medRxiv : the preprint server for health sciences · 2026
Effect of health-system continuous quality improvement on long-term retention in HIV care among pregnant and breastfeeding women in the Democratic Republic of Congo: A cluster-randomized trial.
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Yotebieng Marcel, Rosa Ravelomanana Noro Lantoniaina, Kawende Bienvenu, Tabala Martine, Malongo Fathy, Lumande Fidéle, Zotova Natalia, Babakazo Pelagie
Аннотация
BACKGROUND: Despite relatively high coverage of interventions to prevent vertical transmission, HIV incidence among children born to women living with HIV (WLH) remains above elimination targets, partly because of substantial disengagement from antiretroviral therapy (ART) during the postpartum period. We evaluated the effectiveness of a data-driven continuous quality improvement (CQI) intervention in improving retention in care, virological suppression, and prevention of vertical transmission among pregnant and breastfeeding WLH receiving ART in maternal and child health (MCH) clinics.
METHODS AND FINDINGS: This pragmatic cluster-randomized trial was conducted in 105 MCH clinics- three high-volume clinics in each of the 35 health zones (HZs) of Kinshasa Province, Democratic Republic of the Congo. During the pre-randomization phase (November 2016-December 2017), routine data collection using prevention of mother-to-child transmission registers was strengthened in all participating clinics. In January 2018, HZs were randomized 1:1 to implement CQI or continue the standard of care. In intervention HZs, quality improvement (QI) teams were established at the HZ and clinic levels. Indicators selected collaboratively with QI teams were calculated from routine program data and shared quarterly. Through July 2019, QI teams met quarterly to identify service-delivery challenges and develop strategies to improve outcomes, with an emphasis on retention. Thereafter, responsibility for producing indicators was transferred to QI teams, and meetings continued virtually through WhatsApp.Pregnant and breastfeeding WLH and their infants receiving care at participating clinics between November 2016 and July 2019 were enrolled and followed for at least 24 months. Primary outcomes were loss to follow-up (LTFU), viral suppression (<1,000 copies/mL), and a positive HIV test among live-born infants. Overall, 2,376 women were enrolled, including 1,217 (51.2%) before randomization. The analysis of CQI effectiveness included 1,900 participants who remained in care at randomization or enrolled thereafter: 1,103 (58.1%) in control HZs and 797 (41.9%) in intervention HZs.At 6, 12, and 24 months, LTFU was lower in the intervention group than in the control group: 18.6% versus 21.6% (adjusted risk difference [aRD], -5.2 percentage points; 95% CI, -9.6 to -0.8), 29.2% versus 31.0% (aRD, -3.9; 95% CI, -10.2 to 2.4), and 50.1% versus 55.5% (aRD, -7.1; 95% CI, -15.2 to 1.0), respectively. Estimated effects were larger in PEPFAR-supported and urban clinics, although interaction tests were not statistically significant. Viral-load results were available for 38.2%, 50.4%, and 73.5% of eligible participants at 6, 12, and 24 months, respectively. Neither viral-load-result availability nor viral suppression differed between groups. Infant HIV-test results were available for 8.1%, 32.7%, 34.2%, and 28.5% of eligible infants at 6 weeks and 6, 12, and 24 months, respectively.
CONCLUSIONS: CQI implementation produced a modest improvement in retention, with the clearest evidence at 6 months and favorable but imprecise estimates through 24 months. Limited availability of maternal viral-load and infant HIV-test results precluded definitive conclusions about virological suppression and vertical transmission. Local quality-improvement interventions may strengthen processes within frontline teams' control but cannot alone overcome failures across an interconnected care system. Future studies should align interventions' operational reach with all health-system levels responsible for the intended outcomes.
TRIAL REGISTRATION: http://ClinicalTrials.gov NCT03048669 .
WHY WAS THIS STUDY DONE?: Loss from HIV care during pregnancy and breastfeeding remains an important barrier to preventing HIV transmission from women to their children.Most interventions have focused on supporting individual women, while relatively few have tested approaches that help clinics and local health authorities identify and correct weaknesses in healthcare delivery.Randomized evidence about whether continuous quality improvement can improve long-term retention in maternal HIV care is limited, particularly in resource-constrained settings.
WHAT DID THE RESEARCHERS DO AND FIND?: We conducted a cluster-randomized trial involving 105 maternal and child health clinics across all 35 health zones in Kinshasa, Democratic Republic of Congo; the intervention-period analysis included 1,900 women living with HIV.In intervention health zones, clinic and health-zone teams regularly reviewed performance data, identified barriers to care, and implemented locally selected solutions; comparison health zones continued standard care.Loss to follow-up was approximately 5 percentage points lower at 6 months, 4 percentage points lower at 12 months, and 7 percentage points lower at 24 months in the intervention group after adjustment, although only the 6-month estimate clearly excluded no effect.Viral suppression and infant HIV outcomes did not differ between groups, but these analyses were limited by the low availability of laboratory results.
