Study Summary: Impact of Same-Day HIV Testing and ART Initiation on Patient Care and Outcomes

Background

Timely antiretroviral therapy (ART) initiation and retention in care are critical for optimal clinical outcomes in patients with HIV infection. Among these patients, poor retention in care is associated with various factors, including the current standard of medical care for this patient population. Even before ART begins, the current standard of care for these individuals involves multiple clinic visits for HIV testing, laboratory procedures, and counseling to prepare them for treatment. This imposes a significant burden on patients, and can serve as a barrier that prevents their engagement in long-term clinical care. As a consequence, loss from HIV treatment and care is high: Up to one-third of patients who test positive for HIV may be lost even before they begin ART. Reducing attrition is especially important because earlier treatment initiation has been shown to improve patient outcomes in HIV and decrease transmission of the virus. Although some patients may return to HIV care later, at that point, their disease is more advanced.¹

Results of studies have shown that several factors can help to hasten ART initiation, including availability of HIV point-of-care testing and same-day counseling, as well as the recommendation that CD4 cell count data are no longer needed to initiate ART. With this in mind, Koenig and colleagues set out to investigate whether same-day HIV testing and ART initiation can improve retention in care and, ultimately, health outcomes.¹

Study Design

The researchers performed an unblinded randomized controlled trial of same-day ART initiation compared with standard care for ART initiation. The study took place at the Haitian Group for the Study of Kaposi’s Sarcoma and Opportunistic Infections Clinic in Port-au-Prince, Haiti. Adults with HIV-1 infection with World Health Organization (WHO) stage 1 or 2 disease were recruited between August 2013 and October 2015. During the initial stages of study recruitment, patients were included if they had a CD4 count ≤350 cells/mm³; this threshold was increased in February 2014 to ≤500 cells/mm³ to align with revised guidelines. The researchers excluded patients who knew they had HIV, as well as those who had previously received ART. Patients who were pregnant or breastfeeding, lived outside of the Port-au-Prince metropolis, planned to transfer care, or were unprepared to begin treatment based on responses to an ART readiness survey (administered prior to enrollment) were also excluded from the study.¹

Patients were randomized 1:1 to receive either standard care or same-day HIV testing and ART. Those who received standard care had ART initiation 3 weeks after testing positive for HIV; these patients were required to attend sequential clinic visits for laboratory procedures and individual counseling during the first 7 weeks of the study, both before and after ART initiation. Patients who received same-day HIV testing with immediate ART initiation subsequently made the same number of counseling and physician visits and underwent the same laboratory tests. Only the scheduling of clinician visits and ART initiation timing differed between the 2 groups.¹

After the final counseling visit at week 7, all patients made monthly physician visits and had 12 months of follow-up. The study’s primary outcome was retention in care with an HIV-1 RNA level <50 copies/mL at 12 months after diagnosis of HIV. Additional outcomes included patient survival, retention in care regardless of viral load, and retention in care with a viral load <1000 copies/mL at 12 months after diagnosis of HIV.¹

Results

The study enrolled 762 patients, 49% of whom were women, with a median age of 37 years and a median CD4 count of 248 cells/mm³. Of all patients, 356 received standard care, and 347 received same-day HIV testing and ART initiation; 59 patients transferred to another clinic and were excluded per study protocol.¹

The researchers noted that retention of patients in HIV care with improved virological suppression was significantly better for those who received same-day HIV testing and ART initiation than for those who received standard care. At 12 months after HIV testing, 80% of patients in the same-day ART group were retained in care compared with 72% in the standard-care group (Table).¹ Similarly, a greater proportion of patients in the same-day ART group showed evidence of treatment efficacy, with 53% having a viral load <50 copies/mL, compared with 44% in the standard care group; moreover, 61% of patients in the same-day ART group had an HIV-1 RNA level <1000 copies/mL compared with 52% in the standard care group (Table). After using a multivariable regression analysis to control the effect of confounders, including age, sex, WHO disease stage, and CD4 count, the researchers also noted that patients in the same-day ART group had a significantly reduced risk of mortality compared with those in the standard care group (adjusted RR, 0.43; 95% CI, 0.19-0.94; P = .033; Table).¹

Conclusions

The results of this study show that starting ART on the same day as HIV testing may improve retention in care and viral suppression and reduce mortality. These findings are similar to those from previous randomized trials in South Africa, Kenya, and Uganda, the results of which also showed that rapid initiation of ART resulted in improved retention of patients in HIV care.¹

Acknowledging the limitations of their study, the researchers note that because of its unblinded design, knowledge of group allocation could have affected clinician behavior during the trial. Also, because the study was conducted at only 1 urban clinic, the findings might not be generalizable to other clinical settings.

The researchers also emphasize that despite improved clinical outcomes associated with same-day ART initiation, the rates of both retention in care and viral suppression need to increase further to improve patient outcomes in HIV. Nevertheless, Koenig and colleagues stress the importance of their study findings, especially because the WHO 2016 guidelines² highlighted an insufficiency of evidence at that time to recommend same-day ART initiation. The conclusion of the study team was that same-day ART initiation may be particularly beneficial for patients with HIV in resource-poor settings such as Haiti.¹

Reference

1. Koenig SP, Dorvil N, Dévieux JG, et al. Same-day HIV testing with initiation of antiretroviral therapy versus standard care for persons living with HIV: a randomized unblinded trial. PLoS Med. 2017;14(7):e1002357. doi: 10.1371/journal.pmed.1002357.

2. Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection. Recommendations for a Public Health Approach. Second Edition. Geneva, Switzerland: World Health Organization; 2016. who.int/hiv/pub/arv/arv-2016/en/. Accessed June 20, 2018.