The goal of the University of Zimbabwe-University of California San Francisco Clinical Trials Unit (UZ-UCSF CTU) is to provide scientific leadership, a well organized and efficient research-support infrastructure, and even high-capacity Clinical Research Sites (CRS) to conduct state-of-the-art HIV/AIDS prevention and treatment intervention trials in Zimbabwe, with potential application throughout southern Africa and other highly affected regions. Currently there are three research programs in Zimbabwe that participate in DAIDS network activities: 1) UZ-UCSF HIV Prevention Trials Unit (HPTN funding);2) the UZ-Clinical Research Centre (ACTG and HPTN funding);and 3) the UZ Pediatric AIDS Clinical Trials Unit (PACTG funding), each with well-established CRS. We propose to integrate the three programs and seven of their CRS to continue implementation of 12 transitional protocols (HPTN 035, 046, 052;ACTG A5175, A5199, A5221, A5208, A5225;and PACTG A5190/P1054), and to conduct future trials affiliated with four DAIDS networks;the Adult Clinical Trials Group (ACTG), HIV Prevention Trials Network (HPTN), the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT), and Microbicides Trial Network (MTN). Our CTU brings together many of the world's leading researchers from the finest research and public health institutions around the world.
The specific aims i n this proposal are to:
Aim 1. Develop an integrative Clinical Trials Unit by consolidating three existing research programs into a centralized infrastructure to implement existing transitional protocols associated with four DAIDS Clinical Trials Leadership Groups, and to expand our scientific and logistical capacity to participate in future trials. Objective 1 .a. Provide scientific leadership that promotes high quality research, contributes to priority research areas, oversees capable and productive CRS and supports the development of new researchers. Objective 1 .b. Develop centralized research support components to coordinate fiscal management, quality assurance and control, regulatory, human subjects and ethics, data management, laboratory, pharmacy, training, community advisory board liaison, and counseling functions for all UZ-UCSF CTU activities. Objective 1 .c. Strengthen our management and communication systems to ensure high quality research implementation and effective oversight of the seven proposed CRS. Objective 1 .d. Manage transition of clinical protocols from current awards to the proposed CTU structure.
Aim 2. Contribute scientifically to the leadership and prioritization of research activities in four networks: ACTG, HPTN, IMPAACT, and MTN.
Aim 3. Achieve meaningful community partnership in the CTU clinical research activities through effective outreach and communication and Community Advisory Board (CAB) participation.
Aim 4. Work with established clinical research sites that have proven capacity, experience and a record of scientific productivity. ADMINISTRATIVE COMPONENT:
|Uprety, Priyanka; Lindsey, Jane C; Levin, Myron J et al. (2017) Inflammation and Immune Activation in Antiretroviral-Treated Human Immunodeficiency Virus Type 1-Infected African Infants and Rotavirus Vaccine Responses. J Infect Dis 215:928-932|
|Chirenje, Zvavahera Mike; Gundacker, Holly M; Richardson, Barbra et al. (2017) Risk Factors for Incidence of Sexually Transmitted Infections Among Women in a Human Immunodeficiency Virus Chemoprevention Trial: VOICE (MTN-003). Sex Transm Dis 44:135-140|
|Palumbo, Philip J; Wilson, Ethan A; Piwowar-Manning, Estelle et al. (2017) Association of HIV diversity and virologic outcomes in early antiretroviral treatment: HPTN 052. PLoS One 12:e0177281|
|Riddler, Sharon A; Husnik, Marla; Ramjee, Gita et al. (2017) HIV disease progression among women following seroconversion during a tenofovir-based HIV prevention trial. PLoS One 12:e0178594|
|Akello, Carolyne A; Bunge, Katherine E; Nakabiito, Clemensia et al. (2017) Contraceptive Use and Pregnancy Incidence Among Women Participating in an HIV Prevention Trial. J Womens Health (Larchmt) 26:670-676|
|Tenforde, Mark W; Yadav, Ashish; Dowdy, David W et al. (2017) Vitamin A and D Deficiencies Associated With Incident Tuberculosis in HIV-Infected Patients Initiating Antiretroviral Therapy in Multinational Case-Cohort Study. J Acquir Immune Defic Syndr 75:e71-e79|
|Koss, Catherine A; Bacchetti, Peter; Hillier, Sharon L et al. (2017) Differences in Cumulative Exposure and Adherence to Tenofovir in the VOICE, iPrEx OLE, and PrEP Demo Studies as Determined via Hair Concentrations. AIDS Res Hum Retroviruses :|
|Balkus, Jennifer E; Brown, Elizabeth R; Hillier, Sharon L et al. (2016) Oral and injectable contraceptive use and HIV acquisition risk among women in four African countries: a secondary analysis of data from a microbicide trial. Contraception 93:25-31|
|Hosseinipour, Mina C; Bisson, Gregory P; Miyahara, Sachiko et al. (2016) Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial. Lancet 387:1198-209|
|De Boni, Raquel B; Zheng, Lu; Rosenkranz, Susan L et al. (2016) Binge drinking is associated with differences in weekday and weekend adherence in HIV-infected individuals. Drug Alcohol Depend 159:174-80|
Showing the most recent 10 out of 38 publications