MTN-003 Study-Specific Training
Participant Retention Plans
MTN-003 Retention Targets

MTN-003 retention target = 95% per year
Month of
Study
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
Target %
Retained
99.58
99.17
98.75
98.33
97.92
97.50
97.08
96.67
96.25
95.83
95.42
95.00
94.58
94.17
93.75
93.33
92.92
92.50
Month of
Study
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
Target %
Retained
92.08
91.67
91.25
90.83
90.42
90.00
89.58
89.17
88.75
88.33
87.92
87.50
87.08
86.67
86.25
85.83
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 + 20 = 58
# HIV infections
in control group =
58
With these results
“true” product effectiveness would be
0%
Site-Specific Retention Plans
Some Operational Considerations
Reference SSP Section 8
Site Specific Retention Plans

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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

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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

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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?