[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	Type	Status	Availability
Form 0920-25-0177 Acceptability Survey	Form	Modified	Repair queued
Form 0920-25-0177 Acceptability Survey	Form	Modified	Repair queued
Form 0920-25-0177 Study Visit Survey	Form	Modified	Repair queued
Form 0920-25-0177 Study Visit Survey	Form	Modified	Repair queued
Form 0920-25-0177 Participant Focus Group and Interview Guide	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Participant Focus Group and Interview Guide	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Follow Up Phone Call Survey	Form	Modified	Repair queued
Form 0920-25-0177 Follow Up Phone Call Survey	Form	Modified	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)	Form and Instruction	Removed	Repair queued
Form 0920-1357 Study Visit Survey (SCREENSHOTS)	Form	Removed	Available
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form	Removed	Repair queued
Form 0920-1357 Patient Authorization to Disclose, Release and/or Obtain Protected Health Information	Form and Instruction	Removed	Repair queued
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	Form and Instruction	Removed	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)	Form	Removed	Repair queued
Form 0920-1357 Study Visit Survey (SCREENSHOTS)	Form	Removed	Repair queued
Form 0920-1357 HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form	Removed	Repair queued
Form 0920-25-0177 Gay City Data Collection	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Gay City Data Collection	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Provider Interview Guide	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Provider Interview Guide	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Madison Clinic Data Collection	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Madison Clinic Data Collection	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Release of Information	Form	Modified	Repair queued
Form 0920-25-0177 Release of Information	Form	Modified	Repair queued
Form 0920-25-0177 Screen and Link	Form and Instruction	Modified	Repair queued
Form 0920-25-0177 Screen and Link	Form and Instruction	Modified	Repair queued
Att 5 Consent Form.docx	Supplementary Document	Uploaded 2026-01-13	Repair queued
Att 5 Consent Form.docx	Supplementary Document	Uploaded 2026-01-13	Repair queued
Att 6b UW IRB Approval Continuing.pdf	Supplementary Document	Uploaded 2025-12-22	Repair queued
Att 6b UW IRB Approval Continuing.pdf	Supplementary Document	Uploaded 2025-12-22	Repair queued
Att 6a UW IRB Approval Initial.pdf	Supplementary Document	Uploaded 2025-12-22	Repair queued
Att 6a UW IRB Approval Initial.pdf	Supplementary Document	Uploaded 2025-12-22	Repair queued
Att 1 Auth Legislation.docx	Supplementary Document	Uploaded 2025-12-22	Repair queued
Att 1 Auth Legislation.docx	Supplementary Document	Uploaded 2025-12-22	Repair queued
30 Day FRN GAIN.docx	Supplementary Document	Uploaded 2025-12-22	Repair queued
30 Day FRN GAIN.docx	Supplementary Document	Uploaded 2025-12-22	Repair queued
Burden Table_Gain 0920-1357.docx	Supplementary Document	Uploaded 2024-11-17	Repair queued
Burden Table_Gain 0920-1357.docx	Supplementary Document	Uploaded 2024-11-17	Repair queued
GAIN Consent Form_clean.docx	Supplementary Document	Uploaded 2024-11-17	Repair queued
GAIN Consent Form_clean.docx	Supplementary Document	Uploaded 2024-11-17	Repair queued
Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-11-17	Repair queued
Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-11-17	Missing upstream
Att 2_Estimate of Annualized Burden Hours.docx	Supplementary Document	Uploaded 2023-11-02	Repair queued
Att 2_Estimate of Annualized Burden Hours.docx	Supplementary Document	Uploaded 2023-11-02	Repair queued
Att 1_Summary of Proposed Changes.docx	Supplementary Document	Uploaded 2023-11-02	Repair queued
Att 1_Summary of Proposed Changes.docx	Supplementary Document	Uploaded 2023-11-02	Repair queued
Justification for Nonmaterial Non-substantive Change _rev 110223.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-11-02	Available
Justification for Nonmaterial Non-substantive Change _rev 110223.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2023-11-02	Repair queued
Nonsubstantiative change request justification_GAIN_0920-1357.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-09-13	Repair queued
Nonsubstantiative change request justification_GAIN_0920-1357.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-09-13	Repair queued
Att 16_GAIN patient information sheet_changes accepted_082922.docx	Supplementary Document	Uploaded 2022-09-13	Repair queued
Att 16_GAIN patient information sheet_changes accepted_082922.docx	Supplementary Document	Uploaded 2022-09-13	Repair queued
Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docx	Supplementary Document	Uploaded 2022-09-09	Repair queued
Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docx	Supplementary Document	Uploaded 2022-09-09	Repair queued
Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx	Supplementary Document	Uploaded 2022-09-09	Available
Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx	Supplementary Document	Uploaded 2022-09-09	Repair queued
SSB_GAIN.docx	Supporting Statement B	Uploaded 2025-12-22	Repair queued
SSB_GAIN.docx	Supporting Statement B	Uploaded 2025-12-22	Repair queued
Att 10_Consent Form_RCT Group.pdf	Supplementary Document	Uploaded 2021-06-16	Available
Att 10_Consent Form_RCT Group.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 9_Consent form GAIN study_Gay City HIV+ Group.pdf	Supplementary Document	Uploaded 2021-06-16	Available
Att 9_Consent form GAIN study_Gay City HIV+ Group.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 8_Consent form GAIN study_Testing PEP PrEP Group.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 8_Consent form GAIN study_Testing PEP PrEP Group.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 7_Privacy impact assessment (PIA).pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 7_Privacy impact assessment (PIA).pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 6_GAIN IRB approval letter.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 6_GAIN IRB approval letter.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 4_GAIN data sources and variables.docx	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 4_GAIN data sources and variables.docx	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 3_GAIN study activities and visual overview.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 3_GAIN study activities and visual overview.pdf	Supplementary Document	Uploaded 2021-06-16	Missing upstream
Att 2_60-Day FRN Published 12-21-2020.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 2_60-Day FRN Published 12-21-2020.pdf	Supplementary Document	Uploaded 2021-06-16	Missing upstream
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2021-06-16	Repair queued
SSA_GAIN.docx	Supporting Statement A	Uploaded 2025-12-22	Repair queued
SSA_GAIN.docx	Supporting Statement A	Uploaded 2025-12-22	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
247958	Acceptability Survey	Form	Modified	Acceptability Survey
247958	Acceptability Survey	Form	Modified
247957	Study Visit Survey	Form	Modified	Study Visit Survey
247957	Study Visit Survey	Form	Modified
247955	Participant Focus Group and Interview Guide	Form and Instruction	Modified	Participant Focus Group and Interview Guide
247955	Participant Focus Group and Interview Guide	Form and Instruction	Modified
247954	Follow Up Phone Call Survey	Form	Modified	Follow Up Phone Call Survey
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 and Instruction	Removed	GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
247953	RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form	Removed	Study Visit Survey (SCREENSHOTS)
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	Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
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	GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
247950	HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form	Removed	Study Visit Survey (SCREENSHOTS)
247950	HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form	Removed
247949	Gay City Data Collection	Form and Instruction	Modified	Gay City Data Collection
247949	Gay City Data Collection	Form and Instruction	Modified
247948	Provider Interview Guide	Form and Instruction	Modified	Provider Interview Guide
247948	Provider Interview Guide	Form and Instruction	Modified
247947	Madison Clinic Data Collection	Form and Instruction	Modified	Madison Clinic Data Collection
247947	Madison Clinic Data Collection	Form and Instruction	Modified
247946	Release of Information	Form	Modified	Release of Information
247946	Release of Information	Form	Modified
247945	Screen and Link	Form and Instruction	Modified	Screen and Link
247945	Screen and Link	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1357	ICR Reference No: 202512-0920-007
Status: Active	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
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/19/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/13/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2029	36 Months From Approved
Responses	423	0	0
Time Burden (Hours)	49	0	0
Cost Burden (Dollars)	0	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 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	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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