Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial

Yotebieng, Marcel; Behets, Frieda; Kawende, Bienvenu; Ravelomanana, N.; Tabala, Martine; Okitolonda, Emile

doi:10.1186/s12913-017-2253-9

Cited by 15 publications

(14 citation statements)

References 25 publications

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“…This cross‐sectional study was conducted as part of baseline assessment for the CQI‐PMTCT study: an ongoing cluster randomized trial to evaluate the effect of continuous quality interventions (CQI) on long‐term outcome of ART among pregnant and breastfeeding women (NCT03048669) . Briefly, Health zones were randomized to data driven quality improvement group in which multidisciplinary teams are brought together quarterly to identify key bottlenecks in care delivery system, develop and implement plans to address the bottlenecks at the district or facility levels.…”

Section: Methodsmentioning

confidence: 99%

“…Briefly, Health zones were randomized to data driven quality improvement group in which multidisciplinary teams are brought together quarterly to identify key bottlenecks in care delivery system, develop and implement plans to address the bottlenecks at the district or facility levels. The protocol with detailed description of the intervention has been published elsewhere .…”

Section: Methodsmentioning

confidence: 99%

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HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI‐PMTCT study

et al. 2019

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Introduction Published data on viral suppression among pregnant and breastfeeding women in routine care settings are scarce. Here, we report provincial estimates of undetectable and suppressed viral load among pregnant or breastfeeding women in HIV care in Kinshasa, Democratic Republic of Congo (DRC) and associated risk factors. Methods This cross‐sectional study was conducted as part of a baseline assessment for the CQI‐PMTCT study: an ongoing cluster randomized trial to evaluate the effect of continuous quality interventions (CQI) on long‐term ART outcomes among pregnant and breastfeeding women (NCT03048669). From November 2016 to June 2018, in each of the 35 Kinshasa provincial health zones (HZ), study teams visited the three busiest maternal and child health clinics, enrolled all HIV‐positive pregnant or breastfeeding women (≤1 year post‐delivery) receiving ART, and performed viral load testing. Log binomial models with generalized estimating equations to account for clustering at the HZ level, were used to estimate prevalence ratios comparing participants with undetected (<40 copies/mL) or suppressed (<1000 copies/mL) viral load across levels of individual and site characteristics. Results Of the 1752 eligible women, 1623 had viral load results available, including 38% who had been on ART for <6 months and 74% were on tenofovir‐lamivudine‐efavirenz. Viral load was undetectable in 53% of women and suppressed in 62%. Among women who were on ART for ≥12 months, only 60% and 67% respectively, had undetectable or suppressed viral load. Viral load was undetectable in 53%, 48% and 58% of women testing during pregnancy, at delivery, and in postpartum respectively. In multivariable log binomial models, duration of ART >12 months, older age, being married, disclosure of HIV status, receiving care in an urban health zone or one supported by PEPFAR were all positively associated with viral suppression. Conclusions The observed high level of detectable viral load suggests that high ART coverage alone without substantial efforts to improve the quality of care for pregnant and breastfeeding women, will not be enough to achieve the goal of virtual elimination of vertical HIV transmission in high‐burden and limited resources settings like DRC.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI‐PMTCT study

et al. 2019

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“…This cross sectional study was conducted as part of an ongoing randomized trial to investigate the effect of data-driven continuous quality interventions (CQI) on long term ART outcomes among pregnant and breastfeeding women receiving care in the Kinshasa province (CQI-PMTCT study, NCT03048669) [12]. In each of the 35 health zones in the province, the three busiest maternal and child health (MCH) facilities were selected to be part of the study.…”

Section: Methodsmentioning

confidence: 99%

Hepatitis B infection among pregnant and post-partum women living with HIV and on antiretroviral therapy in Kinshasa, DR Congo: A cross-sectional study

