A stepped-wedge randomised trial on the impact of early ART initiation on HIV-patients’ economic outcomes in eswatini
Open accessAbstract
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 impact on the economic aspects of patients' lives 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’ individual- and household-level economic outcomes. Fourteen healthcare facilities were non-randomly matched into 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 were collected via standardised paper-based surveys with HIV-positive adults who were neither pregnant nor breastfeeding. Outcomes were patients’ time use, employment status, household expenditures, and household living standards. Results: A total sample of 3019 participants were interviewed over the duration of the study. The mean number of participants approached at each facility per time step varied from 4 to 112 participants. Using mixed-effects negative binomial regressions accounting for time trends and clustering at the level of the healthcare facility, 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: Our findings do not provide evidence that should discourage further investments into scaling up immediate ART for all HIV patients. Funding: Funded by the Dutch Postcode Lottery in the Netherlands, Alexander von Humboldt-Stiftung (Humboldt-Stiftung), the Embassy of the Kingdom of the Netherlands in South Africa/Mozambique, British Columbia Centre of Excellence in Canada, Doctors Without Borders (MSF USA), National Center for Advancing Translational Sciences of the National Institutes of Health and Joachim Herz Foundation. Clinical trial number: NCT02909218 and NCT03789448 .
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Steinert et al. (2020) chose the stepped-wedge design to accommodate logistical and practical constraints, allowing phased implementation over three years.
“The stepped-wedge design was chosen to accommodate logistical and practical constraints, allowing for a phased implementation of the intervention over three years.”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [66]
The Materials and methods section (‘Stepped-wedge randomised trial design’; page unavailable) describes facilities transitioning to the intervention in phases over three years. It does not say that logistical or practical constraints motivated the choice of design. (LLM, conf=0.86)
Experimental — accuracy not yet measuredSteinert et al. (2020) allocated health facilities non-randomly into seven pairs based on geographic proximity and catchment size, then randomly assigned the seven pairs to one of seven sequences.
“Health facilities were allocated non-randomly into seven pairs based on geographic proximity and facility catchment size to avoid possible contamination and ensure roughly equal group sizes. The seven pairs were then randomly assigned to one of seven sequences, determining the point in time each facility shifted from the standard of care to the EAAA intervention.”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [66]
Steinert et al. (2020) used seven steps in the stepped wedge design.
“7”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [66]
Steinert et al. (2020) included 14 clusters (government-managed health facilities).
“14”
From Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review (2026) · cites this paper as [66]
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- Authors
- Steinert, J. I., Khan, S., Mlambo, K., Walsh, F. J., Mafara, E., Lejeune, C., Wong, C., Hettema, A., Ogbuoji, O., Vollmer, S., De Neve, J.-W., Mazibuko, S., Okello, V., Bärnighausen, T., & Geldsetzer, P.
- Affiliations
- Heidelberg University (DE)
- Clinton Health Access Initiative (US)
- Clinton Health Acccess Initiative, Boston, United States
- Duke University (US)
- University of Goettingen, Goettingen, Germany
- Heidelberg Institute of Global Health, Heidelberg University, Heidelberg, Germany
- Ministry of Health (SZ)
- Corresponding author
- Steinert, Janina Isabel
- ORCID
- Venue
- eLife
- Publisher
- eLife Sciences Publications, Ltd
- Published
- 2020-08-24
- Volume
- 9
- ISSN
- 2050-084X (ISSN-L)
- PMC
- PMC7529454
- OpenAlex
- W3080933331
- Cited by
- 7
- References
- 47
- Citations by year
- 2026: 1 · 2023: 3 · 2022: 1 · 2021: 2
- FWCI
- 0.20
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- eLife (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- mediaTUM – the media and publications repository of the Technical University Munich (Technical University Munich) (submittedVersion, other-oa)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, other-oa)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, cc-by)
- Funders
- Dutch Postcode Lottery in the Netherlands
- Alexander von Humboldt-Stiftung
- The Embassy of the Kingdom of the Netherlands in South Africa/Mozambique
- British Columbia Centre of Excellence in Canada
- Doctors Without Borders
- National Center for Advancing Translational Sciences (Award Number KL2TR003143)
- Joachim Herz Foundation
- Topics
- Health Sciences › Medicine › Infectious Diseases › HIV/AIDS Research and Interventions
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › HIV/AIDS Impact and Responses
- Social Sciences › Safety Research › Poverty, Education, and Child Welfare
- Keywords
- early antiretroviral therapy initiation, HIV, economic outcomes, household expenditure, employment status, time use, household living standards, household asset ownership, WHO treatment guidelines, Swaziland
- MeSH terms
- Economic Status, Adolescent, Adult, Aged, Aged, 80 and over, Employment, Female, Health Facilities, Humans, Male, Middle Aged, Eswatini, HIV Infections, Anti-HIV Agents, Young Adult, Time-to-Treatment
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