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 · 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 can be found here.

Latest Forms, Documents, and Supporting Material

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

All Historical Document Collections

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

OMB Details

Screen and Link

Federal Enterprise Architecture: Health - Health Care Services

Form 0920-25-0177

Screen and Link

Fillable Fileable

Form and instruction

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