HPTN 059

Phase II Expanded Safety and Acceptability Study of the Vaginal Microbicide 1% Tenofovir Gel

Study Documents

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

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.