HIV Outpatient Study (HOPS)

Forms and Documents

Document Name	Status
Behavioral Survey Form and Instruction	Modified
HOPS SS A_01072021.docx Supporting Statement A	2021-01-07
Att 8_List of study publications_rev.docx Supplementary Document	2021-01-06
Att 9_PIA_HOPS-1080.pdf Supplementary Document	2020-12-21
Att 7_CDC IRB approval.pdf Supplementary Document	2020-12-21
Att 2_60-day FRN pub 9-12-2020.pdf Supplementary Document	2020-12-21
Att 1_Auth Legislation.docx Supplementary Document	2020-12-21
HOPS SS B_12152020.docx Supporting Statement B	2020-12-21

IC Document Collections

IC ID	Document Title	Status
216378	Informed Consent Other-Consent for HOPS Data Abstraction from Medical Chart	Modified
216377	Behavioral Survey Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1080	ICR Reference No: 202011-0920-013
Status: Received in OIRA	Previous ICR Reference No: 201808-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1080
Title: 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	Date Submitted to OIRA: 01/07/2021

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2021
Responses	3,150	2,950
Time Burden (Hours)	428	405
Cost Burden (Dollars)	10,994	0

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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.

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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:
	85 FR 56616	09/14/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 1112	01/07/2021
Did the Agency receive public comments on this ICR? No

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

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

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ICR Summary of Burden

	Total Request	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	2,950	0	200	0	0
Annual Time Burden (Hours)	428	405	0	23	0	0
Annual Cost Burden (Dollars)	10,994	0	0	10,994	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 request for extension of the approved collection. In the previous approval period, the burden for the annual behavioral assessment was based on the estimated participation of 2,500 respondents. This was an empirical estimate of likely participation. In the current request, the burden for the annual behavioral assessment is estimated on the basis of 2,700 respondents (i.e., the total size of the HOPS cohort). CDC revised this estimate to ensure that the HOPS clearance provides capacity for the maximum number of respondents. This change adds 23 burden hours to the previous estimate. There are no changes to information collection content or methods.

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Annual Cost to Federal Government: $2,281,603

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: 01/07/2021

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