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Federal forms, ICRs, and supporting documents

Information Collection Request

[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)

ICR 202512-0920-007 · OMB 0920-1357 · Active

Forms and Documents
DocumentTypeStatusAvailability
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 Repair queued
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 IDCollectionTypeStatusForm
247958 Acceptability Survey Form ModifiedAcceptability Survey
247958 Acceptability Survey Form Modified
247957 Study Visit Survey Form ModifiedStudy Visit Survey
247957 Study Visit Survey Form Modified
247955 Participant Focus Group and Interview Guide Form and Instruction ModifiedParticipant Focus Group and Interview Guide
247955 Participant Focus Group and Interview Guide Form and Instruction Modified
247954 Follow Up Phone Call Survey Form ModifiedFollow 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 RemovedGAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
247953 RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form RemovedStudy 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 RemovedPatient 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 RemovedGAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
247950 HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form RemovedStudy Visit Survey (SCREENSHOTS)
247950 HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form Removed
247949 Gay City Data Collection Form and Instruction ModifiedGay City Data Collection
247949 Gay City Data Collection Form and Instruction Modified
247948 Provider Interview Guide Form and Instruction ModifiedProvider Interview Guide
247948 Provider Interview Guide Form and Instruction Modified
247947 Madison Clinic Data Collection Form and Instruction ModifiedMadison Clinic Data Collection
247947 Madison Clinic Data Collection Form and Instruction Modified
247946 Release of Information Form ModifiedRelease of Information
247946 Release of Information Form Modified
247945 Screen and Link Form and Instruction ModifiedScreen and Link
247945 Screen and Link Form and Instruction Modified
ICR Details
0920-1357 202512-0920-007
Active 202411-0920-009
HHS/CDC 0920-25-0177
[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)
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 02/19/2026
Retrieve Notice of Action (NOA) 01/13/2026
  Inventory as of this Action Requested Previously Approved
02/28/2029 36 Months From Approved
423 0 0
49 0 0
0 0 0
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.
US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None
Not associated with rulemaking
  90 FR 1501 01/08/2025
90 FR 59831 12/22/2025
No
  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
Yes
Miscellaneous Actions
No
This is a reinstatment of a collection that expried on 12/21/2024 seeking three years of approval.
$346,459
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Odion Clunis 770 488-0045 [email protected]
  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/13/2026