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MATRIX-003 Study Documents

Ancillary Documents
Baseline Medical History Review Guide (Download) 2023-11-2039.08 KB
Eligibility Checklist (Download) 2023-11-2056.38 KB
Intravaginal Ring Use Instructions (Download) 2023-10-30427.81 KB
Participant Visit Calendar Tool (Download) 2024-05-0795.37 KB
Prescription (Download) 2024-02-22165.22 KB
Protocol Safety Review Team Query Form (Download) 2024-05-2332.14 KB
Record of Receipt (Download) 2023-10-2629.83 KB
Response Cards (Download) 2024-05-09251.49 KB
Sample Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) 2023-08-1635.52 KB
Sample Informed Consent Coversheet (Download) 2023-08-1632.7 KB
Sample Informed Consent Sexual Partner Subset Coversheet (Download) 2023-08-1636.43 KB
Sample Protocol Counseling Guide and Worksheet (Download) 2024-05-0153.25 KB
Sample Sexual Partner Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) 2023-08-1635.34 KB
Sample Sexual Partner Subset Eligibility Checklist (Download) 2023-07-2141.32 KB
Sample Source Documentation of Study Procedures (Download) 2024-04-1138 KB
Screening and Enrollment Log (Download) 2023-11-2034.64 KB
Study Product Return Log (Download) 2023-10-2633.66 KB
Clinical Research Forms and In-Depth Interview Materials
MATRIX-003 Data Collection Materials Table of Contents (Download) 2024-05-03220.79 KB
Clinical CRF Completion Guidelines (Download) 2024-01-182.43 MB
Sociobehavioral CRF Completion Guidelines (Download) 2024-03-141.49 MB
Adverse Events (Download) 2024-01-05158.74 KB
Baseline Acceptability (BL) CRF (Download) 2023-12-22225.34 KB
Baseline Behavioral (BEH) CRF (Download) 2023-12-22211.4 KB
Baseline Medical and Menstrual History v1.0 (Download) 2024-01-05141.41 KB
Baseline Medical and Menstrual History v1.1 (Download) 2024-02-26144.63 KB
Brief Acceptabiity (FU2) CRF (Download) 2023-12-22216.75 KB
Clinical Observation for Insertion (COI) CRF (Download) 2023-12-22206.56 KB
Clinical Observation for Removal (COR) CRF (Download) 2023-12-22206.01 KB
Clinical Observation for Removal (COR) CRF (Download) 2024-03-07209.57 KB
Concomitant Medications (Download) 2024-01-05100.66 KB
Demographic (DEM) CRF (Download) 2023-12-22214.79 KB
Establish PTID (Download) 2024-01-0594.26 KB
Establish Sexual Partner PTID (Download) 2024-02-2761.71 KB
Follow-up Behavioral and Acceptability (FU3) CRF (Download) 2023-12-22229.05 KB
Follow-up Behavioral and Acceptability (FU4) CRF (Download) 2023-12-22374.04 KB
Follow-up Behavioral and Acceptability (FU4) CRF (Download) 2024-03-07373.67 KB
Hematology Chemistry Results (Download) 2024-01-0596.6 KB
HIV Confirmatory (Download) 2024-01-05113.3 KB
HIV STI Urine Test Results (Download) 2024-01-05131.83 KB
ICF Summary (Download) 2024-01-0596.96 KB
Participant Disposition (Download) 2024-01-05123.45 KB
Participant IDI Guide (PIDI) (Download) 2023-12-22220.79 KB
Pelvic Exam (Download) 2024-01-05130.07 KB
Post-insertion Acceptability (FU1) CRF (Download) 2024-01-09310.65 KB
Pre-existing Conditions (Download) 2024-01-0597.52 KB
Pregnancy Report and Outcome (Download) 2024-01-05146.69 KB
PRN Expulsion Log (EXP) (Download) 2024-03-07160.92 KB
PRN Hematology Chemistry Results (Download) 2024-01-0597.68 KB
