[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 202311-0920-002

OMB: 0920-1357

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Unchanged
Form and Instruction
Unchanged
Form and Instruction
Modified
Form
Modified
Form and Instruction
Modified
Form
Modified
Form and Instruction
Modified
Form and Instruction
Modified
Form and Instruction
Modified
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Supplementary Document
2023-11-02
Supplementary Document
2023-11-02
Justification for No Material/Nonsubstantive Change
2023-11-02
Justification for No Material/Nonsubstantive Change
2022-09-13
Supplementary Document
2022-09-13
Supplementary Document
2022-09-09
Supplementary Document
2022-09-09
Supporting Statement B
2021-06-17
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supplementary Document
2021-06-16
Supporting Statement A
2023-11-02
ICR Details
0920-1357 202311-0920-002
Received in OIRA 202209-0920-005
HHS/CDC 0920-1357-24AQ
[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)
No material or nonsubstantive change to a currently approved collection   No
Regular 11/02/2023
  Requested Previously Approved
12/31/2024 12/31/2024
3,516 4,898
809 1,067
6,037 20,848

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.

US Code: 42 USC 241 Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  85 FR 83087 12/21/2020
86 FR 33294 06/24/2021
Yes

12
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 n/a, 0920-1357 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)

  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 3,516 4,898 0 -1,382 0 0
Annual Time Burden (Hours) 809 1,067 0 -258 0 0
Annual Cost Burden (Dollars) 6,037 20,848 0 -14,811 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
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.

$1,346,479
Yes Part B of Supporting Statement
    No
    No
No
No
No
No
Thelma Sims 4046394771

  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.
11/02/2023


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