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

Forms and Documents

Document Name	Status
Assessing the acceptability and adoptability of HIV-1 pre-exposure prophylaxis (PrEP) technologies with and without contraceptive formulation among African American women in the southeastern United St Form	New
Qualitative Research to Understand Consumer Opinions and Preferences for Emerging HIV Prevention Products among MSM in Atlanta, Houston, and Miami Form and Instruction	New
Assessing the acceptability and adoptability of HIV-1 PrEP technologies among African American women in the SE US Form	New
Form 0920-1091 HIV Prevention and Treatment Services among Young Men of Color who Have Sex with Men (YMSM of Color) and Young Transgender Persons of Color (YTG of Color) in the Deep South" Form	New
Syringe Service Programs' (SSP) User Experiences Form	New
Att 5b_PrivacyImpactAssessApproval_ResSuppServ.pdf Supplementary Document	2018-08-17
Att 5a_PrivacyImpactAssessApproval_Atlas.pdf Supplementary Document	2018-08-17
Att 4_Sample Consent Form.docx Supplementary Document	2018-08-17
Att 3f_Sample Provider Interview Guide.docx Supplementary Document	2018-08-17
Att 3e_Sample Provider Demographic Survey.docx Supplementary Document	2018-08-17
Att 3d_Sample Interview Guide.docx Supplementary Document	2018-08-17
Att 3c_Sample Demographic Survey.docx Supplementary Document	2018-08-17
Att 3b_Sample Contact Information Form.docx Supplementary Document	2018-08-17
Att 3a_Sample Study Screener.docx Supplementary Document	2018-08-17
Att 2 60 Day FRN_Published.pdf Supplementary Document	2018-08-17
Att 1_Auth Legislation.pdf Supplementary Document	2018-08-17
Supporting Statement B.docx Supporting Statement B	2018-08-17
Supporting Statement A.docx Supporting Statement A	2018-08-17

IC Document Collections

IC ID	Document Title	Status
244054	Assessing the acceptability and adoptability of HIV-1 pre-exposure prophylaxis (PrEP) technologies with and without contraceptive formulation among African American women in the southeastern United St Form	New
241844	Qualitative Research to Understand Consumer Opinions and Preferences for Emerging HIV Prevention Products among MSM in Atlanta, Houston, and Miami Form and Instruction	New
238087	Assessing the acceptability and adoptability of HIV-1 PrEP technologies among African American women in the SE US Form	New
235907	HIV Prevention and Treatment Services among Young Men of Color who Have Sex with Men (YMSM of Color) and Young Transgender Persons of Color (YTG of Color) in the Deep South" Form	New
233472	Syringe Service Programs' (SSP) User Experiences Form	New

ICR Details

OMB Control No: 0920-1091	ICR Reference No: 201808-0920-012
Status: Historical Active	Previous ICR Reference No: 201505-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1091
Title: Using Qualitative Methods to Understand Issues in HIV Prevention, Care and Treatment in the United States
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/19/2018
	Date Received in OIRA: 08/22/2018
Terms of Clearance: Previous terms continue: 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	09/30/2021	36 Months From Approved	12/31/2018
Responses	12,000	0	12,000
Time Burden (Hours)	2,754	0	2,754
Cost Burden (Dollars)	0	0	0

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Abstract: This is an EXTENSION request for the current GENERIC information collection request (ICR) 0920-1091. The overall purpose 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. These qualitative studies will collect data using well-established rapid assessment methodologies, including: semi-structured and in-depth qualitative interviews, focus groups; direct observations; document reviews; and structured surveys. 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; women; 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:
	83 FR 10853	03/13/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 34589	07/20/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Assessing the acceptability and adoptability of HIV-1 pre-exposure prophylaxis (PrEP) technologies with and without contraceptive formulation among African American women in the southeastern United St	none, none, none	Screener - screenshots ,   Contact information form ,   Demographic behavioral CAPI - screenshots
Qualitative Research to Understand Consumer Opinions and Preferences for Emerging HIV Prevention Products among MSM in Atlanta, Houston, and Miami	n/a, n/a, n/a, n/a, n/a, n/a	Screener ,   Contact Information Form ,   In-depth Interview Guide ,   Focus Group Guide ,   Survey for Participants Currently on PrEP ,   Survey for Participants Currently Not on PrEP
Syringe Service Programs' (SSP) User Experiences	none, none, none	Client Screener ,   Staff and Stakeholder Screener ,   Contact Information Form
HIV Prevention and Treatment Services among Young Men of Color who Have Sex with Men (YMSM of Color) and Young Transgender Persons of Color (YTG of Color) in the Deep South"	0920-1091, 0920-1091, 0920-1091	Deep South Client Screener (English) ,   Deep South CBO Client Interview Guide ,   Deep South Staff Interview Guide
Assessing the acceptability and adoptability of HIV-1 PrEP technologies among African American women in the SE US	none, none, none	Screener ,   Contact information ,   Demographic and behavioral questionnaire

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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	12,000	0	0	0	0
Annual Time Burden (Hours)	2,754	2,754	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $517,658

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 08/22/2018

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