ss mai 10-06

Ryan White CARE Act Title I

Minority AIDS Initiative (MAI) Report:

(Title I Report)

Supporting Statement

1. Justification

1. Circumstances of Information Collection

The Health Resources and Services Administration (HRSA) is requesting Office of Management and Budget (OMB) approval of the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act Title I Minority AIDS Initiative Report (the Title I MAI Report). The Title I MAI Report will be used to collect performance data from Ryan White CARE Act Title I grantees receiving funds under the Minority AIDS Initiative, (MAI), a targeted allocation aimed at communities of color highly impacted by HIV/AIDS in Title I Eligible Metropolitan Areas (EMAs). The Title I MAI Report will utilize a Web application to upload data collected by Title I grantees. These data will provide the HIV/AIDS Bureau (HAB) at HRSA with information about the disbursal of funds by Title I grantees of record, number and demographics of clients served, types and quantity of services provided, and client outcomes for each service provided.

Ryan White CARE Act

The Ryan White CARE Act was originally passed in 1990, and amended in 1996 and 2000 (codified under Title XXVII of the Public Health Service Act). Signed into law in October, the 2000 amendment re-authorized the Ryan White CARE Act through 2005. The Ryan White CARE Act authorizes funds under four funding streams: Title I, Title II, Title III, and Title IV. This request for OMB approval of data collection activities is specific to Title I.

The purpose of the Title I program is to provide emergency assistance to localities severely affected by the HIV/AIDS epidemic. Funds are used for the development, organization, coordination and operation of more effective and cost-efficient systems of care that provide outpatient, community-based HIV/AIDS primary medical care and related services to low-income persons and families living with HIV/AIDS. Title I provides two types of awards to EMAs: formula grants and supplemental grants. Formula grants are awarded based on the estimated number of living AIDS cases in each EMA during the most recent 10-year period for which data are available, as reported to and confirmed by the Centers for Disease Control and Prevention. Supplemental grants are awarded to EMAs based on demonstrated severe need for additional financial assistance and their capacity to utilize the funds in a manner that is cost-effective and responsive to documented needs. The goal of the Title I grant program is to relieve the overwhelming burden of HIV-related care that currently affects urban health systems by improving access to community-based high quality medical care, treatment, and support services.

Minority AIDS Initiative

The MAI, established by Congress in 1999, responds to the HIV/AIDS epidemic’s overwhelming and disproportionate impact on racial and ethnic minority populations.

The MAI’s three broad funding categories include the following: (1) initiatives to increase access to prevention, care, and treatment services and improve health outcomes; (2) technical assistance, health system infrastructure support and organizational capacity building; and (3) building stronger community linkages to address the HIV prevention and health care needs of specific populations.

The Title I MAI is a component of the Ryan White CARE Act Title I Program to “address substantial need for care and support services for minority populations in eligible metropolitan areas.” The purpose of the Title I MAI is to improve access to high quality HIV care services and health outcomes for persons living with HIV disease in communities of color, including African Americans, Latinos, Native Americans, Asian Americans, Native Hawaiians and Pacific Islanders. Funds are allocated by formula to all Title I grantees based on the proportion of reported minority AIDS cases within each EMA. At the grantee level, funds are allocated following established Planning Council processes for determining funding priorities, and competitive contracts are awarded according to standard grantee contracting processes. Eligible entities include: not-for-profit community-based and faith-based service providers; community health centers, clinics and hospitals; local and state agencies, and Tribal/urban Indian entities.

Administration of MAI Funds

HRSA is responsible for allocating and administering Title I MAI funds, evaluating programs and their impact on the population served, and improving the quantity and quality of care. Data collection on services provided and minority clients served through the MAI continue to be critical to the implementation of the Title I MAI and thus are necessary for HRSA to fulfill its responsibilities. Valid and complete information about the characteristics of clients and the services provided to them is needed from grantees to document the distribution of funds used to serve racial/ethnic minority groups in need of care, client utilization of those services, and health outcomes; to identify gaps in service delivery; and to ensure coordination and quality of care.

