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
Acceptability/Feasibility Assessment Among Clinical and Community Providers Form and Instruction	Unchanged
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey Form and Instruction	Modified
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form Form and Instruction	Unchanged
Participants in POC NAT Acceptability Survey Form and Instruction	Unchanged
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form and Instruction	Modified
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form Form and Instruction	Unchanged
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form and Instruction	Modified
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form Form and Instruction	Unchanged
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey Form and Instruction	Modified
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form Form and Instruction	Unchanged
Monthly Study Report Form Form and Instruction	Unchanged
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_060921.docx Supporting Statement B	2021-06-17
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_changes accepted_082922.docx Supporting Statement A	2022-09-13

IC Document Collections

IC ID	Document Title	Status
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	Modified
247955	Participants in Cross-sectional Comparison of Several POC NATs - ROI Form Form and Instruction	Unchanged
247954	Participants in POC NAT Acceptability Survey Form and Instruction	Unchanged
247953	Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form and Instruction	Modified
247952	Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form Form and Instruction	Unchanged
247950	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form and Instruction	Modified
247949	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form Form and Instruction	Unchanged
247948	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey Form and Instruction	Modified
247947	Participants in Prospective Study of 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
247945	Baseline Data Collection Instruction	Unchanged

ICR Details

OMB Control No: 0920-1357	ICR Reference No: 202209-0920-005
Status: Received in OIRA	Previous ICR Reference No: 202103-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1357-22IR
Title: 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	Date Submitted to OIRA: 09/13/2022

	Requested	Previously Approved
Expiration Date	12/31/2024	12/31/2024
Responses	4,898	4,898
Time Burden (Hours)	1,067	1,067
Cost Burden (Dollars)	20,848	20,848

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Abstract: GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing. These data will describe the real-world performance and clinical effects of HIV RNA POC NAT testing. CDC will not receive any personally-identifiable information. This Non-Substantive Change Request is submitted to modify the incentives provided to study groups and to improve study implementation logistics. The original plan offered varying incentives by study group which presents operational challenges. The change provides a consistent incentive plan across the primary study groups and also modifies language in consent forms. There is no change to the approved burden hours.

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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

IC Title	Form No.	Form Name
Acceptability/Feasibility Assessment Among Clinical and Community Providers	n/a	Participant Focus Group / Interview Guide
Baseline Data Collection
Monthly Study Report Form	n/a	Monthly Study Report Form
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
Participants in POC NAT Acceptability Survey	n/a	NAT Acceptability Survey
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form	n/a	Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	n/a	Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	n/a	Release of Information Form
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022

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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	4,898	4,898	0	0	0	0
Annual Time Burden (Hours)	1,067	1,067	0	0	0	0
Annual Cost Burden (Dollars)	20,848	20,848	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:

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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: 09/13/2022

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