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MATRIX-002 Study Documents

Ancillary Documents
Baseline Medical History Review Guide (Download) 2023-07-1137.55 KB
Chain of Custody Form (Download) 2024-03-2036 KB
Eligibility Checklist (Download) 2023-07-1157.03 KB
Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) 2023-07-1135.38 KB
Informed Consent Coversheet (Download) 2023-07-1135.29 KB
Informed Consent Sexual Partner Subset Coversheet (Download) 2023-07-1135.2 KB
Participant Visit Calendar Tool (Download) 2023-08-0195.51 KB
Prescription (Download) 2023-07-09171.67 KB
Protocol Counseling Guide and Worksheet (Download) 2023-07-1146.85 KB
Protocol Safety Review Team Query Form (Download) 2023-07-1130.82 KB
Record of Receipt (Download) 2023-07-0635.04 KB
Screening and Enrollment Log (Download) 2023-07-11167.52 KB
Sexual Partner Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) 2023-07-1134.72 KB
Sexual Partner Subset Eligibility Checklist (Download) 2023-07-1041.76 KB
Source Documentation of Study Procedures (Download) 2023-07-2534.02 KB
Study Product Return Log (Download) 2023-07-1232.56 KB
Clinical Research Forms and In-Depth Interview Materials
MATRIX-002: Data Collection Materials Table of Contents (Download) 2024-04-12205.84 KB
CRF Completion Guidelines: Clinical (Download) 2023-10-122.87 MB
CRF Completion Guidelines: Socio-behavioral (Download) 2023-10-041.51 MB
Adverse Events Log (Download) 2023-10-12150.68 KB
Baseline acceptability (BL) CRF (Download) 2023-10-02220.24 KB
Baseline behavioral (BEH) CRF (Download) 2023-10-02208.15 KB
Baseline Medical and Menstrual History (Download) 2023-10-12135.08 KB
Brief acceptability (FU2) CRF (Download) 2023-10-12189.66 KB
Brief acceptability (FU2) CRF (Download) 2024-02-08248.56 KB
Clinician Observations (CO) CRF (Download) 2023-10-02203.12 KB
Concomitant Medications Log (Download) 2023-10-1289.66 KB
Demographic (DEM) CRF (Download) 2023-10-02236.31 KB
Establish PTID (Download) 2023-10-12101.91 KB
Establish Sexual Partner PTID (Download) 2024-02-2661.56 KB
Final behavioral and acceptability (FU4) CRF (Download) 2023-10-12338.99 KB
Final behavioral and acceptability (FU4) CRF (Download) 2024-02-08387.22 KB
Follow-up behavioral and acceptability (FU3) CRF (Download) 2023-10-12314.18 KB
Follow-up behavioral and acceptability (FU3) CRF (Download) 2024-02-08350.33 KB
Hematology and Chemistry Results (Download) 2023-10-1295.13 KB
HIV Confirmatory (Download) 2023-10-12105.84 KB
HIV, STI and Urine Test Results (Download) 2023-10-12120.18 KB
ICF Summary (Download) 2023-10-1289.89 KB
In-Depth Interview Debrief Report (Download) 2023-10-19180.17 KB
Participant Disposition (Download) 2023-10-12119.97 KB
Participant In-Depth Interview Guide (Download) 2023-06-02277.34 KB
Pelvic Exam (Download) 2023-10-12137.44 KB
Post-insertion acceptability (FU1) CRF (Download) 2023-10-02208.01 KB
Pre-existing Conditions Log (Download) 2023-10-1288.04 KB
Pregnancy Report and Outcome (Download) 2023-10-12131.36 KB
PRN Expulsion Log (Download) 2024-02-19154.47 KB
PRN Hematology and Chemistry Results (Download) 2023-10-1295.25 KB
PRN Missed Visit (Download) 2023-10-12110.18 KB
PRN Targeted Physical Exam (Download) 2023-10-12105.34 KB
Protocol Deviation Log (Download) 2024-04-12109.77 KB
Randomization (Download) 2023-10-1292.24 KB
