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MATRIX-007 (CARE PrEP) Study Documents

DescriptionDateSize
Ancillary Documents
Breastfeeding Poster (Download) 2024-07-2237.91 KB
Chart Notes (Download) 2024-10-0723.5 KB
Field Report (Download) 2024-09-3032.27 KB
Gestational Age Dating Tool (Download) 2024-08-2042.34 KB
Health Care Provider Form (Download) 2024-09-2330 KB
HIV Rapid Testing Log (Download) 2024-09-2030.56 KB
IC Job aid (Download) 2024-06-185.54 MB
Informed Consent Coversheet (Download) 2024-09-2036.96 KB
Locator Form (Download) 2024-09-2330.42 KB
Name Linkage Log (Download) 2024-09-1223.35 KB
Participant Tracker (Download) 2024-09-25132.9 KB
Permission to Contact Form (Download) 2024-06-2039.47 KB
Permission to Contact Log (Download) 2024-09-1028.13 KB
Pre-screening form (Download) 2024-07-1833.06 KB
Pregnancy Testing Log (Download) 2024-09-2029.99 KB
Safety Sub-Committee Query Form (Download) 2024-09-2041.06 KB
Study Exit Guide (Download) 2024-09-3031.02 KB
Study Factsheet (Download) 2024-08-13837.85 KB
Study Factsheet Generic (Download) 2024-08-13316.7 KB
Syphilis/HIV Combo Testing Log (Download) 2024-09-2028.63 KB
Clarification Memos
Clarification Memo #01 to MATRIX-007 (Download) 2024-10-04215.41 KB
Clinical Research Forms
MATRIX-007 CRF Version and Control (Download) 2024-09-11103.69 KB
Antenatal Care (Download) 2024-07-31144.89 KB
Assign PID (Download) 2024-07-3158.34 KB
Congenital Anomaly Review (Download) 2024-07-3173.73 KB
Demographics (Download) 2024-07-3194.39 KB
Eligibility Screener (Download) 2024-09-11122.09 KB
EPDS (Download) 2024-07-3180.15 KB
Estimated Due Date (Download) 2024-07-3185.21 KB
Infant Feeding Assessment (Download) 2024-07-31100.35 KB
Infant Outcome (Download) 2024-07-31159.85 KB
Infant Physical Exam (Download) 2024-09-11250.17 KB
Medical Events/Conditions (Download) 2024-09-11127.89 KB
Medications (Download) 2024-09-1177.85 KB
Obstetric Care and History (Download) 2024-07-31164.86 KB
Participant Scheduling (Download) 2024-07-3169.6 KB
Participant Transfer (Download) 2024-07-3187.94 KB
Postpartum Care (Download) 2024-07-31103.65 KB
Pregnancy Outcome (Download) 2024-07-31132.99 KB
PrEP Use (Download) 2024-07-3186.99 KB
Protocol Deviation (Download) 2024-07-3171.37 KB
Social Harm (Download) 2024-07-3189.99 KB
Study Exit (Download) 2024-07-3191.59 KB
Study Visit (Download) 2024-07-31122.61 KB
Test Results (Download) 2024-09-1193.46 KB
Ultrasound Results (Download) 2024-09-11126.36 KB
Vitals (Download) 2024-07-3173.18 KB
Protocols
MATRIX-007 Protocol Version 1.0, July 3, 2024 (Download) 2024-07-031.38 MB
Study Specific Procedures Manual - Individual Sections
Overview and Control Log (Download) 2024-09-1247.53 KB
Section 01: Introduction, Site Activation, and Document Requirements (Download) 2024-09-12288.61 KB
Section 02: Study Structure and Oversight (Download) 2024-09-12204.33 KB
Section 03: Informed Consent (Download) 2024-09-12279.42 KB
Section 04: Retention and Accrual (Download) 2024-09-12194.79 KB
Section 05: Study Procedures (Download) 2024-09-12586.91 KB
Section 06: Clinical and Safety Considerations (Download) 2024-09-12837.83 KB
Section 07: Data Collection and Management (Download) 2024-09-121.46 MB
Section 08: Data Communiqués and Operational Guidance (Download) 2024-09-12115.56 KB
Visit Checklists
Antenatal Visit (Download) 2024-09-1246.36 KB
Enrollment Visit (Download) 2024-09-1253.24 KB
Post-natal Visit (Download) 2024-09-1242.64 KB
Pregnancy Outcome Visit (Download) 2024-09-1246.88 KB