2. Purpose and Use of Information

The Title I MAI Report is designed to collect aggregate performance data from Title I grantees, and has two parts: (1) a workbook that collects standardized quantitative and qualitative information, and (2) an accompanying narrative report. Grantees will submit two Title I MAI Reports annually: Title I MAI Plan (Plan) and the Title I MAI Year-End Annual Report (Report).

MAI Workbook

The Plan and Report components of the workbook will be linked to minimize the reporting burden, and designed to include drop-down menu responses, fields for reporting budget, expenditure and aggregate client level data, and open-ended responses for describing client or service-level outcomes. Together the Plan and Report components will collect information from grantees on MAI-funded services, expenditure patterns, the number and demographics of clients served and client-level outcomes.

MAI Narrative

Grantees will be required to submit a two to four page written MAI Narrative with both the Plan and Report that addresses the following:

MAI Plan Narrative: (1) How the EMA determined priorities for the use of the MAI funds and allocation amounts, and how these priorities fit within the context of the overall Title I plan; (2) the timetable and plan for disbursing MAI funds, including how the grantee will insure that providers: are located in/near targeted communities to be served; have a documented history of providing service to the communities; have documented linkages to targeted populations that can help close gaps in access to care; and provide services in culturally and linguistically appropriate manner; (3) how the grantee will monitor services/activities supported by these funds, including progress toward implementing outcome measures that are consistent with HRSA guidance; and (4) any explanation(s) that may be needed to understand data submitted in the Plan sections of the MAI Workbook.

MAI Report Narrative: (1) a summary of program accomplishments for the year in relation to planned MAI goals and objectives, including a summary of client-level or service-level outcomes achieved that year; (2) capacity-development or technical assistance activities that supported MAI-funded services; (3) challenges dealt with by the grantee and/or providers in implementing MAI-funded services, and progress toward resolving them; and, (4) any explanation(s) that may be needed to understand data submitted in the Report sections of MAI Workbook.

The following five key questions will be answered by the Title I MAI Report:

• What specific minority populations were served with Title I MAI funds?

• For what specific types of activities (i.e., outreach, primary outpatient medical care, case management, treatment adherence, etc.) do grantees use Title I MAI funds?

• Have Title I MAI funds been used to expand the availability and accessibility of HIV care services to racial/ethnic minority populations?

• Has the use of Title I MAI funds increased the types of services available to racial/ethnic minority populations?

• Are Title I MAI grantees achieving expected outputs or client-level and/or service-level health outcomes?

The information collected for the Title I MAI Report will serve multiple purposes. These data are needed to monitor and assess: (1) increases and changes in the type and amount of HIV/AIDS health care and related services being provided to each disproportionately impacted community of color; (2) increases in the number of persons receiving HIV/AIDS services within each racial and ethnic community; and (3) the impact of Title I MAI-funded services in terms of client-level and service-level health outcomes. This information will be used to plan new technical assistance and capacity development activities, and inform HRSA policy and program management functions. The Title I MAI Report will also enhance HRSA’s ability to respond to Departmental inquiries regarding the MAI. Data collected through it will be used in the preparation of reports to Congress and the Office of Management and Budget when requested by OHAP, and to respond to inquiries related to Title I MAI-funded activities at HRSA.

In addition to meeting the goal of accountability to Congress, clients, and the general public, information collected for the Title I MAI Report is critical for HRSA grantees, and individual providers to assess the status of existing HIV-related service delivery systems. The partnership between HRSA, grantees, providers, and clients has provided a unique opportunity to ensure that all parties share in the benefits of accurate information to promote improved care for HIV positive individuals and their families. The collective responsibility to ensure that service dollars reach targeted populations, appropriate HIV services are provided, and adequate funding is available to meet future HIV-related service needs, requires a commitment at every level.

