Clinical Sites for HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network (UG1 Clinical Trial Required)

Background
The HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network seeks to evaluate innovative approaches for overcoming barriers and reducing failures in the cervical cancer screening and treatment cascade for women living with HIV. The proposed multicenter network will conduct pragmatic clinical trials to evaluate the effectiveness of clinically proven interventions in intended-use settings with a goal to optimize the cervical cancer screening, management, and precancer treatment cascade for women living with HIV.

Data from these trials will be used to provide the necessary evidence to refine clinical practice guidelines and inform public health policy with a goal to generate crucial actionable evidence for improving cervical cancer prevention implementation programs.

Grant Details
The UG1 Clinical Sites will provide a pluripotent infrastructure for accruing participants to facility-based and field-based clinical trials, and interface with the UG1 Research Bases and U24 Network Coordinating Center during concept and protocol development to provide insights and input on clinical significance and study feasibility. The UG1 Clinical Sites will serve as the study implementation settings in the CASCADE Network providing on-site operational leadership for the successful conduct of the multi-institutional pragmatic clinical trial protocols.

The CASCADE Network is expected to develop and conduct a total of six to eight multicenter clinical trials over the five-year project period in both low- and middle-income countries and in the US. It is expected that at least two of the eight UG1 Clinical Sites will have a focus on underserved women in the US.

Eligibility Requirements
Eligible organizations include higher education institutions, public/state controlled institutions of higher education, private institutions of higher education, nonprofits with 501(c)(3) IRS status (other than institutions of higher education), nonprofits without 501(c)(3) IRS status (other than institutions of higher education), small businesses, for-profit organizations (other than small businesses), local governments, state governments, county governments.

Period of Performance
The maximum project period is 4 years.

Grant Value
NCI intends to commit $1.5 million per year total costs in FY2022 to fund up to five awards for the UG1 Clinical Sites. It is expected that $1.5 million per year will be available in FY2024 - FY2026, but future year amounts will depend on annual appropriations. The requested budget must not exceed $200,000 in direct costs for each year of the 4-year project period.

Place of Performance
Domestically in the US, the UG1 Clinical Sites should include a major focus on women with HIV covered by Medicaid, the CDC National Breast and Cervical Cancer Early Detection Program (NBCCEDP), or by the Health Resources and Services Administration (HRSA)-Ryan White HIV/AIDS Care Program funding, or seen at HRSA-funded Federally Qualified Health Centers (FQHCs) including Community Health Centers, Migrant Health Centers, Health Care for the Homeless, and Health Centers for Residents of Public Housing.

Internationally, the UG1 Clinical Sites should include a major focus on women with HIV receiving clinical care services through ongoing cervical cancer prevention and control initiatives.