Background: Very high rates of patient attrition from HIV care between HIV testing and ART initiation have been documented in sub-Saharan Africa. Accelerating the steps required for ART initiation has been proposed as a way to reduce attrition and achieve earlier treatment initiation.
Methods: The RapIT randomized controlled trial evaluated the effect of immediate ART initiation on ART uptake in two public sector clinics in South Africa. Adult, non-pregnant patients receiving a positive HIV test or first CD4 count were randomized to standard or immediate (rapid) initiation. On the day of HIV test or first CD4 count, patients in the rapid arm received a point-of-care CD4 count if needed; those ART eligible then received a rapid TB test if symptomatic, rapid blood tests, physical exam, accelerated education and counseling, and ARV dispensing. Rapid procedures were conducted by nurses and counselors comparable to clinic staff. Patients in the control arm followed standard clinic procedures (3-4 clinic visits over 2-4 weeks prior to ARV dispensing). Here we report ART uptake and early retention ≤1 month of ART initiation.
Results: Enrollment was completed in August 2014. 172 patients were randomized to rapid and 181 to standard initiation. There were no important differences between arms in gender, age, or CD4 count at study enrolment. In both arms, 83% of patients newly diagnosed with HIV were already eligible for ART. In the rapid arm, 97% (139/143) of patients eligible for ART initiated treatment ≤1 month, including 73% on the same day as study enrollment and 19% ≤1 week. In the standard group, 57% (86/151) initiated ≤1 month (hazard ratio for ART uptake=1.69; 95%CI 1.47-1.95). All those who did not initiate ≤1 month in the rapid arm (n=5) were required to delay ART for TB treatment. Time used for treatment initiation, from study enrollment to dispensing, averaged 2.8 hours for rapid arm patients not requiring TB testing. Within 1 month of initiation, 86% (n=120) of rapid arm and 85% (n=112) of standard arm patients had attended the clinic for their first follow-up visit. Of 54 subjects with ≥6 months follow-up and documented viral load, 91% and 77% were virally suppressed in the rapid and standard arms respectively.
Conclusions: Immediate ART initiation reduces loss of patients between treatment eligibility and treatment initiation significantly and is feasible and acceptable in a public health clinic setting. It should be considered for adoption in high-volume clinics in the public sector in Africa.
Outcomes and Relative Risks by Study Arm