Since the purpose of the Title I MAI is to expand access to medical, health and social support services for disproportionately impacted racial/ethnic minority populations living with HIV/AIDS who are not yet in care, it is important that HRSA is able to report on minorities served by the Title I MAI. The Title I MAI Report is a data collection instrument in which grantees report on the number and characteristics of clients served and services provided in the aggregate. The data provided to HRSA, therefore, will not contain individual or personally identifiable information.

With regard to reporting ethnic and racial demographic data about clients that receive Title I MAI funded services, HRSA proposes that grantees use the format that is consistent with the OMB-approved CARE Act Data Report (CADR, OMB No. 0915-0253). The CADR is HRSA’s aggregate provider-level report that has been in use since 2000 across all CARE Act programs (i.e., Titles I, II, III, and IV). Approved by OMB, the CADR utilizes the aggregate format for data using the OMB standards for the federal collection of race/ethnicity.

The CADR is moving toward a client-level data collection system, at which time the format for reporting client race and ethnicity will change to reflect the OMB standards for individual level collection of race/ethnicity. At that time, HRSA also will change the Title I MAI Report’s format for reporting ethnic and racial demographic data in order to maintain reporting consistency across all CARE Act funded programs.

By keeping the Title I MAI Report’s ethnic and racial categories consistent with HRSA’s principal CARE Act reporting system at the outset and in the future, HRSA will be able to document and compare Title I MAI services utilization and client demographics and assess this initiative’s impact in relation to: a) the Title I program overall, and b) other CARE Act programs funded under Titles II, III and IV. Moreover, maintaining consistency in ethnic and racial demographic reporting formats will minimize the reporting burden for grantees, prevent confusion, and reduce the likelihood of reporting errors. This is critical, since Title I MAI-funded service providers very often receive other CARE Act funds (i.e., they also receive ‘basic’ Title I funds and funds awarded under Title’s II, III, and IV).

3. Use of Improved Information Technology

The Title I MAI Report is designed to collect unduplicated, aggregate-level data about clients and services for better planning and funding allocation for Title I MAI programs. The proposed MAI Workbook and Web application used to implement the report will significantly enhance HRSA’s ability to monitor and measure grantee performance; analyze and assess outcomes attributable to MAI funding for Title I grantees; review processes and take action to improve program operations; and identify successes and problems for policy and program development.

The Title I MAI Report has two parts: (1) a workbook that collects standardized quantitative and qualitative information, and (2) an accompanying narrative report. Grantees will submit two
Title I MAI Reports annually: Title I MAI Plan (Plan) and the Title I MAI Year-End Annual Report (Report). Grantees will use the same workbook to submit data for both the Plan and Report components. By July 1^st of each calendar year, grantees will be required to submit information pertaining to planned activities for the upcoming fiscal year (March 1 through February 28): this comprises the Plan component. By July 1^st of the following fiscal year, grantees will use the same form to report on activities conducted and clients served during the year: this comprises the Report component.

The MAI Workbook will be in spreadsheet format (i.e. Microsoft Excel), or similar alternate format, and will contain multiple worksheets to collect specific information about each service provided and minority population served. The total number of worksheets necessary to complete the Form is dependent upon the number of services and specific populations served by the reporting grantee; each service to a specific minority population will require data entry into a separate worksheet. In 2004, Title I EMAs used MAI funds to provide an average of three different services, with a range between one and eight services.

Grantees will access the MAI Workbook through the HRSA Electronic Handbooks (EHBs). The EHBs are designed to streamline the grants application and administration processes by providing a mechanism for electronic communication between HRSA and its grantees as well as a centralized location for submission of grant-related documents. All members of the grantee organization who will need access to the MAI Workbook must register in the EHBs to create a user account and add the Title I grant to their EHBs Grants Portfolio. This one-time process ensures that only authorized members of the grantee organization have access to grant-related information and documents. Title I grantees, who submitted the 2005 CADR through the EHBs, are familiar with this process.

