Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)

Forms and Documents

Document Name	Status
Phase 2 Behavioral Survey Form and Instruction	Modified
Phase 2 HIV Symptom and Care Survey Form and Instruction	Modified
Phase 1 Enrollment Survey B Form and Instruction	Modified
Phase 1 Enrollment Survey A Form and Instruction	Modified
Att 15_PIA.pdf Supplementary Document	2018-11-16
Att 14_Project Determination.pdf Supplementary Document	2018-11-16
Att 13_Supplemental Study Information.docx Supplementary Document	2018-11-16
Att 5_IRB Approval.pdf Supplementary Document	2018-11-16
Att 4_Certificate of Confidentiality.pdf Supplementary Document	2018-11-16
Att 3_References.docx Supplementary Document	2018-11-16
Att 2_60-Day FRN Published.pdf Supplementary Document	2018-11-16
Att 1_Auth Legislation.docx Supplementary Document	2018-11-16
Supporting Statement B_11082018.docx Supporting Statement B	2018-11-16
Supporting Statement A_11082018.docx Supporting Statement A	2018-11-16

IC Document Collections

IC ID	Document Title	Status
218949	Att 10_Phase 2 Consent Other-Consent Form (English)	Modified
218948	Phase 1 Consent Other-Consent Form (English)	Modified
218947	Phase 2 Behavioral Survey Form and Instruction	Modified
218946	Phase 2 HIV Symptom and Care Survey Form and Instruction	Modified
218945	Phase 1 Enrollment Survey B Form and Instruction	Modified
218918	Phase 1 Enrollment Survey A Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1100	ICR Reference No: 201811-0920-002
Status: Active	Previous ICR Reference No: 201511-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No: 15AEZ
Title: Identification of Behavioral and Clinical Predictors of Early HIV Infection (Project DETECT)
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: 01/16/2019
	Date Received in OIRA: 12/11/2018
Terms of Clearance: Approved consistent with the understanding that any forthcoming publications or communications of the study outcomes will clearly convey the potential limitations in the generalizability of the behavioral findings to other subpopulations and other geographic areas.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2022	36 Months From Approved	02/28/2019
Responses	4,751	0	4,751
Time Burden (Hours)	2,110	0	2,110
Cost Burden (Dollars)	0	0	0

---

Abstract: CDC provides guidelines for HIV testing and diagnosis for the United States, as well as technical guidance for its grantees. The goals of the project are to: 1) characterize the performance of new HIV tests for detecting established and acute HIV infection at the point of care (POC) relative to each other and currently used gold standard, non-POC tests, and 2) identify behavioral and clinical predictors of early HIV infection. CDC will use the HIV testing data collected in this project to update HIV testing guidance documents to reflect the latest available testing technologies and their performance characteristics. CDC will use the information on behavioral and clinical characteristics of persons with early infection to help HIV test providers (including CDC grantees) more effectively target the tests designed to detect early HIV infection, which are the most expensive HIV tests and are most appropriately used to test those at highest risk of infection.

---

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

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 42301	08/21/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 63512	12/10/2018
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Phase 1 Enrollment Survey B	n/a, n/a, n/a, n/a	Phase 1 Enrollment Survey B (English) ,   Phase 1 Enrollment Survey B (Spanish) ,   Phase 1 Enrollment Survey B (screen shots) ,   Phase 1 Enrollment Survey B (screen shots in Spanish)
Phase 2 Behavioral Survey	n/a, n/a, n/a, n/a	Phase 2 Behavioral Survey (English) ,   Phase 2 Behavioral Survey (Spanish) ,   Phase 2 Behavioral Survey (screen shots in Spanish) ,   Phase 2 Behavioral Survey (screen shots in English)
Phase 2 HIV Symptom and Care Survey	n/a, n/a, n/a, n/a	Phase 2 HIV Symptom and Care Survey (English) ,   Phase 2 HIV Symptom and Care Survey (Spanish) ,   Phase 2 HIV Symptom and Care Survey (screen shots) ,   Phase 2 HIV Symptom and Care Survey (screen shots in Spanish)
Phase 1 Consent
Att 10_Phase 2 Consent
Phase 1 Enrollment Survey A	n/a, n/a, n/a	Phase 1 Enrollment Survey A (English) ,   Phase 1 Enrollment Survey A (Spanish) ,   Phase 1 Enrollment Survey A (screen shots)

---

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	4,751	4,751	0	0	0	0
Annual Time Burden (Hours)	2,110	2,110	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:

---

Annual Cost to Federal Government: $867,704

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

---

Common Form ICR:  No

---

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: 12/11/2018

---