Ancillary Documents| Baseline Medical History Review Guide (Download) | 2023-11-20 | 39.08 KB |
| Eligibility Checklist (Download) | 2023-11-20 | 56.38 KB |
| Intravaginal Ring Use Instructions (Download) | 2023-10-30 | 427.81 KB |
| Participant Visit Calendar Tool (Download) | 2024-05-07 | 95.37 KB |
| Prescription (Download) | 2024-02-22 | 165.22 KB |
| Protocol Safety Review Team Query Form (Download) | 2024-05-23 | 32.14 KB |
| Record of Receipt (Download) | 2023-10-26 | 29.83 KB |
| Response Cards (Download) | 2024-05-09 | 251.49 KB |
| Sample Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) | 2023-08-16 | 35.52 KB |
| Sample Informed Consent Coversheet (Download) | 2023-08-16 | 32.7 KB |
| Sample Informed Consent Sexual Partner Subset Coversheet (Download) | 2023-08-16 | 36.43 KB |
| Sample Protocol Counseling Guide and Worksheet (Download) | 2024-05-01 | 53.25 KB |
| Sample Sexual Partner Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) | 2023-08-16 | 35.34 KB |
| Sample Sexual Partner Subset Eligibility Checklist (Download) | 2023-07-21 | 41.32 KB |
| Sample Source Documentation of Study Procedures (Download) | 2024-04-11 | 38 KB |
| Screening and Enrollment Log (Download) | 2023-11-20 | 34.64 KB |
| Study Product Return Log (Download) | 2023-10-26 | 33.66 KB |
Clinical Research Forms and In-Depth Interview Materials| MATRIX-003 Data Collection Materials Table of Contents (Download) | 2024-05-03 | 220.79 KB |
| Clinical CRF Completion Guidelines (Download) | 2024-01-18 | 2.43 MB |
| Sociobehavioral CRF Completion Guidelines (Download) | 2024-03-14 | 1.49 MB |
| Adverse Events (Download) | 2024-01-05 | 158.32 KB |
| Baseline Acceptability (BL) CRF (Download) | 2023-12-22 | 225.34 KB |
| Baseline Behavioral (BEH) CRF (Download) | 2023-12-22 | 211.4 KB |
| Baseline Medical and Menstrual History v1.0 (Download) | 2024-01-05 | 141.41 KB |
| Baseline Medical and Menstrual History v1.1 (Download) | 2024-02-26 | 144.63 KB |
| Brief Acceptabiity (FU2) CRF (Download) | 2023-12-22 | 216.75 KB |
| Clinical Observation for Insertion (COI) CRF (Download) | 2023-12-22 | 206.56 KB |
| Clinical Observation for Removal (COR) CRF (Download) | 2023-12-22 | 206.01 KB |
| Clinical Observation for Removal (COR) CRF (Download) | 2024-03-07 | 209.57 KB |
| Concomitant Medications (Download) | 2024-01-05 | 100.66 KB |
| Demographic (DEM) CRF (Download) | 2023-12-22 | 214.79 KB |
| Establish PTID (Download) | 2024-01-05 | 94.26 KB |
| Establish Sexual Partner PTID (Download) | 2024-02-27 | 61.71 KB |
| Follow-up Behavioral and Acceptability (FU3) CRF (Download) | 2023-12-22 | 229.05 KB |
| Follow-up Behavioral and Acceptability (FU4) CRF (Download) | 2023-12-22 | 374.04 KB |
| Follow-up Behavioral and Acceptability (FU4) CRF (Download) | 2024-03-07 | 373.67 KB |
| Hematology Chemistry Results (Download) | 2024-01-05 | 96.6 KB |
| HIV Confirmatory (Download) | 2024-01-05 | 113.3 KB |
| HIV STI Urine Test Results (Download) | 2024-01-05 | 131.83 KB |
| ICF Summary (Download) | 2024-01-05 | 96.96 KB |
| Participant Disposition (Download) | 2024-01-05 | 123.45 KB |
| Participant IDI Guide (PIDI) (Download) | 2023-12-22 | 220.79 KB |
| Pelvic Exam (Download) | 2024-01-05 | 130.07 KB |
| Post-insertion Acceptability (FU1) CRF (Download) | 2024-01-09 | 310.65 KB |
| Pre-existing Conditions (Download) | 2024-01-05 | 97.52 KB |
| Pregnancy Report and Outcome (Download) | 2024-01-05 | 146.69 KB |
| PRN Expulsion Log (EXP) (Download) | 2024-03-07 | 160.92 KB |
| PRN Hematology Chemistry Results (Download) | 2024-01-05 | 97.68 KB |
| PRN Missed Visit (Download) | 2024-01-05 | 123.7 KB |
| PRN Sexual Partner Events Log (SPE) (Download) | 2024-03-07 | 138.22 KB |
| PRN Sympton-directed Physical Exam (Download) | 2024-01-05 | 120.71 KB |
| Product Hold Discontinuation (Download) | 2024-01-05 | 101.06 KB |
| Protocol Deviations (Download) | 2024-04-12 | 111.12 KB |
| Randomization Assignment (Download) | 2024-01-05 | 82.93 KB |
