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:
|Shivakoti, Rupak; Christian, Parul; Yang, Wei-Teng et al. (2016) Prevalence and risk factors of micronutrient deficiencies pre- and post-antiretroviral therapy (ART) among a diverse multicountry cohort of HIV-infected adults. Clin Nutr 35:183-9|
|Shivakoti, Rupak; Yang, Wei-Teng; Berendes, Sima et al. (2016) Persistently Elevated C-Reactive Protein Level in the First Year of Antiretroviral Therapy, Despite Virologic Suppression, Is Associated With HIV Disease Progression in Resource-Constrained Settings. J Infect Dis 213:1074-8|
|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|
|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|
|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|
|Robertson, K; Jiang, H; Evans, S R et al. (2016) International neurocognitive normative study: neurocognitive comparison data in diverse resource-limited settings: AIDS Clinical Trials Group A5271. J Neurovirol 22:472-8|
|La Rosa, Alberto M; Harrison, Linda J; Taiwo, Babafemi et al. (2016) Raltegravir in second-line antiretroviral therapy in resource-limited settings (SELECT): a randomised, phase 3, non-inferiority study. Lancet HIV 3:e247-58|
|Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San et al. (2016) Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial. J Acquir Immune Defic Syndr 72:304-9|
|van der Straten, Ariane; Brown, Elizabeth R; Marrazzo, Jeanne M et al. (2016) Divergent adherence estimates with pharmacokinetic and behavioural measures in the MTN-003 (VOICE) study. J Int AIDS Soc 19:20642|
|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|
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