02-17160. Monitoring Trends in Prevalence of Sexually Transmitted Disease (STD), Tuberculosis (TB), and Humans Immunodeficiency Virus (HIV) Risk Behaviors Among Men Who Have Sex With Men (MSM); Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a competitive cooperative agreement for Monitoring Trends in Prevalence of STDs, TB, and HIV Risk Behaviors among (MSM) in facilities providing health services to this population. This program addresses the “Healthy People 2010” focus area(s) of STD, HIV, and Immunization and Infectious Diseases.

Objectives

The objectives for this program are:

(1) To assess the prevalence of, and monitor trends in STDs, TB, and HIV risk behaviors among MSM in clinics serving a substantial number of HIV positive MSM, and;

(2) To enhance local prevention services for these populations.

Recent outbreaks of STDs and TB among MSM, many of whom are HIV positive, have identified substantial weaknesses in STD and TB surveillance and control efforts and the need for preventive efforts among this population. Prevention of STDs and HIV in this population is critical to preventing STD, TB, and HIV transmission.

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 and TB Prevention: (1) Improve STD and TB surveillance and control efforts among the MSM population; and (2) Improve HIV and STD prevention programs and continuity of care in the MSM population.

B. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under sections 317 and 317E of the PHS Act, 42 U.S.C. 247b and 247b-6. The Catalog of Federal Domestic Assistance number 93.977.

C. Eligible Applicants

Limited Competition: Funding is limited to state and local governments that received funding under prior announcements.

Assistance will be provided only to project areas which received FY 1999, 2000, or 2001 Competitive Supplemental Funds For Comprehensive STD Prevention Systems for “Monitoring Trends in Prevalence of STDs, TB, and HIV Risk Behaviors among MSM,” Program Announcement 99000. Prior supplemental award recipients are uniquely qualified because they have an established prevalence monitoring project currently in place for STDs, TB, and HIV risk behaviors among MSM. Applicants should review section J. “Where to Obtain Additional Information” on page 21 of this program announcement.

D. Availability of Funds

Approximately $200,000 is available in FY 2002 to fund up to six awards. It is expected that the average award will be $45,000, ranging from $30,000 to $60,000. The awards will begin on or before September 30, 2002. Awards will be made for a 12-month budget period within a project period of up to three years (funding estimates may change). Project areas are expected to sustain these projects beyond the period for which funding is provided.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by quality of quarterly data submitted and availability of funds.

Funding is viewed as money for an activity that is expected to continue, in full or in part, beyond the project period using other local or CDC funds.

1. Use of Funds

Funds are awarded for a specifically defined purpose and may not be used for any other purpose or program. Funds may be used to support personnel and to purchase equipment, supplies, and services directly related to project activities. Funds must be used to improve the collection, management, and reporting of data and, if needed, to supplement prevention activities at participating facilities. Funds may not be used to provide medical care or for pharmaceuticals.

2. Recipient Financial Participation

Recipient financial participation is required for this program in accordance with this program announcement. Recipients will be required to provide 1:3 matching funds (i.e., $1 of new state or local, public or private resources for each $3 of federal resources awarded). New resources may include newly identified funds or newly identified in-kind resources. Matching funds may be used to support laboratory testing or personnel but may not be used for pharmaceuticals.

3. Funding Preferences

Funds may be awarded as to achieve geographical diversity.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. Recipient Activities, and CDC will be responsible for the activities listed under 2. CDC Activities.

1. Recipient Activities

a. Assess which HIV-care facilities in the project area perform routine STD screening. Preferably, facilities will be chosen where routine screening is conducted.

b. Collaborate with one or more facilities serving a total of approximately 25 different HIV-positive MSM per month. These may be primary care clinics, HIV clinics, managed care organizations, or other sites providing primary care services.

c. Provide STD testing data (optimally for chlamydia, gonorrhea, and syphilis) for at least 25 consecutive HIV-positive MSM per month. If a single facility does not have this many entrants or clinic visits per month, the recipient may identify additional facilities that would participate in providing the required sample size.

d. Each participating facility must conduct tuberculin skin tests (TSTs), placed using the Mantoux method, for MSM with HIV infection. For HIV-positive MSM tested for TB, information on history of prior TB disease, prior TST status, TST results, follow-up for TST-positive patients (chest X-ray results, therapy) is required.

