Delivery Visits: Key Concepts and Procedures

Delivery and Postpartum Schedule of Evaluation

When should the Delivery Visit occur? Within 3 days after delivery Within 5 days after delivery Within 14 days after delivery Something else

A mother should still complete the Delivery Visit, even if she does not deliver a live born infant. True False

A mother should still complete the Delivery Visit, even if she does not deliver a live born infant. True False If the mother is willing to do so, she should complete the Delivery visit and all subsequent postpartum visits, even if she does not deliver a live born infant, or if that live born infant dies soon after delivery

Why are Delivery Visits so important?

Primary study outcomes are ascertained at this visit. 9.2.1 Primary Outcome Measures 9.2.1.1 Efficacy HIV-1 RNA <200 copies/mL at delivery (up to 14 days postpartum), using real-time test results obtained at site laboratories 9.2.1.2 Safety Composite outcome of spontaneous abortion (occurring at <20 weeks gestation), fetal death (occurring at ≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile using WHO norms) Maternal grade 3 or higher adverse events, including events resulting in death due to any cause, through 50 weeks postpartum (refer to Section 7.3.3 for severity grading) Infant grade 3 or higher adverse events, including events resulting in death due to any cause, through 50 weeks postpartum (refer to Section 7.3.3 for severity grading)

Several secondary study outcomes are ascertained at this visit. 9.2.2 Secondary Outcome Measures 9.2.2.1 HIV-1 RNA <200 copies/mL at delivery (up to 14 days postpartum) using real-time test results obtained at site laboratories 9.2.2.2 HIV-1 RNA <50 copies/mL at delivery (up to 14 days postpartum) using batched test results obtained from central laboratory HIV-1 RNA <200 copies/mL at 50 weeks postpartum using real-time test results obtained from site laboratories 9.2.2.3 HIV-1 RNA <200 copies/mL at delivery using real-time test results obtained from site laboratories and FDA snapshot algorithm HIV-1 RNA <200 copies/mL at 50 weeks postpartum using real-time results obtained from site laboratories and FDA snapshot algorithm

Several secondary study outcomes are ascertained at this visit. 9.2.2 Secondary Outcome Measures 9.2.2.4 Composite outcome of spontaneous abortion (occurring at <20 weeks gestation), fetal death (occurring at ≥20 weeks gestation), preterm delivery (<37 completed weeks), or small for gestational age (<10th percentile using WHO norms) or major congenital anomaly* Ranked composite infant safety outcome (defined in Section 9.6.2) through 50 weeks postpartum Infant HIV infection at delivery and through 50 weeks postpartum [continues…] 9.2.2.5 Preterm delivery (<37 completed weeks) Small for gestational age (<10th percentile using WHO norms)

Delivery Visit Activity Pink cards for mothers, green for infants Place the cards in the order in which you expect to perform Delivery Visit procedures at your site Integrate mother and infant procedures where applicable Omit any cards that are not applicable; add procedures using “other” cards as needed Note any questions and any procedures for which the protocol is not clear Will have to update the colors once Veronica has prepped

Postpartum Evaluations: Questions and Scenarios

Delivery and Postpartum Schedule of Evaluations Review any questions from the postpartum SoE then transition to scenarios (postpartum scenario)

IMPAACT 2010 Study Drug Considerations at Follow-Up Visits

Visit-Specific Guidance Antepartum Q4 Weeks Dispense 30-day supply at each visit; consider dispensing an additional 30-day “buffer” supply as mother approaches her date of delivery. Remind mother to keep taking her study-supplied tablets through labor and delivery and the protocol-specified Delivery Visit. Delivery Dispense a supply sufficient to cover through the Postpartum Week 6 visit (±2 weeks), including any returns the mother may still have in her possession from prior to delivery.

Visit-Specific Guidance Postpartum Week 6 Dispense at least a 30-day supply and up to a 90-day supply at site discretion. Sites choosing to dispense a 30-day supply should plan interim “pharmacy only” visits to dispense more supplies between protocol-specified visits. Postpartum Weeks 14, 26, and 38 Dispense up to 90-day supply at site discretion. Sites choosing to dispense a 30-day supply should plan interim “pharmacy only” visits to dispense more supplies between protocol-specified visits.

Visit-Specific Guidance Postpartum Week 50 No study drug is permitted to be dispensed. Collect all remaining supplies from the mother at this visit.