학술논문

Care cascade structural intervention versus standard of care in the diagnosis and treatment of HIV in China: a cluster-randomized controlled trial protocol
Document Type
article
Source
BMC Health Services Research. 17(1)
Subject
Health Services and Systems
Nursing
Public Health
Health Sciences
Mental Health
HIV/AIDS
Clinical Trials and Supportive Activities
Cost Effectiveness Research
Infectious Diseases
Prevention
Pediatric AIDS
Pediatric
Clinical Research
Infection
Good Health and Well Being
Adult
China
Clinical Protocols
Cluster Analysis
Counseling
Female
HIV Infections
HIV Seropositivity
Hospitals
Humans
Point-of-Care Systems
Point-of-Care Testing
Standard of Care
HIV test
Point-of-care
CD4 count
Viral load
Viral suppression
Antiretroviral therapy
Mortality
Linkage to care
HIV care cascade
HIV continuum of care
Library and Information Studies
Public Health and Health Services
Health Policy & Services
Health services and systems
Public health
Language
Abstract
BackgroundThe high rate of attrition along the care cascade of infection with human immunodeficiency virus (HIV) results in lost opportunities to provide timely antiretroviral therapy (ART) and to prevent unnecessarily high mortality. This study aims to assess the effectiveness of a structural intervention, the one-stop ("One4All") strategy that streamlines China's HIV care cascade with the intent to improve testing completeness, ART initiation, viral suppression, and mortality.MethodA two-arm, cluster-randomized controlled trial was implemented in twelve county hospitals in Guangxi China to test the effectiveness of the One4All strategy (intervention arm) compared to the current standard of care (SOC; control arm). The twelve study hospitals were selected for homogeneity and allocated one-to-one to the intervention and control arms. All patients screening HIV positive in study hospitals were enrolled. Target study enrollment was 180 participants per arm, 30 participants per hospital. Basic demographic information was collected as well as HIV risk behavior and route of infection. In intervention hospitals, patients then went on to receive point-of-care CD4 testing and in-parallel viral load (VL) testing whereas patients in control hospitals progressed through the usual SOC cascade. The primary outcome measure was testing completeness within 30 days of positive initial HIV screening result. Testing completeness was defined as receipt of all tests, test results, and post-test counseling. The secondary outcome measure was ART initiation (receipt of first ART prescriptions) within 90 days of positive initial HIV screening result. Tertiary outcome measures were viral suppression (≤200 copies/mL) and all-cause mortality at 12 months.DiscussionWe expect that this first-ever, cluster-randomized controlled trial of a bundle of interventions intended to streamline the HIV care cascade in China (the One4All strategy) will provide strong evidence for the benefit of accelerating diagnosis, thorough clinical assessment, and ART initiation via an optimized HIV care cascade. We furthermore anticipate that this evidence will be valuable to policymakers looking to elevate China's overall HIV/AIDS response to meet the UNAIDS 90-90-90 targets and the broader, global goal of eradication of the HIV/AIDS epidemic.Trial registrationClinicalTrials.gov # NCT02084316 . (Registered on March 7, 2014).