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Overview of Follow-up Procedures

Overview of Follow-up Procedures

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Overview of Follow-up Procedures

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  1. Overview of Follow-up Procedures

  2. HOPE Follow-up Visit Schedule

  3. Visit Types Monthly Quarterly PUEV Study Exit Interim Interim Interim

  4. Visit Locations Clinic Off-Site

  5. Month 1 & 2 Procedures • Administrative: • Review/Update Locator • Schedule Next Visit • Reimbursement Clinical: • Medical/Menstrual History • Provide Test Results • Record/Update AEs • Concomitant Meds* • Offer/Provide Contraceptives* • Treatment/referrals* • Physical Exam* • Pelvic Exam* Lab: • Urine: • Pregnancy • Urine culture* • GC and CT* Blood: • HIV-1 Testing • Plasma Storage • Syphilis Serology* • CBC with platelets* • Serum Chemistries* • Pelvic/Other: • Vaginal Fluid (self) • Hair • Used VR* • Trich or other samples if ind* • Behavioral (Counseling): • Contraceptive • HIV pre-/post test • Options Counseling (HIV/STI risk reduction and adherence) • Study Product/Supplies: • Offer Condoms • Offer New VR • Provision of new VR* • Remove/Collect VR* • VR instructions* • Digital Exam* • Behavioral (Assessments): • Adherence

  6. Quarterly Procedures • Administrative: • Review/Update Locator • Schedule Next Visit • Reimbursement Clinical: • Medical/Menstrual History • Provide Test Results • Record/Update AEs • Concomitant Meds* • Offer/Provide Contraceptives* • Treatment/referrals* • Physical Exam* • Pelvic Exam* Lab: • Urine: • Pregnancy • Urine culture* • GC and CT* Blood: • HIV-1 Testing • Plasma Storage • Syphilis Serology* • CBC with platelets* • Serum Chemistries* • Pelvic/Other: • Vaginal Fluid (self) • Hair • Used VR* • Trich or other samples if ind* • Behavioral (Counseling): • Contraceptive • HIV pre-/post test • Options Counseling (HIV/STI risk reduction and adherence) • Study Product/Supplies: • Offer Condoms • Offer New VR • Provision of new VR* • Remove/Collect VR* • VR instructions* • Digital Exam* • Behavioral (Assessments): • Adherence • Behavioral • Social Harms • ACASI (M3)

  7. Differences from ASPIRE? • What do you observe as key differences in follow-up procedures between ASPIRE and HOPE?

  8. Differences from ASPIRE? • More frequent sample collection for adherence measurements (and more sample types!) • Less frequent required physical/pelvic exams • No unique set of procedures for “semi-annual” visits

  9. Visit Checklists

  10. Sequence of Procedures • Modify to maximize efficiency of clinic flow • Very few procedures have required order: • Pelvic Exams • Behavioral Assessments before Counseling (but counseling still early on!) • Ideally, vaginal fluid swab with ring still in place • Ring provision toward end of visit (after clinical/lab assessments and counseling) • Recommend pairing Vaginal Ring (VR) removal/insertion • Flexibility is encouraged

  11. Clinic Flow • Why is efficiency important? • What are some strategies that may help improve clinic flow? • Regular internal reviews of systems is key - proactive rather than reactive

  12. Study Procedures for Non-Acceptors • With the exception of provision/collection of the study vaginal ring and associated instructions, all study procedures are conducted regardless of whether a participant chooses to accept a ring. • Including collection of blood, swabs, hair

  13. Minimum Procedures for VR dispensation: • AE assessment and reporting (verbal report of symptoms is acceptable; if symptoms indicate that further evaluation is necessary, this must be conducted prior to dispensing study product) • HIV testing and counseling (including RR counseling) and pregnancy testing are required for product dispensation if this has not been done within the past 90 days • Collection of Used Ring (and unused, if applicable), if available • Adherence Counseling/Product Use Instructions, as needed

  14. Making up Missed Procedures • MTN-025 visit windows are contiguous, as such no procedures are required to be “made-up” at subsequent scheduled visits • Effort should be made to make up missed procedures as part of a split visit • Note that in the event of a missed visit, an interim visitmay be required to resupply rings (and conduct associated safety assessments and counseling as needed) • If a participant misses her Month 3 visit, ACASI will be considered missed and will not be made up at subsequent quarterly visits

  15. Modified Procedures in the Event of Clinical Hold/Discontinuation • Modified procedures for HIV/pregnancy covered during separate training modules • For all other holds/discontinuations, the only modifications are: • Discontinue ring provision and associated instructions • HIV prevention options counseling will continue and will be tailored to focus on HIV risk reduction plans that do not involve the vaginal ring  • Only resume offering study product should the participant be clinically eligible

  16. HIV Prevention Options Counseling During Follow-Up • Provide residual drug feedback, starting at M3 • Explore how participant is doing with ring use and/or other HIV prevention methods • What went well or did not go well, how the participant is feeling about her HIV prevention approach(es)

