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Studies

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HPTN 061 Quick Links

HPTN 061 Protocol version 2.0

HPTN 061 Fact Sheet

Black Caucus Recommendations

HPTN061 SSP version 1.0

HPTN 061 Alias Lists

HPTN 061 Collaboration Portal

HPTN 061 Recruitment Site

HPTN 061

Feasibility of a community-level, multi-component intervention for Black MSM in preparation for a Phase IIB community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM

Study Documents

The HPTN 061 study team has made the following study documents available. New documents will be posted here as they become available.

HPTN 061 Protocol

HPTN 061 V 2.0 (PDF) (02-Apr-209)

HPTN 061 Study Specific Procedures Manual (SSP)
All SSP Sections are PDF files unless otherwise noted.

HPTN 061 SSP Manual (15 Jul 2009) Zip File
- Section 1: Introduction
- Section 2: Protocol Version 2.0 30 Sep 2009
- Section 3: Documentation Requirements Version 2.0 11 Oct 2009
- Section 4: Participant Accrual Version 3.0 07 Oct 2009
- Section 5: Participant Follow-up
- Section 6: Visit Checklists Version 2.0 30 Sep 2009
- Section 7: Participant Retention and Termination
- Section 8: Clinical and Counseling Procedures Version 2.0 11 Oct 2009
- Section 9: Data Management Version 6.0 07 Sep 2010
- Section 10: Reporting Plan Version 6.0 08 Sept 2010
- Section 11: Laboratory Procedures Version 2.0 09 Oct 2009
- Section 12: Omitted
- Section 13: Peer Health Navigation, Counseling, Qualitative Research
- Appendices TOC
  
  - Appendix A: GCP
  
  - Appendix B: Essential Documents
  - Sub Appendix B: Essential Documents
  - Appendix C: Source Documentation
  - Sub Appendix C: Source Documentation
  - Appendix D: Recruiter Talking Points
  
  - Appendix E: PHN Operations Manual and Appendices
  
  - Appendix F: Counseling Manual
  
  - Appendix G: Qualitative Manual

Notification of Change

Notification of Change SSP Section 9	28 Sep 2010
Notification of Change SSP Section 10	28 Sep 2010

Data Communiqués

08 Sep 2010	Data Communiqué 7
13 Aug 2010	Data Communiqué 6
01 Apr 2010	Data Communiqué 5
11 Mar 2010	Data Communiqué 4
10 Feb 2010	Data Communiqué 3
09 Oct 2010	Data Communiqué 2
09 Oct 2010	Data Communiqué 1

Clarification Memos

Clarification Memo #1 30 Jul 2010

Letters of Amendment

HPTN 061 Publications

061 Sound Bites

HPTN 061 Presentations

Darrell Wheeler's Presentation at NAESM Conference 2009

Black Caucus Recommendations, Presentations and Other Materials

Presentations from 2011 National HIV Prevention Conference in Atlanta, Georgia 14-17 Aug 2011
- Development of a Caucus
- Lessons Learned from a Black Caucus Retreat on Retention
Black Caucus Resource Troubleshooting (REST) Guide 2 Aug 2011
HPTN 061 Black Caucus Retention Recommendations 8 Mar 2011
HPTN 061 Black Caucus Retention Recommendations Appendix 8 Mar 2011

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