Data from: Initiating Antiretroviral Therapy for HIV at a Patient’s First Clinic Visit: The RapIT Randomized Controlled Trial

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 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), non-pregnant patients receiving a positive HIV test or first
treatment-eligible CD4 count were randomized to standard or rapid
initiation. Rapid arm patients received a point-of-care (POC) CD4 count if
needed; those ART-eligible received a POC TB test if symptomatic, POC
blood tests, physical exam, education, counseling, and ARV
dispensing. Standard arm patients followed standard clinic
procedures (3-5 additional clinic visits over 2-4 weeks 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) ≤ 10 months of study
enrollment. Secondary outcomes included initiation of ART ≤ 90
days 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 days. 377 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 and were suppressed at 10 months, compared to 96/190 (51%) in
the standard arm (RR 1.26 [1.05-1.50]. In the rapid arm 182/187 (97%)
initiated ART ≤ 90 days, compared to 136/190 (72%) in the standard arm
(relative risk [95% CI] 1.36 [1.24-1.49]. Among 318 patients who did
initiate ART within 90 days, the hazard of attrition within the first 10
months did not differ between the treatment arms (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%. It should be considered
for adoption in the public sector in Africa.