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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 202411-0920-009 · OMB 0920-1357 · Received in OIRA

Forms and Documents
DocumentTypeStatusAvailability
Form 0920-1357 Acceptability/Feasibility Assessment Among Clinical and Community Providers Form and Instruction Unchanged Repair queued
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey Form and Instruction Unchanged Repair queued
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form Form and Instruction Unchanged Repair queued
Form 0920-1357 POC NAT Acceptability Survey Form and Instruction 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 RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form Form and Instruction Unchanged Repair queued
Form 0920-1357 HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form Unchanged Repair queued
Form 0920-1357 HIV-negative Patients Seeking HIV Testing - ROI Form Form and Instruction Unchanged Repair queued
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 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 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
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 Missing upstream
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 Repair queued
Nonsubstantiative change request justification_GAIN_0920-1357.docx Justification for No Material/Nonsubstantive Change Uploaded 2022-09-13 Missing upstream
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 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 Missing upstream
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 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 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 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 1_Auth Legislation.docx Supplementary Document Uploaded 2021-06-16 Repair queued
SSA_GAIN_CLEAN 110223.docx Supporting Statement A Uploaded 2023-11-02 Repair queued
IC Document Collections
IC IDCollectionTypeStatusForm
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
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
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
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
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
247946 Monthly Study Report Form Form and Instruction Unchanged
247945 Baseline Data Collection Instruction Unchanged
ICR Details
0920-1357 202411-0920-009
Received in OIRA 202311-0920-002
HHS/CDC 0920-1357-24IZ
[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 11/19/2024
  Requested Previously Approved
12/31/2024 12/31/2024
3,516 3,516
880 809
6,037 6,037
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 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
Yes
Miscellaneous Actions
No
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
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.
11/19/2024