Notice of Availability of Administrative Supplements to NCI Cancer Health Disparities Awards for Behavioral Strategies to Accrue and Retain Diverse Underserved Populations in HIV-Related Malignancy Clinical Trials

Notice Number: NOT-CA-11-018

Release Date: June 28, 2011
Receipt Date: July 22, 2011
Earliest Anticipated Start Date: September 15, 2011

National Institutes of Health (NIH)
National Cancer Institute (NCI)

The Center to Reduce Cancer Health Disparities (CRCHD) of the National Cancer Institute (NCI) announces an administrative supplement program to build or expand collaborations focused on cancer among HIV-infected persons from diverse racial/ethnic populations or the underserved (e.g., rural, poor, uninsured) populations. The collaborations proposed are expected to comprise AIDS Malignancy Consortium (AMC) researchers, cancer health disparities (CHD) researchers, and community organizations. Upon conclusion of the supplement program, collaborations will: 1) implement a successful intervention for accruing and retaining patients from diverse backgrounds to HIV-related malignancy clinical trials; (2) test culturally appropriate behavioral strategies for maximizing the success of interventions; and (3) maintain interdisciplinary partnerships within cancer health disparities and HIV-related clinical trials research.

The main goal of this supplemental program is to increase participation of diverse under-represented populations (e.g., racial/ethnic groups, low SES, rural) in AMC clinical trials. To meet the goal of the supplement, eligible awardees requesting supplemental funding need to propose testing a behavioral strategy for increasing clinical trials awareness, accrual, adherence and/or retention within one or more diverse under-represented populations. The administrative supplement program is anticipated to be highly competitive with limited funding.

Behavioral strategies to be proposed for supplemental funding should be derived from theories or models demonstrated to have efficacy in diverse populations. Behavioral strategies may focus on the individual patient, groups, providers, or a combination. The behavioral strategy will be tested within an intervention currently utilized with the target population, or that is within the scope of the parent grant; such as, patient navigation, case management, community outreach, or community health education in HIV-related malignancy clinical trials. As such, requests for supplements must demonstrate that strategies under consideration address issues specific to the selected target population/s. For example, investigators proposing the studies on members of a particular racial/ethnic population in the U.S. who are dually infected with HIV/HPV would need to consider the specific mediators (e.g., self-efficacy, social relatedness, religiosity) and modifiers (e.g., comorbidity, age, insurance status) that could have an impact on participation in HIV-related malignancy clinical trials. Previously tested strategies may be modified in order to account for the social context and critical issues demonstrated to be prevalent in people living with HIV/AIDS (PLWHA); e.g., psychological or physical comorbidity, history of sexual or physical abuse, stigma, low income, or lack of insurance.

A total of $1.15 million is available in FY 2011 for the program. Administrative supplement requests may not exceed $300,000 in total costs. Supplements may be renewable in FY 2012 and FY 2013 based on scientific progress and availability of funds.

These administrative supplements are available to the awardees of the following NCI programs: CRCHD’s Community Networks Program Centers (CNP-C) (U54), or Partnerships to Reduce Cancer Health Disparities (PRCHD) (U54, P20), as well as, the AIDS Malignancy Consortium (AMC) (U01), and the Community Cancer Clinical Oncology Program/Minority-Based Community Cancer Clinical Oncology Program (CCOP/MB-CCOP) Groups (U10). Please contact the Program Director assigned to the parent grant for questions related to scientific or programmatic content and to determine if the supplement fits within the approved scope of the project.

Investigators requesting supplements must meet the following conditions:

• The activities of the administrative supplement must be conducted under the auspices of the original (parent) award.
• Costs for the proposed research in HIV/AIDS-malignancy clinical trials behavioral research cannot have been included in the parent award.
• The Principal Investigator (PI) for the supplement must be the PI of the parent award.
• The applicant must demonstrate that it can easily form a partnership with its counterpart group: CRCHD or CCOP/MB-CCOP awardees must form a partnership with an AMC clinical site, and the AMC U01 must form a partnership with a CRCHD U54 or P20 project to be eligible.
• Community members must be clearly involved in planned activities (e.g., advisory groups, outreach events, specific research activities, or dissemination activities).
• Faculty and investigators from collaborating sites must be able to communicate on a regular basis, including opportunities for cross- mentoring in the disciplines represented by the partnered sites. Therefore, a communication plan, which includes mentoring activities, should be included as part of this application.
• Supplements cannot be longer than three years. The parent grant must have at least 2 years of funding remaining at the time of application for the supplement. Continuation of funding in Years 2 and 3 is contingent on scientific progress and availability of funds.

To be eligible, the parent grant must be active, and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement must be within the general scope of the peer-reviewed activities and aims approved within the parent grant.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes. Please contact the Program Director assigned to the parent grant for questions related to scientific or programmatic content and to determine if the supplement fits within the approved scope of the project.

To be considered for an administrative supplement, the request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO), and must describe the need for additional funding and provide detailed budgets.

This Notice is a one-time announcement and formal requests must be received on or before July 22, 2011. Applications must be signed by the Authorized Organizational Representative (AOR) at the grantee institution.

Applicants are strongly encouraged to submit requests electronically as an e-mail attachment in PDF format; however, the signature of the AOR must be clearly visible. The e-mail address for electronic submission is: martha.hare@nih.gov. In addition, the applicant must send an electronic copy to the Program Director for the parent grant.

