Implementing HIV/Cervical Cancer Prevention CASCADE Clinical Trials in Zimbabwe (ZIM-CASCADE)

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Project Summary/Abstract Zimbabwe is a resource-constrained country with a high burden of HIV and cervical cancer (CXCA). Zimbabwean women with CXCA present with advanced disease and two-thirds die within a year of diagnosis. CXCA screening has low coverage (13%), and is conducted largely through visual inspection with acetic acid (VIA), with plans to migrate to human papillomavirus (HPV) deoxyribonucleic acid (DNA) testing. Precancer treatment is mostly cryotherapy or thermal ablation but is only accessed by 53% of women screen positive. To meet the WHO 2030 target of eliminating CXCA by 2120, Zimbabwe needs new interventions that are acceptable, affordable, point-of-care, scalable, and clinically proven. To optimize CXCA screening and the pre- cancer treatment cascade for women living with HIV (WLWH), University of California, San Francisco (UCSF) and the University of Zimbabwe–Clinical Trials Research Centre (CTRC), in collaboration with local PEPFAR- funded implementation partners Organization for Public Health Interventions and Development (OPHID) and the Zimbabwe Technical Assistance, Training and Education Center for Health (Zim-TTECH) (collectively, ZIM-CASCADE) propose to serve as a LMIC CASCADE UG1 Clinical Site. ZIM-CASCADE draws on extensive experience in conducting clinical research and CXCA screening and treatment among WLWH, with access to 95,000 WLWH, of whom >44,000 are currently receiving comprehensive CXCA screening and treatment through the OPHID and Zim-TTECH programs located in Zimbabwe’s high-density population centers of Harare and Chitungwiza. ZIM-CASCADE will be led by 2 gynecological oncologists with globally recognized expertise in CXCA screening and treatment and will utilize research personnel and infrastructure from dedicated clinical research sites and community-based primary care clinics, whose experience has been developed over nearly 3 decades of continuous research activities. ZIM-CASCADE will participate in all 4 scientific focus areas of the CASCADE Network, and will complete the following Specific Aims: (1) Provide insight as to clinical significance and feasibility of planned trials by drawing on extensive clinical expertise in CXCA prevention among WLWH; (2) Utilize the expansive pluripotent infrastructure and research management systems developed over 28 years to conduct high quality pragmatic clinical trials; (3) Accrue and retain eligible WLWH through effective and equitable engagement with community partners; and (4) Ensure compliance with all protocol procedures and applicable research regulations. Completion of the Aims will contribute critical evidence to inform optimization, implementation, and scale-up of effective cervical cancer prevention interventions for WLWH in resource-limited settings, and the multi-modal CASCADE data will inform public health policy in Zimbabwe and globally.