HIV - Supporting Statement A

Domestic Guidelines for HIV Testing during the Refugee Screening at U.S. Health Departments

OSTLTS Generic Information Collection Request

OMB No. 0920-0879

Supporting Statement – Section A

Submitted: February 6, 2014

Program Official/Project Officer

Deborah Lee

Epidemiologist

Division of Global Migration and Quarantine, CDC

1600 Clifton Rd, NE, Mailstop E-03, Atlanta, GA, 30333

Phone (404) 639-0439

Fax (404) 639-4441

Email [email protected]

Section A – Justification

1. Circumstances Making the Collection of Information Necessary

Background

This data collection is being conducted using the Generic Information Collection mechanism of the OSTLTS Survey Center (OSC) – OMB No. 0920-0879. The respondent universe for this data collection aligns with that of the OSC. Data will be collected from state and District of Columbia Refugee Health Coordinators in U.S. Health Departments acting in their official capacities. It is important to mention that the Office of Refugee Resettlement who funds state refugee health coordinators defines the refugee health coordinator in the District of Columbia as ‘state’ refugee health coordinator. This data collection is authorized by Section 301 of the Public Health Service Act (42 U.S.C. 241).

As of January 4, 2010, refugees and immigrants are no longer required to have HIV testing during the overseas health assessment. The removal of this requirement, however, has left public health gaps that should be addressed. Because of limited access and social and cultural barriers to testing, resettling refugees may not be aware of their HIV status, leading to delays in obtaining appropriate medical care and counseling. (Annually, approximately 50,000 to 80,000 resettle into the U.S.) Federal agencies, state and local health departments, and domestic voluntary resettlement agencies need to collaborate to get refugees tested as part of their post-arrival health assessment, so that additional assistance can be provided to refugees who test positive.

The Federal Refugee Act of 1980 entitles all newly arriving refugees to a comprehensive health screening, to be initiated as soon as possible after arrival. The refugee health screening is recommended to eliminate health-related barriers to successful resettlement, while protecting the health of the US population. In accordance with federal guidelines, refugee health screening must be initiated within 90 days of entry. The screening is usually performed by clinicians affiliated with state and local refugee health department programs. The HIV screening according to CDC domestic guidelines (Attachment A), is recommended for all refugees between 13-64 years of age. HIV screening should be performed in accordance with these guidelines and with individual state HIV testing policies.

The removal of the mandatory HIV testing highlights the importance of CDC guidelines, which recommend that individuals seek voluntary testing to determine their HIV status and the initiation of early treatment for those who are HIV infected. Currently, there is no national comprehensive information on the implications of this change among newly arriving refugees. Thus, the purpose of this proposal is to assess the CDC’s recommended guideline for HIV testing among newly arriving refugees at U.S. health departments, determine the successes and challenges of implementing these guidelines since the final removal of HIV testing requirement prior to arrival into the U.S. and determine any gaps in the guidelines by assessing routinely available aggregate HIV testing results of newly arriving refugees.

Data will be collected through a brief, web-based data collection distribution to state refugee health coordinators. Participation in the data collection will be voluntary.

Data collection from this proposal will be used to assess current implementation of CDC’s HIV screening guidelines to advance evidence-based public health policy and practice. The findings from this assessment will be shared with federal and state public health stakeholders who work with newly arriving refugees.

Privacy Impact Assessment

Overview of the Data Collection System – The assessment is designed to answer several questions regarding the implementation of the CDC’s HIV screening guidelines as well as successes, challenges and gaps of implementing the guidelines since the final removal of the HIV testing requirements prior to arrival. These questions will help CDC understand the immediate and long-term barriers to the HIV screening guidelines among newly arriving refugees. The data will be collected using a web-based questionnaire (see Attachment B– Data Collection Instrument: MS Word version and Attachment C – Data Collection Instrument: Web version) completed by state refugee health coordinators or his or her designee in U.S. health departments. As mentioned, the Office of Refugee Resettlement who funds state refugee health coordinators defines the refugee health coordinator in the District of Columbia as ‘state’ refugee health coordinator. All refugee health coordinators completing the assessment are aware of this definition.

This assessment was pilot tested by 3 public health professionals. Feedback from this group was used to refine questions as needed, ensure accurate programming and skip patterns and establish the estimated time required to complete the assessment.