MAI data submission will be an “Other Deliverable” within the EHBs grants portfolio. Within the grants portfolio there will be a link which will take the grantee to the Title I MAI Report web application where grantees will download their customized MAI Workbook and upload the file once they have completed data entry.

To generate the customized excel file, the grantee will be required to complete web forms specifying the data submitter’s information, funding amounts, service categories, and racial/ethnic groups served. After completing the web forms, the system will generate a customized MAI Workbook that contains only the worksheets required by the grantee and already containing the information provided in the web forms (the identifying information, funding information, etc.), so that grantees do not have to enter them again.

Once the system generates the customized MAI Workbook, the grantee will download and save it. The grantee will be able to enter, edit and save information as many times as is required to complete the report prior to submitting it to HRSA. Grantees will enter brief narrative descriptions in the workbook of their planned outcomes (Plan), the measures they will use to determine whether outcomes were achieved (Plan), and the results of each outcome (Report). Grantees will not be able to make structural changes such as adding or deleting a worksheet to the MAI Workbook itself. All cells that do not require data entry will be restricted to eliminate the possibility of changes resulting in data entry errors.

After completing data entry in the MAI Workbook, the grantee data submitter will upload the excel file to the Title I MAI Report web application through the EHBs. Before the submission process can be completed, the Web application will automatically implement several quality control measures. For example, only files containing the embedded version code and an “.xls” extension (indicating that the file is in MS Excel format), will be accepted. The Web application will also perform a set of validation checks to ensure that the data meets all requirements for a completed report. The grantee data submitter will need to resolve any validation errors before submitting their report. If the file contains any errors, they will be displayed to the user on the web in clear language with instructions for resolving them. These validation checks will significantly reduce the likelihood that HRSA will have to contact grantees to make corrections to the data at a later time, greatly reducing the time and effort it takes the data analysts to correct wrong data.

At the end of the fiscal year, grantees will use the EHB portal to access their submitted MAI Plan and complete the year-end section (Report). After logging in, they will be given an opportunity to amend their original Plan if changes occurred during the year (e.g., any change in the amount budgeted for one or more services). If changes occurred, the HRSA MAI web system will update their file and grantee-specific MAI Workbook. The user will then download their MAI Workbook to enter data/information about each service provided to each ethnic and racial community. (i.e. the amount spent; the number of service units provided; the total number of unduplicated clients served; the unduplicated number of women, infants, children and youth served (separately); and the number of clients who achieved planned outcomes.)

Using the standardized Title I MAI Report and Web application to collect data from grantees will benefit both HRSA and grantees. Grantees will benefit from having a user-friendly mechanism for reporting information with built-in quality assurance checks, which eliminate or substantially reduce the likelihood that grantees will be contacted at a later date to correct errors. It is anticipated that grantees will spend less time preparing and submitting the Title I MAI Report than they would if they had to create an entirely narrative report to respond to HRSA’s requests for the information through grant applications and reports. HRSA will benefit from having accurate, standardized data delivered in a timely matter in a format that can be easily analyzed. In the past, HRSA has spent an enormous amount of manpower extracting information from detailed narrative reports that varied in length and content in order to respond to Congressional and other data requests. The proposed data collection system will streamline the data collection system and result in higher quality data in a format that simplifies the data analysis.

After uploading their grantee-specific MAI Workbook, the user will be asked to upload the accompanying MAI Narrative. The MAI Narrative may be in Microsoft Word, WordPerfect, or Rich Text Format. When both the MAI Workbook and the MAI Narrative sections have been uploaded, the User will be prompted to click a “submit” button to complete the submission process and will be given an opportunity to receive verification that the entire report was successfully submitted. After the report submission period has ended, the data from each grantee report will be merged into a single data file and delivered to HRSA for analysis (see Section 16 of the Justification for more detail about analysis plans).