Screening Physical Exam and Vital Signs (Download) 2023-10-12103.01 KB
Sexual Partner Demographic (SPDEM) CRF (Download) 2023-10-02186.32 KB
Sexual Partner ICF (Download) 2023-10-1259.8 KB
Sexual Partner IDI Guide (Download) 2023-06-05224.92 KB
Sexual Partner In-Depth Interview Debrief Report (Download) 2023-10-20183.51 KB
Sexual Partner Protocol Deviation (Download) 2023-10-12100.1 KB
Sexual Partner Social Benefits (Download) 2023-10-12113.66 KB
Social Harms and Benefits Assessment Log (Download) 2023-10-12148.5 KB
Specimen Storage (Download) 2023-10-1295.55 KB
Study Product Hold/Discontinuation of Log (Download) 2023-10-1291.89 KB
Updated Medical and Menstrual History (Download) 2023-10-12132.66 KB
Visit Summary (Download) 2023-10-12104.61 KB
Pharmacy Manual (Download) 2024-03-281.32 MB
MATRIX-002 Protocol Version 1.0, dated May 24, 2023 (Download) 2023-05-241.43 MB
Study Specific Procedures Manual - Individual Sections
Overview and Control Document-Version History and Notice of Changes (Download) 2024-05-15600 KB
Table of Contents (Download) 2024-05-15168.67 KB
Section 01 - Introduction (Download) 2023-10-12229.61 KB
Section 02 – Documentation Requirements (Download) 2024-05-15307.6 KB
Section 03 – Accrual and Retention (Download) 2023-10-12256.74 KB
Section 04 – Informed Consent (Download) 2023-10-12264.42 KB
Section 05 – Study Procedures (Download) 2023-10-12400.69 KB
Section 06 – Study Product Considerations for Non-Pharmacy Staff (Download) 2023-10-12241.94 KB
Section 07 – Clinical Considerations (Download) 2023-10-12321.89 KB
Section 08 – Adverse Event Reporting and Safety Monitoring (Download) 2023-10-12338.44 KB
Section 09 – Laboratory Considerations (Download) 2024-02-20379.06 KB
Section 10 – Counseling Considerations (Download) 2023-10-12238.26 KB
Section 11 – Behavioral Measures (Download) 2024-05-151.02 MB
Section 12 – Data Collection (Download) 2023-10-12309.39 KB
Section 13 – Data Communiqués and Operational Guidance (Download) 2023-10-12172.8 KB
Section 13 - Data Communique #1 (Download) 2024-02-22406.32 KB
Section 13 - Data Communique #2 (Download) 2024-04-12280.64 KB
Section 14 – Study Reporting Plan for Clinical Data (Download) 2023-10-12228.08 KB
Study Specific Procedures Manual-Operational Guidance
MATRIX-002 Operational Guidance #01 PHARMACY (Download) 2024-04-05371.48 KB
MATRIX-002 Operational Guidance #02 PHARMACY (Download) 2024-03-15370.58 KB
MATRIX-002 Operational Guidance #03 CLINICAL (Download) 2024-05-01449.92 KB
MATRIX-002 Operational Guidance- #01 SBR (Download) 2023-12-08493.31 KB
MATRIX-002 Operational Guidance- #02 SBR (Download) 2024-03-08343.33 KB
Visit Checklists
V1: Screening Visit Checklist (Download) 2023-06-2844.14 KB
V2: Enrollment Visit Checklist (Download) 2024-01-0948.06 KB
V3: 24 – 72 hrs after V2 (1st Film); V7: 24 – 72 hrs after V6 (2nd Film) (Download) 2023-06-2839.16 KB
V4: 1 week after V2 (1st Film); V5: 2 weeks after V2 (1st Film); V8: 2 weeks after V6 (2nd Film) (Download) 2023-06-2839.56 KB
V6: 4-Week Visit (2nd Film) Checklist (Download) 2023-06-2850.12 KB
V9: 8-Week Visit Checklist; Early Termination Visit Checklist (Download) 2024-01-0942.66 KB
V10: Final Telephone Contact/SEV (Download) 2023-06-2838.64 KB
Interim Visit Checklist (Download) 2023-06-2845.91 KB
Sexual Partner Subset Visit Checklist (Download) 2023-07-1939.19 KB