Long Term Outcomes of Therapy in Women Initiated on Lifelong ART Because of Pregnancy in DR Congo

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.

Conditions

• HIV/AIDS
• Antiretroviral Therapy
• Pregnancy Outcomes
• HIV-exposed Infants

Interventions

OTHER

Continuous quality improvement

A quality improvement team at the health district and at the clinics levels. A clinic level QI team will include at least one staff each from antenatal care (ANC), delivery/maternity, and well-child services. The head of the each QI team plus a supervisor from the health district bureau and a study team member constitute the district QI team. Immediately following randomization, we will bring together QI teams to review program and quality indicators from their clinics and across districts to identify key bottlenecks in the care delivery system and agree on an action plan to modify them. QI teams will be responsible for the implementation of the action plan at the level of their respective clinics. Every three months, using data from the monitoring system, the process will be repeated for a duration 18 months. To limit possible contamination, all staff from a randomized district/clinic who may have a dual appointment in another facility will be excluded from QI teams.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• Kinshasa School of Public Health

  collaborator OTHER

• Albert Einstein College of Medicine

  lead OTHER

Principal Investigators

• Marcel Yotebieng, MD, PhD · Albert Einstein College of Medicine

• Emile W Okitolonda, MD, PhD · Kinshasa School of Public Health

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2021-06-30

Completion

2022-06-30

Countries

• Democratic Republic of the Congo

Study Locations