Please select the outcome measures that correspond to the clinical trial below.
Title: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)
Brief Summary: The purpose of this study was to examine, in an integrated and comprehensive fashion, three critical questions currently facing HIV-infected pregnant and postpartum women and their infants:

1. What is the optimal intervention for the prevention of antepartum and intrapartum transmission of HIV?
2. What is the optimal intervention for the prevention of postpartum transmission in breastfeeding (BF) infants?
3. What is the optimal intervention for the preservation of maternal health after the risk period for prevention of mother-to-child-transmission ends (either at delivery or cessation of BF)?

The overall PROMISE protocol had three separate interventional components to address each of these three questions and was conducted at locations in Africa and other parts of the world. Due to variations in the standard of care for HIV-infected pregnant and postpartum women and their infants at different sites, not all of these questions were relevant. Therefore, two separate versions of the PROMISE protocol were developed, each containing only the relevant components. The 1077BF protocol was used at sites where the standard method of infant feeding was breastfeeding, whereas the 1077FF protocol was used at sites where the standard method of infant feeding was formula feeding. The analyses were collapsed across the two protocol versions, and therefore the summaries contain the results of the 1077BF and/or the 1077FF protocols.


Options:
A: Antepartum Component: Number of Confirmed Infant HIV Infections (Measured at birth or Week 1 study visit); Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Obstetrical Complications (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) (Measured at birth); Postpartum Component: Incidence of Confirmed Infant HIV Infection (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death (From study entry until July 7, 2015, an average of 94 weeks of follow-up.)
B: Antepartum Component: Number of Confirmed Infant HIV Infections (Measured at birth or Week 1 study visit); Antepartum Component: Number of Mothers With Grade 3 or Higher Toxicities and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Obstetrical Complications (Measured through the Week 1 postpartum study visit); Antepartum Component: Number of Mothers With Adverse Pregnancy Outcomes (e.g.,Stillbirth, Preterm Delivery (< 37 Weeks), Low Birth Weight (< 2,500 Grams), and Congenital Anomalies) (Measured at birth); Postpartum Component: Incidence of Confirmed Infant HIV Infection (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Postpartum Component: Incidence of Grade 3 or Higher Adverse Events and Selected Grade 2 Hematologic, Renal, and Hepatic Adverse Events (Measured through site recommended duration of breastfeeding, complete cessation of breastfeeding or 18 months of age, whichever comes first); Maternal Health Component: Incidence of Progression to AIDS-defining Illness or Death (From study entry until July 7, 2015, an average of 94 weeks of follow-up.)
C: HIV Infection in Infants Determined to be HIV Uninfected at 6 Weeks Enrolled in Each Arm of the Study (At Month 6); Frequency and Severity of Adverse Reactions Among Participating Infants (6 weeks through 18 months)
D: Tenofovir Safety for mothers measured by incidence of serious adverse events (SAEs) (From baseline (14-28 weeks gestation) through 12 months postpartum); Dual Energy X-ray absorptiometry (DXA) scans of bone mineral density (from delivery through 6 months postpartum); Maternal Tenofovir Pharmacokinetics (16 weeks gestation through delivery); Infant Tenofovir Pharmacokinetics (one timepoint within 12 hours of delivery); Tenofovir safety for infants measured by incidence of serious adverse events (SAEs) (from birth through 12 months of age)

Answer: A