When the Web application becomes officially operational, HRSA or a contractor will provide any browser or web-related technical assistance requested by users during actual data submission, as well as assistance required by HRSA to ensure access to the Web application as necessary. This technical assistance will be available to Title I MAI grantees from 9:00 AM to 5:00 PM EST during the HAB-defined official data-reporting period only. HRSA or a contractor will provide a resolution to grantees requesting such technical assistance immediately upon request. If this is not possible, the technical assistance must occur, at the very least, within 24 hours of each request for such assistance.

4. Efforts to Identify Duplication

Data of the type required to evaluate or monitor the Title I MAI program are not available elsewhere. Studies of people with AIDS, people who are HIV-positive, or sample studies of people in defined demographic or risk groups cannot provide comprehensive, overall program information specifically about grantees, providers, and beneficiaries of the Title I MAI. The
Title I MAI Report is necessary for the program to monitor the objectives that the funding initiative is designed to meet.

5. Involvement of Small Entities

This information collection does not include small businesses or other small entities.

6. Consequences If Information Collected Less Frequently

Grants are awarded to grantees and, through the grantees, contracts are given to service providers on an annual basis. Without annual reporting on the use of grant funds, HRSA would not be able to carry out its responsibility to oversee compliance with the intent of congressional appropriations in a timely manner. Because the epidemiology of AIDS is changing constantly, annual reporting of the characteristics of Title I MAI grants is necessary to determine whether the administration of the funds is responding to changes in the affected population.

If the information is not collected at all, HRSA will not know or be able to report the following:

• Whether program funds are being spent for their intended purposes,

• What types of and how many individuals are receiving services,

• How the distribution of program funds and the characteristics of individual beneficiaries are changing from one year to the next, and,

• Whether funded services are achieving planned client- and service-level outcomes.

7. Consistency with the Guidelines in 5 CFR 1320.5(d) (2)

The data will be collected in a manner fully consistent with the guidelines in 5 CFR 1320.6

8. Consultation Outside the Agency

The notice required in 5 CFR 1320.8(d) was published in the Federal Register on March 30, 2006 (Volume 71, Number 61, Pages 16160-16161) (Tab E). No comments were received.

HRSA conducted an inquiry in 2005 in which all 51 Title I grantees were asked to provide input on the use of a standard format for reporting on MAI services/activities and outcomes achieved. Grantees were invited to offer feedback on proposed data/information fields, definitions of terms used, draft instructions, timeframes for implementation of the new report form, and the amount of resources that would be necessary to start reporting with the new form. Grantee comments were used to develop the submitted draft Title I MAI Report.

In June 2006, a draft of the revised MAI Workbook and instruction manual was reviewed by four Title I MAI grantees. These grantees include:

Chicago: Linda Lesondak, Ph.D. Director of Evaluation HIV/AIDS Public Policy & Programs Chicago Department of Public Health 333 South State Street, 2nd floor Chicago, Illinois 60604 312.747.9669 - telephone 312.747.9663 - fax	Miami: Ms. Theresa Fiano, Ryan White Program Director Miami Dade County Office of Strategic Business Management Ryan White Title I Program 111 NW 1st Street, 22nd floor Miami, FL 33128 Phone: (305) 375-3510 or 4742 Fax: (305) 375-4454 E-mail: fianot@miamidade.gov / www.miamidade.gov/RyanWhite/home.asp
New York: Ms. Jo Ann Hilger, Director, Ryan White CARE Services NYC Department of Health / Mental Hygiene 40 Worth Street, 1502 New York, NY 10013 Phone: (212) 788-5075 x 4904 Fax: (212) 788-4265 E-mail: jhilger@health.nyc.gov	San Diego: CA: Mr. Terry Cunningham, Chief HIV, STD & Hepatitis Branch Public Health Services County of San Diego 3043 4th Avenue San Diego, CA 92103 Phone: (619) 293-4706 Fax: (619) 296-2688 E-mail: Terry.Cunningham@sdcounty.ca.gov

In addition to consultations with grantees, HRSA consulted with the Office of HIV/AIDS Policy (OHAP) staff during the development of the data collection instrument. OHP also was invited to review the draft Title I MAI Report form and instructions, and had no substantive comments.

