[SOPHE Leadership] CDC RFP (fwd)
ccgarcia at u.washington.edu
Thu Jun 6 17:57:01 PDT 2002
> Reducing Sexual Risk for HIV Transmission in Substance-Using Men Who Have
> Sex With Men
> Primary Sponsor: Centers for Disease Control
> Deadline: 7/31/2002
> [Program Announcement 02136]
Contact information at bottom of email.
> A. Purpose
> The Centers for Disease Control and Prevention (CDC) announces the
> availability of fiscal year (FY) 2002 funds for a cooperative agreement
> program to support research on interventions to reduce sexual risk for HIV
> transmission in substance-using men who have sex with men (MSM). This
> program addresses the ``Healthy People 2010'' focus HIV.
> The purpose of the research is to develop and test behavioral
> interventions that focus on reducing risk for HIV transmission by altering
> the sexual risk behavior of substance using and abusing MSM. Under this
> program, the primary outcome of the project will be the development of
> effective interventions for substance-using MSM which may then be adapted
> and replicated by community-based HIV prevention and substance abuse
> agencies among sub-populations of substance-using MSM throughout the U.S.
> This announcement addresses goals of CDC's HIV Prevention Strategic Plan.
> Measurable outcomes of the program will be in alignment with one or more
> of the following performance goals for the National Center for HIV, STD &
> TB Prevention. Through the implementation of HIV prevention programs,
> reduce the number of cases of HIV infection and AIDS: 1. acquired
> heterosexually, 2. related to injecting drug use, 3. associated with
> male-to-male homosexual contact, and 4. acquired perinatally.
> B. Eligible Applicants
> Applications may be submitted by public and private nonprofit
> organizations and by governments and their agencies; that is,
> universities, colleges, research institutions, hospitals, other public and
> private nonprofit organizations, faith-based organizations, State and
> local governments or their bona fide agents, including the District of
> Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the
> Commonwealth of Samoa, Guam, the Federated States of Micronesia, the
> Republic of the Marshall Islands, and the Republic of Palau, and federally
> recognized Indian tribal governments, Indian tribes, or Indian tribal
> Title 2 of United States Code Section 1611 states that an organization
> described in section 501(c)(4) of the Internal Revenue Code of 1986 that
> engages in lobbying activities is not eligible to receive Federal funds
> constituting an award, grant or loan.
> C. Availability of Funds
> Approximately $1,200,000 is expected to be available in FY 2002 to fund up
> to four awards for the first year of project activities. It is expected
> that the average award will be approximately $300,000 in the first year to
> support development of an intervention in additional years and will begin
> on or before September 30, 2002. The award will be made for a 12-month
> budget period, within a project period of up to five years. Funding
> estimates are expected to increase once recruitment and intervention
> activities begin. Continuation awards within an approved project period
> will be made on the basis of satisfactory progress as evidenced by
> required reports, satisfactory participant accrual, and the availability
> of funds. The Catalog of Federal Domestic Assistance number is 93.943.
> Funding Preference
> Funding decisions will attempt to achieve regional diversity of the four
> sites (e.g., Northeast, South, Central, West). Funding decisions will also
> take into consideration geographical locations that afford sufficient
> numbers of men from which to sample.
> D. Program Requirements
> In conducting activities to achieve the purpose of these programs, the
> recipient will be responsible for the activities listed under Recipient
> Activities, and CDC will be responsible for conducting activities listed
> under CDC Activities:
> 1. Recipient Activities
> The program will support four sites to work collaboratively with each
> other and with Federal investigators in conducting an intervention study
> to reduce sexual risk-taking among substance abusing MSM. At each site, it
> is expected that grantees will newly enroll a minimum of 375 men,
> including non-injection drug and other substance-using (including alcohol)
> gay identified and non-gay identified MSM.
> The interventions to be tested should be theory-based, group-level
> interventions appropriate for use among a culturally-diverse population of
> MSM who reside within a challenging socio-cultural context. Intervention
> strategies should be sufficiently brief and of a technical level that
> would facilitate rapid dissemination among community-based organizations.
