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Introduction: The WHO recommends antiretroviral treatment (ART) for all HIV-positive patients regardless of CD4 count or disease stage, referred to as 'Early Access to ART for All' (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government-managed public health system with the aim to examine the 'real world' impact of EAAA on care retention and viral suppression. Methods: In this stepped-wedge 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-naive participants [greater than or equal to]18 years 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. Results: Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12-month HIV care retention rates were 80% (95% Cl: 77 to 83) and 86% (95% CI: 83 to 88). The 12-month combined retention and viral suppression endpoint rates were 44% (95% Cl: 40 to 48) under SoC compared to 80% (95% CI: 77 to 83) under EAAA. EAAA increased both retention (HR: 1x60, 95% Cl: 1x15 to 2x21, p = 0.005) and retention and viral suppression combined (HR: 4.88, 95% Cl: 2.96 to 8.05, p < 0.001). 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. Conclusions: The observed improvement in retention in care and on the combined retention and viral suppression provides an important co-benefit of EAAA to HIV-positive adults themselves, at least in the short term. Our results from this 'rea world' 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. Keywords: universal treatment; HIV retention; viral suppression; Eswatini; Sub-Saharan Africa; antiretroviral therapy Additional information may be found under the Supporting Information tab for this article., 1 | INTRODUCTION In 2018, nearly 38 million people were living with human immunodeficiency virus (HIV), of whom 20.64 million live in sub-Saharan Africa. There has been a 56% decline [...]

Introduction: Retention on antiretroviral therapy (ART) is critical for the successful adoption of the test and treat policy by sub-Saharan African countries, and for realizing the United Nations programme on HIV and AIDS target of 90-90-90. This qualitative study explores HIV positive clients' reasons for discontinuing ART under the MaxART test and treat implementation study in Swaziland. Methods: Clients identified as lost to follow-up (LTFU) in the programme database, who had initiated ART under the intervention arm of the MaxART study, were purposively selected from two facilities. LTFU was defined as stopping ART refill for three months or longer from the date of last appointment, and not being classified as transferred out or deceased. Semi-structured face-to-face interviews were conducted with nine clients and one treatment supporter between July and August 2017. All interviews were conducted in the local language, audio-recorded, summarized or transcribed and translated to English for thematic analysis. Results: Respondents described mobility as the first step in a chain of events that affected retention in care. It was entwined with precarious employment, care delivery, interactions with health workers, lack of social support, anticipated stigma and ART-related side-effects, including the exacerbation of hunger. The chains of events involved several intersecting reasons that occurred one after the other as a series of contiguous and linked events that led to clients' eventual discontinuation of ART. The individual accounts of step-by-step decision-making revealed the influence of multi-layered contexts and the importance of critical life-events. Conclusions: Clients' reasons for abandoning ART are a complex, inextricably interwoven chain of events rather than a single occurrence. Mobility is often the first step in the process and commonly results from precarious economic and social circumstances. Currently the health system poorly caters to the reality of people's mobile lives. Interventions should seek to increase healthcare workers' understanding of the chain of events leading up to discontinuation on ART and the social dilemmas that clients face. Keywords: ARV; Retention; Linkage to care; Intervention; Swaziland; Test and Treat, 1 | INTRODUCTION Between 2000 and 2015, the number of people living with HIV (PLHIV) who access antiretroviral therapy (ART) saw a thirty-fold global increase: from 250,000 to more than [...]

: Introduction: The WHO recommends antiretroviral treatment (ART) for all HIV‐positive patients regardless of CD4 count or disease stage, referred to as “Early Access to ART for All” (EAAA). The health systems effects of EAAA implementation are unknown. This trial was implemented in a government‐managed public health system with the aim to examine the “real world” impact of EAAA on care retention and viral suppression. Methods: In this stepped‐wedge 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‐naïve participants ≥18 years 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. Results: Between September 2014 and August 2017, 3405 participants were enrolled. In SoC and EAAA respectively, 12‐month HIV care retention rates were 80% (95% CI: 77 to 83) and 86% (95% CI: 83 to 88). The 12‐month 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: 1·60, 95% CI: 1·15 to 2·21, p = 0.005) and retention and viral suppression combined (HR: 4.88, 95% CI: 2.96 to 8.05, p < 0.001). 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. Conclusions: The observed improvement in retention in care and on the combined retention and viral suppression provides an important co‐benefit of EAAA to HIV‐positive adults themselves, at least in the short term. Our results from this “real world” 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., Introduction In 2018, nearly 38 million people were living with human immunodeficiency virus (HIV), of whom 20.64 million live in sub‐Saharan Africa. There has been a 56% decline in AIDS‐related [...]

: Introduction: Retention on antiretroviral therapy (ART) is critical for the successful adoption of the test and treat policy by sub‐Saharan African countries, and for realizing the United Nations programme on HIV and AIDS target of 90‐90‐90. This qualitative study explores HIV positive clients’ reasons for discontinuing ART under the MaxART test and treat implementation study in Swaziland. Methods: Clients identified as lost to follow‐up (LTFU) in the programme database, who had initiated ART under the intervention arm of the MaxART study, were purposively selected from two facilities. LTFU was defined as stopping ART refill for three months or longer from the date of last appointment, and not being classified as transferred out or deceased. Semi‐structured face‐to‐face interviews were conducted with nine clients and one treatment supporter between July and August 2017. All interviews were conducted in the local language, audio‐recorded, summarized or transcribed and translated to English for thematic analysis. Results: Respondents described mobility as the first step in a chain of events that affected retention in care. It was entwined with precarious employment, care delivery, interactions with health workers, lack of social support, anticipated stigma and ART‐related side‐effects, including the exacerbation of hunger. The chains of events involved several intersecting reasons that occurred one after the other as a series of contiguous and linked events that led to clients’ eventual discontinuation of ART. The individual accounts of step‐by‐step decision‐making revealed the influence of multi‐layered contexts and the importance of critical life‐events. Conclusions: Clients’ reasons for abandoning ART are a complex, inextricably interwoven chain of events rather than a single occurrence. Mobility is often the first step in the process and commonly results from precarious economic and social circumstances. Currently the health system poorly caters to the reality of people's mobile lives. Interventions should seek to increase healthcare workers’ understanding of the chain of events leading up to discontinuation on ART and the social dilemmas that clients face., Introduction Between 2000 and 2015, the number of people living with HIV (PLHIV) who access antiretroviral therapy (ART) saw a thirty‐fold global increase: from 250,000 to more than 17 million. [...]