Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States

Forms and Documents

Document Name	Status
Form 0920-1091 The Data to Care (D2C) Public Health Strategy: Successes, Challenges, and Lessons Learned in Identifying, Linking, and Reengaging Persons Diagnosed with HIV to Medical Care Form and Instruction	New
Barriers and Facilitators to HIV Prevention, Care and Treatment among Trasngender Women in Atlanta, Philadelphia and Washington, DC Form and Instruction	New
Att 4_Sample Consent Form.docx Supplementary Document	2015-05-21
Att 3f_Sample Provider Interview Guide.docx Supplementary Document	2015-05-21
Att 3e_Sample Provider Demographic Survey.docx Supplementary Document	2015-05-21
Att 3d_Sample Interview Guide.docx Supplementary Document	2015-05-21
Att 3c_Sample Demographic Survey.docx Supplementary Document	2015-05-21
Att 3b_Sample Contact Information Form.docx Supplementary Document	2015-05-21
Att 3a_Sample Study Screener.docx Supplementary Document	2015-05-21
Att 2a_Public Comments.docx Supplementary Document	2015-05-21
Att 2_60 Day FRN.pdf Supplementary Document	2015-05-21
Att 1_Auth Legislation.pdf Supplementary Document	2015-05-21
HIV Prevention Generic_Supporting Statement B - OMB Final_RevisedDec11_2015.docx Supporting Statement B	2015-12-21
HIV Prevention Generic_ Supporting Statement A_OMB Final_RevisedDec11_2015.docx Supporting Statement A	2015-12-21

IC Document Collections

IC ID	Document Title	Status
230695	The Data to Care (D2C) Public Health Strategy: Successes, Challenges, and Lessons Learned in Identifying, Linking, and Reengaging Persons Diagnosed with HIV to Medical Care Form and Instruction	New
225125	Barriers and Facilitators to HIV Prevention, Care and Treatment among Trasngender Women in Atlanta, Philadelphia and Washington, DC Form and Instruction	New
221812	Local Effectiveness Assessment Project (LEAP), Part II Other-WORD	New

ICR Details

OMB Control No: 0920-1091	ICR Reference No: 201505-0920-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 14APJ
Title: Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/22/2015
	Date Received in OIRA: 06/03/2015
Terms of Clearance: OMB approves this collection for a period of three years. To request approval of information collections under this generic approval, the agency must do the following: 1) Submit a Supporting Statement Part A and B for each generic sub-study; 2) Submit the instruments utilized for each generic collection; 3) Include documentation demonstrating IRB approval/exemption; 4) Include specific discussions on the non-generalizable nature of the data collected in all publications and presentations.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved
Responses	12,000	0	0
Time Burden (Hours)	2,754	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this generic ICR is to conduct qualitative studies to quickly identify barriers and facilitators to HIV prevention, care and treatment in specific regions with high HIV burden in the US. Intended use of the resulting data is to identify ways to improve local programmatic activities for specific communities along the continuum of HIV prevention, treatment and care for populations and areas with the greatest HIV burden. The populations to be studied include local networks of persons living with HIV and persons at high risk of acquiring HIV, including: persons with different racial and ethnic, age, and socioeconomic characteristics; men who have sex with men; transgender persons; and persons and organizations providing HIV prevention, care, and treatment services to impacted populations. Data will be analyzed using well established qualitative analysis methods, such as coding interviews for themes about barriers and successes to HIV prevention, care, and treatment. Structured response surveys will be analyzed using descriptive statistics and other appropriate statistical methods.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 9727	02/24/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 30462	05/28/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Local Effectiveness Assessment Project (LEAP), Part II
Barriers and Facilitators to HIV Prevention, Care and Treatment among Trasngender Women in Atlanta, Philadelphia and Washington, DC	none, none, none, none, none, none	Eligibility Screener ,   Demographic Questionnaire - Transgender Women ,   Demographic Questionnaire - Healthcare Providers ,   INterview Guide HIV- Transgender Women ,   Interview Guide - HIV+ Transgender Women ,   Interview Guide Healthcare Providers
The Data to Care (D2C) Public Health Strategy: Successes, Challenges, and Lessons Learned in Identifying, Linking, and Reengaging Persons Diagnosed with HIV to Medical Care	0920-1091, 0920-1091, 0920-1091	D2C Client Screener ,   D2C Client Interview Guide ,   D2C Program Staff Interview Guide

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	12,000	0	0	12,000	0	0
Annual Time Burden (Hours)	2,754	0	0	2,754	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new generic ICR.

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Annual Cost to Federal Government: $515,374

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 06/03/2015

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