| Screening Physical Exam Vital Signs (Download) | 2024-01-05 | 121.65 KB |
| Sexual Partner Demographic and Acceptability (SPDEM) CRF (Download) | 2023-12-22 | 247.36 KB |
| Sexual Partner Demographic and Acceptability (SPDEM) CRF (Download) | 2024-03-07 | 247.75 KB |
| Sexual Partner ICF (Download) | 2024-02-27 | 73.95 KB |
| Sexual Partner IDI Guide (SP) IDI (Download) | 2023-12-22 | 232.38 KB |
| Sexual Partner Protocol Deviation (Download) | 2024-02-27 | 99.46 KB |
| Sexual Partner Social Benefits (Download) | 2024-02-27 | 98.89 KB |
| Social Harms and Benefits Assessment (Download) | 2024-01-05 | 152.56 KB |
| Specimen Storage (Download) | 2024-01-05 | 105.88 KB |
| Updated Medical and Menstrual History v1.0 (Download) | 2024-01-05 | 166.1 KB |
| Visit Summary (Download) | 2024-01-05 | 98.26 KB |
SOUTH AFRICAN Protocol v1.2 and Associated Documents| MATRIX-003 SA Protocol Version 1.2, Dated May 16, 2024 (Download) | 2024-05-16 | 1.49 MB |
| SA Eligibility Checklist (Download) | 2024-05-16 | 56.05 KB |
| SA Eligibility Checklist TRACKED CHANGES ENABLED (Download) | 2024-05-16 | 58.17 KB |
| SA Informed Consent Comprehension Assessment (TRUE/FALSE) (Download) | 2024-05-16 | 36.19 KB |
| SA Informed Consent Comprehension Assessment (TRUE/FALSE) TRACKED CHANGES ENABLED (Download) | 2024-05-16 | 37.97 KB |
| SA Protocol Counseling Guide and Worksheet (Download) | 2024-05-16 | 56.39 KB |
| SA Protocol Counseling Guide and Worksheet TRACKED CHANGES ENABLED (Download) | 2024-05-16 | 58.51 KB |
| SA Screening and Enrollment Log (Download) | 2024-05-16 | 32.76 KB |
| SA Screening and Enrollment Log TRACKED CHANGES ENABLED (Download) | 2024-05-16 | 34.44 KB |
Study Specific Procedures Manual - Individual Sections| Overview and Control Document-Version History and Notice of Changes (Download) | 2024-09-18 | 516.97 KB |
| Table of Contents (Download) | 2024-09-18 | 173.17 KB |
| Section 01: Introduction (Download) | 2024-09-18 | 238.51 KB |
| Section 02: Documentation Requirements (Download) | 2024-05-22 | 355.54 KB |
| Section 03: Accrual and Retention (Download) | 2024-02-20 | 257.05 KB |
| Section 04: Informed Consent (Download) | 2024-02-20 | 267.28 KB |
| Section 05: Study Procedures (Download) | 2024-02-20 | 386.17 KB |
| Section 06: Study Product Considerations for Non-Pharmacy Staff (Download) | 2024-02-20 | 243.58 KB |
| Section 07: Clinical Considerations (Download) | 2024-02-20 | 325.16 KB |
| Section 08: Adverse Event Reporting and Safety Monitoring (Download) | 2024-02-20 | 339.63 KB |
| Section 09: Laboratory Considerations (Download) | 2024-02-20 | 379.98 KB |
| Section 10: Counseling Considerations (Download) | 2024-02-20 | 241.12 KB |
| Section 11: Behavioral Measures (Download) | 2024-05-22 | 932.49 KB |
| Section 12: Data Collection (Download) | 2024-04-24 | 285.82 KB |
| Section 13: Data Communiqués and Operational Guidance (Download) | 2024-02-20 | 171.9 KB |
| Section 13: Data Communique #1 (Download) | 2024-05-01 | 360.31 KB |
| Section 13: Data Communique #2 (Download) | 2024-04-12 | 281.04 KB |
| Section 14: Study Reporting Plan for Clinical Data (Download) | 2024-02-20 | 273.11 KB |
Visit Checklists| Interim Visit Checklist (Download) | 2024-02-20 | 49.34 KB |
| Sexual Partner Subset Visit Checklist (Download) | 2024-02-20 | 39.5 KB |
| Visit 01: Screening Visit Checklist (Download) | 2024-02-20 | 49.36 KB |
| Visit 02: Enrollment Visit Checklist (Download) | 2024-02-20 | 50.95 KB |
| Visit 03 and Visit 07: Seven Days after V2 or V6 (Download) | 2024-02-20 | 41.96 KB |
| Visit 04 and Visit 08: 14 Days After V3 or V7 (Download) | 2024-02-20 | 44.81 KB |
| Visit 05: Day Number 28; First Ring Removal Visit Checklist (Download) | 2024-02-20 | 43.64 KB |
| Visit 06: Second Ring Insertion Visit Checklist (Download) | 2024-02-20 | 46.74 KB |
| Visit 09: Second Ring Removal Visit Checklist; SEV/Early Termination Visit Checklist (Download) | 2024-02-20 | 48.05 KB |
