Very high rates of patient attrition from HIV care between HIV testing and ART initiation have been documented in sub-Saharan Africa. Our objective was to estimate the effect of accelerated initiation procedures on uptake of ART and viral suppression.
We conducted a randomized controlled trial (RapIT Trial, NCT01710397) of immediate ART initiation in two public sector clinics in South Africa (a primary health clinic (PHC) and a hospital-based HIV clinic). Adult (≥18), non-pregnant patients receiving a positive HIV test or first CD4 count were randomized to standard or rapid initiation. On the day of HIV test or first CD4 count, rapid arm patients received a point-of-care (POC) CD4 count (Alere Pima) if needed; those ART eligible received a POC TB test (Xpert MTB/RIF) if symptomatic, rapid POC blood tests (Roche Reflotron), physical exam, education, counseling, and ARV dispensing. Patients in the control arm followed standard clinic procedures (3-5 additional clinic visits over 2-6 weeks prior to ARV dispensing). Follow up was by passive medical record review. Primary outcomes were initiation of ART ≤ 90 days and viral suppression, defined as initiated, retained in care, and suppressed (≤400 copies/ml), ≤ 10 months of study enrollment.
Of 600 patients screened, 377 were eligible for ART and for the study (56% female, median age 35, median CD4 count 210 cells/mm3). In the rapid arm 182/187 (97%) initiated ART ≤ 90 days, compared to 136/190 (72%) in the standard arm (RR 1.36; 1.24-1.49). In the rapid arm, 119/187 (64%) initiated and were suppressed at 10 months, compared to 96/190 (51%) in the standard arm (RR 1.26; 1.05-1.50). Adjustment for sex and baseline CD4 count did not affect results. Effects were larger for the PHC than for the hospital-based HIV clinic, for unemployed than for employed patients, and for patients under age 35 than for patients over 35. 72% of rapid arm patients initiated on the same day as HIV test or first CD4 count (Figure 1). All rapid arm patients in the rapid arm who did not start ART ≤ 180 days were delayed due to TB treatment. Time used for treatment initiation in the rapid arm averaged 2.8 hours.
Offering same-day ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. It is feasible and acceptable in public sector clinics, and not all POC instruments will be essential in the future. It should be considered for adoption in high-volume clinics in the public sector in Africa.