UG1CA284671

Caprisa Cascade Clinical Trials Network Clinical Research Site - Summary

The Center for the AIDS Program of Research in South Africa (CAPRISA) Cascade Clinical Trials Network Clinical Research Site aims to provide clinical trial infrastructure and operational leadership for the conduct of pragmatic clinical trials through the Cascade Clinical Trials Network.

The proposed clinical trial site is strategically located in KwaZulu-Natal (KZN) Province, the epicenter of the Human Immunodeficiency Virus (HIV) epidemic in South Africa. Due to the high background HIV prevalence in this setting, KZN Province remains a region with a high burden of cervical cancer disease, despite expansion and improved access to antiretroviral treatment (ART).

CAPRISA has been undertaking high-impact globally relevant and locally responsive research for nearly two decades. The eThekwini Clinical Research Site (ECRS) is one of four clinical research sites and is based in the central business district in eThekwini. This is a well-established research site, with over 15 years' experience conducting high-quality clinical trials.

We have established research infrastructure which supports the conduct of both CAPRISA-led research as well as National Institutes of Health (NIH) network-affiliated trials, primarily recruiting young women for participation in our trials. To date, our core focus of research has been HIV prevention, although we are equally experienced in research involving HIV pathogenesis and clinical management of women living with HIV (WLHIV).

Together with previous Human Papilloma Virus (HPV) epidemiological studies undertaken by our team, we have begun preliminary work in cervical cancer screening in an ongoing CAPRISA trial, where we are evaluating HPV point-of-care testing in WLHIV. Through the Cascade Network, we aim to support and advance cervical cancer prevention through participation in clinical trials.

Through our relevant clinical trial experience and scientific expertise, we are able to contribute to the four scientific focus areas proposed by the network: increasing screening uptake, improving management of screen positives, facilitating precancer treatment access, and optimizing precancer treatment for cervical cancer prevention in WLHIV.

We have assembled a strong team of investigators to support this program, including a Principal Investigator (PI) and co-investigators who have led multiple HIV and COVID-19 clinical trials at a site level and are leading several NIH-funded protocols as national PIs or protocol co-chairs. The team is able to contribute to protocol development and to provide laboratory, data management, and statistical support for trials undertaken through the network. Furthermore, we are able to collaborate with the respective research bases and coordinating centers proposed by the network.

Considering CAPRISA's expertise in HIV research and preliminary work undertaken in HPV epidemiology and HPV diagnostics, we are well-placed to be a strong partner in the Cascade Network.

Centre For The Aids Program Of Research In South Africa

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]

South Africa

Foreign

Clinical Sites for HIV/Cervical Cancer Prevention 'CASCADE' Clinical Trials Network (UG1 Clinical Trial Required) (RFA-CA-22-051)

Amendment Since initial award the total obligations have increased 258% from $216,000 to $773,000.