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IMPAACT 2009 Quiz Game

The PK Component of the IMPAACT 2009 Study aims to determine TFV-DP concentration associated with adequate adherence to PrEP during pregnancy and postpartum. Participants will be monitored for 12 weeks, and different methods of PrEP administration will be utilized. The study duration is expected to be nine months, with enrollment of women in two groups - singleton pregnancy and postpartum. The study population includes HIV-uninfected pregnant women and their infants from various countries. The secondary objective is to compare TFV-DP concentrations in pregnant and postpartum women. The expected sample size is 40 women, and an "evaluable" participant is defined by meeting specific criteria. Key study documents and materials can be found on the IMPAACT 2009 Study Webpage. The IMPAACT 2009 Clinical Management Committee can be contacted for participant clinical and toxicity management questions.

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IMPAACT 2009 Quiz Game

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  1. IMPAACT 2009 Quiz Game 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

  2. What is the primary objective of the PK Component?

  3. Primary Objective • To determine the concentration of tenofovir diphosphate (TFV-DP) associated with adequate adherence to FTC/TDF among women observed ingesting daily oral PrEP during pregnancy and postpartum

  4. Briefly describe the PK Component study design

  5. Study Design • Study staff will monitor and document maternal participant’s PrEP administration daily, for 12 weeks. • DBS specimens will be collected at weekly intervals.

  6. Name one option participants will have for DOT while taking PrEP

  7. PrEP doses taken will be categorized into one of the following: • Directly observed in-person by study staff • Directly observed in real-time video (live streaming or time/date stamped recording) • Self-reported, including still photos of dose ingestion • Missed dose (missing data or reported as missed)

  8. How long is accrual expected to take?

  9. Study Duration Accrual is expected to take approximately three months.Participants will be in follow-up for three months. Analysis of PrEP drug levels will be completed within approximately three months after the last participant follow-up visit. In total, the PK Component is expected to take nine months.

  10. Women will be enrolled in 2 groups; describe the difference between Group 1 and Group 2

  11. Study Population • Group 1: Enrolled during singleton pregnancy at 14-24 weeks’ gestation • Group 2: Enrolled postpartum within 6-12 weeks after delivery

  12. Briefly describe the IMPAACT 2009 study population

  13. Study Population IMPAACT 2009 will include: • HIV-uninfected pregnant women 16-24 years of age and their infants • From sites in Malawi, Uganda, South Africa, and Zimbabwe

  14. True or False? The Secondary Objective of the PK Component is to: Assess the safety of FTC/TDF for PrEP during pregnancy and postpartum by comparing pregnancy outcomes and maternal and infant safety outcomes between cohorts.

  15. Secondary Objective False! Correct answer: To compare TFV-DP concentrations observed in pregnant and postpartum women

  16. Name the IMPAACT 2009 Protocol Data Managers

  17. Protocol Data Managers Laura Smith and Ben Johnston

  18. What is the expected sample size for the PK Component?

  19. Sample Size • Approximately 40 women (20 per group) to achieve at least 30 evaluable women (15 per group) and their infants

  20. How is an “evaluable” participant defined in the PK Component?

  21. Definition of Evaluable Participant • A participant will be considered evaluable upon meeting the following criteria: • Completes PK Component follow-up, • Has adequate documentation that PrEP doses were directly observed, • Has demonstrated adequate adherence to PrEP*, and • Had adequate DBS samples shipped to PK testing laboratory* • * “Adequate” is defined in protocol Section 9.1.1

  22. What is the national animal of Zimbabwe?

  23. List 3 of the PK Component inclusion criteria

  24. Inclusion Criteria See protocol Section 4.1.1

  25. List 3 of the PK Component exclusion criteria

  26. Exclusion Criteria See protocol Section 4.1.2

  27. Where can sites find key study documents, training materials and study implementation tools?

  28. IMPAACT 2009 Study Webpage

  29. Bonus Question! During study implementation, who should sites contact with participant clinical and/or toxicity management questions?

  30. IMPAACT 2009 Clinical Management Committee (CMC)

  31. Bonus Question! List two of the modifications made in Letter of Amendment (LoA) #1, dated 1 March 2018

  32. LoA #1: Summary of Modifications and Rationale • Correct discrepancies in the laboratory values indicated in the entry criteria for both the PK and PrEP Comparison Components. The requirement for the lab values to be Grade 1 or normal per the DAIDS Table for Grading of the Severity of Adverse Events (Corrected Version 2.1, dated July 2017) remains while the corresponding lab values are corrected for consistency with the grading table. • Correct the requirements for data to be entered into eCRFs. No changes are made to study assessments. • Add required regulatory authority language specifying that U.S., local, and international regulatory entities may review study records.

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