HPTN 058 Protocol V2.0

• 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 2.0 LoA #3 19 Jul 2011 (Chinese PDF)

• HPTN 058 v 2.0 LoA #3 19 Jul 2011 (English PDF)

• HPTN 058 v 2.0 LoA #2, 24 Mar 2011 (PDF)

• HPTN 058 v 2.0 LoA #2, 24 Mar 2011 Chinese (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 v 1.0 LoA #1, 6 Dec 2006 (PDF)

HPTN 058 Clarification Memos

• HPTN 058 v 2.0 CM #1, 17 Mar 2011 (PDF) [Chinese & English]

• HPTN 058 v 2.0 CM #1, 17 Mar 2011 (PDF) [English]

• 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] [Chinese]

• Section 2 - Protocol [English] [Chinese]

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

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

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

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

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

• Section 8 - Retention [English] [Chinese]

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

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

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

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

• Section 13 - Reporting Plan [English] [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)

Sites can obtain the most current set of Case Report Forms in the Atlas website, under the HPTN:058 link. For additional instructions in completing these forms refer to the SSP, Section 7, Data Collection and Data Management. Please contact Huguette Redinger at SCHARP with any further questions.

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

• Final Visit Clarification from the Protocol Chair (2 May 2011) [English] [Chinese]

• HPTN Protocol Deviation Form (Word)

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

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

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

• 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) 

• DAIDS Expedited Adverse Event Report Form for HPTN 058 (Word) V2 27 Apr 2010

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