Care cascade structural intervention versus standard of care in the diagnosis and treatment of HIV in China: a cluster-randomized controlled trial protocolReport as inadecuate




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BMC Health Services Research

, 17:397

Organization, structure and delivery of healthcare

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

KeywordsHIV test Point-of-care CD4 count Viral load Viral suppression Antiretroviral therapy Mortality Linkage to care HIV care cascade HIV continuum of care AbbreviationsAIDSAcquired immunodeficiency syndromes

ARTAntiretroviral therapy

CDCCenter for disease control and prevention

CRFCase reporting form

CRIMSComprehensive response information management system

DSTData and statistics team

EIAEnzyme immunoassay

HIVHuman immunodeficiency virus

HRHazard ratio

ICCIntra-class correlation

IRBInstitutional review boards

NCAIDSNational Center for AIDS-STD Control and Prevention

NIDANational Institute on Drug Abuse

NIHNational Institutes of Health

One4AllThe one-stop strategy intervention

PLHIVPeople living with HIV

POCPoint-of-care

SOCStandard-of-care

UCLAUniversity of California, Los Angeles

UNAIDSThe Joint United Nations Programme on HIV-AIDS

VLViral load

WHOWorld Health Organization





Author: Yurong Mao - Zunyou Wu - Jennifer M. McGoogan - David Liu - Diane Gu - Lynda Erinoff - Walter Ling - Paul VanVeldhuisen -

Source: https://link.springer.com/







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