Please select the outcome measures that correspond to the clinical trial below.
Title: Continuous Quality Improvement Interventions to Improve Long Term Outcomes of Antiretroviral Therapy in Women Initiated on Therapy During Pregnancy or Breastfeeding in the Democratic Republic of Congo
Brief Summary: Despite the rapid adoption of the World Health Organization's 2013 guidelines, many children continue to be infected with HIV perinatally because of sub-optimal adherence to the continuum of HIV care in maternal and child health clinics (MCH). To achieve the UNAIDS goal eliminating mother-to-child HIV transmission, multiple, adaptive interventions will need to be implemented to improve adherence to the HIV continuum. The aim of this open label, parallel groups, randomized controlled trial is to evaluate the effectiveness of Continuous Quality Improvement (CQI) interventions implemented at facility and health district level to improve retention in care and virological suppression through 24 months postpartum among pregnant and breastfeeding women receiving ART in MCH clinics in Kinshasa, Democratic Republic of Congo. Prior to randomization, the current monitoring and evaluation system will be strengthen to enable collection of high quality individual patient-level data necessary for the timely production of indicators and monitoring of program outcomes to inform CQI interventions. Following randomization, in health districts randomized to CQI, quality improvement (QI) teams will be established at the district level and at MCH clinics level. For 18 months, QI teams will be brought together quarterly to identified key bottlenecks in the care delivery system using data from the monitoring system, develop an action plan to address those bottlenecks, and implement the action plan at the level of their district or clinics. If proven to be effective, CQI as designed here, could be scaled up rapidly in DRC and other resource-limited settings to accelerate progress towards the goal of an AIDS free generation.


Options:
A: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (Week 48)
B: 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)
C: Loss-to-follow-up (delivery, six weeks, 12 and 24 weeks postpartum); Virological suppression (delivery, 12 and 24 months postpartum)
D: 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.)

Answer: C