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

Not Applicable

Completed

• Conditions: Pregnancy Outcomes; HIV/AIDS; Antiretroviral Therapy; HIV-exposed Infants
• Interventions: Other: Continuous quality improvement

• Registration Number: NCT03048669
• Lead Sponsor: Albert Einstein College of Medicine

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.

Detailed Description

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5053

Inclusion Criteria

• All women diagnosed with HIV during pregnancy or breastfeeding in the participating maternal and child health (MCH) clinics and initiated on antiretroviral therapy (ART) during the enrollment period

Exclusion Criteria

• Refuse to participate
• Clinics will be excluded if less than 500 pregnant women (less than 5 HIV-infected pregnant women) registered for antenatal care (ANC) in the clinic in 2015

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous quality improvement (CQI)	Continuous quality improvement	Quality improvement initiatives implemented at facility level using participatory data-driven approaches and on-site monitoring and supervisory support

Primary Outcome Measures

Name	Time	Method
Loss-to-follow-up	delivery, six weeks, 12 and 24 weeks postpartum	the proportion of participants for whom the whereabouts is unknown at the evaluation time
Virological suppression	delivery, 12 and 24 months postpartum	Proportion of participants with undetectable viral load

Secondary Outcome Measures

Name	Time	Method
MTCT rates	delivery, six weeks, 12 and 24 weeks postpartum	Proportion of HIV-exposed infant who test positive for HIV
Timely Infant HIV diagnosis	delivery, six weeks, 12 and 24 weeks postpartum	Proportion of HIV-exposed infant with an appropriate HIV test result
Survival	delivery, six weeks, 12 and 24 weeks postpartum	Proportion of participating mothers and infants know to be alive
Timely ART initiation	two weeks from HIV diagnosis	Proportion of HIV-infected participants (mother or infant) initiated on ART within two weeks of diagnosis

Trial Locations

Locations (1)

Kinshasa School of Public Health; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the