e. For each person examined or tested, participating facilities must collect the following core data elements in a standardized format: date of visit, unique patient identification number, sex, age or date of birth, race/ethnicity, zip code or census tract of residence, gender of sex partners, STD symptoms, exam findings, and STD laboratory results (chlamydia, gonorrhea, and syphilis).

f. In addition, collecting the following HIV risk behavior and clinical data (for the last 30 days) is preferable, but not required: Self-identified sexual orientation; number of male and female sex partners; type of sex (oral/anal/vaginal); condom use with various types of sex; whether the person has anonymous sex; number of new sex partners; sex with a known HIV-infected partner; CD4 count; viral load; if currently on HAART therapy; and illicit drug use.

g. Data management: Data should be computerized, in line-listed format to facilitate local analyses and reported quarterly to CDC. Demonstrated capacity to organize, manage, and clean data.

h. Data analysis and dissemination: Demonstrated capacity to analyze data and disseminate findings to public health officials and community planning groups.

i. Commitment to and plan for long-term sustainability of the project.

j. Integrated involvement in this project by local STD, TB, and HIV/AIDS communicable disease surveillance units.

k. Electronically transmit data to CDC on a quarterly basis.

l. Applicants are required to provide Measures of Effectiveness that will demonstrate the accomplishment of the various identified objectives of the grant. Measures must be objective/quantitative and must measure the intended outcome. These Measures of Effectiveness shall be submitted with the application and shall be an element of the evaluation.

2. CDC Activities

a. Conduct one site visit to each funded project for technical assistance.

b. Provide technical assistance, if requested, in the design and conduct of the project.

c. As needed, assist in designing a data management system and as needed assist in designing data analyses to help guide STD and TB prevention and intervention activities.

F. Content

Letter of Intent (LOI)

An LOI is required for this program. The program announcement title and number must appear in the LOI. The narrative should be no more than two double-spaced pages, printed on one side, with one-inch margins, and unreduced fonts. Your letter of intent will be used only as an indicator of the number of applications CDC will receive and will assist CDC staff in preparing and coordinating the review process. Therefore, your letter of intent should state your plans to submit an application.

Use the information in the Program Requirements, Other Requirements, Evaluation Criteria, and this section to develop the application content. Describe your project plan, and budget as outlined below. Then review the evaluation criteria listed below. Your application will be evaluated on the criteria listed, so it is important to organize your application by these criteria. Applicants may submit more than one proposal, but the average award will be $45,000.

The narrative should be no more than ten double-spaced pages, and printed on one side with one-inch margins, unreduced fonts, and a number on each page. Applications with more than ten double-spaced pages will be returned and not reviewed. Please attach a budget with narrative and calculations to support all proposed amounts. Please provide only attachments or appendices that are directly relevant to this request for funding. The table, budget and attachments/appendices are not included in the count for the ten page limit.

Project Plan

Describe your project plan and include a time frame for implementation. Indicate what services will be provided and what medical and risk behavior data will be collected and provided to the local health department and to CDC. Describe the difficulties, if any, in putting data in the standardized format Describe what changes, if any, would be made to the current system, with respect to collection and management of data and provision of medical services. If you cannot examine or test all HIV-positive MSM at participating facilities, describe to whom services would be offered, and explain how you would quantify acceptance of services. Briefly mention how you will disseminate the findings from this project and how this project will contribute to local planning for prevention of STDs, HIV infection, and tuberculosis.

Budget

Provide a justified budget for use of CDC funds. Describe any other STD-related projects funded by CDC that are currently in place or which will be implemented in the same facilities; describe any overlap with this project.

The budget will be reviewed to determine the extent to which it is reasonable, clearly justified, consistent with the intended use of funds.

a. Submit a line-item itemized budget with narrative justification and any other information to demonstrate that the request for CDC assistance is consistent with the purpose and objectives of this cooperative agreement program;

b. Describe any other STD-related projects funded by CDC that are currently in place or which will be implemented in the same facilities; describe any overlap with this project.

c. For contracts, include the name of the person or firm to receive the contract, itemized budget with narrative justification, the method of selection, the period of performance, method of accountability, and a description of the contracted service requested.

