[NCHHSTP] The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)

Forms and Documents

Document Name	Status
Form 0920-25-0177 Acceptability Survey Form	Modified
Form 0920-25-0177 Study Visit Survey Form	Modified
Form 0920-25-0177 Participant Focus Group and Interview Guide Form and Instruction	Modified
Form 0920-25-0177 Follow Up Phone Call Survey Form	Modified
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form	Removed
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form Form and Instruction	Removed
Form 0920-1357 HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form	Removed
Form 0920-25-0177 Gay City Data Collection Form and Instruction	Modified
Form 0920-25-0177 Provider Interview Guide Form and Instruction	Modified
Form 0920-25-0177 Madison Clinic Data Collection Form and Instruction	Modified
Form 0920-25-0177 Release of Information Form	Modified
Form 0920-25-0177 Screen and Link Form and Instruction	Modified
Att 5 Consent Form.docx Supplementary Document	2026-01-13
Att 6b UW IRB Approval Continuing.pdf Supplementary Document	2025-12-22
Att 6a UW IRB Approval Initial.pdf Supplementary Document	2025-12-22
Att 1 Auth Legislation.docx Supplementary Document	2025-12-22
30 Day FRN GAIN.docx Supplementary Document	2025-12-22
Burden Table_Gain 0920-1357.docx Supplementary Document	2024-11-17
GAIN Consent Form_clean.docx Supplementary Document	2024-11-17
Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docx Justification for No Material/Nonsubstantive Change	2024-11-17
Att 2_Estimate of Annualized Burden Hours.docx Supplementary Document	2023-11-02
Att 1_Summary of Proposed Changes.docx Supplementary Document	2023-11-02
Justification for Nonmaterial Non-substantive Change _rev 110223.docx Justification for No Material/Nonsubstantive Change	2023-11-02
Nonsubstantiative change request justification_GAIN_0920-1357.docx Justification for No Material/Nonsubstantive Change	2022-09-13
Att 16_GAIN patient information sheet_changes accepted_082922.docx Supplementary Document	2022-09-13
Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docx Supplementary Document	2022-09-09
Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx Supplementary Document	2022-09-09
SSB_GAIN.docx Supporting Statement B	2025-12-22
Att 10_Consent Form_RCT Group.pdf Supplementary Document	2021-06-16
Att 9_Consent form GAIN study_Gay City HIV+ Group.pdf Supplementary Document	2021-06-16
Att 8_Consent form GAIN study_Testing PEP PrEP Group.pdf Supplementary Document	2021-06-16
Att 7_Privacy impact assessment (PIA).pdf Supplementary Document	2021-06-16
Att 6_GAIN IRB approval letter.pdf Supplementary Document	2021-06-16
Att 4_GAIN data sources and variables.docx Supplementary Document	2021-06-16
Att 3_GAIN study activities and visual overview.pdf Supplementary Document	2021-06-16
Att 2_60-Day FRN Published 12-21-2020.pdf Supplementary Document	2021-06-16
Att 1_Auth Legislation.docx Supplementary Document	2021-06-16
SSA_GAIN.docx Supporting Statement A	2025-12-22

IC Document Collections

IC ID	Document Title	Status
247958	Acceptability Survey Form	Modified
247957	Study Visit Survey Form	Modified
247955	Participant Focus Group and Interview Guide Form and Instruction	Modified
247954	Follow Up Phone Call Survey Form	Modified
247953	RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form	Removed
247952	RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form Form and Instruction	Removed
247950	HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form	Removed
247949	Gay City Data Collection Form and Instruction	Modified
247948	Provider Interview Guide Form and Instruction	Modified
247947	Madison Clinic Data Collection Form and Instruction	Modified
247946	Release of Information Form	Modified
247945	Screen and Link Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1357	ICR Reference No: 202512-0920-007
Status: Received in OIRA	Previous ICR Reference No: 202411-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-25-0177
Title: [NCHHSTP] The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/13/2026

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	423	0
Time Burden (Hours)	49	0
Cost Burden (Dollars)	0	0

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Abstract: The purpose of this information collection is to determine the acceptability and feasibility of NATs that are used at the point-of-care (POC NAT) implementation in clinical and community settings. POC NATs have the potential to help address some of the remaining challenges to ending the HIV epidemic in the United States by assisting with early detection of acute HIV infection and by providing a more efficient viral load monitoring tool for people living with HIV. This study is the first of its kind in the US and is critical to understanding the utility of rapid point-of-care (POC) nucleic acid tests (NAT) and provider and patient perspectives on its use in the US.

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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:
	90 FR 1501	01/08/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 59831	12/22/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Acceptability Survey	0920-25-0177	Acceptability Survey
Follow Up Phone Call Survey	0920-25-0177	Follow Up Phone Call Survey
Gay City Data Collection	0920-25-0177	Gay City Data Collection
HIV-negative Patients Seeking HIV Testing - Study Visit Survey	0920-1357, 0920-1357	Study Visit Survey (SCREENSHOTS) ,   GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
Madison Clinic Data Collection	0920-25-0177	Madison Clinic Data Collection
Participant Focus Group and Interview Guide	0920-25-0177	Participant Focus Group and Interview Guide
Provider Interview Guide	0920-25-0177	Provider Interview Guide
RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	0920-1357	Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	0920-1357, 0920-1357	Study Visit Survey (SCREENSHOTS) ,   GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
Release of Information	0920-25-0177	Release of Information
Screen and Link	0920-25-0177	Screen and Link
Study Visit Survey	0920-25-0177	Study Visit Survey

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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	423	0	0	423	-474	474
Annual Time Burden (Hours)	49	0	0	49	-101	101
Annual Cost Burden (Dollars)	0	0	0	0	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 reinstatment of a collection that expried on 12/21/2024 seeking three years of approval.

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Annual Cost to Federal Government: $346,459

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.     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

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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: 01/13/2026

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