1:45-2pm Break 2-2:30pm New HIV Rapid and Confirmatory Tests HOPE HIV Screening and Algorithms HIV Testing Notification and Query Form LC MTN-025 SSP Section 13 (Laboratory Considerations) MTN-025 Protocol: Appendix II & III MTN HIV Testing Notification & Query Form 2:30-3:15pm HIV Pre- and Post-Test Counseling HIV Counseling Messages for HIV results Risk Reduction Counseling (Screening) FHI 360 SSP tables 12-1, 12-2 and 12-3 (Counseling Considerations) HIV Counseling worksheet (if in use at your site) 3:15-4pm Overview and General Guidance Labeling/Documentation/LDMS Urine Testing Blood Testing/Storage Vaginal Specimens Self-Collected LC SSP Section 13 (Laboratory Considerations) Day 2 Time Presentation Presenter References/Materials* 10-10:15am Information on key safety data from ASPIRE and The Ring Study Safety MDs Dapivirine Ring Investigator’s Brochure V10.0 10:15-11:15am Baseline Medical/Menstrual History Concomitant Medications PrEP Considerations Physical Exams Pelvic Exams Contraceptive Counseling PSRT Safety MDs MTN-025 SSP Section 10 (Clinical Considerations) Baseline medical history questions Pelvic Exam Checklist Contraceptive Counseling Workshop (if in use at your site) Site-specific PrEP SOP 11:15-11:30am Break 11:30-12pm ECI CRFs (Decliner and Enroller) Demographics CRF Baseline Medical History Log Concomitant Medications Log Pelvic/Physical Exam/Vital Signs CRFs SCHARP (recorded) Screening CRF packet (recommend printing hardcopy)
PD log CRF MTN-025 Study Specific Training Phase 2 – Follow-Up Day 3 Time Presentation Presenter References/Materials* 10-10:45am 4-4:45am EST 1. Follow-up Visit Types & Procedures M1&2 Quarterly PUEV/Term Follow-up HIV Prevention Options Counseling Minimum procedures required to dispense rings during f/u Fast-tracking’ ring supply visits 3 Considerations (transition to quarterly visits) FHI 360 SSP Section 6 (Follow-up Procedures) Protocol Section 7.4 and Appendix I Follow-up Checklist (Month 1 & 2/Quarterly) SSP Section 12 (Counseling) 10:45-11:45am 4:45-5:45am EST 2. Follow-up Medical/Menstrual History AE/SAE/EAEs Definitions AE Reporting and Safety MDs SSP Section 10 (Clinical Considerations) SSP Section 11 (AE Reporting and Safety Monitoring) 5:45-6:15am EST 3. Protocol Requirements for Product Holds/Discontinuations Safety MDs SSP Section 10 (Clinical Considerations) Protocol Section 9 Product Use Management Flow Sheets 12:15-1:00pm 6:15-7am EST Lunch Break 1-1:20pm 7-7:20am EST 4. Off Site Visit Procedures and Documentation Considerations FHI 360 SSP Section 2 (Decliners) SSP Section 6 (Follow-up Procedures) SSP Section 8 (Participant Retention) SSP Section 9 (Study Product Considerations) SSP Section 10 (Product Hold/Discontinuation) SSP Section 12 (Counseling) 1:20-1:40pm 7:20-7:40am EST 5. Retention Definitions/Strategies Participant Transfers Termination/Withdrawals FHI 360 SSP Section 5 (Informed Consent) SSP Section 6 (Follow-up Procedures) SSP Section 8 (Participant Retention) Protocol Section 9 (Termination & Early Withdrawal) 1:40-1:55 pm 7:40-7:55am EST 6. Overview of participant tracking database SCHARP SSP Section 8 (Retention) Participant Tracking Database User Manual
1:55-2:10pm 7:55-8:10am EST 7. Product Considerations for Split/Missed/Off-site Visits Review of Ring Resupply/Holds Review of Ring Collection Procedures/Accountability Documentation MTN Pharmacy SSP Section 9 Product Considerations for Non-Pharmacy Staff) 2:10-2:20pm 8:10-8:20am EST Break 2:20-2:40pm 8:20-8:40am EST 8. Hair Collection and Storage LC SSP Section 13.9 (Laboratory Considerations) SSP Section 12.7 (Counseling Considerations) 2:40-2:55 pm 8:40-8:55am EST 9. Review of Visit Windows/Targets Missed/Split Visits/Interim Visits SCHARP SSP Section 14 (Data Collection) 2:55-3:15pm 9:55-10:15am EST 10. Care and Support for Seroconverters Modified Procedures for Seroconverters HIV Resistance Results/Counseling MTN-015 Referral FHI360 SSP Section 6.5 (Follow-up Procedures) SSP Section 10.9 (Clinical Considerations) Seroconverter Visit Checklist 3:15-3:25pm 9:15-9:25am EST Break 3:25-3:45pm 9:25-9:45am EST 11. Clinical Management of Pregnancies Modified Procedures for Pregnant Participants MTN-016 Referral FHI360 SSP Section 6 (Follow-up Procedures) SSP Section 10 (Clinical Considerations) Sample Pregnancy Management Worksheet 3:45-4pm 9:45-10am EST 12. Review of follow-up behavioral CRFs, highlighting guidance for new or unique questions BRWG SSP Section 7 (Behavioral Measures) 4-5pm 10-11am EST 13. Follow-up CRFs, including review of Social Harms/Benefits CRFs AE and GAE CRFs Product Hold CRFs HIV CRFs Pregnancy CRFs SCHARP SSP Section 14 (Data Management) MTN-025 Case Report Forms