UZ-UCSF CTU
openNIAID - National Institute of Allergy and Infectious Diseases
Project Summary/Abstract
For over 2 decades the University of Zimbabwe-University of California, San Francisco Clinical Trials Unit (UZ-
UCSF CTU) has continuously conducted high quality Phase I-IV clinical trials, utilizing experienced teams of
multidisciplinary, cross-trained investigators, and research staff across the multi-Network CTU. The CTU is a
center of excellence in the prevention and control of HIV/AIDS and has contributed to the global understanding
of HIV epidemiology and pathogenesis, policy, and standards of care. In the current funding cycle, the CTU
enrolled over 6,700 participants in 48 clinical trials across all 5 NIH-funded Networks (ACTG, IMPAACT,
HPTN, HVTN, MTN) at 7 Clinical Research Sites (CRSs), generating 138 scientific articles and informing
Zimbabwe’s health policy. The CTU has innovated to overcome operational challenges occasioned by the
political and economic environment in Zimbabwe. The CTU proposes to continue to develop its scientifically
rigorous and well-managed CTU to support the scientific agendas of the 4 proposed Networks (ACTG,
IMPAACT, HPTN, HVTN), train the next generation of research leaders in Zimbabwe, and contribute to the
control and prevention of HIV and TB in Zimbabwe and globally, with 4 Specific Aims: Specific Aim 1. Lead
robust contributions to the research agendas of the ACTG, IMPAACT, HPTN, HVTN Networks; a) Continue to
advance evaluation of novel and durable systemic ARV-based therapeutic and preventive strategies for: (i)
control of HIV replication in the absence of ART; (ii) control of communicable and non-communicable
comorbidities; and (iii) prevention of HIV in Key Populations, including adolescent girls and young women, men
who have sex with men, and female sex workers by evaluating novel PrEP drug delivery systems; b) Continue
evaluation of novel preventative and therapeutic vaccine candidates and broadly neutralizing antibodies for
HIV/TB control among children, adolescents, and adults; c) Implement integrated strategies to evaluate socio-
behavioral, biomedical, and structural interventions for HIV prevention among high-risk Key Populations while
optimizing treatment outcomes among children, adolescents, and adults living with HIV; d) Investigate new
product acceptability, uptake, and adherence using mixed methods to assess the effectiveness of novel
approaches, including Multi-Purpose Prevention Technologies; Specific Aim 2. Intensify community
engagement at all stages of research and evolve Community Advisory Board membership to represent,
mobilize, and empower Key Populations, in support of the UNAIDS 95-95-95 targets; Specific Aim 3. Maintain
and adapt our CTU’s efficient and sophisticated centralized research infrastructures across the CRSs and the
Laboratory, Pharmacy, Community, Regulatory, Quality Management, Administration and Finance
Departments to drive compliance and ensure efficient execution of trials; and Specific Aim 4. Fortify the CTU’s
role as a local, regional, and global knowledge hub with investments in training and mentorship for the next
generation of scientific and community-based leaders.
Up to $874K
health research