UG1CA275416

Botswana Cascade Clinical Trials Site - Project Summary / Abstract

Successful HIV treatment programs in Botswana and elsewhere in Southern Africa have led to dramatic reductions in mortality from tuberculosis, cryptococcosis, and other non-cancer AIDS deaths. However, cancer deaths have not decreased, and cervical cancer now is the leading cause of death for women living with HIV in the region.

Cervical cancer is preventable with early detection and treatment of precancerous lesions, but challenges of limited access to initial screening, poor performance of initial screening technologies, high prevalence of cervical precancers, and persistent or relapsed dysplasia following therapy impair the impact of programs for women living with HIV.

Working to develop strategies to address these challenges, we will establish the Botswana Cascade Clinical Trials Site at BHP that will participate in and contribute to the following high-impact areas of research:

1) Enhancing cervical precancer screening uptake through patient and context-relevant approaches, including HPV self-sampling, non-clinical screening venues, and screening during antenatal care.

2) Strategies and novel technologies to improve management of positive HPV initial screening, maximizing prevention of invasive cancer while minimizing patient risk and consumption of health system resources.

3) Improving precancer treatment access, treatment completion, and outcomes.

4) Optimizing treatment approaches to cervical precancers, including comparative trials of ablation techniques, intervals of repeat evaluation, and vaccines or other immunologic therapies.

The Botswana Cascade Clinical Trials Site will contribute to conducting high-quality clinical research studies, provide context-relevant input on developing trial concepts, understand disparities in access by geography, economic factors, and language/ethnicity, and continue to develop local research capacity through mentoring and training.

Brigham & Womens Hospital

TO REDUCE CANCER RISK, INCIDENCE, MORBIDITY, AND MORTALITY AND ENHANCE QUALITY OF LIFE IN CANCER SURVIVORS THROUGH AN ORDERLY SEQUENCE FROM RESEARCH ON INTERVENTIONS AND THEIR IMPACT IN DEFINED POPULATIONS TO THE BROAD, SYSTEMATIC APPLICATION OF THE RESEARCH RESULTS THROUGH DISSEMINATION AND DIFFUSION STRATEGIES. PRIMARY EMPHASIS IS ON THE INCLUSION OF CANCER PREVENTION AND CONTROL INTERVENTION(S) IN ANY PROPOSED STUDY. CANCER PREVENTION AND CANCER CONTROL RESEARCH STUDIES ARE CLASSIFIED INTO ONE OF FIVE PHASES: (1) HYPOTHESIS DEVELOPMENT, (2) METHODS DEVELOPMENT AND TESTING, (3) CONTROLLED INTERVENTION TRIALS TO ESTABLISH CAUSE-AND-EFFECT RELATIONSHIPS, (4) RESEARCH IN DEFINED POPULATIONS, AND (5) DEMONSTRATION AND IMPLEMENTATION STUDIES. PRIMARY INTERESTS ARE IN RESEARCH ON CANCER CONTROL INTERVENTIONS IN PHASES 2 THROUGH 5, AND ON CANCER PREVENTION RESEARCH IN ALL PHASES. CANCER PREVENTION AND CONTROL PROGRAMS INCLUDE THOSE IN THE FOLLOWING AREAS: (1) CANCER EPIDEMIOLOGY, (2) CANCER COMMUNICATIONS, (3) NUTRITION, DIET, AND PHYSICAL ACTIVITY, (4) SCREENING AND EARLY DETECTION IN HEALTH CARE DELIVERY, (5) BIOBEHAVIORAL MECHANISMS, (6) TOBACCO CONTROL, (7) HEALTH DISPARITIES RESEARCH, (8) SUPPORTIVE CARE AND SURVIVORSHIP, (9) HEALTH SERVICES AND OUTCOMES RESEARCH, AND (10) SURVEILLANCE RESEARCH. CANCER CONTROL USES SMALL BUSINESS INNOVATION RESEARCH (SBIR) AND SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAMS TO ENGAGE DOMESTIC SMALL BUSINESS CONCERNS IN FEDERAL RESEARCH AND DEVELOPMENT THAT HAS POTENTIAL FOR COMMERCIALIZATION. THE GOALS OF THE SBIR & STTR PROGRAMS ARE TO STIMULATE TECHNOLOGICAL INNOVATION, INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF FEDERAL RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERALLY FUNDED RESEARCH AND DEVELOPMENT, AND FOSTER PARTICIPATION BY SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE STTR PROGRAM REQUIRES THE SMALL BUSINESS CONCERN TO FORMALLY COLLABORATE WITH A RESEARCH INSTITUTION IN PHASE I AND PHASE II OF THE PROGRAM.

93.399 - Cancer Control

National Cancer Institute (NCI) [HHS - NIH]

Boston, Massachusetts 021156110 United States

Single Zip Code

Clinical Sites for HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network (UG1 Clinical Trial Required) (RFA-CA-21-047)

Amendment Since initial award the total obligations have increased 351% from $257,815 to $1,163,675.