HIV Prevention Trials Network

Study Documents

The HPTN 057 study team has made the following study documents available.  New documents will be posted here as they become available.

HPTN 057 Protocol

• HPTN 057 Protocol v 2.0 28-October 2009 (PDF)
• Summary of Changes to V 2.0 (PDF)
• HPTN 057 Protocol v 1.0 and successive documents (PDF)
• HPTN 057 Protocol Signature Page v 1.0 (Word)

Clarification Memos

• Clarification Memo #1 to V2.0 15 July 2010 (PDF)

HPTN 057 Study Specific Procedures Manual

• HPTN 057 SSP Manual v 4.0 Zip File (in revision)

• Change Log  (Word) (PDF) (in revision)

• Front Matter

  • Inside Front Cover (Word) (PDF) (18 Feb 2010)

  • Acronym List (Word) (PDF) (18 Feb 2010)

• Table of Contents (Word) (PDF) (24 Jun 2010))

• Section 1  Introduction (Word) (PDF) (18 Feb 2010)

• Section 2  Protocol (Word) (PDF) (18 Feb 2010)

• Section 3  Documentation Requirements (Word) (PDF) (18 Feb 2010

• Section 4  Participant Accrual (Word) (PDF) (18 Feb 2010

• Section 5  Participant Follow-up (Word) (PDF) (18 Feb 2010)

• Section 6  Visit Checklists (Word) (PDF) (18 Feb 2010)

• Section 7  Retention (Word) (PDF) (18 Feb 2010)

• Section 8  Study Product Considerations (Word) (PDF) (18 Feb 2010)

  • Clinic Packet Log Form for Cohort 4 (Word)

• Section 9  Clinical and Counseling Procedures (Word) (PDF) (18 Feb 2010)

• Section 10  Laboratory Procedures (Word) (PDF) (11 Mar 2010)

  • Network Lab Communiqué #1 (20 Jul 2007)

  • Network Lab Communiqué #2 (31 Oct 2007)

• Section 11  Adverse Event Reporting and Safety Monitoring (Word) (PDF) (18 Feb 2010)

• Section 12  DataFax (PDF) (18 Feb 2010)

• Section 13 Reporting Plan (PDF) (22 Jun 2010)

HPTN 057 Case Report Forms

Please contact Lynda Emel at SCHARP to obtain the latest version of the HPTN 057 CRFs

HPTN 057 Study Implementation Documents and Resources

• Sample HPTN 057 Informed Consent Coversheet (Word)
• Sample HPTN 057 Study Staff Roster and Signature Sheet (Word)
• Sample HPTN 057 Screening and Enrollment Log (Excel)
• Suggested Filing Structure for HPTN 057 Essential Documents (Word)
• Protocol Deviation Form (Word)
• HPTN 057 Investigator of Record Signature Page (Word)

HPTN 057 Site-Specific Study Operating Procedures (SOPs)

• SOP Content Guidelines (Word)
• SOP Template (Word)

HPTN 057 Safety Monitoring and Adverse Event Reporting

• HPTN 057 Supplemental Table for Grading the Severity of Malnutrition and Fever (Word)
• HPTN 057 Specific DAIDS Expedited Adverse Event Report Form
• HPTN 057 PSRT AE Notification Form (Word)
• HPTN 057 Pausing Procedures (PDF)

HPTN 057 Resources

• Viread® (tenofovir disoproxil fumarate) Package Insert
• DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (PDF with 2009 clarification)