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
Open accessAbstract
BACKGROUND: 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. CONCLUSIONS: 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 ClinicalTrials.gov under registration number NCT02626351.
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Yapa et al. (2020) included seven clusters.
“7”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [56]
Methods > Participants identifies seven study clinics, but Methods > Trial design says the two smallest clinics were merged into one cluster. The trial therefore included six clusters, not seven; the claim appears to count clinics as clusters. (LLM, conf=0.92)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredYapa et al. (2020) used four steps in the stepped wedge design.
“4”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [56]
The Methods > Trial design section explicitly calls this an “8-step stepped-wedge RCT,” not a four-step design. Its figure description also identifies steps from Step 0 through Step 7. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredYapa et al. (2020) used a stepped wedge design where all clusters receive intervention in randomised sequence, with masking only until randomisation status identified at the start of each intervention step.
“All clusters receive intervention, in randomised sequence. Masking was only until randomisation status identified at the start of each intervention step.”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [56]
The Methods > Trial design passage says every cluster rolled over from control to intervention in random order. Methods > Randomisation and blinding says investigators and healthcare workers remained blinded until each cluster was revealed two weeks before its scheduled intervention rollover, not until the start of that step. (LLM, conf=0.88)
Experimental — accuracy not yet measuredIn several stepped-wedge studies, randomization was combined with masking to reduce bias during the intervention phase.
“In several studies, randomization was combined with masking to reduce bias during the intervention phase (43, 56).”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [56]
The Methods sections on Trial design and Randomisation and blinding describe a stepped-wedge trial with randomised clinic rollout and investigators and healthcare workers blinded to the allocation sequence. But each cluster’s allocation was revealed two weeks before its intervention rollover, so the paper does not support masking during that cluster’s intervention phase. (LLM, conf=0.85)
Experimental — accuracy not yet measuredYapa et al. (2020) had a duration of 2 months between steps.
“2 months”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [56]
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Cited by
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Musa, Z. A., Akinsolu, F. T., Salako, A. O., Abodunrin, O. R., Ola, O. M., & Ezechi, O. C. (2026) · Frontiers in Epidemiology · doi:10.3389/fepid.2026.1529289
- Authors
- Yapa, H. M., De Neve, J.-W., Chetty, T., Herbst, C., Post, F. A., Jiamsakul, A., Geldsetzer, P., Harling, G., Dhlomo-Mphatswe, W., Moshabela, M., Matthews, P., Ogbuoji, O., Tanser, F., Gareta, D., Herbst, K., Pillay, D., Wyke, S., & Bärnighausen, T.
- Affiliations
- UNSW Sydney (AU)
- South African Medical Research Council (ZA)
- Africa Health Research Institute (ZA)
- King's College Hospital NHS Foundation Trust (GB)
- Heidelberg University (DE)
- University of KwaZulu-Natal (ZA)
- Duke University (US)
- Centre for the AIDS Programme of Research in South Africa (ZA)
- Harvard University (US)
- Corresponding author
- Yapa, H. Manisha
- ORCID
- Venue
- PLOS Medicine
- Publisher
- Public Library of Science (PLoS)
- Published
- 2020-10-07
- Volume
- 17
- Issue
- 10
- Pages
- e1003150
- ISSN
- 1549-1277 (ISSN-L)
- 1549-1676
- PMC
- PMC7540892
- OpenAlex
- W3092619729
- Cited by
- 31
- References
- 64
- Citations by year
- 2026: 4 · 2025: 2 · 2024: 8 · 2023: 8 · 2022: 5 · 2021: 3 · 2020: 1
- FWCI
- 4.43
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (acceptedVersion, cc-by-sa)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- European Commission (EuropeAid/134286/L/ACT/ZA)
- Wellcome Trust (082384/Z/07/Z)
- Howard Hughes Medical Institute
- South African Population Research Infrastructure Network
- Australian Government Research Training Programme (Scholarship)
- Department of Health, Australian Government
- Alexander von Humboldt-Stiftung (Professor award)
- South African Medical Research Council (Clinician Researcher Programme)
- National Center for Advancing Translational Sciences (KL2TR003143)
- Bundesministerium für Bildung und Forschung
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (R01-HD084233)
- National Institute on Aging (P01-AI112339)
- Fogarty International Center (D43-TW009775)
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Health Sciences › Health Professions › Health Information Management › Healthcare Quality and Management
- Keywords
- continuous quality improvement, antenatal HIV testing, HIV viral load monitoring, mother-to-child transmission of HIV, repeat HIV testing, nurse-led primary care, PDSA cycle, quality improvement tools, rural South Africa, pregnant women living with HIV, implementation research, health system strengthening, resource-limited settings
- MeSH terms
- Implementation Science, Adult, Female, HIV Seropositivity, Humans, Pregnancy, Prenatal Care, Primary Health Care, RNA, Viral, Rural Population, South Africa, HIV Infections, Process Assessment, Health Care, Total Quality Management, Infectious Disease Transmission, Vertical, Anti-HIV Agents, Viral Load, Quality Indicators, Health Care, Young Adult, Practice Patterns, Nurses', Quality Improvement
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