HPTN 058 Protocol

• HPTN 058 Protocol v 2.0 - English (PDF)

• Summary of Changes v 2.0 (PDF)

• HPTN 058 Protocol v 2.0 - Chinese (PDF)

• HPTN 058 Protocol v 2.0 - Vietnamese (PDF)

HPTN 058 Letters of Amendment

• HPTN 058 v 1.0 LoA #1, 6 Dec 2006 (PDF)

• HPTN 058 v 2.0 LoA #1, 25 Sep 2009 (PDF)

• HPTN 058 v 2.0 LoA #1, 25 Sep 2009 Vietnamese (PDF)

• HPTN 058 v 2.0 LoA #1, 25 Sep 2009 Chinese (PDF)revised

HPTN 058 Clarification Memos

• HPTN 058 v 1.0 CM #3, 6 Jul 2007 (PDF)

• HPTN 058 v 1.0 CM #2, 23 Jun 2006 (PDF)

• HPTN 058 v 1.0 CM #1, 21 Dec 2005 (PDF)

HPTN 058 Study Specific Procedures Manual (SSP)
All SSP Manual sections are PDF files unless otherwise noted.

SSP Version 2.0

• Table of Contents [English]

• Section 1 - Introduction [English] [Mandarin Chinese]

• Section 2 - Protocol [English] [Mandarin Chinese]

• Section 3 - Documentation Requirements [English] [Mandarin Chinese]

• Section 4 - Participant Accrual [English] [Mandarin Chinese]

• Section 5 - Participant Follow-up [English] [Mandarin Chinese]

• Section 6 - Visit Checklists [English] [Mandarin Chinese]

• Section 7 - Data Collection and Data Management [English] [Mandarin Chinese]

• Section 8 - Retention [English] [Mandarin Chinese]

• Section 9 - Study Product Considerations [English] [Mandarin Chinese]

• Section 10 - Clinical and Counseling Procedures [English] [Mandarin Chinese]

• Section 11 - Laboratory Procedures [English] [Mandarin Chinese]

• Section 12 - Adverse Event Reporting and Safety Monitoring [English] [Mandarin Chinese]

• Section 13 - Reporting Plan [English] [Mandarin Chinese]

SSP Version 3.0

• Section 7 - Data Collection and Data Management [English] [Chinese]

• Section 10 - Clinical and Counseling Procedures [English] [Chinese]

SSP Version 4.0

• Section 7 - Data Collection and Data Management [English] [Chinese]

HPTN 058 Case Report Forms (CRFs)

All Case Report Forms can be found in Appendix F (above) and review Section 7 Data Collection and Data Management (above) for more instructions in completing these forms. Please contact Huguette Redinger at SCHARP with any further questions.

HPTN 058 Study Implementation Materials
Materials are PDF files unless otherwise noted.

• HPTN Protocol Deviation Form (Word)

• HPTN 058 BUP/NX Treatment Manual V6, August 2010 [English] [Chinese - V6 pending]

• Behavioral Drug and Risk Reduction Counseling Treatment Manual [English]

• Visit Scheduler Training Presentation (PowerPoint)

HPTN 058 Safety Monitoring and Adverse Event Reporting

• HPTN 058 Summary Table of AE Reporting and Documentation Requirements (Word)

• Suboxone (buprenorphine naloxone) Package Insert (PDF)

• HPTN 058 Protocol Safety Review Team (PSRT) Query Form (Word) (30 Jul 2008)

• DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (PDF) 

• Manual for Expedited Reporting of Adverse Events 2.0 [English] [Chinese] (PDF) (Version 2.0 of this manual is not in use yet)

• DAIDS Expedited Adverse Event Report Form for HPTN 058 (Word)

• DAIDS Expedited Adverse Event Report Form Instructions (PDF) 

HPTN 058 Sample Forms and Documents 

• Sample Informed Consent Coversheet (Word)

• Sample Study Staff Roster and Signature Sheet (Word)

• Sample Screening and Enrollment Log (Word)

• Suggested Filing Structure for HPTN 058 Essential Documents (Word)

HPTN 058 Rapid Policy Assessment Final Reports

• Rapid Policy Assessment - Guangxi and Xinjiang, China

• Rapid Policy Assessment - Chiang Mai, Thailand

• "Law on the books" and High Risk Populations in Thailand

• All of the above documents combined in one file

• For more information about Rapid Policy Assessment tools and training materials visit the Rapid Policy Assessment and Response website - www.rpar.org

HPTN 058 Resources

HPTN Manual of Operations

DAIDS Standard Operating Procedures for Essential Documents and Source Documentation