IRB Approval

https://eresearch.emory.edu/Emory/Doc/0/4FJEFPV5QMMKVBO4BPU...

TO:

AD McNaghten, Ph.D
Principal Investigator
Epidemiology

DATE: April 18, 2013
RE:

Notification of Amendment Approval
AM3_IRB00057255
IRB00057255
Evaluation of Rapid HIV Self-Testing among MSM in High Prevalence Cities

Thank you for submitting an amendment request. The Emory IRB reviewed and approved this
amendment under the expedited review process on 4/19/2013. This amendment includes the
following:
Changes to Consent Forms:
Added: Part 4 In-Depth Interview Consent Form 03.28.2013
Added: Part 4 Participant Self-Test Referral Sheet 03.28.2013
Added: Part 4 Study Consent Form 03.28.2013
Added: Part 4 Messages for Different Self-Reported Test Results_03.28.2013
Added: Part 4 Focus Group Consent Form 03.28.2013
Added: Part 4 Basic Study Information 03.28.2013
Changes to Protocol Documents:
Added: eSTAMP Part 4 Lay Summary 3.28.2013
Added: eSTAMP Part 4 Protocol 3.27.2013
Added: Part 4 Eligibility Screener 03.28.2013
Added: Part 4 Follow Up Survey 03.28.2013
Added: Part 4 In-Depth Interview Guides 03.28.2013
Added: Part 4 Reporting of Self-Test Results 03.28.2013
Added: Part 4 Registration 03.28.2013
Added: Part 4 Focus Group Discussion Guides 03.28.2013
Added: Part 4 Baseline Survey 03.28.2013
Changes to Study Team:
Added: Laura Graves and Colleen Kelley
Changes to study enrollment
Added Part 4 which increases subjects total to 4495

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https://eresearch.emory.edu/Emory/Doc/0/4FJEFPV5QMMKVBO4BPU...

Important note: If this study is NIH-supported, you may need to obtain NIH prior approval for
the change(s) contained in this amendment before implementation. Please review the NIH policy
directives found at the following links and contact your NIH Program Officer, NIH Grants
Management Officer, or the Emory Office of Sponsored Programs if you have questions.
Policy on changes in active awards: http://grants.nih.gov/grants/guide/notice-files/NOTOD-12-129.html
Policy on delayed onset awards: http://grants.nih.gov/grants/guide/notice-files/NOTOD-12-130.html
In future correspondence with the IRB about this study, please include the IRB file ID, the name
of the Principal Investigator and the study title. Thank you.
Sincerely,
Aric Edwards
Research Protocol Analyst
This letter has been digitally signed

CC:

Gravens
Ricca
Sharma
Stephenson
Sullivan

Laura
Alexandra
Akshay
Robert
Patrick

Public Health
Public Health
Public Health
Global Health
Epidemiology

Emory University IRB
1599 Clifton Road, 5th Floor - Atlanta, Georgia 30322
Tel: 404.712.0720 - Fax: 404.727.1358 - Email: [email protected] - Web: http://www.irb.emory.edu/
An equal opportunity, affirmative action university

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