One of the most serious challenges facing antiretroviral therapy (ART) programs in resource-constrained settings is the failure of ART-eligible patients to complete the steps required to initiate treatment. The high rate of loss to cae of patients who are treatment-eligible at HIV diagnosis may be due in part to the large number of steps required between receiving an HIV diagnosis and obtaining the first dose of antiretrovirals (ARVs). In South Africa, these steps usually require 2-4 clinic visits over a perio of 2-8 weeks before a patient can start treatment. One strategy proposed for reducing losses among those eligible for ART is to simplify and condense the steps required for starting treatment. This is now possible because new, point-of-care (POC) tests for CD4 counts and TB diagnosis are available. These technologies can be combined with changes to clinic schedules to allow all steps required for ART initiation (lab tests, medical exam, education) to take place on the day the patient presents for an HIV test. The study is designed as an unblinded randomized strategy trial comparing the current standard of care to a rapid ART initiation strategy for outpatient adults and pregnant women who come to a South African clinic for an HIV test and are eligible for ART. Those who are offered rapid ART initiation will have the chance to receive their first dose of ARVs on the same day, while those in the comparison arm of the study will follow the clinic's usual procedures for starting ART. The study aims to evaluate whether offering rapid ART initiation is an effective and cost-effective strategy for increasing th proportion of ART-eligible patients who are successfully treated, as indicated by having no virus detectable within 9 months of HIV testing. This study is significant because prior research by the study team and others has shown that losses from HIV care before ART initiation may be as high as two thirds, resulting in continued late presentation for treatment, unnecessary morbidity and mortality, and substantial wasted resources. The intervention is innovative because it combines novel diagnostic technologies in a new setting, aims to maximize treatment initiations, and considers whether the strategy is both affordable and cost effective. It is also innovative because it examines the effect of the strategy on pregnant women as well as on the general adult population. Finally, it will help to build the evidence base for "test-and-treat," one of the most innovative ideas currently considered to prevent HIV transmission.
The proposed study aims to address one of the most serious challenges facing HIV care and treatment programs in resource-limited settings throughout the world: how to promote earlier treatment initiation and reduce the loss from care before they actually start treatment of patients who are eligible for antiretroviral therapy (ART). By changing how the steps leading up to ART initiation are organized and using new, rapid technologies for performing lab tests needed before starting ART, the study may identify a way to improve the outcomes of patients on HIV treatment and strengthen efforts to use ART as an HIV prevention strategy. In settings with a high prevalence of HIV infection, this may be an important component of an overall approach to reducing the burden of HIV on public health.