Starting antiretroviral therapy (ART) the same day as testing positive for HIV may improve retention in care as well as virologic suppression, according to a new study published online in PLoS Medicine.1
“The results of this randomized controlled trial show that among HIV-infected adults with early WHO Stage disease and CD4 count ≤500 cells/uL, 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,” wrote first author Serena Koenig, MD, of Harvard Medical School, and colleagues.
Before starting ART, patients often need to attend several clinic visits for counseling, laboratory testing, and adherence counseling. Such requirements may contribute to high rates of attrition: between 25-30% of patients who test positive for HIV may be lost before starting ART, according to the authors.
That’s a problem, because earlier treatment for HIV can improve outcomes and decrease transmission. And even if some patients return at a later date, they will likely start treatment with more advanced disease.
However, the advent of point-of-care testing and same-day counseling, along with the fact that CD4 counts are no longer required to start ART, can potentially expedite ART initiation.
To see whether same-day starts can work, researchers did an unblinded, randomized trial in Port-au-Prince, Haiti. The study was part of the Haitian group for the Study of Kaposi’s Sarcoma and Opportunistic Infections (GHESKIO)--the largest provider of HIV care in the Caribbean. It included adults (49% women) with WHO stage 1 or 2 disease and CD4 count ≤500 cells/uL, who were recruited between August 2013 and October 2015. Researchers randomly assigned 356 participants to standard ART initiation 3 weeks after testing positive for HIV, or 347 same-day HIV testing and ART initiation. All patients received counseling and evaluation for ART-readiness using a standardized questionnaire. Multivariable analyses were adjusted for age, sex, education, income, marital status, WHO stage, CD4 count, and BMI.
- Retention in care at 12 months was significantly better for same day (80%) vs standard start (72%) (p=0.028)
- Retention in care at 12 months with HIV-1 RNA <50 copies/mL:
- Standard start: 44%
- Same-day start: 53%
- Same-day start: 24% more likely to achieve this outcome vs standard start (RR 1.24 [95% CI: 1.06, 1.41], p = 0.008)
- Retention in care at 12 months with HIV-1 RNA <1000 copies/mL:
- Standard start: 52%
- Same-day start: 61%
- Same-day start: 20% more likely to achieve this outcome vs standard start (RR 1.20 [95% CI: 1.05], 1.33; p = 0.008)
- Standard start: 6%
- Same-day start: 3%
- Same-day starts: 57% lower risk of dying vs standard starts (RR 0.43 [95% CI: 0.19, 0.94]; p = 0.033)
They authors point out that findings were similar to past randomized controlled trials in other resource-poor settings in South Africa, Uganda, and Kenya, which also found improved retention in care with rapid start ART.
“Our findings suggest that ART initiation as soon as possible after HIV testing may be beneficial for clinically stable patients. In resource-poor settings with fragile delivery systems, such as Haiti, the provision of immediate support by care providers at the time of HIV diagnosis can have both structural and individual impact. In addition to making treatment initiation logistically easier for patients, we believe that same-day counseling and ART initiation increase the sense of hope, optimism, and overall connectedness to the healthcare system for patients, which have been shown to be important for retention,” they concluded.
Study limitations include the unblinded design. Also, the study was conducted at a single urban clinic, so results may not generalize to other settings.
Take Home Points
- Study in Port-au-Prince Haiti suggests starting ART the same day as testing positive in clinically stable patients may improve retention in care and viral suppression, and decrease mortality
- Results add to growing evidence that same-day starts for ART are feasible and may be more effective than standard starts in resource- poor settings