1. Planning for HOPE PUEVs and Study Exit Visits

2. HOPE PUEVs
PUEVs for HOPE participants enrolled on or before 15 Sep 2017 will take place at Month 12 (visit code 8.00)
Participants enrolled between 16 Sep 2017 and 25 May 2018 will have abbreviated follow-up schedules ending with a PUEV visit around Sep/Oct 2018
Note: The management team should be notified of any participants who enroll on or after 16 September 2017 and will provide additional guidance on each participant’s visit schedule and the scheduling and visit code of her PUEV.
Screen
Enroll M1 M2 M3 M6 M9
M12: PUEV
M13:Exit

3. PUEV Procedures
PUEVs include most follow-up visit procedures, with the following modifications:
HIV prevention options counseling will be modified to focus on risk reduction plans without the dapivirine ring
Use “End Visit, Month 12” Options Flipchart
Review Options Manual pg , recommend mocks
No vaginal rings are offered
For participants who ever accepted a ring: Complete vaginal ring request slip for “Product Use Period Completed” and send to pharmacy.
Do NOT complete Product Hold/Discontinuation CRF
Note: Detailed guidance for completion of the product hold/discontinuation CRF for participants with ongoing product holds is provided in the operational guidance document

4. PUEV Procedures (Cont)
PUEVs include most follow-up visit procedures, with the following modifications:
Conduct a physical and pelvic exam
Complete testing for GC/CT, Syphilis, and Trichomonas
Collect blood for serum chemistries/CBC
Complete BA (note additional questions), Vaginal Practices, and Social Influences CRFs
Administer PUEV/Discontinuers ACASI
Note: If the participant already completed her PUEV/Discontinuers questionnaire at the time of permanent discontinuation (prior to her PUEV), do not complete a second questionnaire.

5. Study Product Considerations
It is expected that participants will return their VRs during the PUEV visit (used and unused).
All VRs remaining in the participant’s possession should be returned by the SEV (at the latest).
If the participant does not bring her remaining VRs (used or unused) to the SEV, study staff must arrange to retrieve the VR within 5 business days
If the study product(s) are not retrieved within that timeframe, the MTN-025 PSRT must be informed.

6. Seroconversion at PUEV
If a participant has a positive rapid HIV test at PUEV:
If a final HIV positive status is confirmed at PUEV (based on Geenius completed on that day) then scheduling the SEV is not necessary. 
If the participant is confirmed HIV negative, or if her status is not resolved as of the time of PUEV, then then scheduling of the SEV should proceed. 
HIV testing may be omitted from the Study Exit Visit if the participant completed algorithm testing and was determined to be HIV-infected prior to the visit.

7. CRF Completion for PUEV
Required Visit 8 - PUEV CRFs
Date of Visit
Follow-up Visit Summary
Behavior Assessment (+Y/N prompt)
Vaginal Practices (+Y/N prompt)
Social Influences Assessment (+Y/N prompt)
Ring Adherence (+Y/N prompt)
ACASI Tracking (+Y/N prompt)
HIV Test Results
Pregnancy Test Results
Specimen Storage
Concomitant Medications Log Y/N
Pelvic Exam (+ Pelvic Exam Diagrams non-Rave form)
Ring Collection and Insertion
Additional Study Procedures Y/N
Physical Exam
Vital Signs
Adverse Experience Y/N
Laboratory Results
STI Test Results
Note: Detailed guidance on form completion is outlined within the Operational guidance document

8. CRF Completion for V8 - PUEV
On the Follow-up Visit Summary CRF, select “PUEV” as the response for “Is this visit a PUEV, scheduled Study Exit Visit, or an early Termination?” item:
Behavior Assessment, Vaginal Practices, & Social Influences Assessment CRFs available in local language
Complete the PUEV/Discontinuers ACASI assessment if not previously completed and document on the ACASI Tracking CRF

9. Study Exit Visits (SEVs)
SEVs will occur approximately 4 weeks after the PUEV (**Use SEV calculator**)
Exception: no SEVs for Seroconverters (seroconverters will be terminated at PUEV)
Minimum of 2 weeks between a participant’s PUEV and SEV.
If a participant misses her scheduled Study Exit Visit, efforts to complete this visit should continue until the end of the study, after which no further study visits will occur.
Note: Teams will be notified of the official end of study date by the management team.

