Please select the arm or intervention descriptions that belong 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: Arm Label: E/C/F/TAF; Type: EXPERIMENTAL; Interventions: Drug: E/C/F/TAF | Arm Label: Stay on Baseline Treatment Regimen (SBR); Type: ACTIVE_COMPARATOR; Interventions: Drug: E/C/F/TDF, Drug: EFV/FTC/TDF, Drug: RTV, Drug: ATV, Drug: FTC/TDF, Drug: COBI | Intervention Type: DRUG; Name: E/C/F/TAF; Assigned to Arm(s): E/C/F/TAF | Intervention Type: DRUG; Name: E/C/F/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: EFV/FTC/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: RTV; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: ATV; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: FTC/TDF; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR) | Intervention Type: DRUG; Name: COBI; Assigned to Arm(s): Stay on Baseline Treatment Regimen (SBR)
B: Arm Label: 2A; Type: EXPERIMENTAL; Interventions: Drug: Nevirapine | Arm Label: 2B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Nevirapine placebo | Intervention Type: DRUG; Name: Nevirapine; Assigned to Arm(s): 2A | Intervention Type: DRUG; Name: Nevirapine placebo; Assigned to Arm(s): 2B
C: Arm Label: Continuous quality improvement (CQI); Type: EXPERIMENTAL; Interventions: Other: Continuous quality improvement | Arm Label: Standard of care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Continuous quality improvement; Assigned to Arm(s): Continuous quality improvement (CQI)
D: Arm Label: Antepartum Arm A; Type: ACTIVE_COMPARATOR; Interventions: Drug: Zidovudine (ZDV), Drug: Nevirapine (NVP): Antepartum Mothers, Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail, Drug: Nevirapine (NVP): Infant short-course | Arm Label: Antepartum Arm B; Type: EXPERIMENTAL; Interventions: Drug: Lamivudine-Zidovudine (3TC-ZDV), Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Antepartum Arm C; Type: EXPERIMENTAL; Interventions: Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Late Presenters; Type: OTHER; Interventions: Other: No Intervention | Arm Label: Postpartum Arm A (Maternal Prophylaxis); Type: EXPERIMENTAL; Interventions: Drug: Lopinavir-ritonavir (LPV-RTV), Drug: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]), Drug: Nevirapine (NVP): Infant short-course | Arm Label: Postpartum Arm B (Infant Prophylaxis); Type: EXPERIMENTAL; Interventions: Drug: Nevirapine (NVP): Infant extended | Arm Label: Maternal Health Arm A (Continue triple ARVs); Type: EXPERIMENTAL; Interventions: Other: Continue triple ARVs | Arm Label: Maternal Health Arm B (Discontinue triple ARVs); Type: ACTIVE_COMPARATOR; Interventions: Other: Discontinue triple ARVs | Intervention Type: DRUG; Name: Zidovudine (ZDV); Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Nevirapine (NVP): Antepartum Mothers; Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]) tail; Assigned to Arm(s): Antepartum Arm A | Intervention Type: DRUG; Name: Lamivudine-Zidovudine (3TC-ZDV); Assigned to Arm(s): Antepartum Arm B | Intervention Type: DRUG; Name: Lopinavir-ritonavir (LPV-RTV); Assigned to Arm(s): Antepartum Arm B, Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Emtricitabine-tenofovir disoproxil fumarate (Truvada [TRV]); Assigned to Arm(s): Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Nevirapine (NVP): Infant short-course; Assigned to Arm(s): Antepartum Arm A, Antepartum Arm B, Antepartum Arm C, Postpartum Arm A (Maternal Prophylaxis) | Intervention Type: DRUG; Name: Nevirapine (NVP): Infant extended; Assigned to Arm(s): Postpartum Arm B (Infant Prophylaxis) | Intervention Type: OTHER; Name: No Intervention; Assigned to Arm(s): Late Presenters | Intervention Type: OTHER; Name: Discontinue triple ARVs; Assigned to Arm(s): Maternal Health Arm B (Discontinue triple ARVs) | Intervention Type: OTHER; Name: Continue triple ARVs; Assigned to Arm(s): Maternal Health Arm A (Continue triple ARVs)

Answer: C