Items of Information to be Collected—There are up to 15 questions. Questions 1 and 2 will help determine in which facilities types and what proportion of newly arriving refugees are screened in general and for HIV infection. In Question 3, if no facilities screen for HIV, the data collection will end. If any facilities screen for HIV, data collection will continue to Question 4. Question 4 will determine in the facilities which provide HIV testing, when HIV testing began, the average number of days from arrival into the U.S. refugees are screened for HIV infection, and the ‘opt-in’ or ‘opt-out’ HIV screening characteristics. The adherences of the CDC’s HIV screening guidelines are inquired in Questions 5 thorough 7. Questions 8 through 10 will help CDC understand the successes and challenges of implementing the guidelines since the final removal of the HIV testing requirements prior to arrival. Questions 11 and 12 will determine if individual or aggregate-level HIV testing data is collected. Finally, by gathering routinely available aggregate screening results of newly arriving refugees in Questions 13 through 15, this will help CDC understand the gaps such as newly arriving refugee populations who are not screened and those who are not aware of their status prior to arrival.

Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age – The data collection system involves using a web-based data collection. Respondents will be sent a link directing them to the online data collection only (i.e., not a website). No website content will be directed at children.

2. Purpose and Use of the Information Collection

In order to learn more about the implications of the final removal of the HIV testing requirement prior to U.S. arrival among newly arriving refugees, CDC plans to conduct a data collection to assess the implementation of the CDC’s domestic guidelines for HIV screening during the refugee medical screening at U.S. health departments. The purposes of this data collection are to assess the CDC’s recommended guideline for HIV testing among newly arriving refugees at U.S. health departments (Screening for HIV Infection During the Refugee Domestic Medical Examination), determine the successes and challenges of implementing these guidelines after the final removal of HIV testing requirement prior to arrival into the U.S., and determine any gaps in the guidelines by assessing routinely available aggregate HIV testing results of newly arriving refugees.

Data will be collected through a web-based data collection system (i.e., Survey Monkey). This data will be collected from 51 state refugee health coordinators or their designee. This information is needed to help CDC carry out its mission to improve the health of newly arriving refugees and protect public health by providing the appropriate recommendations based on findings. The data collected will be used to inform with federal and state public health stakeholders who work with newly arriving refugees. Without collecting this information, CDC will not know if the recommended guidelines are in use and if refugees are provided the appropriate care especially if they are unaware of their HIV status.

Privacy Impact Assessment

Completion of the questions in this data collection by a state poses no risk to the respondent state because such matters are widely known within each State and are a matter of public record. To protect the individual privacy of respondents, data collection will not record the participant’s name and will refer to their interview by the state in which they are located.

3. Use of Improved Information Technology and Burden Reduction

Data will be collected via a web-based questionnaire allowing respondents to complete and submit their responses electronically. This method was chosen to reduce the overall burden on respondents. The data collection was designed to collect the minimum information necessary for the purposes of this project.

4. Efforts to Identify Duplication and Use of Similar Information

The information being collected is specific to domestic HIV screening as indicated by CDC guidelines. There is currently no information available that can substitute for data collection responses as of August 2013. There is no federal agency that can provide a national assessment of this kind. A single wave of data collection is being conducted.

5. Impact on Small Businesses or Other Small Entities

No small businesses will be involved in this data collection.

6. Consequences of Collecting the Information Less Frequently

If data are not collected, there are several implications:

• No information on the use of the domestic HIV guidelines which highly recommends HIV testing among newly arriving refugees might delay enhanced guidelines. (For example, if refugees are not being tested for HIV, there is potential for increase in the number of those who are infected with HIV and yet, unaware of readily available treatment and counseling adding to the already estimates 21% of all person infected with HIV in the U.S. )

• Potential stigma to newly arriving refugees since there are documented increase risk of HIV infection among foreign-born, thus, jeopardizing U.S. refugee resettlement.

• Best practices/outcomes and challenges as a result of the removal of HIV testing prior to arrival into the U.S. will not be shared.

Without this assessment, CDC will not know whether their guidelines are being understood and applied to newly arriving refugees, or what can be done in the future to monitor and assess the effectiveness of the guidelines. This request is for a one time data collection. There are no legal obstacles to reduce the burden.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

There are no special circumstances with this information collection package. This request fully complies with the regulation 5 CFR 1320.5 and will be voluntary.