If preferred, a hard copy of the request packet (with original signatures of the authorized business official) may be sent to:

Martha L. Hare, PhD, RN
Program Director
Center to Reduce Cancer Health Disparities
National Cancer Institute (NCI)
6116 Executive Boulevard; Suite 602, MSC 8341
Rockville, MD 20852
Telephone: (301) 594-1908
Fax: (301) 435-9225 (fax)
martha.hare@nih.gov

In addition, submit one original, hard copy of the request packet (with original signatures of the authorized business official) to the address listed below:

Carol Perry
Team Leader, DCTD Grants Branch
Office of Grants Administration (OGA)
National Cancer Institute (NCI)
6120 Executive Boulevard, EPS Room 243
Bethesda, MD 20892-7150 (for U.S. Postal Service express or regular mail)
Rockville, MD 20852 (for non-USPS delivery)
Telephone: (301) 496-7800
Fax: (301) 496-8601
Email: Perryc@gab.nci.nih.gov

Requests should be submitted on the PHS398 Application Guide forms (font size and other formatting rules apply as designated in the instructions), as indicated below.

Include only the following elements:

1. Cover Letter which cites this Notice, and the following information:

• Principal Investigator (PI) name
• Parent grant number and title
• Amount of the requested supplement
• Name and title of the institutional official, and
• Phone, email, and address information for both the PI and institutional official.
• The cover letter must be signed by the authorized organizational representative/institutional official.

2. PHS 398 Form Page 1 (Face page)

• The title of the project should be the title of the parent award.
• This Notice should be cited in Box 2, and the yes box should be checked.
• The Principal Investigator (PI) must be the same as the PI on the parent award. For Multiple PI parent awards, the Contact PI must be the PI listed on the supplement request, and the supplement cannot change the Multiple PI team.
• The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.

3. PHS 398 Form Page 2

• Note: The project summary is that of the administrative supplement, not the parent grant.

4. A brief proposal (not to exceed 6 pages) describing the project, including:

• Describe the roles of the proposed partnerships, and qualifications of key staff members from each partner.
• A letter of support from the main partner (i.e., AMC Clinical Site investigator for CRCHD or CCOP/MB-CCOP applicant; CRCHD investigator for AMC applicant) is strongly encouraged. Additional letters from community partners are appropriate. Letters should be appended and do not count as part of the 6-page limit.
• Provide preliminary information demonstrating capacity in partnered research concerning cancer health disparities, and/or prior research to accrue and retain participants in HIV-related prevention or treatment malignancy clinical trials.
• State the specific aims for the supplement project and indicate their relationship to the parent grant. For example, testing behavioral strategies within patient navigation to an AMC clinical trial may be an expansion of research concerning patient navigation to clinical trials among other underserved populations.
• Discuss the behavioral strategy to be tested in the proposed supplement project.
• Describe the intervention that will serve as the platform for testing the strategy. For example, who will provide the intervention (e.g., lay/professional navigator, community outreach worker, or case manager)? What are the components of the services offered as part of the intervention (e.g., assess barriers, phone follow-up, home visits, peer counseling)?
• Describe the design that will be used to assess the efficacy of the proposed strategy. Two examples, among many possibilities, are:
• Comparison of patient navigation with or without a behavioral strategy for addressing stigma among PLWHA.
• Comparison of standard services (e.g., patient navigation, case management) with services that include behavioral strategies tailored to specific subpopulations; e.g., Latino women with dual HIV/HPV infection; African-American men; underserved populations in rural locations.
• Describe the plan for community involvement.
• Describe the plan for communication between the partnership investigators.
• Provide a timeline with milestones by year.

5. Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs. In addition, the budget format should be the same as that used for the parent grant i.e. modular or detailed. If a no cost extension is necessary, it must be in place per the applicable automatic or prior approval procedures before a supplement request can be awarded.

6. Biographical Sketch for all new key personnel (those who are additions on the supplemental project

7. Human Subjects/ Vertebrate Animal documentation (if applicable).

• Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
• Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted.
• When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions.

Administrative supplement requests will be reviewed administratively by NIH Staff. Selection factors will include the following:

• Relevance of the proposed activities to the parent grant.
• Progress of the parent grant.
• Progress in prior year CRCHD-funded HIV-related malignancy supplement, if applicable.
• Assessment of the behavioral strategy proposed including sensitivity to cultural, contextual or other issues that need to be considered in developing the strategy.
• Evidence that the behavioral strategy can be tested within an intervention, such as patient navigation, case management, community outreach or community health education.
• Determination that a viable partnership between the AMC investigators and cancer health disparities investigators is present or readily available.
• Appropriate and well-described plan to accomplish the project s activities within the timeframe proposed, with appropriate milestones.
• Expertise of the research/scientific team proposed to conduct and achieve the goals of the supplemental study among PLWHA from diverse racial/ethnic groups and underserved populations.
• Plan for communication, including co-mentoring, among collaborators and for involvement of community members.

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.
Responses to this Administrative Supplement announcement should be submitted to the Program Director for the Parent Grant with a copy to:

Ms. Traci Mitchell
Program Analyst
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: (301) 435-9222
E-mail: mitchelltr@mail.nih.gov

General inquiries and copies of responses may also be sent to:

Martha L. Hare, Ph.D., RN
Program Director
Center to Reduce Cancer Health Disparities (CRCHD)
National Cancer Institute (NCI)
Telephone: (301) 594-1908
E-mail: martha.hare@nih.gov