Att 5c_MOU Emory and partners

Addressed to: Centers for Disease Control and Prevention

Date: December 12, 2018

Page: 3

Memorandum of Understanding

Between

Emory University, Rollins School of Public Health

and

University of North Carolina – Chapel Hill, School of Medicine

and

University of Michigan, School of Nursing

Regarding

Sharing of the iSTAMP Dataset

Implementation of Rapid HIV Self-Testing among MSM Project

This Memorandum of Understanding (MOU) sets forth the terms and understanding between Emory University's Rollins School of Public Health (hereinafter referred to as Emory University), the University of North Carolina – Chapel Hill’s School of Medicine (hereinafter referred to as University of North Carolina), and the University of Michigan’s School of Nursing (hereinafter referred to as University of Michigan) for the release of participant data from the Implementation of Rapid HIV Self-Testing among MSM Project (iSTAMP).

Background

The Implementation of Rapid HIV Self-Testing among MSM Project (iSTAMP) is a longitudinal, implementation science study of an intervention consisting of mailing out rapid HIV self-testing kits to men who have sex with men (MSM) in the United States and providing those participants access to HIV video prevention counseling through Zoom and to one of two HIV prevention technologies, the HealthMindr mobile application or the healthMpowerment mobile-optimized website. Full access to the data from iSTAMP will allow the University of North Carolina and University of Michigan to conduct their respective aspects of this study among MSM in the United States.

Purpose

The purpose of this MOU is to describe the parties' responsibilities for receipt of participant data, including personally identifiable information (PII¹), for iSTAMP. iSTAMP data provided to the University of Michigan is restricted to study staff responsible for overseeing aspects of the study related to participant use of Zoom HIV video prevention counseling. iSTAMP data provided to the University of North Carolina is restricted to study staff responsible for overseeing aspects of the study related to participant use of the healthMpowerment intervention.

Data Use Agreement

1. iSTAMP data provided through this MOU are only for use in conducting study-related activities (oversight of healthMpowerment website use by participants and use of Zoom HIV video prevention counseling. Use of iSTAMP data for other analyses or projects are prohibited without signed revision to this MOU.

2. Emory University will provide participant data from iSTAMP for MSM who consented to participate by granting tiered access to the SMART database.

3. The University of Michigan and the University of North Carolina will use the iSTAMP data in compliance with their own institutional review board approvals. Emory University is released of any liability due to the University of Michigan and/or University of North Carolina's use and dissemination of the iSTAMP data.

4. The University of Michigan will restrict use of iSTAMP data to IRB-approved study staff related to participant use of Zoom HIV video prevention counseling. The University of North Carolina will restrict use of iSTAMP data to IRB-approved study staff related to participant use of the healthMpowerment intervention.

5. The University of Michigan and the University of North Carolina will maintain iSTAMP data securely on network drives with access control limited to study staff approved by the IRB. Data should not be stored on laptops or personal computers unless they are encrypted and password-protected.

6. Emory University retains the right to conduct analyses of and disseminate all iSTAMP data.

Funding

This MOU is not a commitment of funds. The data will be provided to the University of Michigan and the University of North Carolina free of charge and may be used solely for the purpose of conducting study-related activities. The agreement to share data will not confer additional funds beyond what have already been committed for study-related activities.

Duration

This MOU shall become effective upon signature by the authorized officials from Emory University and the University of Michigan and the University of North Carolina and will remain in effect until terminated or modified. This MOU may be terminated at any time by either party. This MOU may be modified at any time by mutual consent of Emory University and the University of Michigan and the University of North Carolina.

Authorized Officials

Dr. Patrick Sullivan

Principal Investigator, iSTAMP

Professor, Department of Epidemiology

Emory University

1518 Clifton Rd

Atlanta, GA 30322

404-727-8403

[email protected]

Rob Stephenson

Site Investigator, iSTAMP

Department Chair, Department of Systems, Populations and Leadership

University of Michigan School of Nursing

400 North Ingalls Building, Room 4170A

734-763-1188

[email protected]

Lisa Hightow-Weidman

Site Investigator, iSTAMP

Associate Professor, Division of Infectious Diseases

University of North Carolina School of Medicine

130 Mason Farm Road, CB#7030, Bioinformatics Building

919-843-0033

[email protected]

Date:______________

Patrick Sullivan

(iSTAMP Principal Investigator, Emory University)

Date:______________

Rob Stephenson

(iSTAMP Site Investigator, University of Michigan)

Date:______________

Lisa Hightow-Weidman

(iSTAMP Site Investigator, University of North Carolina)

1 PII refers to the name, phone number, e-mail address, and/or physical address associated with a study participant.

Emory University Tel 404.727.8710

1518 Clifton Road NE Fax 404.727.8737

Atlanta, GA 30322 USA