ICR Documents

Document Date Uploaded
SSA_GAIN.docx 12/22/2025

Document Date Uploaded
SSB_GAIN.docx 12/22/2025

Title Document Document Type Date Uploaded
Authorizing Legislation Att 1_Auth Legislation.docx Supplementary Document 06/16/2021
60-day Federal Register Notice Att 2_60-Day FRN Published 12-21-2020.pdf Supplementary Document 06/16/2021
GAIN Study Activities and Visul Overview Att 3_GAIN study activities and visual overview.pdf Supplementary Document 06/16/2021
GAIN Data Sources and Variables Att 4_GAIN data sources and variables.docx Supplementary Document 06/16/2021
IRB Approval Letter Att 6_GAIN IRB approval letter.pdf Supplementary Document 06/16/2021
Privacy Impact Assessment Att 7_Privacy impact assessment (PIA).pdf Supplementary Document 06/16/2021
Consent Form: Testing, PEP, and PrEP Group Att 8_Consent form GAIN study_Testing PEP PrEP Group.pdf Supplementary Document 06/16/2021
Consent Form: Gay City HIV+ Group Att 9_Consent form GAIN study_Gay City HIV+ Group.pdf Supplementary Document 06/16/2021
Consent Form: Randomized Controlled Trial Group Att 10_Consent Form_RCT Group.pdf Supplementary Document 06/16/2021
Consent form GAIN study_Testing PEP PrEP Group 09SEP2022 Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx Supplementary Document 09/09/2022
Consent form GAIN study_HIV+ Group 09SEP2022 Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docx Supplementary Document 09/09/2022
Information Sheet - University of Washington Att 16_GAIN patient information sheet_changes accepted_082922.docx Supplementary Document 09/13/2022
Summary of Changes Att 1_Summary of Proposed Changes.docx Supplementary Document 11/02/2023
Summary of Burden Hours Att 2_Estimate of Annualized Burden Hours.docx Supplementary Document 11/02/2023
Consent Form GAIN Consent Form_clean.docx Supplementary Document 11/17/2024
Burden Table Burden Table_Gain 0920-1357.docx Supplementary Document 11/17/2024
30 Day FRN 30 Day FRN GAIN.docx Supplementary Document 12/22/2025
Authorizing Legislation Att 1 Auth Legislation.docx Supplementary Document 12/22/2025
IRB Att 6a UW IRB Approval Initial.pdf Supplementary Document 12/22/2025
IRB Continued Att 6b UW IRB Approval Continuing.pdf Supplementary Document 12/22/2025
Consent Att 5 Consent Form.docx Supplementary Document 01/13/2026
GAIN Study - Change Request Memo 13SEP2022 Nonsubstantiative change request justification_GAIN_0920-1357.docx Justification for No Material/Nonsubstantive Change 09/13/2022
Change Request Justification Justification for Nonmaterial Non-substantive Change _rev 110223.docx Justification for No Material/Nonsubstantive Change 11/02/2023
Change Request Justification Memo for Nonsubstantive Change Request_0920-1357_GAIN.docx Justification for No Material/Nonsubstantive Change 11/17/2024

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