Participant Retention Plans MTN-003 Study-Specific Training

MTN-003 Retention Targets  MTN-003 retention target = 95% per year

MTN-003 Retention Definitions  During the study: Retention is based on whether participants complete scheduled visits within the visit windows Retained = completed visit within the window Not retained = did not complete visit within the window Retention can fluctuate over time / across visits Retention shortfalls at a given visit can be made up at later visits by ensuring participants return after missed visits

MTN-003 Retention Definitions  At the end of the study: Retention is based on whether participants complete HIV testing at their scheduled PUEV Although every effort must be made to complete each participant’s PUEV within the visit window, PUEVs will be allowed to take place at any time through the study end date at each site Participants who complete their PUEV before the study end date, and have HIV testing at that visit, will be considered retained at the end of the study Retention for the Termination Visit is important and will also be monitored.

MTN-003 Retention Targets  MTN-003 retention target = 95% per year  Why is 95% so important?  To ensure the accuracy of the study results by minimizing bias that can be caused by missing data

One Possible Study Result # HIV infections in active product group = 38 # HIV infections in control group = 58 With these results, product effectiveness would be calculated as 35%

With Loss to Follow-Up Now imagine 40 women in the active product group and 40 women in the control group are lost to follow-up (LFUP) As a worst case scenario, also imagine: - Half (20) of the LFUP women in the active group are HIV-positive (but this is not known to the study) - All (40) of the LFUP women in the control group are HIV-negative

With Loss to Follow-Up # HIV infections in active product group = 38 # HIV infections in control group = 58 With these results “true” product effectiveness would be 0% + 20 = 58

Site-Specific Retention Plans Some Operational Considerations Reference SSP Section 8

Site Specific Retention Plans  Site-specific retention goals  Methods for tracking actual versus targeted retention  Procedures for collecting and reviewing/updating locator information  Site-specific definition of “adequate” locator information  Visit reminder methods and timeframes  Methods and timeframes for identifying missed appointments

Site Specific Retention Plans  Planned retention methods, including what outreach/locator efforts are taken within 24 hours, 1-3 days, 1 week, 2 weeks, and 3-4 weeks after a missed visit  Methods for timely evaluation of the utility of retention methods  Ethical and human subjects considerations  Staff responsibilities for all of the above  QC/QA procedures related to the above

Operational Tips and Reminders  Designate a Retention Coordinator who is responsible for tracking retention rates and managing retention efforts over time  Hold weekly meetings among staff involved in retention to discuss current and ongoing strategies  Discuss retention issues and strategies at monthly study team meetings  Engage community representatives on retention issues and strategies throughout the study

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