Effective management of patients on antiretroviral therapy (ART) is essential to improve clinical outcomes and prevent HIV transmission, but monitoring life-long ART for over 13 million HIV-infected people has become a challenge, particularly in low- and middle-income countries (LMICs). As programs continue to focus on identifying HIV-infected people and starting ART at higher CD4 thresholds, HIV providers have been overburdened, which has resulted in poor retention rates. In addition, laboratories have been working to implement HIV viral load (VL) testing since the World Health Organization's recommendation to move away from routine CD4 count monitoring [WHO, HIV guidelines 2013]. As ART coverage scales up to include millions more people, additional strain will be placed on HIV clinicians and laboratories to manage stable patients on chronic ART. Implementing point-of-care HIV VL testing to enable task shifting to nurses for chronic HIV care may help mitigate these burdens. However, evidence for a combined implementation of point-of-care HIV VL testing and task shifting among healthcare workers as a novel and effective strategy for managing chronic HIV care in LMICs is needed. The scientific objective of this project is to test the clinical equivalence and reduced cost of implementing a model for chronic HIV care that uses a point-of-care HIV VL assay to enable task shifting among healthcare workers at an urban clinic in South Africa. The central hypothesis is that rapid HIV VL testing, implemented by nurses, is an effective and cost-efficient strategy for management of chronic HIV infection in the majority of patients, thereby allowing more resources to be directed at the minority of patients who need greater attention. The plan to objectively test the central hypothesis will be completed by the following two specific aims: (1) to test the clinical equivalence of an implementation model for chronic HIV care using point-of-care HIV VL testing to enable task shifting in an urban South African clinic, and (2) to assess the costs, both incurred and averted, of implementing the proposed model in Aim #1, and the cost per HIV-positive person virally suppressed on ART and retained in care. This work is innovative because it uses a randomized evaluation of an implementation model that combines a novel diagnostic point-of-care test with task shifting among healthcare workers compared to standard of care for chronic HIV care in a resource-limited setting. This randomized trial will then form the basis of a larger, multi-country proposal to demonstrate the clinical equivalence and cost-effectiveness of implementing an integrated point-of-care HIV VL testing and task shifting model for chronic HIV care in LMICs. If nurses using clinic-based HIV VL testing were cost-effective for achieving both viral suppression and retention in care among patients on ART, then implementation of our chronic HIV care model would alleviate the strain on existing HIV providers and laboratories in LMICs.
Effective management of patients on antiretroviral therapy (ART) is essential to improve patient outcomes and prevent HIV transmission, but monitoring life-long ART for over 13 million HIV-infected people has become a challenge, particularly in low- and middle-income countries (LMICs). In this study, we will evaluate a combined implementation of clinic-based point-of-care HIV viral load testing and task shifting among healthcare workers as a novel and effective strategy for managing chronic HIV care in LMICs. Our intervention will allow the most highly-trained professionals and laboratories to focus on people with new HIV diagnoses, those starting ART, and those with complication of HIV or ART, which will facilitate the expansion of ART to reach the estimated 25 million people who are eligible.
