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

Autoři: H. Manisha Yapa aff001;  Jan-Walter De Neve aff003;  Terusha Chetty aff004;  Carina Herbst aff002;  Frank A. Post aff005;  Awachana Jiamsakul aff001;  Pascal Geldsetzer aff003;  Guy Harling aff002;  Wendy Dhlomo-Mphatswe aff008;  Mosa Moshabela aff002;  Philippa Matthews aff002;  Osondu Ogbuoji aff011;  Frank Tanser aff002;  Dickman Gareta aff002;  Kobus Herbst aff002;  Deenan Pillay aff002;  Sally Wyke aff002;  Till Bärnighausen aff002
Působiště autorů: The Kirby Institute, University of New South Wales Sydney, NSW, Australia aff001;  Africa Health Research Institute (AHRI), KwaZulu-Natal, South Africa aff002;  Heidelberg Institute of Global Health (HIGH), Medical Faculty and University Hospital, Heidelberg University, Heidelberg, Germany aff003;  Health systems Research Unit, South African Medical Research Council, Durban, South Africa aff004;  King’s College Hospital NHS Foundation Trust, London, United Kingdom aff005;  Division of Primary Care and Population Health, Department of Medicine, Stanford University, Stanford, California, United States of America aff006;  Institute for Global Health, University College London, London, United Kingdom aff007;  School of Clinical Medicine, Discipline of Obstetrics and Gynaecology, University of KwaZulu-Natal, Durban, South Africa aff008;  School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa aff009;  Islington GP Federation, London, United Kingdom aff010;  Global Health Institute, Duke University, Durham, North Carolina, United States of America aff011;  Lincoln International Institute for Rural Health, University of Lincoln, Lincoln, United Kingdom aff012;  Centre for the AIDS Programme of Research in South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa aff013;  Division of Infection and Immunity, University College London, London, United Kingdom aff014;  Institute for Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom aff015;  MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa aff016;  Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, United States of America aff017
Vyšlo v časopise: 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 Med 17(10): e32767. doi:10.1371/journal.pmed.1003150
Kategorie: Research Article
doi: 10.1371/journal.pmed.1003150



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.

Methods and findings

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.


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.

Trial registration

This trial is registered at under registration number NCT02626351.

Klíčová slova:

Antenatal care – HIV – HIV diagnosis and management – Medical risk factors – Pregnancy – Primary care – South Africa – Virus testing


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