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First Paper from the CTN Study on Testing and Linkage to HIV Care in China Published

October 1, 2017
Wu Z, et al.
Wu Z, et al. Testing and Linkage to HIV Care in China: A Cluster-Randomized Trial. Lancet HIV 2017 (in press)
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  • Many patients are lost at each step along the HIV care cascade.
  • The current standard-of-care pathway from screening to starting antiretroviral therapy (ART) in China involves multiple hospital visits, separate blood draws, and protracted waiting periods, resulting in substantial loss to follow-up, delays in diagnosis, incomplete clinical assessment, and late treatment initiation. Incomplete engagement of patients along the care cascade translates into high preventable mortality.
  • 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:

  • Achieved testing completeness within 30 days: 67% of the One4All group, 26% of the standard-of-care group;
  • Initiated ART within 90 days of HIV screening: 54% of the One4All group, 25% of the standard-of-care group;
  • Deaths at 12 months: 28% of the One4All group, 47% of the standard-of-care group;
  • Number of hospital admissions at 90 days: No difference was observed between study groups.

    Conclusions: This study provides strong evidence for the benefits of a patient-centered 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.

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