MTN-003Training.pptVIP

* * * * * Also, am not yet sure how and when to address this but should we take on the issue of scheduling the first few visits early to build up the seven day extra supply of product that Jeanna has specified the sites should be aiming for? Maybe that needs to come later … in the scenarios? MC: SEE NEW SLIDE 16 – DOES THIS WORK? I THINK IT WILL BE GOOD TO DISCUSS THIS ONCE WE PRESENT SLIDE 16 – IT WILL HELP BREAK UP THE PRESENTATION A BIT * * * * * * * * Speaker notes: distinguish between split visits and interim visits, using lab re-draw as example. For last bullet point, reference visit window. * * * * * * * * * * MTN-003 Training Follow-up Visit Scheduling and Visit Coding SSP Sections 14.3.2 and 14.3.3 MTN-003 Follow-up Period For the study overall: Duration of follow-up will depend on how long it takes to observe the required number of HIV infections (endpoints) across sites For planning purposes as of now, follow-up is expected to continue for 14 months after completion of accrual Will be monitored by the SMC and DSMB Protocol Team will use SMC and DSMB guidance to set a final study end date which will be communicated to all sites MTN-003 Follow-up Period Each participant will be followed: 1) For a minimum of 12 months on product plus 2 months off product 2) For a maximum of 33 months on product plus 2 months off product OR 3) Through the study end date Therefore, the overall follow-up period for each participant is expected to range from 14-35 months Though participants are seen monthly, the type of visit performed will vary: MONTHLY visits are performed at months 1,2, 4, 5, 7, 8, 10, 11, 13, 14, 16, 17, 19, 20, 22, 23, 25, 26, 28, 29, 31, and 32 QUARTERLY visits are performed at months 3, 9, 15, 21, and 27 SEMI-ANNUAL visits are performed at months 6, 18, and 30 ANNUAL visits are performed at months 12 and 24 MTN-003 Required Follow-up Visits The second-to-last scheduled visit is called the PRODUCT USE END VISIT (PU