[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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-1357 Participant Focus Group/Interview Guide Gay City and Madison Clinic Testing, PEP & PrEP (participants testing negative only)	Form and Instruction	Unchanged	Available
Form 0920-1357 Acceptability/Feasibility Assessment Among Clinical and Community Providers	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022	Form and Instruction	Unchanged	Available
Study Visit Survey	Form and Instruction	Unchanged	Repair queued
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Unchanged	Repair queued
Release of Information Form	Form and Instruction	Unchanged	Available
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 NAT Acceptability Survey (SCREENSHOTS)	Form and Instruction	Unchanged	Available
Form 0920-1357 POC NAT Acceptability Survey	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)	Form and Instruction	Unchanged	Available
Form 0920-1357 Study Visit Survey (SCREENSHOTS)	Form	Unchanged	Repair queued
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form	Unchanged	Repair queued
Form 0920-1357 Patient Authorization to Disclose, Release and/or Obtain Protected Health Information	Form and Instruction	Unchanged	Available
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)	Form	Unchanged	Available
Form 0920-1357 Study Visit Survey (SCREENSHOTS)	Form	Unchanged	Available
Form 0920-1357 HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form	Unchanged	Repair queued
Form 0920-1357 Patient Authorization to Disclose, Release and/or Obtain Protected Health Information	Form and Instruction	Unchanged	Available
Form 0920-1357 HIV-negative Patients Seeking HIV Testing - ROI Form	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022	Form and Instruction	Modified	Available
Form 0920-1357 Study Visit Survey	Form and Instruction	Modified	Available
Form 0920-1357 HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified	Repair queued
Form 0920-1357 Patient Authorization to Disclose, Release and/or Obtain Protected Health Information	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	Form and Instruction	Unchanged	Repair queued
Monthly Study Report Form	Form and Instruction	Unchanged	Available
Monthly Study Report Form	Form and Instruction	Unchanged	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	Available
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	Available
Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2024-11-17	Repair queued
Att 2_Estimate of Annualized Burden Hours.docx	Supplementary Document	Uploaded 2023-11-02	Available
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	Available
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	Available
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	Repair queued
Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx	Supplementary Document	Uploaded 2022-09-09	Repair queued
SSB_GAIN_060921.docx	Supporting Statement B	Uploaded 2021-06-17	Available
SSB_GAIN_060921.docx	Supporting Statement B	Uploaded 2021-06-17	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	Available
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	Available
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	Available
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	Available
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	Available
Att 3_GAIN study activities and visual overview.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	Available
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	Available
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2021-06-16	Repair queued
SSA_GAIN_CLEAN 110223.docx	Supporting Statement A	Uploaded 2023-11-02	Available
SSA_GAIN_CLEAN 110223.docx	Supporting Statement A	Uploaded 2023-11-02	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
247958	Acceptability/Feasibility Assessment Among Clinical and Community Providers	Form and Instruction	Unchanged	Participant Focus Group/Interview Guide Gay City and Madison Clinic Testing, PEP & PrEP (participants testing negative only)
247958	Acceptability/Feasibility Assessment Among Clinical and Community Providers	Form and Instruction	Unchanged
247957	Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Unchanged	GAIN Study Visit Survey - Revised 09SEP2022
247957	Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Unchanged	Study Visit Survey
247957	Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Unchanged
247955	Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	Form and Instruction	Unchanged	Release of Information Form
247955	Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	Form and Instruction	Unchanged
247954	POC NAT Acceptability Survey	Form and Instruction	Unchanged	NAT Acceptability Survey (SCREENSHOTS)
247954	POC NAT Acceptability Survey	Form and Instruction	Unchanged
247953	RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form and Instruction	Unchanged	GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
247953	RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form	Unchanged	Study Visit Survey (SCREENSHOTS)
247953	RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form	Unchanged
247952	RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	Form and Instruction	Unchanged	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	Unchanged
247950	HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form	Unchanged	GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
247950	HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form	Unchanged	Study Visit Survey (SCREENSHOTS)
247950	HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form	Unchanged
247949	HIV-negative Patients Seeking HIV Testing - ROI Form	Form and Instruction	Unchanged	Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
247949	HIV-negative Patients Seeking HIV Testing - ROI Form	Form and Instruction	Unchanged
247948	HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified	GAIN Study Visit Survey - Revised 09SEP2022
247948	HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified	Study Visit Survey
247948	HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified
247947	HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	Form and Instruction	Unchanged	Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
247947	HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	Form and Instruction	Unchanged
247946	Monthly Study Report Form	Form and Instruction	Unchanged	Monthly Study Report Form
247946	Monthly Study Report Form	Form and Instruction	Unchanged
247945	Baseline Data Collection	Instruction	Unchanged

ICR Details

OMB Control No: 0920-1357	ICR Reference No: 202411-0920-009
Status: Historical Active	Previous ICR Reference No: 202311-0920-002
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1357-24IZ
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: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 11/20/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/19/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2024	12/31/2024	12/31/2024
Responses	3,516	0	3,516
Time Burden (Hours)	880	0	809
Cost Burden (Dollars)	6,037	0	6,037

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Abstract: CDC is re-prioritizing the aims/components of the project and adjusting the enrollment totals for the different aims accordingly. This change is made in response to changing priorities in the field of point-of-care nucleic acid (POC NAT) testing for HIV, and in light of study progress and the remaining study timeline.

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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:
	85 FR 83087	12/21/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 33294	06/24/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

table that charts list of burden

IC Title	Form No.	Form Name
HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	0920-1357, 0920-1357	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Acceptability/Feasibility Assessment Among Clinical and Community Providers	0920-1357	Participant Focus Group/Interview Guide Gay City and Madison Clinic Testing, PEP & PrEP (participants testing negative only)
Baseline Data Collection
HIV-negative Patients Seeking HIV Testing - ROI Form	0920-1357	Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
HIV-negative Patients Seeking HIV Testing - Study Visit Survey	0920-1357, 0920-1357	Study Visit Survey (SCREENSHOTS) ,   GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)
HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	0920-1357	Patient Authorization to Disclose, Release and/or Obtain Protected Health Information
Monthly Study Report Form	n/a	Monthly Study Report Form
POC NAT Acceptability Survey	0920-1357	NAT Acceptability Survey (SCREENSHOTS)
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	n/a	Release of Information Form
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
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)

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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	3,516	3,516	0	0	0	0
Annual Time Burden (Hours)	880	809	0	71	0	0
Annual Cost Burden (Dollars)	6,037	6,037	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: CDC is re-prioritizing the aims/components of the project and adjusting the enrollment totals for the different aims accordingly. This change is made in response to changing priorities in the field of point-of-care nucleic acid (POC NAT) testing for HIV, and in light of study progress and the remaining study timeline.

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Annual Cost to Federal Government: $1,346,479

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: 11/19/2024

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