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

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-1100 Att 8b_Phase 2 Behavioral Survey (Spanish)	Form	Modified	Available
Form 0920-1100 Att 11a_Phase 2 Consent form (English)	Form	Modified	Repair queued
Form 0920-1100 Phase 2 Consent	Form	Modified	Repair queued
Form 0920-1100 Att 10b_Phase 1 Consent Form (Spanish)	Form and Instruction	Modified	Repair queued
Form 0920-1100 Phase 1 Consent	Form	Modified	Available
Form 0920-1100 Phase 1 Consent	Form	Modified	Available
Form 0920-1100 Att 8b_Phase 2 Behavioral Survey (Spanish)	Form and Instruction	Modified	Available
Form 0920-1100 Att 8a_Phase 2 Behavioral Survey (English)	Form and Instruction	Modified	Available
Form 0920-1100 Phase 2 Behavioral Survey	Form and Instruction	Modified	Repair queued
Form 0920-1100 Att 9b_Phase 2 HIV Symptom and Care Survey (Spanish)	Form and Instruction	Modified	Available
Form 0920-1100 Att 9a_Phase 2 HIV Symptom and Care Survey (English)	Form and Instruction	Modified	Available
Form 0920-1100 Phase 2 HIV Symptom and Care Survey	Form and Instruction	Modified	Available
Form 0920-1100 Att 7b_Phase 1 Enrollment Survey (Spanish)	Form and Instruction	Modified	Available
Form 0920-1100 Att 7a_Phase 1 Enrollment Survey (English)	Form and Instruction	Modified	Available
Form 0920-1100 Phase 1 Enrollment Survey	Form and Instruction	Modified	Repair queued
Att 13 Project Determination.pdf	Supplementary Document	Uploaded 2021-12-07	Repair queued
Privacy Act Checklist.docx	Supplementary Document	Uploaded 2021-12-07	Repair queued
Att 4 IRB approval (JHU_Hamill).pdf	Supplementary Document	Uploaded 2021-12-07	Repair queued
Att 3_References.docx	Supplementary Document	Uploaded 2021-12-07	Repair queued
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2021-12-07	Repair queued
Summary of changes to questionnaire - DETECT 2.0 - 03.11.2021.xlsx	Supplementary Document	Uploaded 2021-03-25	Repair queued
Justification for Change for 0920-1100_DETECT clean_final.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-03-25	Repair queued
Att 15_PIA.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 14_Project Determination.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 13_Supplemental Study Information.docx	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 5_IRB Approval.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 4_Certificate of Confidentiality.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 3_References.docx	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 2_60-Day FRN Published.pdf	Supplementary Document	Uploaded 2018-11-16	Repair queued
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2018-11-16	Repair queued
Supporting Statement B.docx	Supporting Statement B	Uploaded 2021-12-07	Available
Supporting Statement A.docx	Supporting Statement A	Uploaded 2021-12-07	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
218949	Phase 2 Consent	Form	Modified	Att 8b_Phase 2 Behavioral Survey (Spanish)
218949	Phase 2 Consent	Form	Modified	Att 11a_Phase 2 Consent form (English)
218949	Phase 2 Consent	Form	Modified
218948	Phase 1 Consent	Form and Instruction	Modified	Att 10b_Phase 1 Consent Form (Spanish)
218948	Phase 1 Consent	Form	Modified	Phase 1 Consent
218948	Phase 1 Consent	Form	Modified
218947	Phase 2 Behavioral Survey	Form and Instruction	Modified	Att 8b_Phase 2 Behavioral Survey (Spanish)
218947	Phase 2 Behavioral Survey	Form and Instruction	Modified	Att 8a_Phase 2 Behavioral Survey (English)
218947	Phase 2 Behavioral Survey	Form and Instruction	Modified
218946	Phase 2 HIV Symptom and Care Survey	Form and Instruction	Modified	Att 9b_Phase 2 HIV Symptom and Care Survey (Spanish)
218946	Phase 2 HIV Symptom and Care Survey	Form and Instruction	Modified	Att 9a_Phase 2 HIV Symptom and Care Survey (English)
218946	Phase 2 HIV Symptom and Care Survey	Form and Instruction	Modified
218945	Phase 1 Enrollment Survey	Form and Instruction	Modified	Att 7b_Phase 1 Enrollment Survey (Spanish)
218945	Phase 1 Enrollment Survey	Form and Instruction	Modified	Att 7a_Phase 1 Enrollment Survey (English)
218945	Phase 1 Enrollment Survey	Form and Instruction	Modified
218945	Phase 1 Enrollment Survey	Other-Screenshot	Modified

ICR Details

OMB Control No: 0920-1100	ICR Reference No: 202112-0920-002
Status: Historical Active	Previous ICR Reference No: 202103-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1100-21DY
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: 01/19/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 12/07/2021
Terms of Clearance: Previous terms continue: 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. Limitations should also discuss any changes to the protocol.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2025	36 Months From Approved	01/31/2022
Responses	4,751	0	4,751
Time Burden (Hours)	1,594	0	1,594
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. The main purpose of this Change Request is to allow collection continuation with an additional site with other minor changes.

---

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:
	86 FR 36555	07/12/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 67952	11/30/2021
Did the Agency receive public comments on this ICR? No

---

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

table that charts list of burden

IC Title	Form No.	Form Name
Phase 1 Consent	0920-1100, 0920-1100	Phase 1 Consent ,   Att 10b_Phase 1 Consent Form (Spanish)
Phase 1 Enrollment Survey	0920-1100, 0920-1100	Att 7a_Phase 1 Enrollment Survey (English) ,   Att 7b_Phase 1 Enrollment Survey (Spanish)
Phase 2 Behavioral Survey	0920-1100, 0920-1100	Att 8a_Phase 2 Behavioral Survey (English) ,   Att 8b_Phase 2 Behavioral Survey (Spanish)
Phase 2 Consent	0920-1100, 0920-1100	Att 11a_Phase 2 Consent form (English) ,   Att 8b_Phase 2 Behavioral Survey (Spanish)
Phase 2 HIV Symptom and Care Survey	0920-1100, 0920-1100	Att 9a_Phase 2 HIV Symptom and Care Survey (English) ,   Att 9b_Phase 2 HIV Symptom and Care Survey (Spanish)

---

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	4,751	4,751	0	0	0	0
Annual Time Burden (Hours)	1,594	1,594	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: $1,258,676

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? No

---

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: 12/07/2021

---