HPTN 058 Protocol

• HPTN 058 Protocol v 2.0 - English (PDF)

• Summary of Changes v 2.0 (PDF)

• HPTN 058 Protocol v 2.0 - Mandarin Chinese (PDF)

• Investigator Signature Page v 2.0 (Word)

• HPTN 058 Protocol v 1.0 (PDF)

• Investigator Signature Page v 1.0 (Word)

HPTN 058 Letters of Amendment

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

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 (December 2008)

• 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]

HPTN 058 Case Report Forms

See Section 7 Data Collection and Data Management (above), please contact Huguette Redinger at SCHARP for more information.

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

• HPTN Protocol Deviation Form (Word)

• HPTN 058 BUP/NX Treatment Manual [English] [Chinese]

• Behavioral Drug and HIV Risk Counseling for Opioid Dependent Individuals: HPTN 058 Counseling Manual [English] [Chinese]

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 to DAIDS (PDF) 

• 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

DAIDS Standard Operating Procedures for Essential Documents and Source Documentation