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Intern. AIDS Soc."],"published-print":{"date-parts":[[2020,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>The WHO recommends antiretroviral treatment (ART) for all HIV\u2010positive patients regardless of CD4 count or disease stage, referred to as \u201cEarly Access to ART for All\u201d (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government\u2010managed public health system with the aim to examine the \u201creal world\u201d impact of EAAA on care retention and viral suppression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this stepped\u2010wedge randomized controlled trial, 14 public sector health facilities in Eswatini were paired and randomly assigned to stepwise transition from standard of care (SoC) to EAAA. ART\u2010na\u00efve participants \u226518\u00a0years who were not pregnant or breastfeeding were eligible for enrolment. We used Cox proportional hazard models with censoring at clinic transition to estimate the effects of EAAA on retention in care and retention and viral suppression combined.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12\u2010month HIV care retention rates were 80% (95% CI: 77 to 83) and 86% (95% CI: 83 to 88). The 12\u2010month combined retention and viral suppression endpoint rates were 44% (95% CI: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA. EAAA increased both retention (HR: 1\u00b760, 95% CI: 1\u00b715 to 2\u00b721,<jats:italic>p<\/jats:italic>\u00a0=\u00a00.005) and retention and viral suppression combined (HR: 4.88, 95% CI: 2.96 to 8.05,<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.001). We also identified significant gaps in current health systems ability to provide viral load (VL) monitoring with 80% participants in SoC and 66% in EAAA having a missing VL at last contact.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The observed improvement in retention in care and on the combined retention and viral suppression provides an important co\u2010benefit of EAAA to HIV\u2010positive adults themselves, at least in the short term. Our results from this \u201creal world\u201d health systems trial strongly support EAAA for Eswatini and countries with similar HIV epidemics and health systems. VL monitoring needs to be scaled up for appropriate care management.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jia2.25610","type":"journal-article","created":{"date-parts":[[2020,9,19]],"date-time":"2020-09-19T08:35:49Z","timestamp":1600504549000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Early access to antiretroviral therapy versus standard of care among HIV\u2010positive participants in Eswatini in the public health sector: the MaxART stepped\u2010wedge randomized controlled trial"],"prefix":"10.1002","volume":"23","author":[{"given":"Shaukat","family":"Khan","sequence":"first","affiliation":[{"name":"Clinton Health Access Initiative (CHAI) Mbabane Swaziland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4006-4650","authenticated-orcid":false,"given":"Donna","family":"Spiegelman","sequence":"additional","affiliation":[{"name":"Center on Methods for 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