et al. 2019

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Background Hepatitis B virus (HBV) co-infection in HIV-infected individuals increases the risk of hepatic complications and mortality. Further, the risk of perinatal HBV transmission increases among HBV/HIV co-infected pregnant women. Although HBV is endemic in the Democratic Republic of Congo, there is little data on HBV/HIV co-infection. We aimed to assess the burden and risk factors of HBV surface antigen (HBsAg) positivity among HIV-infected pregnant and post-partum women. Methods This cross-sectional study was conducted as part of an ongoing trial to assess the effect of data-driven continuous quality improvement interventions (CQI) for optimal prevention of mother-to-child transmission (PMTCT) of HIV (CQI-PMTCT study, NCT03048669). In each of the 35 health zones of Kinshasa province, all HIV-infected pregnant or breastfeeding women (≤1 year post-delivery) presenting for care in one of the three busiest maternal and child health clinics of the health zone were tested for HBsAg using Alere Determine, Japan. We used logistic regression with general estimating equation accounting for within-clinic clustering to assess risk factors of HBsAg positivity. Results Between November 2016 and June 2018, a total of 1377 women, all on antiretroviral therapy, were tested for HBsAg. Overall, 4.7% [95% binomial confidence interval (CI): 3.7%-5.7%] tested positive for HBsAg. HBsAg prevalence was 3.3% (95% CI: 2.1%-4.8%) for women tested during pregnancy, 4.5% (2.5%-7.4%) for those tested at delivery, and 8.5% (5.6%-12.2%) for those tested post-partum ( P trend = 0.001). In multivariate models including socio-economic status (SES), type of care facility, duration of antiretroviral therapy, HIV viral load, and self-reported intimate partner violence (IPV), lowest tertile of SES, ≤ 6 months of ART, and IPV were all consistently and positively associated with higher prevalence of HBsAg across pregnancy, delivery, and postpartum period while been tested in a health centre or having a viral load ≥ 1000 copies/mL were consistently associated with lower prevalence. However, only the association with IPV (OR = 2.74, 95% CI: 1.10–6.84) and viral load between 40–1000 copies/ml (OR = 4.28, 95% CI: 1.22–15.01) achieved statistical significance among pregnant women. Conclusion This study revealed an overall high prevalence of HBsAg among HIV-infected pregnant and post-partum women in Kinshasa with the latter showing the highest HBsAg prevalence. Among pregnant women, intimate partner violence was independently and statistically associated with HBsAg positivity, requiring further investigation.

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“…In collaboration with the Expanded Program on Immunization (EPI), the required monovalent vaccine doses were acquired and stored within the existing cold chain system. We leveraged the infrastructure of an ongoing randomized trial of continuous quality interventions on long-term ART outcomes among pregnant/postpartum women in Kinshasa (CQI-PMTCT study, NCT03048669), through which we were already screening HIV-infected pregnant women for Hepatis B and C. 13,14…”

Section: Study Setting and Designmentioning

confidence: 99%

Arresting Vertical Transmission of Hepatitis B Virus (AVERT-HBV) in the Democratic Republic of the Congo

Thompson¹,

Ce²,

Ngimbi

et al. 2021

Preprint

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BackgroundHepatitis B virus (HBV) remains endemic throughout sub-Saharan Africa despite the widespread availability of effective vaccines. We evaluated the feasibility of adding HBV testing and treatment of pregnant women and birth-dose vaccination of HBV-exposed infants to the HIV prevention of MTCT (PMTCT) program infrastructure in the Democratic Republic of the Congo (DRC), where HBV treatment and birth-dose vaccination programs are not established.MethodsAs part of the HIV PMTCT program at two maternity centers in Kinshasa, DRC, pregnant women were screened for HBV at routine prenatal care registration. Pregnant women with high viral load and/or HBeAg positivity were offered tenofovir disoproxil fumarate (TDF). HBV-exposed infants received a birth-dose of HBV vaccine within 24 hours of life. The primary endpoint was the feasibility and acceptability of the study.FindingsOf 4,016 women screened, 109 (2.7%) were HBsAg-positive. Ten of 91 (11.1%) women evaluated had high-risk disease. Of 88 infants, 60 (68.2%) received a birth-dose vaccine; of these, 46 (76.7%) received a timely birth-dose. No cases of HBV MTCT were observed in our cohort. There were no serious adverse events associated with TDF nor with birth-dose vaccine. The study procedures were highly acceptable (>80%) among mothers.InterpretationAdding HBV screening and treatment of pregnant women and infant birth-dose vaccination to existing HIV PMTCT platforms is feasible in countries like the DRC. Birth-dose vaccination against HBV integrated within the current Expanded Programme on Immunization (EPI) and HIV PMTCT program could accelerate progress toward HBV elimination in Africa.

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Continuous quality improvement interventions to improve long-term outcomes of antiretroviral therapy in women who initiated therapy during pregnancy or breastfeeding in the Democratic Republic of Congo: design of an open-label, parallel, group randomized trial

Cited by 15 publications

References 25 publications

HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI‐PMTCT study

HIV viral suppression among pregnant and breastfeeding women in routine care in the Kinshasa province: a baseline evaluation of participants in CQI‐PMTCT study

Hepatitis B infection among pregnant and post-partum women living with HIV and on antiretroviral therapy in Kinshasa, DR Congo: A cross-sectional study

Arresting Vertical Transmission of Hepatitis B Virus (AVERT-HBV) in the Democratic Republic of the Congo

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