> Approximately one-third of the men should identify as African American,
> one-third as Hispanic/Latino and one-third as Caucasian at each study
> site. Men who are recruited into the study must currently use drugs and/or
> alcohol at a heavy level and have been sexually active within the past
> three months. Men recruited into the study can be poly-drug users
> (including alcohol), but without current intravenous drug use. Men can be
> recruited from a variety of venues, including drug using venues, bars,
> public sex environments known also to be sites for drug/alcohol use as
> well as substance abuse treatment organizations. The design of the study
> should include an attention control strategy, so that men randomized to
> the control condition are invited to equivalent time spent in groups that
> focus on an issue of interest to this population.
> Applicants should develop (1) sampling and recruitment strategies that
> ensure that the study includes a demographically diverse group of MSM, (2)
> culturally-sensitive measures of antecedent and outcome variables,
> including both quantitative and qualitative assessments, (3) an
> intervention plan that relates directly to an identified theoretical model
> of sexual risk reduction, (4) a core set of measures that will facilitate
> assessment of substance use and sexual risk behavior, (5) a sampling plan
> that will successfully recruit and retain a large number of research
> participants whose substance use is associated with high risk sexual
> behavior at some level, and (6) stringent safeguards for protecting
> confidentiality of participants.
> Applicants must develop protocols and assessment instruments that will
> increase understanding of a broad array of sociocultural, structural,
> psychological, and behavioral factors as they relate to HIV infection risk
> in substance-using MSM. These factors must be addressed in the design of
> intervention activities, so that the forces that are promoting high risk
> sexual activity within these populations are addressed in the
> intervention. Clear hypotheses should be developed to test how these
> variables--and drug and alcohol use themselves--mediate or moderate target
> risk behaviors. After sites are funded, but before research activities
> begin, grantees and Federal investigators will work collaboratively to
> refine the protocols so that they fit together across sites and address
> behavioral intervention research issues in a scientifically rigorous
> Collaborate with other Federally sponsored researchers, including
> developing and using common data collection instruments and data
> management procedures, as determined in post-award grantee planning
> Recipients will be required to pool data for analysis and publication, but
> can also conduct independent site-specific analyses, as agreed to by the
> multi-site study group. Recipients are also required to work
> collaboratively as a study group to:
> a. Attend meeting(s) at CDC to develop collaborative research protocol.
> b. Develop the research study protocols and standardized data collection
> forms across sites, including standardized measures of drug and alcohol
> use and high risk sexual behaviors.
> c. Prepare an IRB protocol for approval at the local and CDC levels.
> d. Identify, recruit, obtain informed consent from, and newly enroll an
> adequate number of study participants as determined by the study protocols
> and the program requirements.
> e. Follow study participants as determined by the study protocols.
> f. Develop the intervention and intervention procedures in collaboration
> with the other funded investigators and implement the intervention as
> defined in study protocols.
> g. Establish procedures to maintain the rights and confidentiality of all
> study participants.
> h. Perform laboratory tests (when appropriate) and data analysis as
> determined in the study protocols.
> i. Collaborate and share data (when appropriate) with other collaborators
> to answer specific research questions.
> j. Conduct data analysis with all collaborators.
> k. Present and publish research findings.
> l. Participate in conference calls with all collaborators.
> m. Attend scheduled meetings with other funded grantees.
> 2. CDC Activities
> a. Provide technical assistance as needed in intervention development and
> in the design and conduct of research.
> b. Assist in the development of a research protocol for Institutional
> Review Board (IRB) review by all cooperating institutions participating in
> the research project. The CDC IRB will review and approve the protocol
> initially and on at least an annual basis until the research project is
> c. Assist as needed in designing a data management system.
> d. Assist as needed in performance of selected laboratory tests.
> e. Work collaboratively with investigators to help facilitate research
> activities across sites involved in the same research project.
> f. Analyze data and present findings at meetings and in publications.
> E. Application Content
> Use the information in the Program Requirements, Other Requirements, and
> Evaluation Criteria sections to develop your application. Your application
> will be scored based on the criteria listed in the Evaluation Criteria, so
> it is important to follow them in laying out your program plan. The
> narrative should be no more than 20 double-spaced pages, printed on one
> side with one inch margins in a 12- point font or greater. Follow the
> directions for completing the application that are found in the Public
> Health Service (PHS) 398 kit.
