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

September 7, 2017 at 8:15 am

PLoS Med. 2017 Jul 25;14(7):e1002357.

Koenig SP1,2, Dorvil N1, Dévieux JG3, Hedt-Gauthier BL4, Riviere C1, Faustin M1, Lavoile K1, Perodin C1, Apollon A1, Duverger L1, McNairy ML5,6, Hennessey KA1, Souroutzidis A7, Cremieux PY7, Severe P1, Pape JW1,5.

Author information

1 Haitian Study Group for Kaposi’s Sarcoma and Opportunistic Infections (GHESKIO), Port-au-Prince, Haiti.

2 Division of Global Health Equity, Brigham and Women’s Hospital, Boston, Massachusetts, United States of America.

3 AIDS Prevention Program, Florida International University, Miami, Florida, United States of America.

4 Department of Global Health and Social Medicine, Harvard Medical School, Harvard University, Boston, Massachusetts, United States of America.

5 Center for Global Health, Department of Medicine, Weill Cornell Medical College, Cornell University, New York, New York, United States of America.

6 Division of General Internal Medicine, Department of Medicine, Weill Cornell Medical College, Cornell University, New York, New York, United States of America.

7 Analysis Group, Boston, Massachusetts, United States of America.

Abstract

BACKGROUND:

Attrition 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 FINDINGS:

We 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.

CONCLUSIONS:

Same-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 REGISTRATION:

This study is registered with ClinicalTrials.gov number NCT01900080.

PDF

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5526526/pdf/pmed.1002357.pdf

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Entry filed under: Antirretrovirales, HIV/SIDA, HIV/SIDA HAART.

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