HIV/cervical cancer cOntrol and Prevention clinical sitE in Kenya (HOPE-Kenya)

ABSTRACT Cervical cancer (CC) is a highly preventable disease and yet hundreds of thousands of women die each year from CC with the large majority of deaths occurring in low- and middle-income countries (LMICs). LMICs in sub- Saharan Africa (SSA) are particularly affected because of the dual burden of human papillomavirus (HPV) and HIV infection which interact with deadly synergism. Women living with HIV (WLWH) have accessed antiretroviral therapy (ART) across SSA but have yet to fully benefit from integrated CC screening and treatment services. The challenges lie not in any particular barrier to care but in the many gaps that occur in the cascade of CC prevention from screening uptake to management of positive cases to treatment access and application. Clinical research sites are needed worldwide to implement clinical trials that examine potential interventions and one of the most ideal locations may be found at the Coptic Hope Center for Infectious Diseases in Nairobi, Kenya. Co- founded by Dr. Michael Chung (MPI) and Dr. Samah Sakr (MPI) at the Coptic Hospital in 2004, the Hope Center is one of the largest single-site ART treatment centers in Kenya having enrolled over 20,000 people living with HIV (PLWH) with over 6,000 WLWH currently in care. The Hope Center has been screening WLWH for cervical cancer since 2005 and has been the site for HIV CC research and many clinical trials conducted by Treatment, Research, and Expert Education (TREE), which Dr. Chung leads as Executive Director. Based at the Hope Center, TREE has a powerful physical, administrative, and laboratory infrastructure that has been implementing HIV clinical trials at the site for over a decade including a study that screened over 6,000 WLWH with Papanicolaou (Pap) smear and colposcopy-directed biopsy, randomized 400 to cryotherapy and loop electrosurgical excision procedure (LEEP), and examined recurrence of cervical intraepithelial neoplasia (CIN), cervical shedding of HIV, and clearance of HPV over 2-year follow-up. In this proposal, Dr. Chung and Dr. Sakr will co-lead the implementation of a clinical site at the Hope Center in Nairobi by Coptic Hospital and TREE that, with assistance from Drs. Mary Nderitu (co-I) and Evans Nyongesa-Malav (co-I), will study interventions that will: 1) increase screening uptake among WLWH; 2) improve management of women who screen positive; and 3) optimize precancer treatment for WLWH. They will achieve this by providing: 1) a pluripotent infrastructure for accruing participants to network clinical trials from the Hope Center and a network of four Coptic HIV Clinics throughout the country that are overseen by Dr. Andrew Nagy (co-I) for a total of 6,533 CC screen eligible WLWH between the ages of 25 and 49; 2) insights and input on clinical significance and study feasibility during concept and protocol development through the participation of Dr. Chung and Dr. Sakr; and 3) and on-site operational leadership for the successful conduct of network clinical trials by TREE and its staff led by Dr. Rose Kosgei (co-I).