> F. Submission and Deadline
> Submit the original and two copies of PHS-398 (OMB Number 0925- 0001)
> (adhere to the instructions on the Errata Instruction Sheet for PHS 398).
> Forms are in the application kit and at the following Internet address:
> On or before July 31, 2002 submit the application to:
> Technical Information Management Section, PA <#>02136, Procurement and
> Grants Office, Centers for Disease Control and Prevention (CDC), 2920
> Brandywine Road, Room 3000, Atlanta, GA 30341- 4146.
> Deadline: Applications shall be considered as meeting the deadline if they
> Received on or before the deadline date.
> Late Applications: Applications which do not meet the criteria above will
> be returned to the applicant.
> G. Evaluation Criteria
> Applicants are required to provide Measures of Effectiveness that will
> demonstrate the accomplishment of the various identified objectives of the
> grant or cooperative agreement. Measures of Effectiveness must relate to
> the performance goal (or goals) as stated in section ``A. Purpose'' of
> this announcement. Measures must be objective and quantitative and must
> measure the intended outcome. These Measures of Effectiveness shall be
> submitted with the application and shall be an element of evaluation.
> Each application will be evaluated individually against the following
> criteria by an independent review group appointed by CDC. Applications
> will be ranked on a scale of 100 maximum points. Applications will be
> reviewed and evaluated based on the evidence submitted and the applicant's
> abilities to meet the following criteria:
> 1. Familiarity With and Access to the Study Population (25 points)
> a. Extent of the applicant's knowledge of issues faced by study
> population, including substance use and sexual risk behaviors, access to
> the study population and experience in working with the population.
> b. Existence of linkages to facilitate recruitment from and referral to
> community-based programs providing services for the study population,
> including letters of support given in an appendix.
> c. Feasibility of plans to involve the study population, their advocates,
> or service providers in the development of research activities and to
> inform them of research results.
> d. Feasibility of plans for recruitment and outreach to new study
> participants (e.g. not men currently enrolled in an ongoing study). 2.
> Description and Justification of an Intervention and Research Plan (40
> a. Quality of the review of the scientific literature pertinent to the
> proposed study, including the theoretical basis for the investigation and
> relevance of research questions.
> b. The originality of the research, including the extent to which it
> addresses important gaps in knowledge and has strong relevance for guiding
> behavioral interventions.
> c. Applicant's understanding of the research objectives as evidenced by
> the quality of the proposed research plan, specific study design and the
> choice of the theory to guide the intervention activities as well as the
> quality of the plan to operationalize intervention activities.
> d. Feasibility of plan to sample, recruit, obtain informed consent and
> newly enroll 375 study participants in a culturally and linguistically
> appropriate manner. This includes plans for achieving a demographically
> diverse sample within the African-American and Hispanic populations,
> conducting multi-venue sampling.
> e. Feasibility of plan for collecting both quantitative and qualitative
> formative research data and to follow research participants over time.
> f. Comprehensiveness of the plan to protect the rights and confidentiality
> of all participants.
> g. Thoroughness of statistical analysis plans, including data cleaning,
> management, and substantive analyses, and plans for timely provision of
> data for pooled analyses.
> h. Extent to which study proposal demonstrates agreement to comply with
> multi-site research requirements (e.g., common protocol, data collection,
> and computer and data management systems).
> i. The degree to which the applicant has met the HHS Policy requirements
> regarding the inclusion of ethnic and racial groups in the proposed
> research. This includes: (1) the proposed plan for the inclusion of racial
> and ethnic minority populations for appropriate representation; (2) the
> proposed justification when representation is limited or absent; (3) a
> statement as to whether the design of the study is adequate to measure
> differences when warranted;
> j. Provide a statement as to whether the plans for recruitment and
> outreach for study participants include the process of establishing
> partnerships with communities and recognition of mutual benefits.
> k. Provide general time line for conducting the research and a detailed
> time line for the first year of the study, including measurable process
> objectives for the first year of the study.