WHAT DO THESE FINDINGS MEAN?: Data-driven continuous quality improvement may produce modest improvements in retention when frontline clinic and health-zone teams can directly act on the barriers responsible for poor outcomes.Local quality-improvement activities may have less effect on outcomes that depend on services outside their operational control, such as testing and reporting performed through a centralized laboratory system.The longer-term estimates were imprecise, implementation varied among clinics, and many laboratory results were unavailable; the findings should therefore be interpreted cautiously and confirmed in other health systems.
METHODS AND FINDINGS: This pragmatic cluster-randomized trial was conducted in 105 MCH clinics- three high-volume clinics in each of the 35 health zones (HZs) of Kinshasa Province, Democratic Republic of the Congo. During the pre-randomization phase (November 2016-December 2017), routine data collection using prevention of mother-to-child transmission registers was strengthened in all participating clinics. In January 2018, HZs were randomized 1:1 to implement CQI or continue the standard of care. In intervention HZs, quality improvement (QI) teams were established at the HZ and clinic levels. Indicators selected collaboratively with QI teams were calculated from routine program data and shared quarterly. Through July 2019, QI teams met quarterly to identify service-delivery challenges and develop strategies to improve outcomes, with an emphasis on retention. Thereafter, responsibility for producing indicators was transferred to QI teams, and meetings continued virtually through WhatsApp.Pregnant and breastfeeding WLH and their infants receiving care at participating clinics between November 2016 and July 2019 were enrolled and followed for at least 24 months. Primary outcomes were loss to follow-up (LTFU), viral suppression (<1,000 copies/mL), and a positive HIV test among live-born infants. Overall, 2,376 women were enrolled, including 1,217 (51.2%) before randomization. The analysis of CQI effectiveness included 1,900 participants who remained in care at randomization or enrolled thereafter: 1,103 (58.1%) in control HZs and 797 (41.9%) in intervention HZs.At 6, 12, and 24 months, LTFU was lower in the intervention group than in the control group: 18.6% versus 21.6% (adjusted risk difference [aRD], -5.2 percentage points; 95% CI, -9.6 to -0.8), 29.2% versus 31.0% (aRD, -3.9; 95% CI, -10.2 to 2.4), and 50.1% versus 55.5% (aRD, -7.1; 95% CI, -15.2 to 1.0), respectively. Estimated effects were larger in PEPFAR-supported and urban clinics, although interaction tests were not statistically significant. Viral-load results were available for 38.2%, 50.4%, and 73.5% of eligible participants at 6, 12, and 24 months, respectively. Neither viral-load-result availability nor viral suppression differed between groups. Infant HIV-test results were available for 8.1%, 32.7%, 34.2%, and 28.5% of eligible infants at 6 weeks and 6, 12, and 24 months, respectively.
CONCLUSIONS: CQI implementation produced a modest improvement in retention, with the clearest evidence at 6 months and favorable but imprecise estimates through 24 months. Limited availability of maternal viral-load and infant HIV-test results precluded definitive conclusions about virological suppression and vertical transmission. Local quality-improvement interventions may strengthen processes within frontline teams' control but cannot alone overcome failures across an interconnected care system. Future studies should align interventions' operational reach with all health-system levels responsible for the intended outcomes.
TRIAL REGISTRATION: http://ClinicalTrials.gov NCT03048669 .
WHY WAS THIS STUDY DONE?: Loss from HIV care during pregnancy and breastfeeding remains an important barrier to preventing HIV transmission from women to their children.Most interventions have focused on supporting individual women, while relatively few have tested approaches that help clinics and local health authorities identify and correct weaknesses in healthcare delivery.Randomized evidence about whether continuous quality improvement can improve long-term retention in maternal HIV care is limited, particularly in resource-constrained settings.
WHAT DID THE RESEARCHERS DO AND FIND?: We conducted a cluster-randomized trial involving 105 maternal and child health clinics across all 35 health zones in Kinshasa, Democratic Republic of Congo; the intervention-period analysis included 1,900 women living with HIV.In intervention health zones, clinic and health-zone teams regularly reviewed performance data, identified barriers to care, and implemented locally selected solutions; comparison health zones continued standard care.Loss to follow-up was approximately 5 percentage points lower at 6 months, 4 percentage points lower at 12 months, and 7 percentage points lower at 24 months in the intervention group after adjustment, although only the 6-month estimate clearly excluded no effect.Viral suppression and infant HIV outcomes did not differ between groups, but these analyses were limited by the low availability of laboratory results.
WHAT DO THESE FINDINGS MEAN?: Data-driven continuous quality improvement may produce modest improvements in retention when frontline clinic and health-zone teams can directly act on the barriers responsible for poor outcomes.Local quality-improvement activities may have less effect on outcomes that depend on services outside their operational control, such as testing and reporting performed through a centralized laboratory system.The longer-term estimates were imprecise, implementation varied among clinics, and many laboratory results were unavailable; the findings should therefore be interpreted cautiously and confirmed in other health systems.