerere U. Johns Hopkins U. Research Collaboration (MU-JHU) CRS will be affiliated with a) the Clinical Research Network for HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations focusing on PMTCT and treatment of HIV infected infants and young children;b) the Network on Integrated Strategies to Prevent HIV Infection;and c) the Network on Microbicides to Prevent HIV Infection. 2. The Pediatric Infectious Diseases Clinic/ Baylor College of Medicine Children's Foundation of Uganda Institute (PIDC) CRS, an independent nonprofit NGO entity in Uganda will focus on pediatric and adolescent HIV treatment trials and will be affiliated with the Network on Infections in Pediatric and Maternal Populations. 3. The Nanning CRS site in Nanning China will be affiliated with a) the Network for HIV/AIDS and HIV associated Infections in Pediatric and Maternal Populations focusing on PMTCT and treatment of HIV infected infants and young children;b) the Network on Integrated Strategies to Prevent HIV Infection;and c) the Network on Therapeutics for HIV and associated infections.

Public Health Relevance

The configuration of the JHU K-N CTU/CRS is designed to maximize the capacity for high enrollment of diverse at-risk international populations (adult injection drug users, women at risk, pregnant women and children) and to carry out the state-of-the-art HIV research agenda proposed within four clinical trial networks to significantly reduce HIV related morbidity and mortality in these populations.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
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Special Emphasis Panel (ZAI1-RRS-A (S2))
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Potter, Dara G
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Johns Hopkins University
Schools of Medicine
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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
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
Mensch, Barbara S; Brown, Elizabeth R; Liu, Karen et al. (2016) Reporting of Adherence in the VOICE Trial: Did Disclosure of Product Nonuse Increase at the Termination Visit? AIDS Behav 20:2654-2661
Barlow-Mosha, Linda; Angelidou, Konstantia; Lindsey, Jane et al. (2016) Nevirapine- Versus Lopinavir/Ritonavir-Based Antiretroviral Therapy in HIV-Infected Infants and Young Children: Long-term Follow-up of the IMPAACT P1060 Randomized Trial. Clin Infect Dis 63:1113-1121

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