Study Documents

The HPTN 059 study team has made the following study documents available.  New documents will be posted here as they become available.

HPTN 059 Protocol

• HPTN 059 v 2.0 (PDF)
• Summary of Changes (PDF)
• HPTN 059 v 1.0 (PDF)

HPTN 059 Letters of Amendment

• Not applicable

HPTN 059 Clarification Memos

• Clarification Memorandum #4, 18 June 2007 (PDF)
• Clarification Memorandum #3, 16 May 2007 (PDF)
• Clarification Memorandum # 2, 22 September 2006 (PDF)
• Clarification Memorandum # 1, 03 August 2006 (PDF)
  • Memo Correction Notice, 03 August 2006 (PDF)

Study-Specific Procedures Manual
All SSP sections are PDF files.

• Overview and Version Control (11 Oct 2006)
• Section 1: Introduction (01 Jun 2006)
• Section 2: Protocol (01 Jun 2006)
• Section 3: Documentation Requirements (01 Jun 2006)
• Section 4: Participant Accrual (01 Jun 2006)
• Section 5: Informed Consent (01 Jun 2006)
• Section 6: Participant Follow-up (01 Jun 2006)
• Section 7: Visit Checklists (01 Jun 2006)
• Section 8: Participant Retention (01 Jun 2006)
• Section 9: Study Gel Considerations for Non-Pharmacy Staff (01 Jun 2006)
• Section 10: Clinical Considerations (30 Aug 2006)
• Section 11: Adverse Event Reporting and Safety Monitoring (22 Jun 2006)
• Section 12: Laboratory Considerations (09 Oct 2006)
• Section 13: Data Collection (27 Jun 2006)
• Section 14: Data Communiques (28 Jun 2006)
• Section 15: Study Reporting Plan (28 Jun 2006)
• Appendix IV: Sample Informed Consent Forms (13 Mar 2006)

Study Implementation Materials
All documents are MS Word files unless otherwise noted.

• Checklists
  • Screening
  • Screening Pelvic Exam
  • Final Screening/Enrollment
  • Enrollment
  • Final Screening/Enrollment Pelvic Exam
  • Week 4 Follow-Up Visit
  • Week 8 Follow-Up Visit
  • Week 12 Follow-Up Visit
  • Week 4 or 12 Pelvic Exam
  • Week 16 Follow-Up Visit
  • Week 20 Follow-Up Visit
  • Week 24/Early Termination Visit - non-CHBV participants
  • Week 24/Early Termination Visit - CHBV participants
  • Week 24/Early Termination Pelvic Exam
  • Week 28 or 32 Follow-Up Visit - CHBV participants
  • Week 36 Follow-Up Visit - CHBV participants
  • Interim Follow-Up Visit
  • Final Contact
• Protocol Safety Review Team Query Form

HPTN 059 Resources

• Lab Value Converter - Use this link to access the Lab Value Converter located on the Frontier Science website.
• Protocol Safety Review Team Query Form
• Alternate Condoms and Use of Vaginal Lubricants Memo