Lancet HIV 2017;4(12):e555-e565
Wu, Zunyou | Tang, Zhenzhu | Mao, Yurong | VanVeldhuisen, Paul C. | Ling, Walter | Liu, David S. | Shen, Zhiyong | Detels, Roger | Lan, Guanghua | Erinoff, Lynda | Lindblad, Robert | Gu, Diane | Tang, Houlin | Hu, Lian | Zhu, Qiuying | Lu, Li | Oden, Neal L. | Hasson, Albert L. | Zhao, Yan | McGoogan, Jennifer M. | Ge, Xianmin | Zhang, Nanci | Rou, Keming | Zhu, Jinhui | Wei, Hui | Shi, Cynthia X. | Jin, Xia | Li, Jian | Montaner, Julio S. G.
This is the Results Article for CTN-0056-Ot.
Multistage, stepwise HIV testing and treatment procedures can result in lost opportunities to provide timely antiretroviral therapy (ART). Incomplete engagement of patients along the care cascade translates into high preventable mortality. This study aimed to identify whether a structural intervention to streamline testing and linkage to HIV health care, the "One4All" intervention, would improve testing completeness, ART initiation, and viral suppression and reduce mortality.
This cluster-randomised, controlled trial in Guangxi, China was conducted in 12 hospitals, similar in structural characteristics, past patient caseloads, and testing procedures. Hospitals were randomly assigned (1:1) to either the One4All intervention or standard of care. Hospitals were randomised in a block design and stratified by the historical rate of testing completeness of the individual hospital during the first 6 months of 2013.
A total of 478 patients were enrolled (232 in One4All, 246 in standard of care). They were aged 18 years or older who were identified as HIV-reactive during screening in study hospitals, who sought inpatient or outpatient care in a study hospital, and who resided in the study catchment area. The One4All strategy incorporated rapid, point-of-care HIV screening and CD4 counts, and in-parallel viral load testing, to promote fast and complete diagnosis and staging and provide immediate ART to eligible patients. Participants in control hospitals received standard care services. All enrolled patients were assessed for the primary outcome, which was testing completeness within 30 days, defined as completion of three required tests and their post-test counselling. Safety assessments were hospital admissions for the first 90 days and deaths up to 12 months after enrolment.
Although no difference was observed between study groups in the number of hospital admissions at 90 days, by 12 months there were 65 deaths (28%) in the in the One4All group compared with 115 (47%) in the standard-of-care group (Cox proportional hazard ratio 0·44, 0·19–1·01, p=0·0531). The One4All package of interventions also substantially increased the odds of achieving testing completeness within 30 days and ART initiation within 90 days.
Conclusions: The study provides strong evidence for the benefits of a patient-centred approach to streamlined HIV testing and treatment that could help China change the trajectory of its HIV epidemic, and help to achieve the goal of an end to AIDS. Taken together with new, strong evidence of the benefits of treating all people with HIV regardless of CD4 level, a patient-centered approach to streamline HIV testing and ART initiation regardless of CD4 count is clearly beneficial.
Keywords: CTN platform/ancillary study results | HIV/AIDS | HIV rapid testing | Lancet HIV (journal)
Document No: 1282 ; PMID: 28867267 ; PMCID: PMC6639122
Submitted by: John Harris, CALIBRE Systems (09/14/2017)