> 3. Demonstration of Staff's Capability to Conduct Research (20 points)
> a. Applicant's ability to carry out the proposed research as demonstrated
> by the training, experience, and expertise of the principal investigator
> and the proposed research team and organizational setting, including
> demonstration of ability to collect, manage, and analyze accurate data in
> a timely manner.
> b. Evidence of plan for establishing a partnership with at least one
> community based organization to link participants with prevention and
> medical services as needed, and to consult on study procedures as needed.
> c. Demonstration of epidemiologic, behavioral intervention, clinical,
> administrative, and management expertise needed to conduct the proposed
> d. Demonstration that principal investigator and staff have experience
> working with the targeted population of study participants.
> e. Demonstration that investigative team includes a staff member with
> expertise in qualitative formative data analysis.
> 4. Staffing, Facilities, and Time-Line (15 points)
> a. Availability of qualified personnel with realistic and sufficient
> percentage-time commitments (including an estimated staffing plan for
> years in which intervention activities will occur); clarity of the
> described duties and responsibilities of project personnel including clear
> lines of authority and supervisory capacity over the behavioral,
> epidemiologic, clinical, administrative, data management, and statistical
> aspects of the research.
> b. Adequacy of the facilities, equipment, data processing and analysis
> capacity, and systems for management of data security and participant
> c. Adequacy of base staff to keep pace with anticipated workload.
> d. Adequacy of time-line for conducting the research.
> 5. Other (not scored)
> a. Budget: The extent to which it is reasonable, clearly justified,
> consistent with the intended use of funds, and allowable. All budget
> categories should be itemized.
> b. Human Subjects: The application adequately address the requirements of
> Title 45 CFR Part 46 for the protection of human subjects.
> H. Other Requirements
> Technical Reporting Requirements
> Provide CDC with original plus two copies of
> 1. annual progress reports;
> 2. financial status report, no more than 90 days after the end of the
> budget period; and
> 3. final financial status and performance reports, no more than 90 days
> after the end of the project period.
> Send all reports to the Grants Management Specialist identified in section
> J (``Where to Obtain Additional Information'') of this document.
> The following additional requirements are applicable to this program. For
> a complete description of each, see Attachment 1 in the application kit.
> AR-1 Human Subjects Requirements
> AR-2 Requirements for Inclusion of Women and Racial and Ethnic
> Minorities in Research
> AR-4 HIV/AIDS Confidentiality Provisions
> AR-5 HIV Program Review Panel Requirements
> AR-6 Patient Care
> AR-7 Executive Order 12372 Review
> AR-9 Paperwork Reduction Act Requirements
> AR-10 Smoke-Free Workplace Requirements
> AR-11 Healthy People 2010
> AR-12 Lobbying Restrictions
> AR-22 Research Integrity
> J. Where to Obtain Additional Information
> This and other CDC announcements can be found on the CDC home page
> Internet address-- http://www.cdc.gov Click ``Funding'' then ``Grants and
> Cooperative Agreements.''
> If you have questions after reviewing the contents of all the documents,
> business management technical assistance may be obtained from:
> Lynn Mercer, Grants Management Officer, Grants Management Branch,
> Procurement and Grants Office, Announcement <#>02136, Centers for Disease
> Control and Prevention (CDC), 2920 Brandywine Rd. Room 3000, Mailstop
> E-15, Atlanta, GA 30341, Telephone: (770) 488-2810, E-mail address:
> lzm2 at cdc.gov.
> For program technical assistance, contact: Craig Studer, Deputy Chief,
> Behavioral Intervention Research Branch, Division of HIV/AIDS
> Prevention--IRS, National Center for HIV, STD, TB Prevention ,Centers for
> Disease Control and Prevention (CDC), 1600 Clifton Road, NE., Mailstop
> E-37, Atlanta, Georgia 30333, Telephone: (404) 639-1900, E- mail address:
> CStuder at cdc.gov.
Elaine Auld, MPH, CHES
Society for Public Health Education
750 First St, NE, #910
Washington, DC 20002
phone: (202) 408-9804
fax: (202) 408-9815
SOPHE 53rd Annual Meeting
November 8-9, 2002
Holiday Inn Crowne Plaza
email: eauld at sophe.org
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