[NCHHSTP] HIV Outpatient Study (HOPS)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Behavioral Survey	Form and Instruction	Modified	Available
Behavioral Survey (screenshots)	Form and Instruction	Modified	Available
Behavioral Survey	Form and Instruction	Modified	Repair queued
HOPS SS A_final.docx	Supporting Statement A	Uploaded 2023-05-23	Repair queued
Att 8_List of study publications.docx	Supplementary Document	Uploaded 2023-05-23	Repair queued
Att 9_PIA.pdf	Supplementary Document	Uploaded 2023-05-23	Repair queued
Att 7 IRB-Continuation Approval.pdf	Supplementary Document	Uploaded 2023-05-23	Available
Att 2_60-day FRN Pub 2-17-2023.pdf	Supplementary Document	Uploaded 2023-05-23	Available
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2023-05-23	Repair queued
HOPS SS B.docx	Supporting Statement B	Uploaded 2023-05-23	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
216378	Informed Consent	Other-Consent for HOPS Data Abstraction from Medical Chart	Modified
216377	Behavioral Survey	Form and Instruction	Modified	Behavioral Survey
216377	Behavioral Survey	Form and Instruction	Modified	Behavioral Survey (screenshots)
216377	Behavioral Survey	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1080	ICR Reference No: 202305-0920-009
Status: Historical Active	Previous ICR Reference No: 202011-0920-013
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1080
Title: [NCHHSTP] HIV Outpatient Study (HOPS)
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: 06/27/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/26/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2026	36 Months From Approved	02/29/2024
Responses	3,150	0	3,150
Time Burden (Hours)	428	0	428
Cost Burden (Dollars)	10,994	0	10,994

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Abstract: The HIV Outpatient Study (HOPS) combines medical records data abstraction on HIV-infected adults at 8 HIV clinics in the U.S. with a brief behavioral survey for patients who agree to complete the survey annually. The 7-minute survey administered by telephone or through a web interface includes questions on HIV-positive patients' risk behaviors (including sexual, drug use, tobacco use) which can then be linked to diagnoses, treatments and laboratory findings obtained through the abstraction of medical records, in order to inform secondary HIV prevention. The HOPS allows for examining the trends in the epidemiology of chronic HIV disease in this aging U.S. cohort; the identification of interactions between HIV disease, antiretroviral therapy, and other comorbidities; the characterization of the optimal management strategies for HIV-infected patients to reduce morbidity and mortality (e.g., data on drug toxicities, effectiveness of clinical interventions); and monitoring of sexual and drug use behaviors of HIV-infected patients to inform risk-reduction programs. This is an Extension without changes.

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Authorizing Statute(s): US Code: 30 USC (241)a Name of Law: Research and Investigations
  

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:
	88 FR 10336	02/17/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 34156	05/26/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Behavioral Survey	n/a, n/a	Behavioral Survey (screenshots) ,   Behavioral Survey
Informed Consent

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ICR Summary of Burden

table that charts list 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	3,150	3,150	0	0	0	0
Annual Time Burden (Hours)	428	428	0	0	0	0
Annual Cost Burden (Dollars)	10,994	10,994	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: $2,654,459

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.     Yes

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? No

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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: 05/26/2023

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