IMPAACT 2009Section 6 and Schedule of Evaluations Protocol Version 1.0, with LoA #1
Screening Visits Key operational reminders: • Screening may be initiated after written informed consent is obtained • Screening procedures must be performed within 30 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 * Except for HIV RNA test; HIV negative NAT test result, from a specimen collected within 14 days prior to enrollment, is required prior to Entry.
True False A mother’s baseline medical history is first recorded at the Screening Visit.
Where in the protocol can you find the required elements of the baseline medical history? Section 6.8
True False A complete maternal physical exam is required at the Screening Visit.
Where in the protocol can you find the required elements of the complete maternal physical exam? Section 6.9
Appendix IA (Schedules of Evaluation): Maternal PK Component Group 1 and 2 Completephysical exam required; refer to protocol Section 6.9 for list of evaluations that should be included Targetedphysical exam required • Per LoA #1, weight and height (at Entry only) should be entered into eCRFs. Temperature and blood pressure should be entered into eCRFs if abnormal; other abnormal findings may also be entered into eCRFs if required as specified in Section 7.2.
True False For Group 1, fetal ultrasound must be performed within 14 days prior to Entry.
Fetal Ultrasound • For Group 1, fetal ultrasound report is required prior to entry to: • Estimate gestational age • Assess for multiple gestation • If ultrasound is performed during the screening period, results must be considered for purposes of eligibility determination • Prior ultrasound results can be used to meet this requirement, if a report of biometric measurements is available as documentation
True False Urinalysis (protein and glucose) results must be available prior to Entry.
True False As long as screening creatinine test results are available, it is not necessary to calculate CrCl prior to Entry.
True False Plasma should be stored for HIV drug resistance testing for all mothers who are screened, regardless of whether they enroll in the study.
Entry Visits Key operational reminders • 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, HIV rapid test) should be performed first, prior to final eligibility determination • If a participant is found to be ineligible on the day of enrollment, enrollment must not occur
ENTRY Visits Key operational reminders • Rapid HIV test, and final eligibility determination and confirmation must precede enrollment • Blood collection for baseline TFV-DP level must precede ingestion of first dose of study drug • Prescribing must precede dispensing and administering of study drug • Day of Entry = Day 0
Which of the following procedures are not required at the maternal Entry visit? • iNSC • HSV 2 Testing • DBS for Baseline TFV-DP Level • Chlamydia and Gonorrhea Testing • CASI • Demographic/Behavioral Questionnaires
Refer to protocol Section 5.3.1 Refer to protocol Section 6.16
Maternal Follow up visits Key operational reminders • Mothers will have once weekly follow-up visit for 12 weeks following Entry. • The Week 4, 8, 12 study visits must be conducted at the study clinic. • Weekly visits at other time points (Weeks 1-3, 5-7 and 9-11) may be conducted in the study clinic OR at an approved offsite location (refer to protocol Section 6.1.1). • At all visits when study drug is dispensed (Weeks 4 and 8), a negative rapid HIV test result must be available prior to prescribing PrEP. • Daily adherence to PrEP will be assessed with directly observed therapy (DOT). Study staff will develop an individualized DOT plan for each participant. • For participants in Group 1 who deliver prior to completing all12 weekly visits, the follow-up schedule should be maintained to the extent possible after delivery. The L&D visit may be combined with a weekly visit.
True False During follow-up, blood is collected for ALT, Creatinine, and CrCl at Weeks 4 and 12 only.
True False For Group 2, pregnancy testing is required at Weeks 4, 8, and 12.
QLW10046: IMPAACT 2009 Sociodemographics Questionnaire & QLW10055: IMPAACT 2009 Risk and Sexual Behavior Questionnaire
Labor and Delivery visit Key operational reminders • Regardless of whether a maternal participant has completed 12 weeks of follow-up, a visit will be conducted within 14 days after delivery to: • Document the pregnancy outcome • Evaluate the infant (refer to Protocol Section 6.1.2) • If the Labor and Delivery (L&D) Visit falls within the window of one of the weekly visits, visits may be combined • If the participant has completed the 12 weeks of follow-up prior to L&D, then this visit will be the final maternal study visit • If the participant had elected to remain on study drug beyond the 12 weeks of PK assessment, then study drug should be retrieved at the L&D Visit
Which of the following procedures are not required at the Labor and Delivery Visit? • Rapid HIV Test • DBS for TFV-DP Level • Collect Blood for Creatinine and CrCl • Store Plasma for HIV Drug Resistance Testing • Demographic/Behavioral Questionnaires
INFANT VISITS Key operational reminders • Infants in Group 1 will have twostudy visits at birth and six weeks postpartum • The infant Birth Visit will be conducted within 14 days after birth; whenever possible, this visit should occur on the same day as the Labor and Delivery Visit • There is no corresponding maternal visit for the infant’s Postpartum Week 6 Visit • Infants in Group 2 will have three study visits at Entry, Week 6 and Week 12 after study entry. These time points correspond to the maternal enrollment visit and two of the maternal follow-up visits; whenever possible, infant visits should be scheduled on the same date of the corresponding maternal visit • Given that Group 2 maternal participants are enrolled at 6-12 weeks postpartum, infants in this group enter the study at 6-12 weeks of age, follow-up visit scheduling is then based on the date of enrollment and unrelated to the infant’s date of birth
True False Infant feeding history must be collected at every visit.
Where in the protocol can you find the more information about collection of data pertaining to infant feeding history? Section 6.12
True False For Group 1 infants, a complete physical exam is required at the Birth Visit.
Where in the protocol can you find the required elements of the complete infant physical exam? Section 6.13
Targetedphysical exam required Completephysical exam required; refer to protocol Section 6.9 for list of evaluations that should be included • Per LoA #1, weight, length, and head circumference should be entered into eCRFs. Temperature should be entered into eCRFs if abnormal; other abnormal findings may also be entered into eCRFs if required as specified in Section 7.2.