10. SEV Visit Calculator

11. SEV Procedures
SEVs include most follow-up visit procedures, with the following modifications:
No HIV prevention options counseling is completed, however, participants still receive HIV risk reduction counseling per site SOPs
No vaginal rings are routinely offered or collected
Study Exit Assessment (behavioral CRF) is completed
Contraceptive counseling only occurs if indicated (note this is recommended per standard of care)
Next visit scheduling only occurs if indicated

12. Seroconversion at SEV
If the participant has positive rapid(s) at her Study Exit visit, complete algorithm testing and additional required sample collection.
If the confirmatory test is positive, refer the participant for treatment and complete termination visit procedures on that same day.
If the confirmatory test is negative or indeterminate, query the LC as required by protocol and notify the management team for guidance. Do not complete termination visit procedures until her HIV status is finalized.
This participant is still eligible for MTN-015 after exit from ASPIRE since she seroconverted during participation in the parent protocol. Approach for enrollment once algorithm confirms HIV infection per protocol; recommend as soon as possible to avoid loss to follow-up.

13. Termination Procedures
The following procedures are unique to the Termination Visit (PUEV for seroconverters, SEV for all other participants):
Completion of the Termination Form
Review all AEs that meet the protocol safety endpoint definitions (related G2, all G3/G4 AEs, and all SAEs) to confirm relationship status, AE grade, and outcome are accurately documented in the participant record.
Complete documentation of how best to contact for study results, as well as permission to contact for future research, in particular 032/AHA
Template study exit worksheet and permission to contact logs available on MTN website
Follow up referrals for ongoing care post-study should be provided as needed

14. CRF Completion for V9 - SEV
Date of Visit
Follow-up Visit Summary
Study Exit Assessment (+Y/N prompt)
HIV Test Results
Pregnancy Test Result
Specimen Storage
Concomitant Medications Log Y/N
Adverse Experience Y/N
Additional Study Procedures Y/N
Termination
Note: Detailed guidance on form completion is outlined within the Operational guidance document

15. CRF Completion for V9 - SEV
Things to consider:
On the Follow-up Visit Summary CRF, select “scheduled Study Exit Visit” as the response for “Is this visit a PUEV, scheduled Study Exit Visit, or an early Termination?” item:
Study Exit Assessment CRF available in local language

16. CRF Completion at Study Termination
Things to consider:
Review all AE and Concomitant Medications Log CRFs to ensure each is closed or marked as “continuing at end of study participation” or “continuing at end of study”, respectively.
Review each completed Social Impact log CRF to ensure that a resolution date is provided or that ‘unresolved at end of study’ is selected for the item “Record current status”.

17. CRF Completion at Study Termination
Things to consider:
Complete “Was the participant instructed to resume study product use” for any open Clinical Product Holds
Ensure that for every vaginal ring dispensed per the Pharmacy Ring Dispensation, there is an associated log line and ‘stored/not stored’ status for that ring.

18. CRF Completion at Study Termination
Things to consider:
Double check all forms (with exception of
Additional Study Procedures Y/N)
are completed within participant’s casebook,
including Y/N admin forms
Pregnancy Outcomes for all pregnancies ongoing at Termination must be obtained and recorded on the Pregnancy Outcome CRF
No date within the RAVE database should be after the participant’s termination date specified on the Termination CRF.

19. Considerations for Pregnant Participants
Participants who are pregnant at the SEV will continue to be followed until the pregnancy outcome is ascertained (or, in consultation with the PSRT, it is determined that the pregnancy outcome cannot be ascertained)
Offer enrollment or continue follow-up for MTN-016, as appropriate

20. AEs Requiring Follow-up
A subset of AEs must be followed after a participant's termination
Ongoing SAE/EAEs at termination
AEs that are found to have increased in severity at termination
For AEs that are continuing at the termination visit but do not meet the criteria above, it is left to the discretion of the IoR/designee as to whether the AE needs to be followed. The PSRT can be consulted as needed.

21. Frequency of Follow-up on AEs
IoR/designee must establish a clinically appropriate follow-up plan for AEs requiring follow-up
At a minimum, re-assess 30 days after SEV
Additional evaluations also may take place at the discretion of the IoR/designee
Continue to reassess at least once per month while the study is ongoing until resolution or stabilization
If the AE has not resolved by study end (i.e., once all participants are exited), these AEs should be re-assessed at least once more within days after the study end date

22. Participant Contacts after Termination
After the Termination visit, a ‘final contact’ may be needed for some participants to ensure test results are provided and/or AEs are followed up as needed.
NO CRFs are completed for these final contacts, but these contacts should be documented in the chart notes.

23. Preparing for PUEV/SEVs
Start to educate and prepare participants starting at their Month 9 visits (or between Month 9 and PUEV)
Familiarize yourself with PUEV/SEV CRFs in Medidata MTN-025 TRAIN database
Reviewing current PUEV/Termination visit checklist to ensure up to date

24. Thank you!