KEMRI-PHRD CLINICAL TRIAL SITE FOR CASCADE NETWORK ‘CERVICAL CANCER PREVENTION FOR WOMEN LIVING WITH HIV Project Summary/Abstract: Cervical cancer is the leading cause of cancer-related deaths in women in eastern and southern Africa, the regions with the highest burden of HIV infection globally. (1) In East Africa, 2020 estimates reported that a quarter of new cervical cancer cases could be attributed to HIV infection. (2) Cervical cancer morbidity and mortality reflects global inequity with the most vulnerable populations carrying the greatest disease burden. The KEMRI-CCR-PHRD research clinic in partnership with LVCT Health Dhibiti HIV/TB PEPFAR/CDC program (supporting 31,800 PLHIV in central region of Kenya) have organized a consortium of HIV and cervical cancer clinical, research and program experts and through this application propose to join the UG1 as a Network clinical trial site and implement HIV/cervical cancer prevention studies. We propose to implement the UG1 Network studies at three selected HIV care clinics based in rural urban public hospitals in Kiambu county (Thika level 5, Ruiru level 4, Igegania level 4 hospitals). The three selected hospitals are part of ten reproductive health (RH) clinics implementing the ‘TIBA’ study (5R01CA258590-02 Mugo), an implementation science study evaluating the implementation of Screen and Treat (SAT) + Single Visit Approach (SVA) with Thermal Ablation (TA). We have capacity and resources to participate in all four proposed focal UG1 research areas; increase screening uptake, improve management of screen positives, facilitate precancer treatment access and optimize precancer treatments for cervical cancer prevention for WLWH. Through partnership with LVCT Health Dhibiti HIV/TB CDC/PEPFAR funded care program and leveraging on- going implementation science studies conducted in the selected public health facilities, we propose in Aim 1, to provide infrastructure to recruit, enroll and retain WLWH to the UG1 network studies. The three selected facilities have an estimate of 4,000 WLWH enrolled in the HIV/TB care clinics, with the option to expand to 10,000 by incorporating the ten TIBA study clinics. In Aim 2, we propose to interface with the UG1 Research Bases and U24 Network Coordinating Center during concept and protocol development to provide insights and input on issues pertaining to clinical significance, study feasibility, implementation and contribute towards raising up relevant priority research questions. KEMRI-CCR-PHRD co-PIs have participated in multiple multisite clinical trials and have been protocol chairs on network studies. In Aim 3, we propose to provide on-site operational leadership for the successful conduct of the network clinical trials. The KEMRI-CCR-PHRD research unit has 16 years’ experience conducting clinical research and has well tested standardized systems and materials for implementation of research in accordance with international regulatory requirements.

Project Narrative: In partnership, KEMRI-CCR–PHRD and LVCT Health (lvcthealth.org) have organized a consortium of scientists and clinicians with expertise in cervical cancer and HIV prevention, care and treatment and the conduct of multi- site clinical trials, behavioral science and propose to join the UG1 as a Network clinical trial site.