OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

[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)

OMB 0920-1357 ยท HHS/CDC.

OMB 0920-1357

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.

The latest form for [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) expires 2029-02-28 and is listed under ICR 202512-0920-007.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form 0920-25-0177 Acceptability SurveyForm
Form 0920-25-0177 Acceptability SurveyForm
Form 0920-25-0177 Study Visit SurveyForm
Form 0920-25-0177 Study Visit SurveyForm
Form 0920-25-0177 Participant Focus Group and Interview GuideForm and Instruction
Form 0920-25-0177 Participant Focus Group and Interview GuideForm and Instruction
Form 0920-25-0177 Follow Up Phone Call SurveyForm
Form 0920-25-0177 Follow Up Phone Call SurveyForm
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)Form and Instruction
Form 0920-1357 Study Visit Survey (SCREENSHOTS)Form
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit FormForm
Form 0920-1357 Patient Authorization to Disclose, Release and/or Obtain Protected Health InformationForm and Instruction
Form 0920-1357 RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI FormForm and Instruction
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022 (SCREENSHOTS)Form
Form 0920-1357 Study Visit Survey (SCREENSHOTS)Form
Form 0920-1357 HIV-negative Patients Seeking HIV Testing - Study Visit SurveyForm
Form 0920-25-0177 Gay City Data CollectionForm and Instruction
Form 0920-25-0177 Gay City Data CollectionForm and Instruction
Form 0920-25-0177 Provider Interview GuideForm and Instruction
Form 0920-25-0177 Provider Interview GuideForm and Instruction
Form 0920-25-0177 Madison Clinic Data CollectionForm and Instruction
Form 0920-25-0177 Madison Clinic Data CollectionForm and Instruction
Form 0920-25-0177 Release of InformationForm
Form 0920-25-0177 Release of InformationForm
Form 0920-25-0177 Screen and LinkForm and Instruction
Att 5 Consent Form.docxSupplementary Document
Att 6b UW IRB Approval Continuing.pdfSupplementary Document
Att 6a UW IRB Approval Initial.pdfSupplementary Document
Att 6a UW IRB Approval Initial.pdf Supplementary Document
Att 1 Auth Legislation.docxSupplementary Document
Att 1 Auth Legislation.docx Supplementary Document
30 Day FRN GAIN.docxSupplementary Document
Burden Table_Gain 0920-1357.docxSupplementary Document
Burden Table_Gain 0920-1357.docx Supplementary Document
GAIN Consent Form_clean.docxSupplementary Document
GAIN Consent Form_clean.docx Supplementary Document
Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docxJustification for No Material/Nonsubstantive Change
Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docx Justification for No Material/Nonsubstantive Change
Att 2_Estimate of Annualized Burden Hours.docxSupplementary Document
Att 2_Estimate of Annualized Burden Hours.docx Supplementary Document
Att 1_Summary of Proposed Changes.docxSupplementary Document
Att 1_Summary of Proposed Changes.docx Supplementary Document
Justification for Nonmaterial Non-substantive Change _rev 110223.docxJustification for No Material/Nonsubstantive Change
Justification for Nonmaterial Non-substantive Change _rev 110223.docx Justification for No Material/Nonsubstantive Change
Nonsubstantiative change request justification_GAIN_0920-1357.docxJustification for No Material/Nonsubstantive Change
Att 16_GAIN patient information sheet_changes accepted_082922.docxSupplementary Document
Att 16_GAIN patient information sheet_changes accepted_082922.docx Supplementary Document
Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docxSupplementary Document
Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docx Supplementary Document
Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docxSupplementary Document
Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx Supplementary Document
SSB_GAIN.docxSupporting Statement B
SSB_GAIN.docxSupporting Statement B
Att 10_Consent Form_RCT Group.pdfSupplementary Document
Att 10_Consent Form_RCT Group.pdf Supplementary Document
Att 9_Consent form GAIN study_Gay City HIV+ Group.pdfSupplementary Document
Att 9_Consent form GAIN study_Gay City HIV+ Group.pdf Supplementary Document
Att 8_Consent form GAIN study_Testing PEP PrEP Group.pdfSupplementary Document
Att 7_Privacy impact assessment (PIA).pdfSupplementary Document
Att 7_Privacy impact assessment (PIA).pdf Supplementary Document
Att 6_GAIN IRB approval letter.pdfSupplementary Document
Att 6_GAIN IRB approval letter.pdf Supplementary Document
Att 4_GAIN data sources and variables.docxSupplementary Document
Att 4_GAIN data sources and variables.docx Supplementary Document
Att 3_GAIN study activities and visual overview.pdfSupplementary Document
Att 3_GAIN study activities and visual overview.pdf Supplementary Document
Att 2_60-Day FRN Published 12-21-2020.pdfSupplementary Document
Att 1_Auth Legislation.docxSupplementary Document
Att 1_Auth Legislation.docx Supplementary Document
SSA_GAIN.docxSupporting Statement A
Acceptability Survey Form
Acceptability Survey Form
Study Visit Survey Form
Study Visit Survey Form
Participant Focus Group and Interview Guide Form and Instruction
Participant Focus Group and Interview Guide Form and Instruction
Follow Up Phone Call Survey Form
Follow Up Phone Call Survey Form
RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form and Instruction
RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form
RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form Form
RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form Form and Instruction
RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form Form and Instruction
HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form
HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form
HIV-negative Patients Seeking HIV Testing - Study Visit Survey Form
Gay City Data Collection Form and Instruction
Gay City Data Collection Form and Instruction
Provider Interview Guide Form and Instruction
Provider Interview Guide Form and Instruction
Madison Clinic Data Collection Form and Instruction
Madison Clinic Data Collection Form and Instruction
Release of Information Form
Release of Information Form
Screen and Link Form and Instruction
Screen and Link Form and Instruction

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202512-0920-007 Reinstatement without change of a previously approved collection 2026-01-13 Approved without change
202411-0920-009 No material or nonsubstantive change to a currently approved collection 2024-11-19 Approved without change
202311-0920-002 No material or nonsubstantive change to a currently approved collection 2023-11-02 Approved without change
202209-0920-005 No material or nonsubstantive change to a currently approved collection 2022-09-13 Approved without change
202103-0920-010 New collection (Request for a new OMB Control Number) 2021-06-24 Approved with change

OMB Details

Screen and Link

Federal Enterprise Architecture: Health - Health Care Services

Information collection instruments
FormNameElectronic accessType
Form 0920-25-0177Screen and LinkFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.