Implementing HIV/Cervical Cancer Prevention CASCADE Clinical Trials in Uganda (CASCADE UGANDA) - PROJECT SUMMARY/ABSTRACT
Uganda is one of 8 countries with the highest burden of cervical cancer (CXCA) among women living with HIV
(WLWH) with an HIV-attributable age-standardized incidence rate of 10–20 per 100,000. Strategies for Cervical
Cancer (CXCA) prevention include targeted Human Papillomavirus (HPV) vaccination, screening of women aged
25-49 years by visual inspection with acetic acid (VIA) or HPV DNA testing, and precancer treatment by
cryotherapy or ablation. However, there is limited and sparse availability of and access to CXCA interventions
which is compounded by low-uptake of ‘screen and treat’ strategies. Scalable, affordable, point-of-care, clinically
proven novel interventions (including HPV self-sampling techniques, HPV molecular biomarker tests, precancer
diagnostics and imaging techniques, and ablative and excisional treatments) are imperative. Further, the
effectiveness of these novel clinically proven interventions remains unknown which limits implementation in
intended-use settings in the US and low- and middle-income countries (LMICs). To support on-going efforts to
roll-out novel screen and treat strategies, the Makerere University Walter Reed Project (MUWRP) in partnership
with the U.S. Military HIV Research Program (MHRP) propose to participate in the HIV/Cervical Cancer
Prevention ‘CASCADE’ Clinical Trials Network as a UG1 Clinical Research Site (UG1 CRS) to implement
pragmatic clinical trials in Uganda. We will: 1) leverage MUWRP’s expertise and experience in clinical trials and
CXCA prevention among WLWH to provide valuable insight and input on study feasibility, clinical significance
and local context during concept and protocol development; 2) accrue CASCADE targets in a timely manner and
retain ≥ 95% of study participants leveraging MUWRP’s pluripotent experience, clinical research infrastructure
and resources; and 3) provide competent leadership to ensure procedural fidelity to protocols and all applicable
regulations and guidelines. MUWRP will also support UG1 Research Bases and U24 Coordination Center to
obtain ethical and regulatory approvals for CASCADE trials, and implement clinical trial protocols with fidelity.
MUWRP is an ideal and rational choice for a UG1 CRS as MUWRP has: 1) access to over 37,000 WLWH in
urban, semi-urban, and rural settings at 114 health facilities supported by MUWRP’s Comprehensive HIV/AIDS
Prevention, Care and Treatment in Central Uganda (CARE) program funded by the U.S. President's Emergency
Plan for AIDS Relief (PEPFAR); 2) extensive experience conducting HIV clinical research and CXCA screening
and precancer treatment in the African Cohort Study, and CARE supported CXCA program; and 3) internationally
renowned scientists with experience and expertise in conducting clinical trials involving WLWH in Uganda and
other LMICs. MUWRP’s expertise and capacity will support all four research focus areas of the CASCADE
Network. MUWRP and MHRP will generate evidence that ultimately informs CXCA policy and screen and treat
strategies for WLWH.
