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:

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
Welsch, Sue A
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Johns Hopkins University
Schools of Medicine
United States
Zip Code
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 63:1113-21
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
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
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
Baeten, Jared M; Palanee-Phillips, Thesla; Brown, Elizabeth R et al. (2016) Use of a Vaginal Ring Containing Dapivirine for HIV-1 Prevention in Women. N Engl J Med 375:2121-2132
van der Straten, Ariane; Montgomery, Elizabeth T; Musara, Petina et al. (2015) Disclosure of pharmacokinetic drug results to understand nonadherence. AIDS 29:2161-71
Palanee-Phillips, Thesla; Schwartz, Katie; Brown, Elizabeth R et al. (2015) Characteristics of Women Enrolled into a Randomized Clinical Trial of Dapivirine Vaginal Ring for HIV-1 Prevention. PLoS One 10:e0128857
van der Straten, Ariane; Mayo, Ashley; Brown, Elizabeth R et al. (2015) Perceptions and Experiences with the VOICE Adherence Strengthening Program (VASP) in the MTN-003 Trial. AIDS Behav 19:770-83
Marrazzo, Jeanne M; Ramjee, Gita; Richardson, Barbra A et al. (2015) Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med 372:509-18
Mgodi, Nyaradzo M; Kelly, Cliff; Gati, Brenda et al. (2015) Factors associated with bone mineral density in healthy African women. Arch Osteoporos 10:206

Showing the most recent 10 out of 13 publications