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:

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
Adedeji, Bola
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of California San Francisco
Obstetrics & Gynecology
Schools of Medicine
San Francisco
United States
Zip Code
Fowler, Mary Glenn; Coovadia, Hoosen; Herron, Casey M et al. (2014) Efficacy and safety of an extended nevirapine regimen in infants of breastfeeding mothers with HIV-1 infection for prevention of HIV-1 transmission (HPTN 046): 18-month results of a randomized, double-blind, placebo-controlled trial. J Acquir Immune Defic Syndr 65:366-74
Sarnquist, Clea C; Moyo, Precious; Stranix-Chibanda, Lynda et al. (2014) Integrating family planning and prevention of mother to child HIV transmission in Zimbabwe. Contraception 89:209-14
Grinsztejn, Beatriz; Hosseinipour, Mina C; Ribaudo, Heather J et al. (2014) Effects of early versus delayed initiation of antiretroviral treatment on clinical outcomes of HIV-1 infection: results from the phase 3 HPTN 052 randomised controlled trial. Lancet Infect Dis 14:281-90
Balkus, Jennifer E; Richardson, Barbra A; Rabe, Lorna K et al. (2014) Bacterial vaginosis and the risk of trichomonas vaginalis acquisition among HIV-1-negative women. Sex Transm Dis 41:123-8
Borok, Margaret Z; Busakhala, Naftali; Makadzange, Tariro et al. (2014) Setting the research agenda in a resource-limited setting--viewpoint. J Acquir Immune Defic Syndr 65 Suppl 1:S3-4
Touzard Romo, F; Smeaton, L M; Campbell, T B et al. (2014) Renal and metabolic toxicities following initiation of HIV-1 treatment regimen in a diverse, multinational setting: a focused safety analysis of ACTG PEARLS (A5175). HIV Clin Trials 15:246-60