1. Retention

2. Numbers that Matter 3476= total number of women enrolled at least 95% retention at each visit, at each study site 100% attention to data quality, safety Everything else flows from these…

3. What is the overall accrual target for ASPIRE? 3476 A single experience inside or outside of the clinic can affect a participant’s retention in the study. Why do we care about each participant attending every single visit when there are thousands of ppts in the study? Answer: missed visits = 0% product use

5. What might affect a participant’s retention in ASPIRE? Examples: AE Social Harm Ease/ difficulty of ring use Ease/difficulty/length of clinic visits and/or study procedures

6. Overview of Retention Exercise Imagine your ideal experience as a participant in a study attending a regularly scheduled monthly visit. Reflect on your ideal experience. Be guided through a regularly scheduled monthly visit as a participant in the study. Reflect on this different experience. Discuss as a larger group the different aspects of the visits.

7. Visualization Exercise – Set up Please close your eyes. [Pause for 3-5 full seconds for the attendees to calm down and focus.] You are a participant in a clinical trial using an experimental drug. Imagine that you are going to the study clinic today for your monthly visit. What is your ideal study visit experience? [Pause for approximately 10 full seconds before continuing on the next slide/ questions.]

8. Visualization Exercise – Ideal – When you get to the clinic, the receptionist greets you and asks you to please sit in the waiting room. – You visit with some of the other women and have some tea while waiting. – Soon, the study nurse asks for you to go with her for your study visit. – The visit with the nurse goes smoothly. She asks you questions about a headache you report having the past few days and reassures you that the medication you usually take will not interfere with ring use. – The visit continues as you are seen by the counselor and the study doctor. – You leave the clinic after about 2 hours and have the rest of the day to yourself.

9. Visualization Exercise – Transition Okay. [Pause for 3-4 seconds for the attendees to transition out of the visualization.] Please open your eyes and quietly reflect on this experience that you just created. [Pause for 10 full seconds.]

10. Visualization Exercise – Transition Please quietly stand and move to the chair to your left. Notice that this is a new chair; one you have not sat in before. [Brief pause.] Now I’m going to walk you through another scenario. Please close your eyes. [Pause for 3-5 full seconds for the attendees to calm down and refocus.]

11. Visualization Exercise – Set up You are a participant in a clinical trial using an experimental drug. You have gone to the clinic for one day a month during the work week for the past 13 months. The study is projected to continue for another 11 months. [Pause for approximately 5-6 full seconds before continuing on the next slide/ prompts.]

12. Visualization Exercise – Difficult When you get to the clinic this morning: The receptionist tells you that the scheduler was incorrect and you are not due for your visit until next week. They are still able to see you today. While waiting, you get thirsty and the receptionist directs you to the store across the street. You go to the store and buy some water and return to the clinic. One hour passes as other participants are being seen by the study staff but no one has spoken to you yet. You begin to get a little bored and start to get hungry.

13. Visualization Exercise – Difficult The study nurse is ready to see you now and hurries you to the exam room. Once you are in the exam room, the nurse begins to ask you questions about your medical history. Without looking at you, she writes your responses in her chart. You tell her that you have had a headache the past few days. She does not ask you any question about it and replies that the clinician will be with you soon. You wait in the exam room for half an hour before the clinician arrives.

14. Visualization Exercise – Difficult The clinician asks you the same questions that the nurse had asked you and also writes in her chart. Eventually, you tell the clinician about your headache and she writes you a prescription for some medicine without asking for any details. The visit continues as you go from the clinician, to another nurse, to a counselor, back to a nurse and finally to the last counseling session. By the time you leave the clinic, it is 3:00 PM and you debate whether to go back to work or just go home. Later that day you get a call from the clinic to return the next day for a missed procedure. [Pause for a full 10-15 seconds to allow the attendees to complete their experience in their minds.]

15. Visualization Exercise – Difficult The visit continues as you go from the clinician, to another nurse, to a counselor, back to a nurse and finally to the last counseling session. By the time you leave the clinic, it is 3:00 PM. You debate whether to go to work or just go home. [Pause for 6-8 full seconds.] Later that day you get a call from the clinic to return the next day for a missed procedure. [Pause for a full 10-15 seconds to allow the attendees to complete their experience in their minds.]

16. Visualization Exercise – Transition/ Purpose Please open your eyes, and remain quiet as you reflect on this experience. [Pause for 4-5 seconds for the attendees to transition out of the visualization.] This was to get you thinking creatively of how a participant might experience a regular monthly study visit. Before we debrief on these experiences, I would like to acknowledge that this exercise focused on the participant, but as study staff…

17. Visualization Exercise – Discussion It’s a balancing act!! Conducting high quality research and managing/ caring for hundreds of study participants takes a ton of hard work, time, and organization!! While as study staff members we can’t affect every single aspect of a participant’s day, we can affect the environment in which she experiences the study visit. We will now return to our seats, but I would like you to remember your experiences as the two participants.

18. Visualization Exercise – Discussion How did you feel as a participant in the first scenario? - What were some positive aspects of this visit? How did you feel as a participant in the second scenario? - What were some negative aspects of this visit?

19. Visualization Exercise – Discussion We’re now going to break into small groups. I would like each group to brainstorm how your site would address the items that we’ve listed on the flipcharts. These could be things that your site is already doing (such as providing water, tea, and snacks), or could be new ideas. We’ll have about 10 minutes for the small groups and then come together and hear what people have come up with. Are there any questions?

20. Visualization Exercise – Discussion Take notes, and utilize strategies from your site’s Retention SOP. Try to think of creative ways in which to address some of the issues we’ve listed. – How will things be communicated across the site team? – What measures do you already have in place to address some of these issues? – How often will retention be addressed/ discussed at your site? Retention is everyone’s job (not just the retention team), retention/outreach team needs to grapple with these challenges.

21. What are your questions?