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 2.0  30 Sep 2009
  • Section 10: Reporting Plan
  • 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

Clarification Memos

• Clarification Memo #1 30 Jul 2010

Letters of Amendment

• LOA #1 22 Sep 2009
• LOA #2 8 Jan 2010
• LOA #3 1 Apr 2010

HPTN 061 Presentations

• Darrell Wheeler's Presentation at NARSM Conference 2009