  17. HIV Prevention Options Counseling During Follow-Up • Develop HIV risk reduction plan for the coming month(s) • Including her desire to start or continue using the ring as part of her HIV prevention strategy (if relevant), and assessment of confidence in plan • Check-in on attendance to study visits • Provide informational support, as needed

  18. Residual Drug Feedback

  19. 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

  20. Month 3 Counseling Considerations • Risk reduction plans should take into account that it may be three months before the participant returns to the clinic for her next visit • Discuss how the participant feels about accepting additional rings at her quarterly visits moving forward

  21. Month 3 Considerations (Cont.) • Where the participant will store her unused rings and used rings post-removal • Why it is important to change the ring on time each month and how the participant will remember when it is time to change her ring • The importance of not sharing rings with friends or family members

  22. Month 3 Considerations (Cont.) • Any questions or concerns the participant has about having extra rings in her possession • Alternatives to accepting additional rings at this visit, as needed (namely, that participants have the option to return to the clinic each month to pick up a new ring if she feels uncomfortable having a supply of two unused rings in her home)

  23. Month 3 Considerations (cont.) • Provide instructions for tracking order of ring use and information that will be requested about each ring at her next visit • Rate how well she felt she was able to use each ring • Approximately how many days each ring was removed

  24. Month 3 Considerations (cont.) • Contraceptive method/next dose • What to do in case of suspected pregnancy between visits • What to do in case of suspected HIV exposure between visits

  25. Considerations for Interim Contacts During Quarterly Follow-up Schedule • Consider strategies for supporting participants between quarterly visits with interim contacts such as by phone or through SMS • The goals of these contacts could range from general check-ins, to supporting retention (visit reminders), to supporting ring use or reminders to change rings. • Permission from participant must be provided/documented (e.g. on site locator) • Frequency/content determined by site • Ensure IRB approvals in place, if required

  26. Visits to Pick Up Rings During Quarterly Follow-up Schedule • Visits for the sole purpose of picking up a new ring during a quarterly schedule should be streamlined • The only procedures required are those necessary to collect her used ring and dispense a new ring • Document as an interim visit • What strategies will you use for flagging/fast tracking these visits? • What are your plans for reimbursement of these visits?

  27. PUEV Procedures • Administrative: • Review/Update Locator • Schedule Next Visit • Reimbursement Clinical: • Medical/Menstrual History • Provide Test Results • Record/Update AEs • Physical Exam • Pelvic Exam • Concomitant Meds* • Offer/Provide Contraceptives* • Treatment/referrals* Lab: • Urine: • Pregnancy • GC and CT • Urine culture* Blood: • HIV-1Testing • PlasmaStorage • Syphilis Serology • CBC with platelets • Serum Chemistries • Pelvic/Other: • VaginalFluid(self) • Hair • Trich • Used VR* • Other samples if ind* • Behavioral (Counseling): • Contraceptive • HIV pre-/post test • Options Counseling (HIV/STI risk reduction) • Study Product/Supplies: • OfferCondoms • Remove/Collect VR* • Behavioral (Assessments): • Adherence • Behavioral • Social Harms • ACASI (PUEV)

  28. Study Exit Procedures • Administrative: • Review/Update Locator • Reimbursement • Schedule Next Visit* Clinical: • Medical/Menstrual History • Provide Test Results • Record/Update AEs • Concomitant Meds* • Offer/Provide Contraceptives* • Treatment/referrals* • Physical Exam* • Pelvic Exam* Lab: • Urine: • Pregnancy • Urine culture* • GC and CT* Blood: • HIV-1 Testing • Plasma Storage • Syphilis Serology* • CBC with platelets* • Serum Chemistries* • Pelvic/Other: • Vaginal Fluid (self) • Hair • Trich or other samples if ind* • Behavioral (Counseling): • HIV pre-/post test • HIV/STI risk reduction • Contraceptive* • Study Product/Supplies: • Offer Condoms • Behavioral (Assessments): • Study Exit Assessment

  29. Follow-up Pop Quiz Get out your quiz paper!

  30. 1. Which of these procedures is required at all scheduled follow-up visits? • Physical Exam • Pelvic Exam • Collection of blood, swabs and hair for adherence measurements • Behavioral Assessments

  31. 2. What is the primary difference between monthly and quarterly visit procedures? Monthly Quarterly

  32. 3. True or False: With the exception of provision/collection of the study vaginal ring and associated instructions, all study procedures are conducted regardless of whether a participant chooses to accept a ring.

  33. 4. Name one consideration for counseling at a participant’s Month 3 visit

  34. 5. Which of the following procedures is required prior to providing a ring? • AE assessment and reporting • HIV testing and counseling and pregnancy testing if this has not been done within the past 90 days • Collection of Used Ring (and unused, if applicable), if available • Adherence Counseling/Product Use Instructions, as needed • All of the Above

  35. How did you do?? 1. Required at all visits: Collection of blood, swabs, hair • Primary difference between monthly/quarterly: Behavioral assessments done at quarterly visit • True: With the exception of provision/collection of the study vaginal ring and associated instructions, all study procedures are conducted regardless of whether a participant chooses to accept a ring. • Month 3 Considerations: Varied responses • Minimum procedures required to provide a ring: (E) All of the above

  36. Questions?