PROTOCOL NIDA-CTN-0056-Ot


Testing and Linkage to HIV Care in China: A Cluster Randomized Trial

Walter Ling, MD
Co-Lead Investigator
Director, Integrated Substance Abuse Programs, UCLA
lwalter@ix.netcom.com

Zunyou Wu, MD, PhD
Co-Lead Investigator

China Center for Diseases Control and Prevention
wuzunyou@chinaaids.cn

The high proportions of patients lost at each step along the continuum of HIV care result in suboptimal benefits of life-saving antiretroviral therapy (ART) in developing countries. This project examined the effects of a hospital-based structural intervention (One4All) designed to ensure that HIV-positive individuals receive a confirmed HIV diagnosis and determination of treatment eligibility. The primary aim was to determine whether implementation of the One4All intervention increases the propotion of HIV-positive, treatment-eligible patients who are identified and linked to ART and who achieve VL suppression, thereby reducing mortality.

CTN-0056 Study Protocol

PRIMARY FINDINGS

In the One4All group, 177 (76%) of 232 patients achieved testing completeness within 30 days versus 63 (26%) of 246 in the standard-of-care group (odds ratio 19.94, 95% CI 3.86-103.04, p=0.0004). 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 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).

Results Article: Wu Z, Tang Z, Mao Y, et al. Testing and Linkage to HIV Care in China: A Cluster-Randomised Trial. Lancet HIV 2017;4(12):e555-e565. [get article]

RELATED RESOURCES

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Publications about CTN-0056-Ot

ClinicalTrials.gov (NCT02084316)

NIDA protocol page


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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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