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

This data collection is being conducted using the Generic Information Collection mechanism of the OSTLTS Survey Center (OSC) – OMB No. 0920-0879. A 60-day Federal Register Notice was published in the Federal Register on October 22, 2010, Vol. 75, No. 204; pp. 65353-54. Two comments were received from the Association of State and Territorial Health Officials (ASTHO), and the National Association of County and City Health Officials (NACCHO).

CDC partners with professional STLT organizations, such as the Association of State and Territorial Health Officials (ASTHO), the National Association of County and City Health Officials (NACCHO), and the National Association of Local Boards of Health (NALBOH) along with the National Center for Health Statistics (NCHS) to ensure that the collection requests under individual ICs are not in conflict with collections they have or will have in the field within the same timeframe.

9. Explanation of Any Payment or Gift to Respondents

CDC will not provide payments or gifts to respondents.

10. Assurance of Confidentiality Provided to Respondents

The Privacy Act does not apply to this data collection. Employees of state and local public health agencies will be speaking from their official roles and will not be asked, nor will they provide individually identifiable information. This data collection is not research involving human subjects.

11. Justification for Sensitive Questions

No information will be collected that are of personal or sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

The estimate for burden hours is based on a pilot test of the data collection instrument by three of public health professionals. In the pilot test, the average time to complete the data collection including time for reviewing instructions, gathering needed information and completing the data collection, was approximately 30 minutes. Based on these results, the estimated time range for actual respondents to complete the data collection is between 15-30 minutes. For the purposes of estimating burden hours, the upper limit of this range (i.e., 30 minutes) is used.

Estimates for the average hourly wage for respondents are based on the Department of Labor (DOL) National Compensation Survey estimate for management occupations – medical and health services managers in state government (http://www.bls.gov/ncs/ocs/sp/nctb1349.pdf). Based on DOL data, an average hourly wage of $18.56 is estimated for all 51 respondents. Table A-12 shows estimated burden and cost information.

Table A-12: Estimated Annualized Burden Hours and Costs to Respondents

Type of Respondent	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours	Hourly Wage Rate	Total Respondent Costs
State and District of Columbia health department Refugee Health Coordinator	51	1	30/60	26	$18.56	$482.56
TOTALS	51	1	30/60	26	$18.56	$482.56

13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

There will be no direct costs to the respondents other than their time to participate in each data collection.

14. Annualized Cost to the Government

Table A-14: Estimated Annualized Cost to the Federal Government

Staff (FTE)	Average Hours per Collection	Average Hourly Rate	Average Cost
Health Scientist—GS-13	80	$45.06	$3,604.8
Estimated Total Cost of Information Collection			$3,604.8

15. Explanation for Program Changes or Adjustments

This is a new data collection.

16. Plans for Tabulation and Publication and Project Time Schedule

Results of this assessment will be used by CDC to improve understanding of current knowledge and implementation of CDC’s domestic HIV screening guidelines for newly arriving immigrants and refugees at the state and local levels. It is anticipated that the findings of this assessment effort will be disseminated to state refugee health programs. CDC would be the primary author of any reports. As part of the standard agency protocol, DGMQ is seeking Institutional Review Board (IRB) clearance through the Human Resource Protection Office in the Office of the Associate Director for Science.

Project Time Schedule

• Design data collection questionnaire (Complete)

• Develop data collection protocol, instructions, and analysis plan (Complete)

• Pilot test data collection questionnaire (Complete)

• Prepare OMB package (Complete)

• Submit OMB package (Complete)

• OMB approval (TBD)

• Conduct data collection (3 weeks)

• Collect, code, enter, quality control, and analyze data (2 weeks)

• Prepare report (4 weeks)

• Disseminate results/publication of findings (6 weeks)

17. Reason(s) Display of OMB Expiration Date is Inappropriate

We are requesting no exemption.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification. These activities comply with the requirements in 5 CFR 1320.9.

LIST OF ATTACHMENTS – Section A

Note: Attachments are included as separate files as instructed.

Attachment A – Screening for HIV Infection during the Refugee Domestic Medical Examination

Attachment B –Data Collection Instrument: MS Word version

Attachment C – Data Collection Instrument: Web