9. Remuneration of Respondents

Respondents will not be remunerated.

10. Assurance of Confidentiality

The Title I MAI Report form does not require any information that could identify individual clients. Names and personal identifiers are not included in this aggregate data report. All reports and tabulated data that are released to the general public are summaries of information across providers, which protect individual providers from being identified.

11. Questions of a Sensitive Nature

There are no questions of a sensitive nature collected in the Title I MAI Report. No patient or client-level identifying data are reported. Identification of the grantees as recipients of CARE Act or Title I MAI funds is a matter of public record, as these agencies receive funds directly from HRSA. Only aggregate data summarizing Title I MAI Report responses will be included in reports published by HRSA.

12. Estimates of Annualized Hour Burden

The estimate of average annualized hour burden for respondents is shown in Table 1. As Table 1 shows, an estimated total of 51 respondents will submit the Title I MAI Report. Each respondent will submit two responses, (1) the Title I MAI Plan and (2) the Title I MAI Annual Report and each response has both a workbook and narrative component. Each grantee’s response will take approximately 6 hours on-average to complete. The total number of respondents (51) times two responses per grantee times the estimated 6 hours per response results in a combined total burden estimate of 612 hours for this activity.

Table 1. Estimates of Average Annualized Hour Burden

Form	Estimated Number of Respondents	Responses per Respondent	Hours per response	Total Burden Hours
Title I MAI Report	51	2	6 hrs	612

13. Estimates of Annualized Cost Burden to Respondents

There are no direct costs to respondents other than their time spent completing the Title I MAI Report. There are no capital or start up costs for respondents related to this effort.

14. Estimate of Annualized Cost to the Federal Government

HRSA has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner that shall enhance, where appropriate, the utility of information to agencies and the public.

HRSA estimates an annual investment of approximately $250,000, for data system operation and maintenance; ongoing support for grantee questions about 1) the content and format of the report and 2) the Web application system; data analysis; and report preparation.

15. Changes in Burden

This is a new collection of information.

16. Time Schedule, Publication, and Analysis Plans

Development of the Web application that grantees will access to upload the Title I MAI Report to HRSA’s EHBs will begin immediately following OMB approval and is expected to take approximately five months to complete. This phase includes understanding the system requirements, developing the software and user interface, integration with the EHBs, pilot testing, and making adjustments to the system based on pilot test results.

Following the development of the Web application, grantees will submit a completed Title I MAI Report twice each year. It is anticipated that the first data submission will occur in 2007, pending OMB approval. By July 1, 2007, and every subsequent year, grantees will submit the Plan component of the Title I MAI Report. Then, by July 1^st of the following year (2008 for the first year of data collection, and then each year following that), grantees will submit the Report component. The Plan will include information about planned services and outcomes for the forthcoming fiscal year, March 1 – February 28. The Report will include service and outcome data for the same time period, submitted at the end of the fiscal year. HRSA or a contractor will provide support both for the Web application system and in the form of technical assistance to grantees as they complete and submit their Title I MAI Report.

After each data submission (which includes built-in quality assurance checks), the Web application manager (HRSA or a contractor) will supply HRSA with a complete dataset in SQL, SPSS, SAS, or spreadsheet format for analysis. HRSA will analyze these data for inclusion in annual MAI reports (i.e., Secretary’s Fund Report and OHAP data request), generally due to Congress in December of each year, and other data requests made throughout the year. The first full year of data, which includes data from both the Plan and Report components, is expected to be ready for analysis in August/September of 2008 (4-8 weeks after Report submission).

17. Exemption for Display of Expiration Date

The expiration date will be displayed.

18. Certifications

This information collection fully complies with 5 CFR 1329.9. The certifications are included in the package.