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

• Published in: PLoS medicine Vol. 17; no. 10; p. e1003150
• Main Authors: Yapa, H Manisha, De Neve, Jan-Walter, Chetty, Terusha, Herbst, Carina, Post, Frank A, Jiamsakul, Awachana, Geldsetzer, Pascal, Harling, Guy, Dhlomo-Mphatswe, Wendy, Moshabela, Mosa, Matthews, Philippa, Ogbuoji, Osondu, Tanser, Frank, Gareta, Dickman, Herbst, Kobus, Pillay, Deenan, Wyke, Sally, Bärnighausen, Till
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 07.10.2020; Public Library of Science (PLoS)
• Subjects: Adult; Advisors; Anti-HIV Agents - therapeutic use; Biology and Life Sciences; Clinics; Data collection; Female; Health aspects; HIV; HIV Infections - blood; HIV Infections - diagnosis; HIV Infections - drug therapy; HIV Infections - prevention & control; HIV Seropositivity - diagnosis; HIV tests; Human immunodeficiency virus; Humans; Implementation Science; Infections; Infectious Disease Transmission, Vertical - prevention & control; Maternal health services; Medical research; Medical tests; Medicine and Health Sciences; Methods; People and places; Practice Patterns, Nurses; Pregnancy; Prenatal care; Prenatal Care - standards; Primary care; Primary Health Care; Process Assessment, Health Care; Quality control; Quality Improvement; Quality Indicators, Health Care; Quality management; Research data management; RNA, Viral - blood; Rural areas; Rural health services; Rural Population; Rural women; South Africa; Surveillance; Total quality; Total Quality Management; Viral Load - statistics & numerical data; Womens health; Young Adult; South Africa; Nigeria; Malawi; Africa
• ISSN: 1549-1676; 1549-1277; 1549-1676
• 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. 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. This trial is registered at ClinicalTrials.gov under registration number NCT02626351.