Overview of Enrollment Procedures

1. Overview of Enrollment Procedures

2. Remember: Screening Window Enrollment Screening 56 Days

3. How is the enrollment visit different from other study visits? • Confirm eligibility • Document baseline conditions • Enroll in the study • No Split Visits for Enrollment

4. Enrollment Visit Checklist • Used to guide site staff through required procedures and document that they were done.

5. Note: • Enrollment IC will take place at the start of the visit – this includes consent for off-site visits. • Long term specimen storage consent – may be a stand-alone form or included in Enrollment ICF. If stand-alone, can conduct at Enrollment or M1. • Behavioral, clinical and laboratory eligibility criteria must be assessed after IC obtained.

6. Enrollment Behavioral Eligibility Worksheet

7. Note: • Behavioral assessment includes Baseline Behavior Assessment, Baseline Vaginal Practices, and Enrollment ACASI

8. HIV Prevention Options Counseling • A combined counseling session beginning at Enrollment that covers HIV/STI risk reduction and protocol adherence counseling. Continues through PUEV.

9. HIV Prevention Options Counseling • Counselors must be certified to provide this counseling: • Three mock sessions reviewed/approved by BRWG • Strongly encouraged for participants to see the same counselor throughout study, if possible. • Prevention options counselor should not conduct behavioral assessments or qualitative interviews during visit for the same participant.

10. HIV Prevention Options Counseling at Enrolment • Orient participant to purpose and content of sessions • Help her make an informed decision about accepting or not accepting the ring as an HIV prevention method

11. HIV Prevention Options Counseling at Enrolment • Discuss other HIV prevention strategies (building upon the risk reduction counseling provided during the screening visit) • Reinforce importance of accurate reporting • Begin building relationship/rapport between counselor and participant

12. Looking Forward: HIV Prevention Options Counseling During Follow-Up • Focus on the HIV risk reduction plans developed at the previous session • Explore how participant is doing with ring use and/or other HIV prevention methods

13. Looking Forward: HIV Prevention Options Counseling During Follow-Up • Review residual drug feedback (available M3, 6, 9, PUEV) • Develop new risk reduction plan for the coming month(s) • Check-in on attendance to study visits • Provide informational support, as needed

14. HIV Prevention Options Counseling Documentation • Chart notes or site-specific • worksheet • Document after the session • NOT a summary of • procedural steps – focus on • capturing participant-specific • information • Include enough detail to inform and guide participant’s next session • Mark that counseling was done on visit checklist and whether the participant chooses to use the ring

15. Non-Acceptors • Questions about reasons for declining ring for recording on RCI should be asked in a neutral and non-judgmental manner. • Understanding the reasons why participants do not accept rings is a study objective

16. HIV Prevention Options Counseling Q/A and Mentorship • ALL counseling sessions audio recorded (ppts receive verbal or written information about this) • Fidelity monitoring by BRWG through systematic review of a subset of recorded sessions • Monthly coaching calls to provide mentorship to counselors • Ongoing training and support provided, as needed

17. NOTE: • If indicated, perform physical and/or pelvic to follow up to any otherwise exclusionary findings from screening or newly reported symptoms. • ONLY collect pelvic specimens if needed for one of these reasons. • Participant diagnosed during screening with a UTI, PID or STI/RTI requiring treatment may be enrolled after completing treatment if all symptoms have resolved.

18. NOTE: • Baseline plasma collection critical for confirming eligibility of participant who later seroconvert • If blood tests meet exclusionary criteria at Screening they should be retested prior to Enrollment to allow for TAT.

19. NOTE: • Highlights are revisions made in LoA#1 to allow for choice in HOPE • Insertion of one study VR is also “if indicated” and will be clarified in upcoming CM

20. First Product Use • If participant accepts ring, staff member providing it should review instructions/important information, and debrief first product use experience • Check ring placement if participant expresses discomfort or want reassurance of correct placement

21. Same messages as in ASPIRE except: • Avoid • Do Not Share • Storage

22. Definition of Enrollment • Once a participant has provided written informed consent for enrollment AND • Designated staff have completed the final sign off of the Eligibility Checklist (see next slide)

24. Visit Flow • The only parts of the visit that must happen after participant is enrolled are: • Provision of study VR instructions, if indicated • Provision of VR and insertion, if participant accepts • Digit exam, if indicated • Behavioral assessments should come before ring insertion, but may happen after enrollment.

25. Visit Flow • Be flexible! Rearrange order of procedures, when allowable per protocol, to maximize efficiencies. • Think about which procedures might be able to happen concurrently: • HIV Prevention Options Counseling and Final Eligibility Determination • Baseline Behavioral Assessments while waiting for pharmacy to dispense the first ring • Others?

26. What if all enrollment procedures are not completed in one day? • Expected to be VERY rare • If participant cannot complete the visit or enrollment procedures are missed for any reason (other than plasma – see next slide), contact the MTN-025 management team for guidance

27. What if plasma archive is missed? • This is necessary to confirm eligibility as needed later in the trial and should always be collected prior to enrollment (before contact with study product). • She should be scheduled to come in as soon as possible for the collection of this

28. Enrollment Pop Quiz Get out your quiz paper!

29. 1. Which of these procedures is required at enrollment? • Physical Exam • Pelvic Exam • HIV Prevention Options Counseling • Provision of a Vaginal Ring

30. 2. What is the definition of enrollment for HOPE?

31. 3. Which of these procedures must come after ‘enrollment’? • Plasma and vaginal swab collection • Baseline behavioral assessments (ACASI/CRFs) • Provision of VR and insertion, if participant accepts

32. 4. True or False: HIV Risk Reduction Counseling must be done separately from HIV Prevention Options Counseling

33. 5. Name one key element of HIV Prevention Options Counseling at Enrollment

34. How did you do?? 1. Required: HIV Prevention Options Counseling • Enrollment Definition: Signed IC + Final Sign off of Eligibility Criteria CRF • Must come after enrollment: Provision of VR and insertion, if participant accepts • False: HIV risk reduction counseling is included in HIV prevention options counseling • Options Counseling Key Elements: Orient participant to counseling, educate about prevention options, help make informed choice, build rapport/relationship, reinforce accurate reporting

35. References • Protocol Section 7.3 (Enrollment Visit) • Protocol Appendix 1 • SSP: • Section 4.4 (Enrollment Procedures) • Section 12 (Counseling)

36. Questions?