1:45-2pm Break 2-2:30pm LC MTN-025 SSP Section 13 (Laboratory New HIV Rapid and Confirmatory Considerations) MTN-025 Protocol: Appendix II & III Tests MTN HIV Testing Notification & HOPE HIV Screening and Query Form Algorithms HIV Testing Notification and Query Form 2:30-3:15pm FHI 360 SSP tables 12-1, 12-2 and 12-3 HIV Pre- and Post-Test Counseling (Counseling Considerations) HIV Counseling worksheet (if in use HIV Counseling Messages for HIV at your site) results Risk Reduction Counseling (Screening) 3:15-4pm LC SSP Section 13 (Laboratory Overview and General Guidance Considerations) Labeling/Documentation/LDMS Urine Testing Blood Testing/Storage Vaginal Specimens Self-Collected Day 2 Time Presentation Presenter References/Materials* 10-10:15am Safety Dapivirine Ring Investigator’s Information on key safety data Brochure V10.0 MDs from ASPIRE and The Ring Study 10:15-11:15am Safety MTN-025 SSP Section 10 (Clinical Baseline Medical/Menstrual Considerations) MDs Baseline medical history questions History Concomitant Medications Pelvic Exam Checklist PrEP Considerations Contraceptive Counseling Workshop Physical Exams (if in use at your site) Pelvic Exams Site-specific PrEP SOP Contraceptive Counseling PSRT 11:15-11:30am Break 11:30-12pm SCHARP Screening CRF packet (recommend ECI CRFs (Decliner and Enroller) printing hardcopy) (recorded) Demographics CRF Baseline Medical History Log Concomitant Medications Log Pelvic/Physical Exam/Vital Signs CRFs
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)
MTN-025%20HOPE%20Study%20Specific%20Training%20Full%20Agenda.docx