This article reports on NIDA Clinical Trials Network protocol CTN-0056-Ot, “Testing and Linkage to HIV Care in China,” a cluster-randomized, controlled trial in 12 hospitals in Guangxi, China. All hospitals were required to be level 2A county general hospitals and ART delivery sites; they were the 12 most similar hospitals in terms of structural characteristics, past patient caseloads, and testing procedures.
Hospitals were randomly assigned (1:1) to either the One4All intervention or standard of care. 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.
Patients enrolled in the study had to be 18 years or older and be identified as HIV-reactive during screening in study hospitals, seeking inpatient or outpatient care in a study hospital, and residing in the study catchment area. Between February 2 and November 25, 2014, 478 patients were enrolled: 232 in One4All and 246 in standard of care.
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 counseling. Safety assessments were hospital admissions for the first 90 days and deaths up to 12 months after enrollment.
Findings were as follows:
Funding for this Addiction Science Made Easy project is provided by the Addiction Technology Transfer Center National Office, under the cooperative agreement from the Center for Substance Abuse Treatment of SAMHSA.
Articles were written based on the following published research:
Wu Z, et al. Testing and Linkage to HIV Care in China: A Cluster-Randomized Trial. Lancet HIV 2017 (in press)