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

The US President's Emergency Plan for AIDS Relief (PEPFAR) goal of an AIDS-free generation, re-emphasized in PEPFAR 3.0, will not be achieved without substantial improvement in the adherence to the HIV care continuum among women in maternal and child health clinics (MCH) in resource-limited settings. In a recent meta-analysis of loss to follow-up (LTFU) across the prevention of mother-to-child transmission of HIV (PMTCT) cascade, about 50% of HIV+ pregnant women are already LTFU by delivery; within 3 months of delivery 33.9% of mother-infant pairs are also LTFU. Consequently, half of pediatric infections are currently estimated to occur in the postpartum period during breastfeeding and fewer than 40% of HEI are tested for HIV at 2-3 months. Determinants of this poor performance occur at multiple levels: healthcare delivery systems, providers, and beneficiaries (HIV-infected mothers). Current evidence suggest that beyond individual-level factors, healthcare delivery system level factors are paramount. Quality Improvement (QI) Collaborative is one of the most popular methods for organizing sustained improvement efforts at hospitals and ambulatory practices worldwide. In the Breakthrough Series approach also refer to as continuous quality improvement (CQI),10 QI teams from multiple sites across a region or country are brought together to focus on a common problem. Over one or two years, experts in clinical and performance improvement provide the group with periodic instructions and encourage the teams to share lessons learned and best practices. However, its popularity, CQI effectiveness has never been demonstrated in a randomized trial or a well-designed comparative study. The aims of the proposed study are: 1) to evaluate the effectiveness of CQI interventions in improving long-term retention in care and virological suppression in women who start lifelong ART in MCH clinics and 2) to identify modifiable health delivery system factors associated with retention in care and sustained virological suppression in women who start lifelong ART in MCH clinics. The study will be implemented in Kinshasa, Democratic Republic of Congo (DRC): an extremely resource-limited country that has struggled to emerge from decades of gross mismanagement, rampant corruption, and wars that have left its health infrastructures in shambles. We will conduct a cluster-randomized trial with health districts as the randomization unit. MCH clinics in the intervention group, will undergo CQI initiatives using participatory data-driven approaches and on-site monitoring and supervisory support. We will use surveys of health facilities, including selected staff, and service beneficiaries (HIV infected mothers) to collect data on key characteristics of the service delivery's organization and providers' and patients' perspective of the HIV care delivery performance. The main outcomes will be LTFU/retention in care, virological suppression and MTCT rates evaluated at 24 months postpartum.