Participant Retention Plans

MTN-003 Study-Specific Training

MTN-003 Retention Targets

MTN-003 retention target = 95% per yearMonth of

StudyTarget % Retained

1 99.582 99.173 98.754 98.335 97.926 97.507 97.088 96.679 96.2510 95.8311 95.4212 95.0013 94.5814 94.1715 93.7516 93.3317 92.9218 92.50

Month of Study

Target % Retained

19 92.0820 91.6721 91.2522 90.8323 90.4224 90.0025 89.5826 89.1727 88.7528 88.3329 87.9230 87.5031 87.0832 86.6733 86.2534 85.8335 85.42

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

What are your questions?