The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.

<h4>Background</h4>Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa.<h4>Methods and findings</...

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Main Authors: H Manisha Yapa, Jan-Walter De Neve, Terusha Chetty, Carina Herbst, Frank A Post, Awachana Jiamsakul, Pascal Geldsetzer, Guy Harling, Wendy Dhlomo-Mphatswe, Mosa Moshabela, Philippa Matthews, Osondu Ogbuoji, Frank Tanser, Dickman Gareta, Kobus Herbst, Deenan Pillay, Sally Wyke, Till Bärnighausen
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2020-10-01
Series:PLoS Medicine
Online Access:https://doi.org/10.1371/journal.pmed.1003150
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author H Manisha Yapa
Jan-Walter De Neve
Terusha Chetty
Carina Herbst
Frank A Post
Awachana Jiamsakul
Pascal Geldsetzer
Guy Harling
Wendy Dhlomo-Mphatswe
Mosa Moshabela
Philippa Matthews
Osondu Ogbuoji
Frank Tanser
Dickman Gareta
Kobus Herbst
Deenan Pillay
Sally Wyke
Till Bärnighausen
author_facet H Manisha Yapa
Jan-Walter De Neve
Terusha Chetty
Carina Herbst
Frank A Post
Awachana Jiamsakul
Pascal Geldsetzer
Guy Harling
Wendy Dhlomo-Mphatswe
Mosa Moshabela
Philippa Matthews
Osondu Ogbuoji
Frank Tanser
Dickman Gareta
Kobus Herbst
Deenan Pillay
Sally Wyke
Till Bärnighausen
author_sort H Manisha Yapa
collection DOAJ
description <h4>Background</h4>Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa.<h4>Methods and findings</h4>We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention.<h4>Conclusions</h4>We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success.<h4>Trial registration</h4>This trial is registered at ClinicalTrials.gov under registration number NCT02626351.
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spelling doaj.art-9e32c813a6cd49cba72a812b3a1d7b8f2023-05-03T05:30:44ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762020-10-011710e100315010.1371/journal.pmed.1003150The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.H Manisha YapaJan-Walter De NeveTerusha ChettyCarina HerbstFrank A PostAwachana JiamsakulPascal GeldsetzerGuy HarlingWendy Dhlomo-MphatsweMosa MoshabelaPhilippa MatthewsOsondu OgbuojiFrank TanserDickman GaretaKobus HerbstDeenan PillaySally WykeTill Bärnighausen<h4>Background</h4>Evidence for the effectiveness of continuous quality improvement (CQI) in resource-poor settings is very limited. We aimed to establish the effects of CQI on quality of antenatal HIV care in primary care clinics in rural South Africa.<h4>Methods and findings</h4>We conducted a stepped-wedge cluster-randomised controlled trial (RCT) comparing CQI to usual standard of antenatal care (ANC) in 7 nurse-led, public-sector primary care clinics-combined into 6 clusters-over 8 steps and 19 months. Clusters randomly switched from comparator to intervention on pre-specified dates until all had rolled over to the CQI intervention. Investigators and clusters were blinded to randomisation until 2 weeks prior to each step. The intervention was delivered by trained CQI mentors and included standard CQI tools (process maps, fishbone diagrams, run charts, Plan-Do-Study-Act [PDSA] cycles, and action learning sessions). CQI mentors worked with health workers, including nurses and HIV lay counsellors. The mentors used the standard CQI tools flexibly, tailored to local clinic needs. Health workers were the direct recipients of the intervention, whereas the ultimate beneficiaries were pregnant women attending ANC. Our 2 registered primary endpoints were viral load (VL) monitoring (which is critical for elimination of mother-to-child transmission of HIV [eMTCT] and the health of pregnant women living with HIV) and repeat HIV testing (which is necessary to identify and treat women who seroconvert during pregnancy). All pregnant women who attended their first antenatal visit at one of the 7 study clinics and were ≥18 years old at delivery were eligible for endpoint assessment. We performed intention-to-treat (ITT) analyses using modified Poisson generalised linear mixed effects models. We estimated effect sizes with time-step fixed effects and clinic random effects (Model 1). In separate models, we added a nested random clinic-time step interaction term (Model 2) or individual random effects (Model 3). Between 15 July 2015 and 30 January 2017, 2,160 participants with 13,212 ANC visits (intervention n = 6,877, control n = 6,335) were eligible for ITT analysis. No adverse events were reported. Median age at first booking was 25 years (interquartile range [IQR] 21 to 30), and median parity was 1 (IQR 0 to 2). HIV prevalence was 47% (95% CI 42% to 53%). In Model 1, CQI significantly increased VL monitoring (relative risk [RR] 1.38, 95% CI 1.21 to 1.57, p < 0.001) but did not improve repeat HIV testing (RR 1.00, 95% CI 0.88 to 1.13, p = 0.958). These results remained essentially the same in both Model 2 and Model 3. Limitations of our study include that we did not establish impact beyond the duration of the relatively short study period of 19 months, and that transition steps may have been too short to achieve the full potential impact of the CQI intervention.<h4>Conclusions</h4>We found that CQI can be effective at increasing quality of primary care in rural Africa. Policy makers should consider CQI as a routine intervention to boost quality of primary care in rural African communities. Implementation research should accompany future CQI use to elucidate mechanisms of action and to identify factors supporting long-term success.<h4>Trial registration</h4>This trial is registered at ClinicalTrials.gov under registration number NCT02626351.https://doi.org/10.1371/journal.pmed.1003150
spellingShingle H Manisha Yapa
Jan-Walter De Neve
Terusha Chetty
Carina Herbst
Frank A Post
Awachana Jiamsakul
Pascal Geldsetzer
Guy Harling
Wendy Dhlomo-Mphatswe
Mosa Moshabela
Philippa Matthews
Osondu Ogbuoji
Frank Tanser
Dickman Gareta
Kobus Herbst
Deenan Pillay
Sally Wyke
Till Bärnighausen
The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.
PLoS Medicine
title The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.
title_full The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.
title_fullStr The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.
title_full_unstemmed The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.
title_short The impact of continuous quality improvement on coverage of antenatal HIV care tests in rural South Africa: Results of a stepped-wedge cluster-randomised controlled implementation trial.
title_sort impact of continuous quality improvement on coverage of antenatal hiv care tests in rural south africa results of a stepped wedge cluster randomised controlled implementation trial
url https://doi.org/10.1371/journal.pmed.1003150
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