1. IMPAACT 2010 Screening Visits
Maybe re-assign teams after lunch

2. Protocol References Section Title 6.1 Screening Visits Appendix 1
Schedule of Evaluations ─ Antepartum

3. Screening Visits Key operational reminders:
Screening may be initiated after written informed consent is obtained
Screening procedures must be performed within 14 days prior to enrollment
Screening procedures may be performed on multiple days, including on the date of enrollment
Screening procedures may be repeated, with the latest outcome used for eligibility determination

4. Repeat Screening Attempts
If the 14-day screening period is exceeded, the screening process may be repeated, if adequate time remains to permit enrollment within 14 days of non-study ART initiation.
In this case, all procedures listed in protocol Section 6.1, including the informed consent process, must be repeated except:
New PIDs should not be assigned
Confirmatory HIV testing need not be repeated
Fetal ultrasound need not be repeated
Previously documented medical and medications history information should be reviewed and updated through the date of re-screening (it is not necessary to re-record history information that was previously documented)
Section 6.1, bottom of page 54

5. A mother’s baseline medical history is first recorded at the Screening Visit.
True
False

6. Where in the protocol can you find the required elements of the maternal baseline medical history?
Section 6.11
Text and Table 3

7. A complete maternal physical exam is required at the Screening Visit.
True
False

8. Where in the protocol can you find the required elements of the complete maternal physical exam?
Section 6.12

9. Fetal ultrasound must be performed within 14 days prior to enrolment.
True
False

10. Fetal Ultrasound
Fetal ultrasound should be performed if possible during the study screening period to:
Estimate gestational age
Assess for multiple gestation and fetal anomalies
If ultrasound is performed during the screening period, results must be considered for purposes of eligibility determination
If ultrasound cannot be performed during the screening period (should be rare), the best available method should be used to perform these assessments for purposes of eligibility determination

11. Fetal Ultrasound
If a fetal ultrasound is not performed prior to entry, it must be done as soon as possible and within 14 days after study entry
Ultrasound findings will then be used in algorithms to calculate gestational age at study entry and at delivery
If a fetal ultrasound is performed after entry, enrolled participants will not be withdrawn from the study if the ultrasound identifies an exclusionary condition

12. AST and ALT test results must be available prior to enrollment.
True
False
4.1.4

13. If an exclusionary ALT result is obtained at screening, the test may be repeated, with the latest outcome used for eligibility determination.
True
False
4.1.4

14. When can enrollment occur?
SUN
MON
TUE
WED
THU
FRI
SAT 1
Starts ART 2 3
Screening
Visit 4 5 6 7 8
Screening lab results received 9 10 11 12 13 14
Last day to enroll 15 16 17 18 19 20 21 22 23 24 25 26
In this example, we have the same ART initiation and screening visit dates as in previous examples, so we know that the last day to enroll falls on the 14th of the month.
We have also noted in this example that screening lab results are received on the 8th of the month.
Looking at the calendar, we need to consider whether there enough time to recall the participant to the clinic and repeat the tests, with results received before the last day to enroll.
This may or may not be possible, depending on when lab test results are received, and this example highlights the importance of coordination and communication between the clinic and the lab during the study screening period.

15. As long as screening creatinine test results are available, it is not necessary to calculate CrCl prior to enrolment.
True
False

16. Plasma stored at the Screening Visit should be kept for all mothers who are screened, regardless of whether they enroll the study.
True
False

17. What are your questions?

18. IMPAACT Entry Visits
Pick up from here AFTER Entry Visit Activity

19. Protocol References Section Title 6.2 Entry Visit Appendix 1
Schedule of Evaluations ─ Antepartum

20. Entry Visits Key operational reminders
For eligible mother-infant pairs, enrollment must occur at weeks gestation and within 14 days of the mother initiating ART in the current pregnancy
All Entry Visit procedures are expected to be performed on the day of enrollment
Procedures that may provide information relevant to eligibility for the study (e.g., medical history, physical examination) should be performed first, prior to final eligibility determination.

21. Entry Visits Key operational reminders
Final eligibility determination and confirmation must precede enrollment
Enrollment must precede prescribing of study drug
Prescribing must precede dispensing of study drug
Blood collection should ideally precede enrollment and must precede ingestion of the first dose of study drug

22. A mother is considered enrolled in the study when …
She provides written informed consent
She and her infant are found to meet all study eligibility criteria
She and her infant are assigned SIDs by the Subject Enrollment System

23. An infant is considered enrolled in the study when …
The infant’s mother provides written informed consent
The mother and infant are found to meet all study eligibility criteria
The mother and infant are assigned SIDs by the Subject Enrollment System
The infant is born

24. What are your questions?