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

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 thestandardand 347 in thesame-dayart groups. in thestandardart group 156 44 participants were retained incarewith 12-monthhiv-1 rna><50 copies and 184 52 had><1,000 copies ml 20 participants 6 died. in thesame-dayart group 184 53 participants were retained withhiv-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 withhiv-1 rna><50 copies ml was 1.21 95 ci: 1.04 1.38 p="0.015)" for thesame-dayart group compared to thestandardart group and the unadjusted rr for being retained withhiv-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.