The HPTN 035 study team has made the following study documents available.  The authors of these documents retain copyright.  New documents will be posted here as they become available.

HPTN 035 Protocol

• HPTN 035 v 3.0 Protocol and successive documents (PDF)
• Summary of Changes v 2.0 - 3.0 (PDF)
• HPTN 035 v 2.0 Protocol and successive documents (PDF)
• Summary of Changes v 1.0 - v 2.0 (PDF)
• HPTN 035 v 1.0 Protocol (PDF)

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

• Overview and Version Control (18 Apr 2008)
• Section 1: Introduction (31 Jan 2007)
• Section 2: Protocol (31 Jan 2007)
• Section 3: Documentation Requirements (31 Jan 2007)
• Section 4: Participant Accrual (31 Jan 2007)
• Section 5: Informed Consent (31 Jan 2007)
• Section 6: Participant Follow-up (18 Apr 2008)
• Section 7: Visit Checklists (1 Apr 2008)
• Section 8: Participant Retention (31 Jan 2007)
• Section 9: Study Product Considerations for Non-Pharmacy Staff (31 Jan 2007)
• Section 10: Clinical Considerations (7 Nov 2007)
• Section 11: Adverse Event Reporting and Safety Monitoring (1 Aug 2007)
• Section 12: Laboratory Considerations (7 Nov 2007)
• Section 13: Data Collection (07 Nov 2007)
• Section 14: Data Communiqués (24 Oct 2008)
• Section 15: Study Reporting Plan (31 Jan 2007)
• Section 16: DAIDS Standard Operating Procedures
  • DAIDS SOP for Essential Documents
    • Superseded DAIDS Essential Documents SOP
  • DAIDS SOP for Source Documentation
    • Superseded DAIDS Source Documentation SOP

Accrual Plan

• Accrual Plan (9 Jul 2007) (Excel)

Study Implementation Materials

• HPTN 035 ONGOING Informed Consent Comprehension Checklist (14 Dec 2006)
• Sample Worksheet for Documenting HPTN 035 Ongoing Comprehension Assessment
• HPTN 035 Enrollment Informed Consent Comprehension Checklist - English (12 Apr 2006) (PDF)
• HPTN 035 Enrollment Informed Consent Comprehension Checklist - English (12 Apr 2006) (Excel)
• HPTN 035 Gel Re-Supply Worksheet - Long Version (7 Nov 2006) (PDF)
• HPTN 035 Gel Re-Supply Worksheet - Short Version (7 Nov 2006) (PDF)
• HPTN 035 Sample Pregnancy Management Worksheet (Word)
• HPTN 035 Protocol Safety Review Team Query Form (21 Jul 2008) (Word)
• DAIDS Expedited Adverse Event Report Form for HPTN 035 (Word)
• DAIDS Expedited Adverse Event Report Form Instructions
• HPTN 035 Sample Informed Consent Coversheet (Word)
• HPTN 035 PTD Tools  (Zip File)
• HPTN 035 PTD v 2.0 Tools (Zip File)
• Sample Certificate of Completion A (01 Aug 2007 ) (Word)
• Sample Certificate of Completion B (01 Aug 2007 ) (Word)
• Study Exit Worksheet (01 Aug 2007 ) (Word)
• HPTN 035 ACASI Users Manual (11 Mar 2008) (PDF)