Core-001 - COPE Core B

NIH RePORTER · NIH · P01 · $331,765 · view on reporter.nih.gov ↗

Abstract

Core B: Clinical, Outreach, Pathology and Ethics (COPE) Core - ABSTRACT The Clinical, Outreach, Pathology and Ethics (COPE) Core’s mission is to ethically collect, store and provide the biological specimens needed for the scientific aims of the HIV Obligate MicroEnvironment (HOME) program. A highly innovative component of our program and the COPE Core is the peri-mortem translational research model, ‘Last Gift’ cohort. The cohort is comprised of persons with HIV (PWH) who have a terminal illness, usually from a non-AIDS related condition who wish to participate in HIV cure-related research before they die and donate their entire bodies after death for rapid research autopsy. These participants will be recruited from palliative care programs and clinics in San Diego that provide services to PWH. The COPE Core will fulfill four specific aims: Aim 1. Community Outreach: A critical and consistent component of the HOME project will be the involvement of community partners in all phases of the program. We will continue robust community and stakeholder engagement efforts to ensure acceptance and sustainability of the Last Gift cohort. This will consist of scheduled activities with community advisory groups. We will also actively engage with local residential palliative care programs that provide end-of-life care for PWH. We will also continue to engage with clinical and research partners who are critical to the success of the program. Aim 2. Support of the Last Gift cohort: This will include study recruitment, data collection, collection of pre- mortem samples (e.g., genital secretions, cerebrospinal fluid, lymph node, adipose tissues and rectal biopsies), body transport, rapid autopsy protocol and tissue processing for the HOME program. Aim 3. Support of the Last Gift biorepository: External investigators will be able to access the Last Gift biorepository through a concept sheet review process. The COPE Core will review and organize the collection and processing of all specimens, as well as labeling, bar coding, transporting and cryostoring of specimens. Aim 4: Ethics of end-of-life research: The COPE Core will engage an Ethics Oversight Committee (EOC) in the review of all Last Gift protocols and community engagement activities. The EOC will evaluate ethical and safety issues related to the program. The COPE Core will also conduct qualitative socio-behavioral and empirical ethics research with Last Gift participants next-of-kin/loved ones, and clinical and rapid research autopsy staff to ensure ethical conduct of research and patient/participant-centered approaches.

Key facts

NIH application ID
10459873
Project number
1P01AI169609-01
Recipient
UNIVERSITY OF CALIFORNIA, SAN DIEGO
Principal Investigator
SUSAN JANET LITTLE
Activity code
P01
Funding institute
NIH
Fiscal year
2022
Award amount
$331,765
Award type
1
Project period
2022-04-01 → 2027-03-31