A stepped-wedge randomized trial on the impact of early ART initiation on HIV patients' economic welfare in Eswatini
- Technical University of Munich, Germany
- Clinton Health Acccess Initiative, United States
- Duke University, United States
- University of Göttingen, Germany
- Heidelberg Institute of Global Health, Germany
- Ministry of Health of the Kingdom of Eswatini, Eswatini
- University of Heidelberg, Germany
- Stanford University, United States
Abstract
Background: Since 2015, the World Health Organisation (WHO) recommends immediate initiation of antiretroviral therapy (ART) for all HIV-positive patients. Epidemiological evidence points to important health benefits of immediate ART initiation; however, the policy's economic impact remains unknown. Methods: We conducted a stepped-wedge cluster-randomised controlled trial in Eswatini to determine the causal impact of immediate ART initiation on patients' economic welfare. Fourteen healthcare facilities were non-randomly matched in pairs and then randomly allocated to transition from the standard of care (ART eligibility at CD4 counts of < 350 cells/mm3 until September 2016 and <500 cells/mm3 thereafter) to the 'Early Initiation of ART for All' (EAAA) intervention at one of seven timepoints. Patients, healthcare personnel, and outcome assessors remained unblinded. Data was collected via standardised paper-based surveys with HIV-positive, ART-naïve adults who were neither pregnant nor breastfeeding. Outcomes were patients' time use, employment status, household expenditures and household wealth. Results: A total sample of 3,019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility and time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering, we found no significant difference between study arms for any economic outcome. Specifically, the EAAA intervention had no significant effect on non-resting time use (RR= 1.00, [CI: 0.96, 1.05, p=0.93]) or income-generating time use (RR= 0.94, [CI: 0.73,1.20, p=0.61]). Employment and household expenditures decreased slightly but not significantly in the EAAA group, with risk ratios of 0.93 [CI: 0.82, 1.04, p=0.21] and 0.92 [CI: 0.79, 1.06, p=0.26], respectively. We also found no significant treatment effect on households' asset ownership and living standards (RR=0.96, [CI 0.92, 1.00, p=0.253]). Lastly, there was no evidence of heterogeneity in effect estimates by patients' sex, age, education, timing of HIV diagnosis and ART initiation. Conclusions: Given the neutral effect on patients' economic welfare but positive effects on health, our findings support further investments into scaling-up immediate ART for all HIV patients. Trial Registration: ClinicalTrials.gov, NCT02909218 and NCT03789448; ethical approval: Eswatini National Health Service Review Board & Harvard T.H. Chan School of Public Health Review Board.
Data availability
All data generated or analysed during this study are included in the manuscript and supporting files. Source data files have been provided for Figures 2-4 and all supplementary fogures (Figures S1-S9).
Article and author information
Author details
Janina Isabel Steinert
Jan-Walter De Neve
Funding
Dutch Postcode Lottery in the Netherlands (NA)
- Till Bärnighausen
Alexander von Humboldt-Stiftung
- Till Bärnighausen
the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique
- Till Bärnighausen
British Columbia Centre of Excellence in Canada
- Till Bärnighausen
Doctors Without Borders
- Till Bärnighausen
National Center for Advancing Translational Sciences of the National Institutes of Health (Award Number KL2TR003143)
- Pascal Geldsetzer
Joachim Herz Foundation
- Janina Isabel Steinert
The funders had no role in study design, data collection and interpretation, or the decision to submit the work for publication.
Ethics
Human subjects: Ethical approval for this study was obtained from the Eswatini National Health Service Review Board in July 2014 (Reference Number: MH/599C/FWA 000 15267). Respondents gave verbal and written consent before completing the interview and were informed about their right to decline or withdraw their participation at any point in time. The study was further granted an exemption for non-human subjects research from the ethics review board of the Harvard T.H. Chan School of Public Health.
Copyright
© 2020, Steinert et al.
This article is distributed under the terms of the Creative Commons Attribution License permitting unrestricted use and redistribution provided that the original author and source are credited.
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A stepped-wedge randomized trial on the impact of early ART initiation on HIV patients' economic welfare in Eswatini
eLife 9:e58487.
https://doi.org/10.7554/eLife.58487
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Funding: Supported by the Brazilian Ministry of Health and the Brazilian National Research Council.
