Research Article: Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: A randomized unblinded trial

Date Published: July 25, 2017

Publisher: Public Library of Science

Author(s): Serena P. Koenig, Nancy Dorvil, Jessy G. Dévieux, Bethany L. Hedt-Gauthier, Cynthia Riviere, Mikerlyne Faustin, Kerlyne Lavoile, Christian Perodin, Alexandra Apollon, Limathe Duverger, Margaret L. McNairy, Kelly A. Hennessey, Ariadne Souroutzidis, Pierre-Yves Cremieux, Patrice Severe, Jean W. Pape, Elvin H. Geng

Abstract: BackgroundAttrition during the period from HIV testing to antiretroviral therapy (ART) initiation is high worldwide. We assessed whether same-day HIV testing and ART initiation improves retention and virologic suppression.Methods and findingsWe conducted an unblinded, randomized trial of standard ART initiation versus same-day HIV testing and ART initiation among eligible adults ≥18 years old with World Health Organization Stage 1 or 2 disease and CD4 count ≤500 cells/mm3. The study was conducted among outpatients at the Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic infections (GHESKIO) Clinic in Port-au-Prince, Haiti. Participants were randomly assigned (1:1) to standard ART initiation or same-day HIV testing and ART initiation. The standard group initiated ART 3 weeks after HIV testing, and the same-day group initiated ART on the day of testing. The primary study endpoint was retention in care 12 months after HIV testing with HIV-1 RNA <50 copies/ml. We assessed the impact of treatment arm with a modified intention-to-treat analysis, using multivariable logistic regression controlling for potential confounders. Between August 2013 and October 2015, 762 participants were enrolled; 59 participants transferred to other clinics during the study period, and were excluded as per protocol, leaving 356 in the standard and 347 in the same-day ART groups. In the standard ART group, 156 (44%) participants were retained in care with 12-month HIV-1 RNA <50 copies, and 184 (52%) had <1,000 copies/ml; 20 participants (6%) died. In the same-day ART group, 184 (53%) participants were retained with HIV-1 RNA <50 copies/ml, and 212 (61%) had <1,000 copies/ml; 10 (3%) participants died. The unadjusted risk ratio (RR) of being retained at 12 months with HIV-1 RNA <50 copies/ml was 1.21 (95% CI: 1.04, 1.38; p = 0.015) for the same-day ART group compared to the standard ART group, and the unadjusted RR for being retained with HIV-1 RNA <1,000 copies was 1.18 (95% CI: 1.04, 1.31; p = 0.012). The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain.ConclusionsSame-day HIV testing and ART initiation is feasible and beneficial in this setting, as it improves retention in care with virologic suppression among patients with early clinical HIV disease.Trial registrationThis study is registered with ClinicalTrials.gov number NCT01900080

Partial Text: The Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 targets state that 90% of HIV-infected persons know their status, 90% initiate antiretroviral therapy (ART), and 90% achieve virologic suppression by the year 2020 to curb the AIDS epidemic [1]. In 2015, the World Health Organization (WHO) updated their guidelines to recommend ART for all persons living with HIV based on evidence that earlier treatment improves outcomes and decreases transmission [2–4]. To achieve these goals, patients must be promptly linked to HIV services, initiated on ART, and retained in lifelong care [5].

A total of 821 patients were screened, and 762 were enrolled in the study and underwent randomization (Fig 2). After randomization, 59 participants (28 in the standard ART and 31 in same-day ART group) transferred to another clinic and were excluded from all analyses, as per protocol. The median age was 37 years old (IQR: 30–45 years), 347 (49%) were women, and the median CD4 count was 248 cells/mm3 (IQR: 148, 345).

The results of this randomized controlled trial show that among HIV-infected adults with early WHO Stage disease and CD4 count ≤500 cells/mm3, same-day HIV testing and ART initiation, as compared to standard care, improves retention in care with virologic suppression and, in the multivariable analysis, decreases mortality. These results are important given recent WHO 2016 guidelines stating the lack of evidence in support of same-day ART initiation.

Source:

http://doi.org/10.1371/journal.pmed.1002357

 

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