PRN Missed Visit (Download) 2024-01-05123.7 KB
PRN Sexual Partner Events Log (SPE) (Download) 2024-03-07138.22 KB
PRN Sympton-directed Physical Exam (Download) 2024-01-05120.71 KB
Product Hold Discontinuation (Download) 2024-01-05101.06 KB
Protocol Deviations (Download) 2024-04-12111.12 KB
Randomization Assignment (Download) 2024-01-0582.93 KB
Screening Physical Exam Vital Signs (Download) 2024-01-05121.65 KB
Sexual Partner Demographic and Acceptability (SPDEM) CRF (Download) 2023-12-22247.36 KB
Sexual Partner Demographic and Acceptability (SPDEM) CRF (Download) 2024-03-07247.75 KB
Sexual Partner ICF (Download) 2024-02-2773.95 KB
Sexual Partner IDI Guide (SP) IDI (Download) 2023-12-22232.38 KB
Sexual Partner Protocol Deviation (Download) 2024-02-2799.46 KB
Sexual Partner Social Benefits (Download) 2024-02-2798.89 KB
Social Harms and Benefits Assessment (Download) 2024-01-05152.56 KB
Specimen Storage (Download) 2024-01-05105.88 KB
Updated Medical and Menstrual History v1.0 (Download) 2024-01-05166.1 KB
Visit Summary (Download) 2024-01-0598.26 KB
MATRIX-003 Protocol Version 1.0, dated June 29, 2023 (Download) 2023-06-291.9 MB
Study Specific Procedures Manual - Individual Sections
Overview and Control Document-Version History and Notice of Changes (Download) 2024-04-24559.84 KB
Table of Contents (Download) 2024-04-24168.88 KB
Section 01: Introduction (Download) 2024-02-20230.41 KB
Section 02: Documentation Requirements (Download) 2024-02-20354.14 KB
Section 03: Accrual and Retention (Download) 2024-02-20257.05 KB
Section 04: Informed Consent (Download) 2024-02-20267.28 KB
Section 05: Study Procedures (Download) 2024-02-20386.17 KB
Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) 2024-02-20243.58 KB
Section 07: Clinical Considerations (Download) 2024-02-20325.16 KB
Section 08: Adverse Event Reporting and Safety Monitoring (Download) 2024-02-20339.63 KB
Section 09: Laboratory Considerations (Download) 2024-02-20379.98 KB
Section 10: Counseling Considerations (Download) 2024-02-20241.12 KB
Section 11: Behavioral Measures (Download) 2024-03-28935.43 KB
Section 12: Data Collection (Download) 2024-04-24285.82 KB
Section 13: Data Communiqués and Operational Guidance (Download) 2024-02-20171.9 KB
Section 13: Data Communique #1 (Download) 2024-05-01360.31 KB
Section 13: Data Communique #2 (Download) 2024-04-12281.04 KB
Section 14: Study Reporting Plan for Clinical Data (Download) 2024-02-20273.11 KB
Study Specific Procedures Manual-Operational Guidance
SBR Operational Guidance #1 (Download) 2024-05-01327.02 KB
Visit Checklists
Interim Visit Checklist (Download) 2024-02-2049.34 KB
Sexual Partner Subset Visit Checklist (Download) 2024-02-2039.5 KB
Visit 01: Screening Visit Checklist (Download) 2024-02-2049.36 KB
Visit 02: Enrollment Visit Checklist (Download) 2024-02-2050.95 KB
Visit 03 and Visit 07: Seven Days after V2 or V6 (Download) 2024-02-2041.96 KB
Visit 04 and Visit 08: 14 Days After V3 or V7 (Download) 2024-02-2044.81 KB
Visit 05: Day Number 28; First Ring Removal Visit Checklist (Download) 2024-02-2043.64 KB
Visit 06: Second Ring Insertion Visit Checklist (Download) 2024-02-2046.74 KB
Visit 09: Second Ring Removal Visit Checklist; SEV/Early Termination Visit Checklist (Download) 2024-02-2048.05 KB