A clinical trial of same-day initiation of antiretroviral therapy (ART) for HIV patients in South Africa led to a higher proportion of people starting treatment and to better health outcomes, according to a new study led by a Boston University School of Public Health researcher.
The study found that 97% of patients in the rapid-initiation group (dubbed the RapIT intervention) had started ART within 90 days, compared to 72% receiving standard care. And by 10 months after enrolment, 64% of patients in the rapid group had good outcomes, in terms of viral suppression, compared to 51 percent in the standard arm.
The World Health Organisation recommends that people with HIV should start treatment soon after diagnosis. Despite those guidelines, most people with HIV in South Africa, which has world’s largest HIV treatment program, start ART later than they should, said Sydney Rosen, lead author of the study and a research professor of global health. Once they get to a clinic, the treatment initiation process is long and complicated, Rosen said, with a first visit for an HIV test; a second visit to determine treatment eligibility; and several more visits for a physical exam, adherence education, and counselling.
The researchers hypothesised that offering patients a chance to start treatment on the same day as their first clinic visit would improve the proportion of patients who made it through all the steps and were successfully established on ART. The study randomly assigned 377 adult patients at two public clinics in Johannesburg to two groups: One that was offered the chance to start treatment on the same day, using rapid lab tests and accelerated counselling and a physical exam, and the other assigned to standard treatment procedures, usually requiring three to five more clinic visits over a two- to four-week period.
“The RapIT intervention showed clinically meaningful improvements in ART uptake and viral suppression, providing proof of principle that a single-visit treatment approach can have benefits,” Rosen said. “The patients who likely benefitted the most from it are those who would not otherwise have initiated treatment at all, or who would have waited until they were sick enough to compromise their prognosis.”
Interestingly, the study found that among patients who did start treatment within three months of study enrolment, loss to follow-up was higher in the rapid-intervention group than the standard group. But so many more patients in the standard group failed to start treatment at all – 28%, compared to the rapid group’s 3% – that patients in the rapid group still had overall better outcomes than did those in the standard group.
Rosen said that while the rapid intervention was successful in increasing the overall proportion of patients with successful health outcomes, “the rate of post-initiation attrition is a reminder that early retention in care and adherence support, once patients start treatment, remain high priorities for further research and interventions.”
Based on this study’s results, the authors said, “Consideration could be given to accelerating the process of ART initiation in many different settings and for different types of patients.”
Besides Rosen, SPH co-authors on the study include: Matthew Fox, associate professor of epidemiology, and Julia Rohr, a former doctoral student at SPH. Other co-authors are from the University of Witwatersrand in Johannesburg and the City of Johannesburg Health Department.
Background: High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.
Methods and Findings: RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (≥18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study (“rapid arm”) received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study (“standard arm”) followed standard clinic procedures (three to five additional clinic visits over 2–4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ≤90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 d. Three hundred and seventy-seven patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm3). In the rapid arm, 119/187 patients (64%) initiated treatment and were virally suppressed at 10 mo, compared to 96/190 (51%) in the standard arm (relative risk [RR] 1.26 [1.05–1.50]). In the rapid arm 182/187 (97%) initiated ART ≤90 d, compared to 136/190 (72%) in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24–1.49). Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [HR] 1.06; 95% CI 0.61–1.84). The study was limited by the small number of sites and small sample size, and the generalizability of the results to other settings and to non-research conditions is uncertain.
Conclusions: Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. This intervention should be considered for adoption in the public sector in Africa.