G. Submission and Deadline

Letter of Intent (LOI)

On or before July 12,2002 submit the original and two copies of your letter of intent to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and two copies of PHS 5161-1 (OMB Number 0920-0428) and, if applicable, the Optional Form 310, “Protection of Human Subjects Assurance Identification/Certification/ Declaration”. Forms are available in the application kit and at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

Application forms must be submitted in the following order:

Cover Letter

Table of Contents

Application

Budget Information Form

Budget Justification

Checklist

Assurances

Certifications

Disclosure Form

HIV Assurance Form (if applicable)

Human Subjects Certification (if applicable)

Indirect Cost Rate Agreement (if applicable)

Narrative

The application must be received on or before August 5, 2002. Submit your application to the: Technical Information Management Section, 2920 Brandywine Road, Suite 3000, Atlanta, Georgia 30341.

Deadline: Letters of intent and applications shall be considered as meeting the deadline if they are received before 5 P.M. Eastern Time on the deadline date. Applicants sending applications by the United States Postal Services or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Applications which do not meet the above criteria will not be eligible for competition and will be discarded. Applicants will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

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.

1. Adequacy of Study Participants (20 Points)

The extent to which the number of HIV positive MSM who will be routinely examined and tested and among whom data will be collected at the participating facilities meets or exceeds the requirement of 25 per month. (Provide letters of support from each participating facility documenting the ability to do this); and Does the application adequately address the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

A. The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

B. The proposed justification when representation is limited or absent.

C. A statement as to whether the design of the study is adequate to measure differences when warranted.

D. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

2. Data Interpretation and Management (15 Points)

Demonstrated ability to manage, clean, and submit data in a timely way as demonstrated by previous involvement in similar projects.

3. Adequacy of Facility Data Collection Activities (15 Points)

The extent to which STD testing is provided at the facility(ies) and the standard data elements are routinely collected [ie. date of visit, sex, date of birth, race/ethnicity, zip code or census tract of residence, gender of sex partners, STD symptoms, exam findings, and STD laboratory results (chlamydia, gonorrhea, and syphilis).

4. Routine Data Collection (10 Points)

Extent to which the suggested data elements are routinely collected, including previous HIV test results, CD4 count, viral load, and behavioral risk variables (e.g., number of sex partners, type of sex [oral/anal].

5. Program Capacity (10 Points)

Evidence that TB testing is routinely provided for HIV-positive MSM at the facility(ies) and that the data elements for HIV-positive MSM (ie. history of prior TB, prior TST status, TST results, and follow-up chest X-ray results, and therapy) are routinely collected.

6. Project Assessment and Support (10 Points)

Provide letters of support from each participating facility. Describe how an assessment of STD testing in HIV-care facilities in the project area was performed, and provide evidence that facilities are chosen where routine STD screening is conducted.

7. Project Sustainability (10 Points)

Potential sustainability of project, as determined by the extent to which current project activities have been integrated with existing program activities, and local program support for the proposed project so that it may be continued Without federal funding beyond the project period.

8. Data Analysis and Dissemination (5 Points)

Demonstrated ability to analyze data and disseminate findings to public health officials and community planning groups.

9. Collaboration (5 Points)

Extent of participation by STD, TB, and HIV/AIDS communicable disease surveillance units, as indicated by letters of support.

10. Budget (Reviewed, But Not Scored)

The extent to which the itemized budget for conducting the project is reasonable and well justified.

11. Human Subjects (Not Scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable). Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects?

I. Other Requirements

Technical Reporting Requirements

Provide CDC with the original plus two copies of:

1. Annual progress reports (The progress report will include a data requirement that demonstrates measures of effectiveness).

2. Financial status report, no more than 90 days after the end of the budget period, and

3. Final financial 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 the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I 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-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 on “Funding” then “Grants and Cooperative Agreements.”

To obtain business management technical assistance, contact: Gladys T. Gissentanna, Grants Management Specialist, Procurement and Grants Office, Grants Management Branch, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146, Telephone: [phone], Email address: [e-mail].

For program technical assistance, contact: Catherine McLean, MD, Division of STD Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, MS E02, Atlanta, GA 30333, Telephone: [phone], Email: [e-mail].

Dated: July 2, 2002.

Sandra R. Manning,

CGFM, Director, Procurement and Grants Office, Centers for Disease Control and Prevention.