Getting to 90-90-90: Experiences from the MaxART Early Access to ART for All (EAAA) Trial in Eswatini.

PURPOSE OF REVIEW: The MaxART Consortium-led by the Eswatini Ministry of Health-implemented multiple interventions between 2012 and 2017 to achieve UNAIDS 90-90-90 targets. We summarize key findings from community outreach strategies in support of the first 90 goal, and from the Early Access to ART for All (EAAA) trial on the implementation of a "Treat All" strategy to achieve the second and third 90 goals within a government-managed public health system. RECENT FINDINGS: The MaxART Consortium demonstrated that "Fast Track," a problem-solving approach, was effective at increasing testing coverage in the community. Compared with baseline data at 3 months prior to the start of the Fast Track, there was a 273% proportional increase in HIV tests conducted among adolescent males, adolescent females, and adult men, and 722% over baseline for adolescent males. The MaxART EAAA trial further showed that implementation of the Treat All policy was associated with significant two-fold shorter time from enrollment into care to ART initiation than under the standard CD4+ cell threshold-based treatment guidelines. Finally, through the MaxART trial, Eswatini was able to identify areas for further investment, including addressing the system-side barriers to routine viral load monitoring, and designing and implementing innovative community-based approaches to reach individuals who were not more routinely accessing HIV testing and counseling services. As low- and middle-income countries adopt the Treat All approach in their national HIV care and treatment guidelines, further implementation science research is needed to understand and address the system-level barriers to achieving the benefits of Treat All for HIV-infected individuals and those at risk.

Experiences from a community advisory Board in the Implementation of early access to ART for all in Eswatini: a qualitative study.

BACKGROUND: Engaging communities in community-based health research is increasingly being adopted in low- and middle-income countries. The use of community advisory boards (CABs) is one method of practicing community involvement in health research. To date, few studies provide in-depth accounts of the strategies that CAB members use to practice community engagement. We assessed the perspectives, experiences and practices of the first local CAB in Eswatini (formerly known as Swaziland), which was implemented as part of the MaxART Early Access to ART for All study. METHODS: Trained Swazi research assistants conducted two focus group discussions and 13 semi-structured interviews with CAB members who had been part of the MaxART study for at least 2.5 years. Interviews explored CAB composition and recruitment, the activities of CAB members, the mechanisms used to engage with communities and the challenges they faced in their role. RESULTS: The MaxART CAB played an active role in the implementation of the Early Access to Art for All study, and activities mainly focused on: (1) promoting ethical conduct, in particular privacy, consent and confidentiality; (2) communication and education, communicating about the study and educating the community on the benefits of HIV testing and early access to HIV treatment; and (3) liaising between the community and the research team. Strategies for interacting with communities were varied and included attending general community meetings, visiting health facilities and visiting public places such as cattle dipping tanks, buses, bars and churches. Differences in the approach to community engagement between CAB members living in the study areas and those residing outside were identified. CONCLUSION: The experiences of the first CAB in Eswatini demonstrate that community engagement using CABs is a valuable mechanism for engaging communities in implementation studies. Considerations that could impact CAB functioning include clearly defining the scope of the CAB, addressing issues of CAB independence, the CAB budget, providing emotional support for CAB members, and providing continuous training and capacity building. These issues should be addressed during the early stages of CAB formation in order to optimize functioning.

Early access to antiretroviral therapy versus standard of care among HIV-positive participants in Eswatini in the public health sector: the MaxART stepped-wedge randomized controlled trial.

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.

Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland's public sector health system: study protocol for a stepped-wedge randomized trial.

BACKGROUND: There is robust clinical evidence to support offering early access to antiretroviral treatment (ART) to all HIV-positive individuals, irrespective of disease stage, to both improve patient health outcomes and reduce HIV incidence. However, as the global treatment guidelines shift to meet this evidence, it is still largely unknown if early access to ART for all (also referred to as "treatment as prevention" or "universal test and treat") is a feasible intervention in the resource-limited countries where this approach could have the biggest impact on the course of the HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's public sector health system. METHODS: This is a three-year stepped-wedge randomized design with open enrollment for all adults aged 18 years and older across 14 government-managed health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, patient satisfaction, and cost per patient per year. Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each four-month step. This design will result in approximately one half of the total observation time to accrue in the intervention arm and the other half in the control arm. Our estimated enrolment number, which is supported by conservative power calculations, is 4501 patients over the course of the 36-month study period. A multidisciplinary, mixed-methods approach will be adopted to supplement the randomized controlled trial and meet the study aims. Additional study components include implementation science, social science, economic evaluation, and predictive HIV incidence modeling. DISCUSSION: A stepped-wedge randomized design is a causally strong and robust approach to determine if providing antiretroviral treatment for all HIV-positive individuals is a feasible intervention in a resource-limited, public sector health system. We expect our study results to contribute to health policy decisions related to the HIV response in Swaziland and other countries in sub-Saharan Africa. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02909218 . Registered on 10 July 2016.