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 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.